TW202502368A - Oral product - Google Patents

Abstract

The present disclosure provides a melatonin-free oral product comprising a combination of active ingredients to promote sleep and relaxation. Also disclosed is the use of a combination of active ingredients to promote sleep of a human or animal, wherein the promotion of sleep optionally includes at least one of inducing sleep and maintaining sleep.

Description

Translated fromChinese

口服產品Oral Products

發明領域Invention Field

本揭露內容係關於一種無褪黑激素之口服產品、用於產生該口服產品之方法以及該口服產品之用途。The present disclosure relates to a melatonin-free oral product, a method for producing the oral product, and the use of the oral product.

發明背景Invention Background

本揭露內容係關於欲供人類使用之產品及組成物。該等產品經組態成供口服使用且在使用期間遞送諸如活性成分及/或風味劑之類物質。This disclosure relates to products and compositions intended for human use. These products are formulated for oral use and deliver substances such as active ingredients and/or flavoring agents during use.

近年來，易於經口投予且可對人類或動物之特定情緒狀態提供有益作用的產品變得越來越受歡迎。舉例而言，含有維生素或其他激勵情緒之活性劑的糖果型產品(例如軟糖或含片)提供此類活性成分的便利且令人愉悅之投予模式。其他便利的投予模式係食品及飲料，例如能量飲料。此類產品可包括活性成分，該等活性成分被遞送給使用者以便在該使用者體內引起可增強該使用者之身體或精神健康及/或表現的生物反應。一些使用者攝入諸如洋甘菊(chamomile)茶及其他草藥茶之其他飲料，以幫助諸如睡眠及放鬆之生理反應。In recent years, products that are easily administered orally and that can provide beneficial effects on specific emotional states in humans or animals have become increasingly popular. For example, confectionery-type products (such as gummies or lozenges) containing vitamins or other mood-stimulating actives provide a convenient and enjoyable mode of administration of such active ingredients. Other convenient modes of administration are foods and beverages, such as energy drinks. Such products may include active ingredients that are delivered to the user in order to cause a biological response in the user that can enhance the user's physical or mental health and/or performance. Some users ingest other beverages such as chamomile tea and other herbal teas to help with physiological responses such as sleep and relaxation.

需要提供一種經組態成供口服使用之口服產品，該口服產品可將活性成分以一種有效形式，諸如以濃縮飲品(liquid shot)形式遞送給消費者。There is a need to provide an oral product formulated for oral use that can deliver the active ingredient to the consumer in an effective form, such as in the form of a liquid shot.

發明概要Summary of the invention

本揭露內容大體上提供經組態成供口服使用之產品，該等產品包含活性成分之組合。該等口服產品可呈適於口服使用之任何形式，諸如呈錠劑或口含錠形式、呈鬆散的粉末或液體形式(例如呈飲料形式，諸如濃縮飲品形式)。較佳地，口服產品呈液體形式，例如呈飲料形式，諸如濃縮飲品形式。The present disclosure generally provides products configured for oral use, which include a combination of active ingredients. Such oral products can be in any form suitable for oral use, such as tablets or lozenges, loose powders or liquid forms (e.g., in beverage form, such as concentrated beverage form). Preferably, the oral product is in liquid form, such as in beverage form, such as concentrated beverage form.

根據本文所描述之一些實施例，提供一種無褪黑激素之口服產品，其包含活性成分之組合，其中該組合包含：(i)鎂或其鹽；(ii)包含至少維生素B2及維生素B6之B族維生素之組合；(iii)人參；及(iv)西番蓮(passionflower)。According to some embodiments described herein, a melatonin-free oral product is provided, comprising a combination of active ingredients, wherein the combination comprises: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower.

根據本文所描述之一些實施例，提供一種用於製備無褪黑激素之口服產品之方法，該方法包含：(a)將活性成分組合，其中該等活性成分包括：(i)鎂或其鹽；(ii)包含至少維生素B2及維生素B6之B族維生素之組合；(iii)人參；及(iv)西番蓮；(b)使該等活性成分與水接觸；及(c)將該等活性成分與水混合以製備口服產品。According to some embodiments described herein, a method for preparing a melatonin-free oral product is provided, the method comprising: (a) combining active ingredients, wherein the active ingredients include: (i) magnesium or a salt thereof; (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passion flower; (b) contacting the active ingredients with water; and (c) mixing the active ingredients with water to prepare the oral product.

根據本文所描述之一些實施例，提供活性成分之組合促進人類或動物之睡眠的用途，其中活性成分之組合包含：(i)鎂或其鹽；(ii)包含至少維生素B2及維生素B6之B族維生素之組合；(iii)人參；及(iv)西番蓮，且其中活性成分之組合不含褪黑激素。此類組合較佳如本文所描述。在所有此類實施例中，促進睡眠可包括誘導睡眠及維持睡眠中之至少一者。According to some embodiments described herein, there is provided a use of a combination of active ingredients for promoting sleep in humans or animals, wherein the combination of active ingredients comprises: (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passionflower, and wherein the combination of active ingredients does not contain melatonin. Such combinations are preferably as described herein. In all such embodiments, promoting sleep may include at least one of inducing sleep and maintaining sleep.

在較佳實施例中，以上實施例之各口服產品可呈液體劑型形式，諸如濃縮飲品(亦即體積為至多約100 mL之液體)提供。In a preferred embodiment, each oral product of the above embodiments can be provided in a liquid dosage form, such as a concentrated drink (i.e., a liquid with a volume of up to about 100 mL).

本揭露內容之此等及其他特徵、態樣及優勢將藉由閱讀以下實施方式而顯而易見。本發明包括上述實施例中之二者、三者、四者或更多者之任何組合以及本揭露內容中所示任何二個、三個、四個或更多個特徵或要素的組合，不管此類特徵或要素是否在本文之具體實施例描述中明確地組合。本揭露內容意圖整體地讀取，由此除非上下文另有明確規定，否則在各個態樣及實施例中之任一者中所揭露之發明的任何可分開之特徵或要素應被視為可組合的。These and other features, aspects and advantages of the present disclosure will become apparent by reading the following embodiments. The present invention includes any combination of two, three, four or more of the above embodiments and any combination of two, three, four or more features or elements shown in the present disclosure, regardless of whether such features or elements are explicitly combined in the specific embodiment description herein. The present disclosure is intended to be read as a whole, and thus any separable features or elements of the invention disclosed in any of the various aspects and embodiments should be considered combinable unless the context clearly dictates otherwise.

為便於參考，本發明之此等及其他態樣現在適當的章節標題下論述。然而，在各章節下之教示未必受限於各特定章節。For ease of reference, these and other aspects of the present invention are now discussed under appropriate section headings. However, the teachings under each section are not necessarily limited to each specific section.

較佳實施例之詳細說明DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

應理解，本發明不限於本文所揭露之特定組態、方法步驟及材料，因為此類組態、方法步驟及材料在某種程度上可變化。亦應理解，本文所使用之術語僅用於描述特定實施例之目的且不意欲為限制性的，因為本發明之範圍僅由隨附申請專利範圍及其等效物限制。It should be understood that the present invention is not limited to the specific configurations, method steps and materials disclosed herein, as such configurations, method steps and materials may vary to some extent. It should also be understood that the terminology used herein is only for the purpose of describing specific embodiments and is not intended to be limiting, as the scope of the present invention is limited only by the scope of the accompanying patent applications and their equivalents.

除非上下文另有明確規定，否則如本說明書及申請專利範圍中所使用，單數形式「一(a/an)」及「該(the)」包括多個提及物。提及「乾重量%」或「以乾重計」或「乾重」係指基於乾燥成分(亦即，除水外的所有成分)計之重量。提及「濕重」係指包括水在內之產品或組成物的重量。除非另有指示，否則提及產品或組成物之「重量%」(或「wt%」)反映產品或組成物之總濕重(亦即，包括水)。As used in this specification and claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. References to "dry weight %" or "by dry weight" or "dry weight" refer to weight based on dry ingredients (i.e., all ingredients excluding water). References to "wet weight" refer to the weight of a product or composition including water. References to "weight %" (or "wt %) of a product or composition reflect the total wet weight (i.e., including water) of the product or composition, unless otherwise indicated.

在本說明書中，除非另外說明，否則修飾本發明之口服產品中或本發明之方法中所用之成分之量的術語「約」係指可例如因以下而出現的數量變化：現實世界中用於製造濃縮物或使用溶液之典型量測及液體操作程序；此等程序中之無意錯誤；用於製造該口服產品或執行方法之成分的製造、來源或純度差異；及其類似情形。術語「約」亦涵蓋由於特定初始混合物引起的產品或組成物之不同平衡條件而有差異的量。無論是否由術語「約」修飾，申請專利範圍包括數量的等效量。口服產品In this specification, unless otherwise stated, the term "about" as used to modify the amount of an ingredient in the oral products of the invention or used in the methods of the invention refers to variations in the amount that can occur, for example, due to typical real-world measurements and fluid handling procedures for making concentrates or using solutions; unintentional errors in such procedures; differences in the manufacture, source, or purity of the ingredients used to make the oral product or perform the method; and the like. The term "about" also encompasses amounts that vary due to different equilibrium conditions of the product or composition resulting from a particular initial mixture. Whether or not modified by the term "about," the scope of the claim includes equivalent amounts of the amount.Oral Products

如本文所描述，提供一種無褪黑激素之口服產品，其包含活性成分之組合，其中該組合包含：(i)鎂或其鹽；(ii)包含至少維生素B2及維生素B6之B族維生素之組合；(iii)人參；及(iv)西番蓮。As described herein, a melatonin-free oral product is provided that includes a combination of active ingredients, wherein the combination includes: (i) magnesium or a salt thereof; (ii) a combination of B vitamins including at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passion flower.

片語「無褪黑激素」與「不含褪黑激素」在本文中可互換使用，且意謂口服產品不含有毛黑激素作為活性成分或其他。The phrases "melatonin-free" and "melatonin-free" are used interchangeably in this article and mean that the oral product does not contain melatonin as an active ingredient or otherwise.

口服產品均經組態以用於經口使用，且因此用於插入使用者之口(亦即口腔)中。在本說明書中，除非另外說明，否則與產品相關之術語「口服」係指在正常使用時適合於在使用者口腔中某處攝取或置放的產品。舉例而言，該產品可呈使用者可經口食用之液體形式(亦即，呈飲料形式)，或該產品可置放於口中(例如呈錠劑、口含錠、小袋或其類似形式)。較佳地，該產品可呈使用者可經口食用之液體形式(亦即，呈飲料形式，尤其呈濃縮飲品形式)。Oral products are configured for oral use and are therefore intended to be inserted into the user's mouth (i.e., oral cavity). In this specification, unless otherwise specified, the term "oral" in relation to a product refers to a product that is suitable for ingestion or placement somewhere in the user's oral cavity during normal use. For example, the product may be in the form of a liquid that the user can consume orally (i.e., in the form of a drink), or the product may be placed in the mouth (e.g., in the form of a tablet, lozenge, sachet, or the like). Preferably, the product may be in the form of a liquid that the user can consume orally (i.e., in the form of a drink, especially in the form of a concentrated drink).

本文所提供之範圍可單獨獲取或與一或多個其他組分範圍組合以提供本發明之較佳態樣。 活性成分之組合The ranges provided herein may be taken alone or in combination with one or more other component ranges to provide a better aspect of the invention.Combinations of Active Ingredients

本文所揭露之產品包括活性成分。該等活性成分可為天然存在的或以合成方式獲得的。活性成分之組合包含引起人類或動物之生理反應的適合活性成分。The products disclosed herein include active ingredients. The active ingredients may be naturally occurring or synthetically obtained. The combination of active ingredients includes suitable active ingredients that elicit a physiological response in humans or animals.

根據本發明之一個態樣，活性成分之組合包含至少(i)鎂或其鹽；(ii)包含至少維生素B2及維生素B6之B族維生素之組合；(iii)人參；及(iv)西番蓮，其中活性成分之組合不含褪黑激素。口服產品促進個體(亦即人類或動物)之睡眠。就此而言，該等活性成分各自可以適於在人類或動物體內提供所希望之反應的量存在。本發明人已發現口服產品中所包括之活性成分之特定組合會在個體中促進睡眠及/或幫助睡眠品質。詳言之，已發現口服產品中活性成分之特定組合藉由誘導及/或維持睡眠來促進睡眠。促進睡眠亦可增加愉快及幸福之總體感覺，伴隨放鬆、信心、快樂及激勵之感覺增加。According to one aspect of the present invention, the combination of active ingredients comprises at least (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passion flower, wherein the combination of active ingredients does not contain melatonin. The oral product promotes sleep in an individual (i.e., a human or an animal). In this regard, each of the active ingredients may be present in an amount suitable for providing a desired response in a human or an animal. The inventors have discovered that a specific combination of active ingredients included in the oral product promotes sleep and/or helps sleep quality in an individual. In detail, it has been discovered that a specific combination of active ingredients in the oral product promotes sleep by inducing and/or maintaining sleep. Promoting sleep can also increase an overall sense of pleasure and well-being, with increased feelings of relaxation, confidence, happiness, and motivation.

亦已發現，本文所描述的活性成分之組合可提供一種具有所希望之藥物動力學(Tmax、Cmax、半衰期)、生體可用率及代謝的安全產品。It has also been discovered that the combination of active ingredients described herein can provide a safe product with desirable pharmacokinetics (Tmax, Cmax, half-life), bioavailability and metabolism.

鎂係動物體中之必需膳食營養素及最豐富礦物質之一。其對生理過程之正常功能至關重要；充當電解質；充當數百酶系統中之酶輔因子；且在許多重要生物過程中起關鍵作用，該等生物過程包括能量產生、蛋白質、DNA及RNA合成、離子(例如鈣及鉀)活性細胞膜轉運、骨骼生長及維持、肌肉及神經功能以及血糖及血壓調節。鎂與主要抑制性神經傳遞質γ-胺基丁酸(亦稱為GABA)相互作用，GABA可調節神經細胞接收、建立或傳導來自其他神經細胞之化學信號傳導的能力。Magnesium is an essential dietary nutrient and one of the most abundant minerals in animals. It is essential for the normal function of physiological processes; acts as an electrolyte; acts as an enzyme cofactor in hundreds of enzyme systems; and plays a key role in many important biological processes, including energy production, protein, DNA and RNA synthesis, active cell membrane transport of ions (such as calcium and potassium), bone growth and maintenance, muscle and nerve function, and blood sugar and blood pressure regulation. Magnesium interacts with the major inhibitory neurotransmitter gamma-aminobutyric acid (also known as GABA), which regulates the ability of nerve cells to receive, establish or transmit chemical signals from other nerve cells.

在無褪黑激素之口服產品的活性成分之組合中，鎂可呈鹽形式存在。鎂鹽之身分不受限制且包括適於人類或動物攝入之任何鎂鹽。此類鹽可為有機鹽或無機鹽。鹽亦可呈溶劑合物形式，例如水合物。因此，術語「鹽」意謂「鹽或溶劑合物」。舉例而言，鎂鹽可選自硫酸鎂、氧化鎂、甘胺酸鎂、檸檬酸鎂、乳酸鎂、牛磺酸鎂、蘋果酸鎂、葡糖酸鎂、乳清酸鎂、天冬胺酸鎂、氯化鎂、抗壞血酸鎂、蘇糖酸鎂(L-)、碳酸鎂、碳酸鎂、吡酮酸鎂(magnesium pidolate)或其組合。In the combination of active ingredients of the oral product without melatonin, magnesium may be present in the form of a salt. The identity of the magnesium salt is not limited and includes any magnesium salt suitable for human or animal ingestion. Such salts may be organic salts or inorganic salts. Salts may also be in the form of a solvent complex, such as a hydrate. Therefore, the term "salt" means "salt or solvent complex". For example, the magnesium salt can be selected from magnesium sulfate, magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurine, magnesium appletate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium chloride, magnesium ascorbate, magnesium sulphonate (L-), magnesium carbonate, magnesium carbonate, magnesium pidolate or a combination thereof.

在一些實施例中，鎂鹽係選自氧化鎂、甘胺酸鎂、檸檬酸鎂、乳酸鎂、牛磺酸鎂、蘋果酸鎂、葡糖酸鎂、乳清酸鎂、天冬胺酸鎂、抗壞血酸鎂、(L-)蘇糖酸鎂或其組合。在較佳實施例中，鎂鹽係選自氧化鎂、甘胺酸鎂、檸檬酸鎂、葡糖酸鎂、氯化鎂、硫酸鎂、乳酸鎂、L-蘇糖酸鎂、天冬胺酸鎂或其組合。尤其較佳為氧化鎂及甘胺酸鎂。其他較佳鹽包括氯化鎂及硫酸鎂。In some embodiments, the magnesium salt is selected from magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurine, magnesium appletate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium ascorbate, (L-) magnesium sulphate or a combination thereof. In a preferred embodiment, the magnesium salt is selected from magnesium oxide, magnesium glycinate, magnesium citrate, magnesium gluconate, magnesium chloride, magnesium sulfate, magnesium lactate, magnesium L-sulphonate, magnesium aspartate or a combination thereof. Particularly preferred are magnesium oxide and magnesium glycinate. Other preferred salts include magnesium chloride and magnesium sulfate.

鎂鹽為市售的且以其各種益處而聞名。舉例而言，甘胺酸鎂以其對焦慮、睡眠及壓力之有益作用而聞名。其可以雙甘胺酸鹽形式購得。氧化鎂以其抗酸特性而聞名且典型地用於緩解胃灼熱、酸胃或酸性消化不良。氧化鎂亦可用作輕瀉劑。氯化鎂以其放鬆作用著稱；其可幫助身體解毒，減少疼痛及痛，緩解壓力及焦慮，且為肌肉提供能量。硫酸鎂用作治療及預防低血鎂之藥物。Magnesium salts are commercially available and are known for their various benefits. For example, magnesium glycinate is known for its beneficial effects on anxiety, sleep, and stress. It is available as bisglycinate. Magnesium oxide is known for its antacid properties and is typically used to relieve heartburn, sour stomach, or acid indigestion. Magnesium oxide can also be used as a laxative. Magnesium chloride is known for its relaxant effects; it can help the body detoxify, reduce aches and pains, relieve stress and anxiety, and provide energy to muscles. Magnesium sulfate is used as a medication to treat and prevent low magnesium levels.

在本發明之口服產品中，咸信鎂或其鹽有助於促進睡眠。In the oral product of the present invention, magnesium or its salt is believed to help promote sleep.

鎂或其鹽以任何適合之量存在於活性成分之組合中。在一些實施例中，鎂或其鹽以口服產品之至少約0.01重量%、至少約0.05重量%或至少約0.1重量%之量存在。在一些實施例中，鎂或其鹽以不超過口服產品之約20重量%、不超過約15重量%或不超過約10重量%之量存在。Magnesium or its salt is present in any suitable amount in the combination of active ingredients. In some embodiments, magnesium or its salt is present in an amount of at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, magnesium or its salt is present in an amount of no more than about 20% by weight, no more than about 15% by weight, or no more than about 10% by weight of the oral product.

在一些實施例中，鎂或其鹽以口服產品之約0.01重量%至約20重量%之量存在。舉例而言，鎂或其鹽以口服產品之約0.05重量%至約15重量%之量存在。鎂或其鹽可較佳以口服產品之約0.1重量%至約10重量%之量存在。In some embodiments, magnesium or its salt is present in an amount of about 0.01% to about 20% by weight of the oral product. For example, magnesium or its salt is present in an amount of about 0.05% to about 15% by weight of the oral product. Magnesium or its salt may preferably be present in an amount of about 0.1% to about 10% by weight of the oral product.

根據活性成分之組合乾重，鎂或其鹽以任何適合之量存在，諸如以組合乾重之至少約10重量%、至少約15重量%或至少約20重量%之量存在。術語「乾重」如上文所定義；「組合乾重」係指無水之活性劑組合中之乾燥成分的總重量。在一些實施例中，鎂或其鹽以不超過組合乾重之約60重量%、不超過約50重量%或不超過約40重量%之量存在。Magnesium or its salt is present in any suitable amount based on the combined dry weight of the active ingredients, such as at least about 10% by weight, at least about 15% by weight, or at least about 20% by weight of the combined dry weight. The term "dry weight" is as defined above; "combined dry weight" refers to the total weight of the dry ingredients in the anhydrous active agent combination. In some embodiments, magnesium or its salt is present in an amount of no more than about 60% by weight, no more than about 50% by weight, or no more than about 40% by weight of the combined dry weight.

在一些實施例中，鎂或其鹽以組合乾重之約10重量%至約60重量%之量存在。舉例而言，鎂或其鹽以組合乾重之約15重量%至約50重量%之量存在。鎂或其鹽可較佳以組合乾重之約20重量%至約40重量%之量存在。In some embodiments, magnesium or its salt is present in an amount of about 10% to about 60% by weight of the combined dry weight. For example, magnesium or its salt is present in an amount of about 15% to about 50% by weight of the combined dry weight. Magnesium or its salt may preferably be present in an amount of about 20% to about 40% by weight of the combined dry weight.

在一些實施例中，鎂或其鹽包含硫酸鎂、氧化鎂、甘胺酸鎂、檸檬酸鎂、乳酸鎂、牛磺酸鎂、蘋果酸鎂、葡糖酸鎂、乳清酸鎂、天冬胺酸鎂、氯化鎂、抗壞血酸鎂、(L-)蘇糖酸鎂或其組合，且以口服產品之約0.01 wt%至約20 wt%之量存在於活性劑之組合中。In some embodiments, magnesium or a salt thereof comprises magnesium sulfate, magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurine, magnesium appletate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium chloride, magnesium ascorbate, magnesium (L-) suenate, or a combination thereof, and is present in the combination of active agents in an amount of about 0.01 wt % to about 20 wt % of the oral product.

在一些實施例中，鎂或其鹽包含氧化鎂、甘胺酸鎂、檸檬酸鎂、乳酸鎂、牛磺酸鎂、蘋果酸鎂、葡糖酸鎂、乳清酸鎂、天冬胺酸鎂、抗壞血酸鎂、(L-)蘇糖酸鎂或其組合，且以口服產品之約0.05 wt%至約15 wt%之量存在於活性劑之組合中。In some embodiments, magnesium or a salt thereof comprises magnesium oxide, magnesium glycinate, magnesium citrate, magnesium lactate, magnesium taurine, magnesium appletate, magnesium gluconate, magnesium orotate, magnesium aspartate, magnesium ascorbate, magnesium (L-) suenate, or a combination thereof, and is present in the combination of active agents in an amount of about 0.05 wt % to about 15 wt % of the oral product.

在較佳實施例中，鎂或其鹽包含氧化鎂、甘胺酸鎂、檸檬酸鎂、葡糖酸鎂、氯化鎂、硫酸鎂、乳酸鎂、L-蘇糖酸鎂、天冬胺酸鎂或其組合，且以口服產品之約0.05 wt%至約15 wt%，較佳約0.1 wt%至約10 wt%之量存在於活性劑之組合中。尤其較佳為氧化鎂及甘胺酸鎂，其可以口服產品之約0.1 wt%至約10 wt%存在。其他較佳實施例包括可以口服產品之約0.1 wt%至約10 wt%存在的氯化鎂。In a preferred embodiment, magnesium or its salt comprises magnesium oxide, magnesium glycinate, magnesium citrate, magnesium gluconate, magnesium chloride, magnesium sulfate, magnesium lactate, magnesium L-sucrose, magnesium aspartate or a combination thereof, and is present in the active agent combination in an amount of about 0.05 wt% to about 15 wt%, preferably about 0.1 wt% to about 10 wt% of the oral product. Particularly preferred are magnesium oxide and magnesium glycinate, which can be present in about 0.1 wt% to about 10 wt% of the oral product. Other preferred embodiments include magnesium chloride that can be present in about 0.1 wt% to about 10 wt% of the oral product.

活性成分之組合進一步包含B族維生素之組合。B族維生素之組合包含至少維生素B2及維生素B6。The combination of active ingredients further comprises a combination of B vitamins. The combination of B vitamins comprises at least vitamin B2 and vitamin B6.

術語「B族維生素」包括一組八種水溶性維生素，其對細胞功能具有作用；例如細胞代謝及紅血球合成。B族維生素在有關細胞生理功能之大量酶過程中充當輔酶。B族維生素一般可分成二個類別：充當異化性酶反應(引起能量產生)之輔酶的B族維生素及充當同化性酶反應(引起腦功能增強)之輔酶的B族維生素。The term "B vitamins" includes a group of eight water-soluble vitamins that play a role in cellular functions; for example, cell metabolism and red blood cell synthesis. B vitamins act as coenzymes in a large number of enzymatic processes involved in cellular physiological functions. B vitamins can generally be divided into two categories: B vitamins that act as coenzymes for catabolic enzyme reactions (resulting in energy production) and B vitamins that act as coenzymes for anabolic enzyme reactions (resulting in enhanced brain function).

B族維生素被認為在腦功能及能量產生之態樣中發揮作用。該八種水溶性B族維生素係維生素B1 (硫胺素)、維生素B2 (核黃素)、維生素B3 (菸鹼酸)、維生素B5 (泛酸或其鹽，例如泛酸鈣)、維生素B6 (鹽酸吡哆醇)、維生素B7 (生物素)、維生素B9 (葉酸鹽或葉酸)、維生素B12 (氰鈷胺素)。已發現，維生素B2、B3、B6、B9及B12支持同化代謝且增強腦功能。已發現，維生素B1、B2、B3、B5及B7支持異化代謝且增大能量位準。術語「同化性B族維生素」係指對同化路徑具有作用之彼等B族維生素，而術語「異化性B族維生素」係指對異化路徑具有作用之彼等B族維生素。B vitamins are thought to play a role in brain function and energy production. The eight water-soluble B vitamins are vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid or a salt thereof, such as calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folate or folic acid), vitamin B12 (cyanocobalamin). Vitamins B2, B3, B6, B9, and B12 have been found to support anabolic metabolism and enhance brain function. Vitamins B1, B2, B3, B5, and B7 have been found to support catabolic metabolism and increase energy levels. The term "anabolic B vitamins" refers to those B vitamins that act on the anabolic pathway, while the term "catabolic B vitamins" refers to those B vitamins that act on the anabolic pathway.

口服產品包括支持同化代謝之B族維生素中之至少二者，亦即維生素B2及B6。已發現，包括此等B族維生素可幫助調節心理及認知功能，包括促進睡眠。The oral product includes at least two of the B vitamins that support anabolic metabolism, namely vitamins B2 and B6. Including these B vitamins has been found to help regulate mental and cognitive functions, including promoting sleep.

在一些實施例中，B族維生素之組合進一步包含至少一種選自由以下組成之群的異化性B族維生素：維生素B1、維生素B5、維生素B7及其組合。在較佳實施例中，B族維生素之組合由維生素B2及維生素B6組成。In some embodiments, the combination of B vitamins further comprises at least one isocyanate B vitamin selected from the group consisting of vitamin B1, vitamin B5, vitamin B7 and combinations thereof. In a preferred embodiment, the combination of B vitamins consists of vitamin B2 and vitamin B6.

組合中包括的B族維生素之總量為適於提供所希望效果，同時亦提供安全食用且具有減少之副作用之產品的任何量。詳言之，組合中包括的B族維生素之總量為適於提供所希望之促進睡眠之作用的任何量。The total amount of B vitamins included in the combination is any amount suitable for providing the desired effect while also providing a product that is safe to consume and has reduced side effects. In particular, the total amount of B vitamins included in the combination is any amount suitable for providing the desired sleep-promoting effect.

B族維生素之總量為任何適合量，諸如口服產品之至少約0.001重量%、至少約0.0025重量%或至少約0.004重量%之量。在一些實施例中，B族維生素之總量不超過口服產品之約2重量%、不超過約1重量%或不超過約0.5重量%。The total amount of B vitamins is any suitable amount, such as at least about 0.001%, at least about 0.0025%, or at least about 0.004% by weight of the oral product. In some embodiments, the total amount of B vitamins is no more than about 2%, no more than about 1%, or no more than about 0.5% by weight of the oral product.

在一些實施例中，B族維生素之總量為口服產品之約0.001重量%至約2重量%，例如約0.0025重量%至約1重量%，且較佳為口服產品之約0.004%至約0.5重量%。In some embodiments, the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, such as about 0.0025% to about 1% by weight, and preferably about 0.004% to about 0.5% by weight of the oral product.

在一些實施例中，B族維生素之組合由維生素B2及維生素B6組成且B族維生素之總量為任何適合量，諸如口服產品之至少約0.001重量%、至少約0.0025重量%或至少約0.004重量%之量。在一些實施例中，由維生素B2及維生素B6組成之B族維生素的總量不超過口服產品之約2重量%、不超過約1重量%或不超過約0.5重量%。In some embodiments, the combination of B vitamins consists of vitamin B2 and vitamin B6 and the total amount of B vitamins is any suitable amount, such as at least about 0.001% by weight, at least about 0.0025% by weight, or at least about 0.004% by weight of the oral product. In some embodiments, the total amount of B vitamins consisting of vitamin B2 and vitamin B6 does not exceed about 2% by weight, does not exceed about 1% by weight, or does not exceed about 0.5% by weight of the oral product.

在一些實施例中，B族維生素之組合由維生素B2及維生素B6組成且B族維生素之總量為口服產品之約0.001重量%至約2重量%，例如約0.0025重量%至約1重量%，且較佳為口服產品之約0.004%至約0.5重量%。In some embodiments, the combination of B vitamins consists of vitamin B2 and vitamin B6 and the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, such as about 0.0025% to about 1% by weight, and preferably about 0.004% to about 0.5% by weight of the oral product.

根據活性成分之組合乾重，B族維生素之總量為任何適合量，諸如組合乾重之至少約0.01重量%、至少約0.025重量%或至少約0.1重量%之量。在一些實施例中，B族維生素之總量不超過組合乾重之約5重量%、不超過約4重量%或不超過約2重量%。The total amount of B vitamins is any suitable amount based on the combined dry weight of the active ingredients, such as at least about 0.01% by weight, at least about 0.025% by weight, or at least about 0.1% by weight of the combined dry weight. In some embodiments, the total amount of B vitamins does not exceed about 5% by weight, does not exceed about 4% by weight, or does not exceed about 2% by weight of the combined dry weight.

在一些實施例中，B族維生素之總量為組合乾重之約0.01重量%至約5重量%。舉例而言，B族維生素之總量可為組合乾重之約0.025重量%至約4重量%。B族維生素之總量可較佳為組合乾重之約0.1重量%至約2重量%之量。In some embodiments, the total amount of B vitamins is about 0.01% to about 5% by weight of the combined dry weight. For example, the total amount of B vitamins can be about 0.025% to about 4% by weight of the combined dry weight. The total amount of B vitamins can preferably be about 0.1% to about 2% by weight of the combined dry weight.

在一些實施例中，維生素B2可以口服產品中B族維生素之總量的約5重量%至約90重量%之量存在。舉例而言，維生素B2可以口服產品中B族維生素之總量的約20重量%至約60重量%之量存在。較佳地，維生素B2以口服產品中B族維生素之總量的約30重量%至約50重量%之量存在。In some embodiments, vitamin B2 can be present in an amount of about 5% to about 90% by weight of the total amount of B vitamins in the oral product. For example, vitamin B2 can be present in an amount of about 20% to about 60% by weight of the total amount of B vitamins in the oral product. Preferably, vitamin B2 is present in an amount of about 30% to about 50% by weight of the total amount of B vitamins in the oral product.

在一些實施例中，維生素B6可以口服產品中B族維生素之總量的約10重量%至約95重量%之量存在。舉例而言，維生素B6可以口服產品中B族維生素之總量的約40重量%至約80重量%之量存在。較佳地，維生素B2以口服產品中B族維生素之總量的約50重量%至約75重量%之量存在。In some embodiments, vitamin B6 can be present in an amount of about 10% to about 95% by weight of the total amount of B vitamins in the oral product. For example, vitamin B6 can be present in an amount of about 40% to about 80% by weight of the total amount of B vitamins in the oral product. Preferably, vitamin B2 is present in an amount of about 50% to about 75% by weight of the total amount of B vitamins in the oral product.

在一些實施例中，維生素B2可以口服產品中B族維生素之總量的約5重量%至約90重量%之量存在，並且維生素B6可以口服產品中B族維生素之總量的約10%至約95%之量存在。在一些實施例中，維生素B2可以口服產品中B族維生素之總量的約20重量%至約60重量%之量存在，並且維生素B6可以口服產品中B族維生素之總量的約40%至約80%之量存在。在一些實施例中，維生素B2可以口服產品中B族維生素之總量的約30重量%至約50重量%之量存在，並且維生素B6可以口服產品中B族維生素之總量的約50%至約75%之量存在。在此等實施例中之任一者中，B族維生素之組合可由維生素B2及維生素B6組成。In some embodiments, vitamin B2 can be present in an amount of about 5% to about 90% by weight of the total amount of B vitamins in an oral product, and vitamin B6 can be present in an amount of about 10% to about 95% of the total amount of B vitamins in an oral product. In some embodiments, vitamin B2 can be present in an amount of about 20% to about 60% by weight of the total amount of B vitamins in an oral product, and vitamin B6 can be present in an amount of about 40% to about 80% of the total amount of B vitamins in an oral product. In some embodiments, vitamin B2 can be present in an amount of about 30% to about 50% by weight of the total amount of B vitamins in an oral product, and vitamin B6 can be present in an amount of about 50% to about 75% of the total amount of B vitamins in an oral product. In any of these embodiments, the combination of B vitamins can consist of vitamin B2 and vitamin B6.

在以上實施例中之任一者中存在的情況下，維生素B1可以口服產品中B族維生素之總量的約0.01重量%至約40重量%之量存在。舉例而言，在存在之情況下，維生素B1可以口服產品中B族維生素之總量的約10重量%至約35重量%之量存在。In any of the above embodiments, vitamin B1, when present, can be present in an amount of about 0.01% to about 40% by weight of the total amount of B vitamins in the oral product. For example, in an amount of about 10% to about 35% by weight of the total amount of B vitamins in the oral product.

在一些實施例中，口服產品可實質上不含(亦即，包括至多0.0001重量%)維生素B3，或可不含(亦即，包括0%)維生素B3。在一些實施例中，口服產品可實質上不含(亦即，包括至多0.0001重量%)維生素B5，或可不含(亦即，包括0%)維生素B5。In some embodiments, the oral product may be substantially free of (i.e., including up to 0.0001% by weight) vitamin B3, or may be free of (i.e., including 0%) vitamin B3. In some embodiments, the oral product may be substantially free of (i.e., including up to 0.0001% by weight) vitamin B5, or may be free of (i.e., including 0%) vitamin B5.

在存在之情況下，維生素B7可以口服產品中B族維生素之總量的約0.01重量%至約5重量%之量存在。舉例而言，在存在之情況下，維生素B7可以口服產品中B族維生素之總量的約0.01重量%至約1重量%之量存在。在一些實施例中，口服產品可實質上不含(亦即，包括至多0.0001重量%)維生素B7，或可不含(亦即，包括0%)維生素B7。Where present, vitamin B7 may be present in an amount of about 0.01% to about 5% by weight of the total amount of B vitamins in the oral product. For example, where present, vitamin B7 may be present in an amount of about 0.01% to about 1% by weight of the total amount of B vitamins in the oral product. In some embodiments, the oral product may be substantially free of (i.e., including up to 0.0001% by weight) vitamin B7, or may be free of (i.e., including 0%) vitamin B7.

在一些實施例中，B族維生素之組合由維生素B2及維生素B6組成且B族維生素之總量為任何適合量，諸如組合乾重之至少約0.01重量%、至少約0.025重量%或至少約0.1重量%之量。在一些實施例中，由維生素B2及維生素B6組成之B族維生素的總量不超過組合乾重之約5重量%、不超過約4重量%或不超過約2重量%。In some embodiments, the combination of B vitamins consists of vitamin B2 and vitamin B6 and the total amount of B vitamins is any suitable amount, such as at least about 0.01% by weight, at least about 0.025% by weight, or at least about 0.1% by weight of the combined dry weight. In some embodiments, the total amount of B vitamins consisting of vitamin B2 and vitamin B6 does not exceed about 5%, about 4%, or about 2% by weight of the combined dry weight.

在一些實施例中，B族維生素之組合由維生素B2及維生素B6組成且B族維生素之總量為組合乾重之約0.01重量%至約5重量%。舉例而言，由維生素B2及維生素B6組成之B族維生素的總量可為組合乾重之約0.025重量%至約4重量%。由維生素B2及維生素B6組成之B族維生素的總量可較佳為組合乾重之約0.1重量%至約2重量%之量。In some embodiments, the combination of B vitamins consists of vitamin B2 and vitamin B6 and the total amount of B vitamins is about 0.01% to about 5% by weight of the dry weight of the combination. For example, the total amount of B vitamins consisting of vitamin B2 and vitamin B6 can be about 0.025% to about 4% by weight of the dry weight of the combination. The total amount of B vitamins consisting of vitamin B2 and vitamin B6 can preferably be about 0.1% to about 2% by weight of the dry weight of the combination.

活性成分之組合進一步包含人參。人參係人參(Panax)屬植物之根，以存在獨特的類固醇皂素植物化學成分(人參皂苷(ginsenoside))及吉托寧(gintonin)為特徵。推定的人參之主要活性組分包含超過100種特定的三萜皂素或「人參皂苷」。人參及人參萃取物亦含有一系列其他潛在生物活性組分，包括生物鹼、植物固醇、倍半萜及多酚。人參可用作能量飲料或草藥茶中的膳食補充劑，且用於傳統醫學中。The combination of active ingredients further comprises ginseng. Ginseng is the root of the plant of the genus Panax, characterized by the presence of unique steroid saponin phytochemicals (ginsenosides) and gintonin. The putative major active components of ginseng include over 100 specific triterpenoid saponins or "ginsenosides". Ginseng and ginseng extracts also contain a range of other potentially bioactive components, including alkaloids, phytosterols, sesquiterpenes and polyphenols. Ginseng can be used as a dietary supplement in energy drinks or herbal teas, and is used in traditional medicine.

人參可包括任何適合形式之人參，諸如高麗參(Panax ginseng) (韓國人參)、三七(Panax notoginseng) (中國人參)及西洋參(Panax quinquefolius) (花旗參(American ginseng))。較佳地，人參呈高麗參(韓國人參)存在。人參可以人參萃取物、切短的人參、切碎的人參或粉末狀人參的形式存在。較佳地，包括呈人參萃取物或粉末狀人參萃取物形式之人參。人參可為白參、鮮人參或紅參。在一些實施例中，人參係紅參，諸如紅參萃取物或粉末狀紅參萃取物。人參已與睡眠之快速眼球運動(REM)階段、入睡時間及睡眠品質有關。Ginseng may include any suitable form of ginseng, such asPanax ginseng (Korean ginseng),Panax notoginseng (Chinese ginseng), andPanax quinquefolius (American ginseng). Preferably, ginseng is present as Korean ginseng (Korean ginseng). Ginseng may be present in the form of ginseng extract, chopped ginseng, chopped ginseng, or powdered ginseng. Preferably, ginseng is included in the form of ginseng extract or powdered ginseng extract. Ginseng may be white ginseng, fresh ginseng, or red ginseng. In some embodiments, ginseng is red ginseng, such as red ginseng extract or powdered red ginseng extract. Ginseng has been associated with the rapid eye movement (REM) stage of sleep, sleep onset time, and sleep quality.

包括的人參可為適於實現所希望功能之任何量，諸如口服產品之至少約0.01重量%、至少約0.05重量%或至少約0.1重量%之量。在一些實施例中，人參可以不超過口服產品之約10重量%、不超過約5重量%或不超過約2.5重量%之量存在。Ginseng can be included in any amount suitable for achieving the desired function, such as at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, ginseng can be present in an amount of no more than about 10% by weight, no more than about 5% by weight, or no more than about 2.5% by weight of the oral product.

在一些實施例中，人參以口服產品之約0.01重量%至約10重量%之量存在。舉例而言，人參可以口服產品之約0.05重量%至約5重量%之量存在。在一些較佳實施例中，人參以口服產品之約0.1重量%至約2.5重量%之量存在。In some embodiments, ginseng is present in an amount of about 0.01% to about 10% by weight of the oral product. For example, ginseng can be present in an amount of about 0.05% to about 5% by weight of the oral product. In some preferred embodiments, ginseng is present in an amount of about 0.1% to about 2.5% by weight of the oral product.

根據活性成分之組合中之乾重，人參以任何適合之量存在，諸如組合乾重之至少約1重量%、至少約2.5重量%或至少約5重量%之量存在。在一些實施例中，人參可以組合乾重之不超過約40重量%、不超過約30重量%或不超過約20重量%之量存在。Ginseng is present in any suitable amount based on the dry weight of the combination of active ingredients, such as at least about 1 wt %, at least about 2.5 wt %, or at least about 5 wt % of the dry weight of the combination. In some embodiments, ginseng may be present in an amount of no more than about 40 wt %, no more than about 30 wt %, or no more than about 20 wt % of the dry weight of the combination.

在一些實施例中，人參以組合乾重之約1重量%至約40重量%之量存在。舉例而言，人參可以組合乾重之約2.5重量%至約30重量%之量存在。人參可較佳以組合乾重之約5重量%至約20重量%之量存在。In some embodiments, ginseng is present in an amount of about 1% to about 40% by weight of the combined dry weight. For example, ginseng can be present in an amount of about 2.5% to about 30% by weight of the combined dry weight. Ginseng can preferably be present in an amount of about 5% to about 20% by weight of the combined dry weight.

在一些實施例(例如，其中口服產品為液體口服劑型)中，人參可以口服產品之約0.01重量%至約10重量%之量存在。在一些實施例(例如，其中口服產品為液體口服劑型)中，人參以口服產品之約0.05重量%至約5重量%、較佳約0.1重量%至約2.5重量%之量存在。In some embodiments (e.g., wherein the oral product is a liquid oral dosage form), ginseng may be present in an amount of about 0.01% to about 10% by weight of the oral product. In some embodiments (e.g., wherein the oral product is a liquid oral dosage form), ginseng is present in an amount of about 0.05% to about 5% by weight, preferably about 0.1% to about 2.5% by weight of the oral product.

在上述實施例中，人參較佳呈高麗參(韓國人參)存在。In the above embodiment, ginseng is preferably present in the form of Korean ginseng.

活性成分之組合進一步包含西番蓮(粉色西番蓮(Passiflora incarnate))。西番蓮係歷史上用於治療焦慮、失眠、癲癇及歇斯底里症之草本營養補充劑。其可以輸注液、茶、液體萃取物及酊劑形式利用，且草本營養補充劑典型地由植物之花、葉及莖構成。西番蓮可以此等形式中之任一者存在於口服產品中。在一些實施例中，西番蓮可呈西番蓮萃取物、切短或切碎的西番蓮(不論自植物之花、葉及/或莖)形式或粉末形式存在。在一些實施例中，西番蓮不以酊劑形式使用。較佳地，西番蓮可呈西番蓮萃取物形式。The combination of active ingredients further comprises passionflower (pink passionflower (Passiflora incarnate )). Passionflower is a herbal nutritional supplement used historically to treat anxiety, insomnia, epilepsy and hysteria. It can be used in the form of infusions, teas, liquid extracts and tinctures, and herbal nutritional supplements are typically composed of the flowers, leaves and stems of plants. Passionflower can be present in oral products in any of these forms. In some embodiments, passionflower can be present in the form of passionflower extracts, chopped or chopped passionflowers (regardless of the flowers, leaves and/or stems of the plant) or powdered forms. In some embodiments, passionflower is not used in the form of tinctures. Preferably, the passion flower may be in the form of a passion flower extract.

在本發明之口服產品中，發現西番蓮有助於促進睡眠。因此包括的西番蓮為適於實現此所希望功能之任何量，諸如口服產品之至少約0.01重量%、至少約0.05重量%或至少約0.1重量%之量。在一些實施例中，西番蓮以不超過口服產品之約10重量%、不超過約5重量%或不超過約2.5重量%之量存在。In the oral product of the present invention, passion flower was found to help promote sleep. Thus, passion flower is included in any amount suitable for achieving this desired function, such as at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, passion flower is present in an amount of no more than about 10% by weight, no more than about 5% by weight, or no more than about 2.5% by weight of the oral product.

在一些實施例中，西番蓮以約0.01重量%至約10重量%之量存在。舉例而言，西番蓮可以口服產品之約0.05重量%至約5重量%之量存在。在一些較佳實施例中，西番蓮以口服產品之約0.1重量%至約2.5重量%之量存在。In some embodiments, passionflower is present in an amount of about 0.01% to about 10% by weight. For example, passionflower can be present in an amount of about 0.05% to about 5% by weight of an oral product. In some preferred embodiments, passionflower is present in an amount of about 0.1% to about 2.5% by weight of an oral product.

根據活性成分之組合中之乾重，西番蓮以適於實現所希望功能之任何量存在，諸如以組合乾重之至少約1重量%、至少約2重量%或至少約5重量%之量存在。在一些實施例中，西番蓮以不超過組合乾重之約40重量%、不超過約30重量%或不超過約20重量%之量存在。According to the dry weight of the combination of active ingredients, passion flower is present in any amount suitable for achieving the desired function, such as at least about 1% by weight, at least about 2% by weight, or at least about 5% by weight of the combined dry weight. In some embodiments, passion flower is present in an amount of no more than about 40% by weight, no more than about 30% by weight, or no more than about 20% by weight of the combined dry weight.

在一些實施例中，西番蓮以組合乾重之約1重量%至約40重量%之量存在。舉例而言，西番蓮可以組合乾重之約2重量%至約30重量%之量存在。西番蓮可較佳以組合乾重之約5重量%至約20重量%之量存在。In some embodiments, passionflower is present in an amount of about 1% to about 40% by weight of the combined dry weight. For example, passionflower can be present in an amount of about 2% to about 30% by weight of the combined dry weight. Passionflower can preferably be present in an amount of about 5% to about 20% by weight of the combined dry weight.

在一些實施例中(例如，其中口服產品為液體口服劑型)西番蓮可以口服產品之約0.01重量%至約10重量%之量存在。在一些實施例中(例如，其中口服產品為液體口服劑型)，西番蓮以口服產品之約0.05重量%至約5重量%、較佳約0.1重量%至約2.5重量%之量存在。In some embodiments (e.g., wherein the oral product is a liquid oral dosage form), passionflower can be present in an amount of about 0.01% by weight to about 10% by weight of the oral product. In some embodiments (e.g., wherein the oral product is a liquid oral dosage form), passionflower is present in an amount of about 0.05% by weight to about 5% by weight, preferably about 0.1% by weight to about 2.5% by weight of the oral product.

除鎂或其鹽、B族維生素之組合、人參及西番蓮以外，活性成分之組合可包括一或多種額外活性成分。額外活性成分可為促進睡眠之任何適合之活性成分，包括藉由誘導睡眠及/或維持睡眠來促進睡眠，且可例如選自其他營養藥劑、益智劑及神經活性劑。該額外活性成分可為天然存在的或以合成方式獲得的。額外活性成分之非限制性實例包括在以下類別之範圍內者：植物性成分(例如假馬齒莧(Bacopa Monieri)或紅景天，或其類似物)、胺基酸或類似物(例如L-茶胺酸)及/或營養藥劑，及/或藥用成分(例如其他維生素，諸如A、C、D、E或K及/或大麻鹼，諸如四氫大麻酚(THC)及大麻二酚(CBD))。在一些實施例中，該等額外活性成分係選自植物性成分、胺基酸、其他維生素以及其組合。In addition to magnesium or its salt, the combination of B vitamins, ginseng and passionflower, the combination of active ingredients may include one or more additional active ingredients. The additional active ingredient may be any suitable active ingredient that promotes sleep, including by inducing sleep and/or maintaining sleep, and may be selected, for example, from other nutritional agents, nootropics and neuroactive agents. The additional active ingredient may be naturally occurring or synthetically obtained. Non-limiting examples of additional active ingredients include those within the following categories: botanical ingredients (e.g., Bacopa Monieri or Rhodiola rosea, or analogs thereof), amino acids or analogs (e.g., L-theanine), and/or nutritional agents, and/or medicinal ingredients (e.g., other vitamins, such as A, C, D, E, or K, and/or cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). In some embodiments, the additional active ingredients are selected from botanical ingredients, amino acids, other vitamins, and combinations thereof.

一或多種額外活性成分可例如選自胺基酸，諸如L-茶胺酸、色胺酸、L-酪胺酸；維生素，諸如維生素A、維生素C、維生素D、維生素E、維生素K；或植物性成分，諸如聖羅勒、檸檬香草、紫花馬蘭菊、纈草根、洋甘菊或洋甘菊萃取物、大麻鹼、硝酸鹽或甜菜汁，或其成分、衍生物或組合。在一些實施例中，額外活性成分可選自胺基酸，諸如L-茶胺酸及植物性成分，諸如洋甘菊萃取物、檸檬香草、纈草根、紫花馬蘭菊及聖羅勒，或其成分、衍生物或組合。One or more additional active ingredients can be selected, for example, from amino acids such as L-theanine, tryptophan, L-tyrosine; vitamins such as vitamin A, vitamin C, vitamin D, vitamin E, vitamin K; or botanical ingredients such as holy basil, lemongrass, chamomile, valerian root, chamomile or chamomile extract, cannabinoids, nitrates or beet juice, or components, derivatives or combinations thereof. In some embodiments, the additional active ingredient can be selected from amino acids such as L-theanine and botanical ingredients such as chamomile extract, lemongrass, valerian root, chamomile and holy basil, or components, derivatives or combinations thereof.

在一些實施例中，活性成分之組合進一步包含L-茶胺酸(亦稱為L-γ-麩胺醯乙醯胺、N⁵-乙基-L-麩醯胺酸或簡稱為茶胺酸)。L-茶胺酸係L-麩胺酸及L-麩醯胺酸之天然存在之非蛋白質胺基酸類似物。其可見於茶葉中且歷史上已用於藉由減少壓力及焦慮位準來促進放鬆。L-茶胺酸顯著增加腦波之α頻帶中之活性，此指示放鬆。L-茶胺酸亦可代謝成麩胺酸且進一步代謝成麩醯胺酸或去羧基，得到γ-胺基丁酸。本發明口服產品中之L-茶胺酸可以天然或合成方式產生。L-茶胺酸可自多種來源購得。在本發明之口服產品中，發現L-茶胺酸在存在時有助於促進睡眠。In some embodiments, the combination of active ingredients further comprises L-theanine (also known as L-γ-glutamyl acetylamine, N⁵ -ethyl-L-glutamic acid or simply theanine). L-theanine is a naturally occurring non-protein amino acid analog of L-glutamine and L-glutamic acid. It can be found in tea leaves and has been used historically to promote relaxation by reducing stress and anxiety levels. L-theanine significantly increases activity in the alpha band of brain waves, which indicates relaxation. L-theanine can also be metabolized to glutamine and further metabolized to glutamic acid or decarboxylated to give gamma-aminobutyric acid. The L-theanine in the oral product of the present invention can be produced naturally or synthetically. L-theanine is available from a variety of sources. In the oral product of the present invention, L-theanine was found to help promote sleep when present.

在存在之情況下，L-茶胺酸可為適於實現所希望功能之任何量，諸如口服產品之至少約0.01重量%、至少約0.05重量%或至少約0.1重量%之量。在一些實施例中，L-茶胺酸可以不超過口服產品之約10重量%、不超過約5重量%或不超過約2.5重量%之量存在。Where present, L-theanine may be present in any amount suitable to achieve the desired function, such as at least about 0.01%, at least about 0.05%, or at least about 0.1% by weight of the oral product. In some embodiments, L-theanine may be present in an amount of no more than about 10%, no more than about 5%, or no more than about 2.5% by weight of the oral product.

在存在之情況下，L-茶胺酸可為口服產品之約0.01重量%至約10重量%或約0.05重量%至約5重量%之量。L-茶胺酸可較佳以口服產品之約0.1重量%至約2.5重量%之量存在。Where present, L-theanine may be present in an amount of about 0.01% to about 10% by weight or about 0.05% to about 5% by weight of the oral product. L-theanine may preferably be present in an amount of about 0.1% to about 2.5% by weight of the oral product.

根據活性成分之組合中之乾重，L-茶胺酸可以任何適合之量存在，諸如以組合乾重之至少約1重量%、至少約2重量%或至少約5重量%之量存在。在一些實施例中，L-茶胺酸可以組合乾重之不超過約40重量%、不超過約35重量%或不超過約30重量%之量存在。Depending on the dry weight of the combination of active ingredients, L-theanine may be present in any suitable amount, such as at least about 1%, at least about 2%, or at least about 5% by weight of the dry weight of the combination. In some embodiments, L-theanine may be present in an amount of no more than about 40%, no more than about 35%, or no more than about 30% by weight of the dry weight of the combination.

在一些實施例中，L-茶胺酸可以組合乾重之約1重量%至約40重量%之量存在。舉例而言，L-茶胺酸可以組合乾重之約2重量%至約35重量%之量存在。L-茶胺酸可較佳以組合乾重之約5重量%至約30重量%之量存在。In some embodiments, L-theanine can be present in an amount of about 1% to about 40% by weight of the combined dry weight. For example, L-theanine can be present in an amount of about 2% to about 35% by weight of the combined dry weight. L-theanine can preferably be present in an amount of about 5% to about 30% by weight of the combined dry weight.

在一些實施例中，活性成分之組合可進一步包含洋甘菊。洋甘菊為展現雛菊樣花之菊科家族之植物的通用名。洋甘菊，尤其西洋甘菊(Matricaria chamomilla)及羅馬洋甘菊(Chamaemelum nobile)，在傳統藥物製劑中為常用的。洋甘菊作為草本營養補充劑，歷史上已用於減少壓力及焦慮、促進睡眠及減輕消化不良之不適。洋甘菊可以輸注液、茶、液體萃取物及酊劑形式利用，且草本營養補充劑典型地由植物之花構成。洋甘菊可以此等形式中之任一者存在於口服產品中。在一些實施例中，洋甘菊可以洋甘菊萃取物、切短或切碎的洋甘菊或粉末狀洋甘菊形式存在。在一些實施例中，洋甘菊不以酊劑形式使用。較佳地，洋甘菊在存在時可來自西洋甘菊(Matricaria chamomilla)及/或羅馬洋甘菊(Chamaemelum nobile)。較佳地，洋甘菊在存在時可呈洋甘菊萃取物形式。已發現，在本發明口服產品中添加洋甘菊可有助於促進睡眠。In some embodiments, the combination of active ingredients may further include chamomile. Chamomile is the common name for plants ofthe Asteraceae family that exhibit daisy-like flowers. Chamomile, especiallyMatricaria chamomilla and Roman chamomile, is commonly used in traditional pharmaceutical preparations. Chamomile, as an herbal nutritional supplement, has been used historically to reduce stress and anxiety, promote sleep, and relieve the discomfort of indigestion. Chamomile is available in the form of infusions, teas, liquid extracts, and tinctures, and herbal nutritional supplements are typically composed of the flowers of the plant. Chamomile can be present in any of these forms in an oral product. In some embodiments, chamomile can be present in the form of chamomile extract, chopped or chopped chamomile, or powdered chamomile. In some embodiments, chamomile is not used in tincture form. Preferably, chamomile, when present, may be fromMatricaria chamomilla and/orChamaemelum nobile . Preferably, chamomile, when present, may be in the form of a chamomile extract. It has been found that the addition of chamomile to the oral product of the present invention may help promote sleep.

在存在之情況下，洋甘菊可為適於實現所希望功能之任何量，諸如口服產品之至少約0.001重量%、至少約0.0025重量%或至少約0.01重量%之量。在一些實施例中，洋甘菊可以不超過口服產品之約10重量%、不超過約5重量%或不超過約1重量%之量存在。Where present, chamomile may be present in any amount suitable to achieve the desired function, such as at least about 0.001%, at least about 0.0025%, or at least about 0.01% by weight of the oral product. In some embodiments, chamomile may be present in an amount of no more than about 10%, no more than about 5%, or no more than about 1% by weight of the oral product.

在存在之情況下，洋甘菊可為口服產品之約0.001重量%至約10重量%或約0.0025重量%至約5重量%之量。洋甘菊可較佳以口服產品之約0.01%至約1重量%之量存在。Where present, chamomile may be present in an amount of about 0.001% to about 10% by weight or about 0.0025% to about 5% by weight of the oral product. Chamomile may preferably be present in an amount of about 0.01% to about 1% by weight of the oral product.

根據活性成分之組合中之乾重，洋甘菊可以適於實現所希望功能之任何量存在，諸如以組合乾重之至少約0.1重量%、至少約0.25重量%或至少約0.5重量%之量存在。在一些實施例中，洋甘菊可以不超過組合乾重之約20重量%、不超過約15重量%或不超過約10重量%之量存在。Based on the dry weight of the combination of active ingredients, chamomile can be present in any amount suitable to achieve the desired function, such as at least about 0.1% by weight, at least about 0.25% by weight, or at least about 0.5% by weight of the dry weight of the combination. In some embodiments, chamomile can be present in an amount of no more than about 20% by weight, no more than about 15% by weight, or no more than about 10% by weight of the dry weight of the combination.

在一些實施例中，洋甘菊可以組合乾重之約0.1重量%至約20重量%之量存在。舉例而言，洋甘菊可以組合乾重之約0.25重量%至約15重量%之量存在。洋甘菊可較佳以組合乾重之約0.5重量%至約10重量%之量存在。In some embodiments, chamomile can be present in an amount of about 0.1% to about 20% by weight of the combined dry weight. For example, chamomile can be present in an amount of about 0.25% to about 15% by weight of the combined dry weight. Chamomile can preferably be present in an amount of about 0.5% to about 10% by weight of the combined dry weight.

纈草(纈草(Valeriana officinalis))亦可存在於口服產品中。纈草，尤其纈草根及纈草根萃取物，傳統上已用作鎮靜劑。其可以輸注液、茶、液體萃取物、錠劑、膠囊及酊劑形式利用，且草本營養補充劑典型地由植物之根、根莖及匍匐莖構成。纈草可以此等形式中之任一者存在於口服產品中。在一些實施例中，纈草可呈纈草萃取物、切短或切碎的纈草(不論自植物之根、根莖及/或匍匐莖)形式或粉末形式存在。在一些實施例中，纈草不以酊劑形式使用。較佳地，纈草在存在時可呈纈草根萃取物形式。已發現，在本發明口服產品中添加纈草可有助於促進睡眠。然而，纈草對於活性劑之組合在口服產品中之所需功能而言並非不可或缺的。Valve (Valeriana officinalis ) can also be present in oral products. Valve, especially valve root and valve root extract, has been traditionally used as a sedative. It is available in the form of infusions, teas, liquid extracts, tablets, capsules and tinctures, and herbal nutritional supplements are typically composed of the roots, rhizomes and runners of the plant. Valve can be present in oral products in any of these forms. In some embodiments, valve can be present in the form of a valve extract, chopped or chopped valve (whether from the roots, rhizomes and/or runners of the plant), or a powder. In some embodiments, valve is not used in the form of a tincture. Preferably, the valerian may be present in the form of a valerian root extract. It has been found that the addition of valerian to the oral product of the present invention may help promote sleep. However, valerian is not essential to the desired function of the combination of active agents in the oral product.

在存在之情況下，纈草可為適於實現所希望功能之任何量，諸如口服產品之至少約0.01重量%、至少約0.025重量%或至少約0.05重量%之量。在一些實施例中，纈草可以口服產品之不超過約5重量%、不超過約2.5重量%或不超過約1重量%之量存在。Where present, the valverine may be present in any amount suitable for achieving the desired function, such as at least about 0.01 wt %, at least about 0.025 wt %, or at least about 0.05 wt % of the oral product. In some embodiments, the valverine may be present in an amount of no more than about 5 wt %, no more than about 2.5 wt %, or no more than about 1 wt % of the oral product.

在存在之情況下，纈草可為口服產品之約0.01重量%至約5重量%之量。舉例而言，纈草可以口服產品之約0.025重量%至約2.5重量%之量，較佳口服產品之約0.05重量%至約1重量%之量存在。Where present, valerian may be present in an amount of about 0.01% to about 5% by weight of the oral product. For example, valerian may be present in an amount of about 0.025% to about 2.5% by weight of the oral product, preferably about 0.05% to about 1% by weight of the oral product.

根據活性成分之組合乾重，纈草可以任何適合之量存在，諸如以組合乾重之至少約0.1重量%、至少約0.5重量%或至少約1重量%之量存在。在一些實施例中，聖羅勒可以不超過組合乾重之約15重量%、不超過約10重量%或不超過約5重量%之量存在。Depending on the combined dry weight of the active ingredients, Valverde can be present in any suitable amount, such as at least about 0.1 wt %, at least about 0.5 wt %, or at least about 1 wt % of the combined dry weight. In some embodiments, Holy Basil can be present in an amount of no more than about 15 wt %, no more than about 10 wt %, or no more than about 5 wt % of the combined dry weight.

在一些實施例中，纈草可以組合乾重之約0.1%至約15重量%之量存在。舉例而言，纈草可以組合乾重之約0.5%至約10重量%之量存在。纈草可較佳以組合乾重之約1%至約5重量%之量存在。In some embodiments, the sedge may be present in an amount of about 0.1% to about 15% by weight of the combined dry weight. For example, the sedge may be present in an amount of about 0.5% to about 10% by weight of the combined dry weight. Preferably, the sedge may be present in an amount of about 1% to about 5% by weight of the combined dry weight.

在一些實施例中，活性成分之組合可進一步包含聖羅勒(神羅勒(Ocimum tenuiflorum)或羅勒(Ocimum sanctum))。聖羅勒亦稱為圖西(tulsi)或圖拉西(tulasi)。聖羅勒為唇形花科羅勒家庭一員。其係歷史上使用，尤其在印度草藥醫學(Ayurvedic medicine)中用於減少壓力及焦慮、促進睡眠、改善記憶及緩解疲勞的草本營養補充劑。認為聖羅勒植物之所有部分均充當適應原，促進代謝增強、減少組織損傷及減少壓力。聖羅勒包括諸如維生素A及C、鈣、鋅、鐵及葉綠素之營養素。其可以輸注液、茶、液體萃取物及酊劑形式利用，且草本營養補充劑典型地由植物之花、葉及莖構成。聖羅勒可以此等形式中之任一者存在於口服產品中。在一些實施例中，聖羅勒可呈聖羅勒萃取物、切短或切碎的聖羅勒(不論自植物之花、葉及/或莖)形式或粉末形式存在。在一些實施例中，聖羅勒不以酊劑形式使用。較佳地，聖羅勒在存在時可呈聖羅勒萃取物形式。已發現，在本發明口服產品中添加聖羅勒可有助於促進睡眠。然而，聖羅勒對於活性劑之組合在口服產品中之所需功能而言並非不可或缺的。In some embodiments, the combination of active ingredients may further comprise holy basil (Ocimum tenuiflorum orOcimum sanctum ). Holy basil is also known as tulsi or tulasi. Holy basil is a member of the basil family of the Labiatae family. It is an herbal nutritional supplement used historically, especially in Ayurvedic medicine, to reduce stress and anxiety, promote sleep, improve memory, and relieve fatigue. All parts of the holy basil plant are believed to act as adaptogens, promoting enhanced metabolism, reducing tissue damage, and reducing stress. Holy basil includes nutrients such as vitamins A and C, calcium, zinc, iron, and chlorophyll. It can be used in the form of infusion, tea, liquid extract and tincture, and herbal nutritional supplements are typically composed of the flowers, leaves and stems of plants. Holy basil can be present in oral products in any of these forms. In some embodiments, holy basil can be in the form of holy basil extract, short or chopped holy basil (regardless of the flower, leaf and/or stem of the plant) or powder form. In some embodiments, holy basil is not used in the form of tincture. Preferably, holy basil can be in the form of holy basil extract when present. It has been found that adding holy basil in the oral product of the present invention can help promote sleep. However, holy basil is not indispensable for the required function of the combination of active agents in oral products.

在存在之情況下，聖羅勒可為適於實現所希望功能之任何量，諸如口服產品之至少約0.01重量%、至少約0.05重量%或至少約0.1重量%之量。在一些實施例中，聖羅勒可以不超過口服產品之約10重量%、不超過約5重量%或不超過約2.5重量%之量存在。Where present, holy basil can be any amount suitable for achieving the desired function, such as at least about 0.01% by weight, at least about 0.05% by weight, or at least about 0.1% by weight of the oral product. In some embodiments, holy basil can be present in an amount of no more than about 10% by weight, no more than about 5% by weight, or no more than about 2.5% by weight of the oral product.

在存在之情況下，聖羅勒可為口服產品之約0.01%至約10重量%或約0.05%至約5重量%之量。聖羅勒可較佳以口服產品之約0.1%至約2.5重量%之量存在。Where present, holy basil may be present in an amount of about 0.01% to about 10% by weight or about 0.05% to about 5% by weight of the oral product. Holy basil may preferably be present in an amount of about 0.1% to about 2.5% by weight of the oral product.

根據活性成分之組合乾重，聖羅勒可以任何適合之量存在，諸如以組合乾重之至少約1重量%、至少約2重量%或至少約5重量%之量存在。在一些實施例中，聖羅勒可以不超過組合乾重之約40重量%、不超過約35重量%或不超過約30重量%之量存在。Depending on the combined dry weight of the active ingredients, holy basil can be present in any suitable amount, such as at least about 1 wt %, at least about 2 wt %, or at least about 5 wt % of the combined dry weight. In some embodiments, holy basil can be present in an amount of no more than about 40 wt %, no more than about 35 wt %, or no more than about 30 wt % of the combined dry weight.

在一些實施例中，聖羅勒可以組合乾重之約1重量%至約40重量%之量存在。舉例而言，聖羅勒可以組合乾重之約2重量%至約35重量%之量存在。聖羅勒可較佳以組合乾重之約5重量%至約30重量%之量存在。In some embodiments, holy basil can be present in an amount of about 1% to about 40% by weight of the combined dry weight. For example, holy basil can be present in an amount of about 2% to about 35% by weight of the combined dry weight. Holy basil can preferably be present in an amount of about 5% to about 30% by weight of the combined dry weight.

在一些較佳實施例中，活性成分之組合包含鎂或其鹽、如本文所定義之B族維生素之組合、人參、西番蓮及L-茶胺酸。In some preferred embodiments, the combination of active ingredients comprises magnesium or a salt thereof, a combination of B vitamins as defined herein, ginseng, passionflower, and L-theanine.

在一些較佳實施例中，活性成分之組合包含鎂或其鹽、如本文所定義之B族維生素之組合、人參、西番蓮、L-茶胺酸及洋甘菊萃取物。In some preferred embodiments, the combination of active ingredients comprises magnesium or a salt thereof, a combination of B vitamins as defined herein, ginseng, passionflower, L-theanine, and chamomile extract.

在一些較佳實施例中，活性成分之組合包含鎂或其鹽、如本文所定義之B族維生素之組合、人參、西番蓮、L-茶胺酸及洋甘菊萃取物及/或聖羅勒。In some preferred embodiments, the combination of active ingredients comprises magnesium or a salt thereof, a combination of B vitamins as defined herein, ginseng, passion flower, L-theanine and chamomile extract and/or holy basil.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.01%至約20%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.001重量%至約2重量%，(iii)以口服產品之重量計約0.01%至約10%人參，及(iv)以口服產品之重量計約0.01%至約10%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.01% to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, (iii) about 0.01% to about 10% ginseng by weight of the oral product, and (iv) about 0.01% to about 10% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.05%至約15%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.0025重量%至約1重量%，(iii)以口服產品之重量計約0.05%至約5%人參，及(iv)以口服產品之重量計約0.05%至約5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.05% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.0025% to about 1% by weight of the oral product, (iii) about 0.05% to about 5% ginseng by weight of the oral product, and (iv) about 0.05% to about 5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.1%至約10%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.004%至約0.5重量%，(iii)以口服產品之重量計約0.1%至約2.5%人參，及(iv)以口服產品之重量計約0.1%至約2.5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.1% to about 10% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.004% to about 0.5% by weight of the oral product, (iii) about 0.1% to about 2.5% ginseng by weight of the oral product, and (iv) about 0.1% to about 2.5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.05%至約15%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.001重量%至約2重量%，(iii)以口服產品之重量計約0.01%至約10%人參，及(iv)以口服產品之重量計約0.01%至約10%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.05% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, (iii) about 0.01% to about 10% ginseng by weight of the oral product, and (iv) about 0.01% to about 10% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.01%至約20%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.0025重量%至約1重量%，(iii)以口服產品之重量計約0.01%至約10%人參，及(iv)以口服產品之重量計約0.01%至約10%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.01% to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.0025% to about 1% by weight of the oral product, (iii) about 0.01% to about 10% ginseng by weight of the oral product, and (iv) about 0.01% to about 10% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.01%至約20%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.001重量%至約2重量%，(iii)以口服產品之重量計約0.05%至約5%人參，及(iv)以口服產品之重量計約0.01%至約10%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.01% to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, (iii) about 0.05% to about 5% ginseng by weight of the oral product, and (iv) about 0.01% to about 10% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.01%至約20%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.001重量%至約2重量%，(iii)以口服產品之重量計約0.01%至約10%人參，及(iv)以口服產品之重量計約0.05%至約5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.01% to about 20% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, (iii) about 0.01% to about 10% ginseng by weight of the oral product, and (iv) about 0.05% to about 5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.1%至約10%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.0025重量%至約1重量%，(iii)以口服產品之重量計約0.05%至約5%人參，及(iv)以口服產品之重量計約0.05%至約5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.1% to about 10% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.0025% to about 1% by weight of the oral product, (iii) about 0.05% to about 5% ginseng by weight of the oral product, and (iv) about 0.05% to about 5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.5%至約15%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.004重量%至約0.5重量%，(iii)以口服產品之重量計約0.05%至約5%人參，及(iv)以口服產品之重量計約0.05%至約5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.5% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.004% to about 0.5% by weight of the oral product, (iii) about 0.05% to about 5% ginseng by weight of the oral product, and (iv) about 0.05% to about 5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.5%至約15%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.0025重量%至約1重量%，(iii)以口服產品之重量計約0.1%至約2.5%人參，及(iv)以口服產品之重量計約0.05%至約5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.5% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.0025% to about 1% by weight of the oral product, (iii) about 0.1% to about 2.5% ginseng by weight of the oral product, and (iv) about 0.05% to about 5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.5%至約15%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.0025重量%至約1重量%，(iii)以口服產品之重量計約0.05%至約5%人參，及(iv)以口服產品之重量計約0.1%至約2.5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.5% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.0025% to about 1% by weight of the oral product, (iii) about 0.05% to about 5% ginseng by weight of the oral product, and (iv) about 0.1% to about 2.5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.05%至約15%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.001重量%至約2重量%，(iii)以口服產品之重量計約0.05%至約5%人參，及(iv)以口服產品之重量計約0.05%至約5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.05% to about 15% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.001% to about 2% by weight of the oral product, (iii) about 0.05% to about 5% ginseng by weight of the oral product, and (iv) about 0.05% to about 5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以口服產品之重量計約0.1%至約10%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為口服產品之約0.0025重量%至約1重量%，(iii)以口服產品之重量計約0.1%至約2.5%人參，及(iv)以口服產品之重量計約0.1%至約2.5%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 0.1% to about 10% magnesium or a salt thereof by weight of the oral product, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.0025% to about 1% by weight of the oral product, (iii) about 0.1% to about 2.5% ginseng by weight of the oral product, and (iv) about 0.1% to about 2.5% passion flower by weight of the oral product, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.01重量%至約10重量%之量的L-茶胺酸。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.05重量%至約5重量%之量，較佳佔口服產品之約0.1重量%至約2.5重量%之量的L-茶胺酸。In any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 0.01% to about 10% by weight of the oral product. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 0.05% to about 5% by weight of the oral product, preferably about 0.1% to about 2.5% by weight of the oral product.

在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.001重量%至約10重量%之量的洋甘菊萃取物。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.0025重量%至約5重量%之量，較佳佔口服產品之約0.01重量%至約1重量%之量的洋甘菊萃取物。In any of these embodiments, the combination of active ingredients may further include chamomile extract in an amount of about 0.001% to about 10% by weight of the oral product. For example, in any of these embodiments, the combination of active ingredients may further include chamomile extract in an amount of about 0.0025% to about 5% by weight of the oral product, preferably about 0.01% to about 1% by weight of the oral product.

在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.01重量%至約10重量%之量的聖羅勒。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.05重量%至約5重量%之量，較佳佔口服產品之約0.1重量%至約2.5重量%之量的聖羅勒。In any of these embodiments, the combination of active ingredients may further include holy basil in an amount of about 0.01% to about 10% by weight of the oral product. For example, in any of these embodiments, the combination of active ingredients may further include holy basil in an amount of about 0.05% to about 5% by weight of the oral product, preferably about 0.1% to about 2.5% by weight of the oral product.

在由口服產品中鎂或其鹽、總B族維生素、人參及西番蓮以重量計之量定義的任一實施例中，活性成分之組合可進一步包含佔口服產品之約0.01重量%至約10重量%之量的L-茶胺酸及佔口服產品之約0.001重量%至約10重量%之量的洋甘菊萃取物。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.05重量%至約5重量%之量的L-茶胺酸及佔口服產品之約0.025重量%至約5重量%之量的洋甘菊萃取物，較佳佔口服產品之約0.1重量%至約2.5重量%之量的L-茶胺酸及佔口服產品之約0.01重量%至約1重量%之量的洋甘菊萃取物。In any of the embodiments defined by the amounts by weight of magnesium or its salt, total B vitamins, ginseng, and passion flower in the oral product, the combination of active ingredients may further include L-theanine in an amount of about 0.01% to about 10% by weight of the oral product and chamomile extract in an amount of about 0.001% to about 10% by weight of the oral product. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 0.05% to about 5% by weight of the oral product and chamomile extract in an amount of about 0.025% to about 5% by weight of the oral product, preferably L-theanine in an amount of about 0.1% to about 2.5% by weight of the oral product and chamomile extract in an amount of about 0.01% to about 1% by weight of the oral product.

在由口服產品中鎂或其鹽、總B族維生素、人參及西番蓮以重量計之量定義的任一實施例中，活性成分之組合可進一步包含L-茶胺酸及聖羅勒，各自佔口服產品之約0.01重量%至約10重量%之相應量。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含L-茶胺酸及聖羅勒，各自佔口服產品之約0.05重量%至約5重量%之相應量，較佳各自佔口服產品之約0.1重量%至約2.5重量%之相應量。In any embodiment defined by the amount of magnesium or its salt, total B vitamins, ginseng and passion flower by weight in the oral product, the combination of active ingredients may further include L-theanine and holy basil, each accounting for a corresponding amount of about 0.01% to about 10% by weight of the oral product. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine and holy basil, each accounting for a corresponding amount of about 0.05% to about 5% by weight of the oral product, preferably each accounting for a corresponding amount of about 0.1% to about 2.5% by weight of the oral product.

在由口服產品中鎂或其鹽、總B族維生素、人參及西番蓮以重量計之量定義的任一實施例中，活性成分之組合可進一步包含佔口服產品之約0.01重量%至約10重量%之量的L-茶胺酸及佔口服產品之約0.001重量%至約10重量%之量的洋甘菊萃取物。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔口服產品之約0.05重量%至約5重量%之量的L-茶胺酸及佔口服產品之約0.0025重量%至約5重量%之量的洋甘菊萃取物，較佳佔口服產品之約0.1重量%至約2.5重量%之量的L-茶胺酸及佔口服產品之約0.01重量%至約1重量%之量的洋甘菊萃取物。In any of the embodiments defined by the amounts by weight of magnesium or its salt, total B vitamins, ginseng, and passion flower in the oral product, the combination of active ingredients may further include L-theanine in an amount of about 0.01% to about 10% by weight of the oral product and chamomile extract in an amount of about 0.001% to about 10% by weight of the oral product. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 0.05% to about 5% by weight of the oral product and chamomile extract in an amount of about 0.0025% to about 5% by weight of the oral product, preferably L-theanine in an amount of about 0.1% to about 2.5% by weight of the oral product and chamomile extract in an amount of about 0.01% to about 1% by weight of the oral product.

在一些實施例中，活性成分之組合包含(i)以組合乾重之重量計約10%至約60%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為組合乾重之約0.1重量%至約5重量%，(iii)以組合乾重之重量計約1%至約40%人參，及(iv)以組合乾重之重量計約1%至約40%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 10% to about 60% magnesium or a salt thereof by weight of the combination dry weight, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.1 wt % to about 5 wt % of the combination dry weight, (iii) about 1% to about 40% ginseng by weight of the combination dry weight, and (iv) about 1% to about 40% passion flower by weight of the combination dry weight, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以組合乾重之重量計約15%至約50%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為組合乾重之約0.2重量%至約4重量%，(iii)以組合乾重之重量計約2.5%至約30%人參，及(iv)以組合乾重之重量計約2%至約30%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 15% to about 50% magnesium or a salt thereof by weight of the combination dry weight, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.2% to about 4% by weight of the combination dry weight, (iii) about 2.5% to about 30% ginseng by weight of the combination dry weight, and (iv) about 2% to about 30% passion flower by weight of the combination dry weight, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在一些實施例中，活性成分之組合包含(i)以組合乾重之重量計約20%至約40%鎂或其鹽，(ii) B族維生素之組合，其中B族維生素之總量為組合乾重之約0.4重量%至約2重量%，(iii)以組合乾重之重量計約5%至約20%人參，及(iv)以組合乾重之重量計約5%至約20%西番蓮，其中B族維生素根據上文所論述之任一實施例定義，其包含至少維生素B2及維生素B6，其中鎂或其鹽根據上文所論述之任一實施例定義，且其中該口服產品不含褪黑激素。In some embodiments, the combination of active ingredients comprises (i) about 20% to about 40% magnesium or a salt thereof by weight of the combination dry weight, (ii) a combination of B vitamins, wherein the total amount of B vitamins is about 0.4% to about 2% by weight of the combination dry weight, (iii) about 5% to about 20% ginseng by weight of the combination dry weight, and (iv) about 5% to about 20% passion flower by weight of the combination dry weight, wherein the B vitamins are defined according to any of the embodiments discussed above, including at least vitamin B2 and vitamin B6, wherein magnesium or a salt thereof is defined according to any of the embodiments discussed above, and wherein the oral product does not contain melatonin.

在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約1重量%至約40重量%之量的L-茶胺酸。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約2重量%至約35重量%之量，較佳佔組合乾重之約5重量%至約30重量%之量的L-茶胺酸。In any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 1% to about 40% by weight of the dry weight of the combination. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 2% to about 35% by weight of the dry weight of the combination, preferably about 5% to about 30% by weight of the dry weight of the combination.

在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約0.1重量%至約20重量%之量的洋甘菊萃取物。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約0.5重量%至約15重量%之量，較佳佔組合乾重之約1重量%至約10重量%之量的洋甘菊萃取物。In any of these embodiments, the combination of active ingredients may further include chamomile extract in an amount of about 0.1% to about 20% by weight of the dry weight of the combination. For example, in any of these embodiments, the combination of active ingredients may further include chamomile extract in an amount of about 0.5% to about 15% by weight of the dry weight of the combination, preferably about 1% to about 10% by weight of the dry weight of the combination.

在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約1重量%至約40重量%之量的聖羅勒。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約2重量%至約35重量%之量，較佳佔組合乾重之約5重量%至約30重量%之量的聖羅勒。In any of these embodiments, the combination of active ingredients may further include holy basil in an amount of about 1% to about 40% by weight of the dry weight of the combination. For example, in any of these embodiments, the combination of active ingredients may further include holy basil in an amount of about 2% to about 35% by weight of the dry weight of the combination, preferably about 5% to about 30% by weight of the dry weight of the combination.

在由組合乾重中鎂或其鹽、總B族維生素、人參及西番蓮以重量計之量定義的任一實施例中，活性成分之組合可進一步包含佔組合乾重之約1重量%至約40重量%之量的L-茶胺酸，及佔組合乾重之約0.1重量%至約20重量%之量的洋甘菊萃取物。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含佔組合乾重之約2重量%至約35重量%之量的L-茶胺酸，及佔組合乾重之約0.5重量%至約15重量%之量的洋甘菊萃取物，較佳佔組合乾重之約5重量%至約30重量%之量的L-茶胺酸，及佔組合乾重之約1重量%至約10重量%之量的洋甘菊萃取物。In any of the embodiments defined by the amounts of magnesium or its salt, total B vitamins, ginseng, and passionflower by weight in the dry weight of the combination, the combination of active ingredients may further comprise L-theanine in an amount of about 1% to about 40% by weight of the dry weight of the combination, and chamomile extract in an amount of about 0.1% to about 20% by weight of the dry weight of the combination. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine in an amount of about 2% to about 35% by weight of the dry weight of the combination, and chamomile extract in an amount of about 0.5% to about 15% by weight of the dry weight of the combination, preferably L-theanine in an amount of about 5% to about 30% by weight of the dry weight of the combination, and chamomile extract in an amount of about 1% to about 10% by weight of the dry weight of the combination.

在由組合乾重中鎂或其鹽、總B族維生素、人參及西番蓮以重量計之量定義的任一實施例中，活性成分之組合可進一步包含L-茶胺酸及聖羅勒，各自佔組合乾重之約1重量%至約40重量%之相應量。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含L-茶胺酸及聖羅勒，各自佔組合乾重之約2重量%至約35重量%之相應量，較佳各自佔組合乾重之約5重量%至約30重量%之相應量。In any embodiment defined by the amount of magnesium or its salt, total B vitamins, ginseng and passionflower by weight in the dry weight of the combination, the combination of active ingredients may further include L-theanine and holy basil, each accounting for a corresponding amount of about 1% to about 40% by weight of the dry weight of the combination. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine and holy basil, each accounting for a corresponding amount of about 2% to about 35% by weight of the dry weight of the combination, preferably about 5% to about 30% by weight of the dry weight of the combination.

在由組合乾重中鎂或其鹽、總B族維生素、人參及西番蓮以重量計之量定義的任一實施例中，活性成分之組合可進一步包含各自佔組合乾重之約1重量%至約40重量%之相應量的L-茶胺酸及聖羅勒，及佔組合乾重之約0.1重量%至約20重量%之量的洋甘菊萃取物。舉例而言，在此等實施例中之任一者中，活性成分之組合可進一步包含各自佔組合乾重之約2重量%至約35重量%之相應量的L-茶胺酸及聖羅勒，及佔組合乾重之約0.5重量%至約15重量%之量的洋甘菊萃取物，較佳各自佔組合乾重之約5重量%至約30重量%之相應量的L-茶胺酸及聖羅勒，及佔組合乾重之約1重量%至約10重量%之量的洋甘菊萃取物。In any of the embodiments defined by the amounts of magnesium or its salt, total B vitamins, ginseng, and passionflower by weight in the dry weight of the combination, the combination of active ingredients may further comprise respective amounts of L-theanine and holy basil, each in an amount of about 1% to about 40% by weight of the dry weight of the combination, and chamomile extract in an amount of about 0.1% to about 20% by weight of the dry weight of the combination. For example, in any of these embodiments, the combination of active ingredients may further include L-theanine and holy basil in respective amounts of about 2% to about 35% by weight of the dry weight of the combination, and chamomile extract in an amount of about 0.5% to about 15% by weight of the dry weight of the combination, preferably L-theanine and holy basil in respective amounts of about 5% to about 30% by weight of the dry weight of the combination, and chamomile extract in an amount of about 1% to about 10% by weight of the dry weight of the combination.

在以上實施例中之任一者中，人參較佳呈高麗參(韓國人參)存在。In any of the above embodiments, ginseng is preferably present as Korean ginseng.

本發明人已發現，如以上所描述之活性成分之量提供促進睡眠之有益作用，包括誘導睡眠及/或維持睡眠，同時提供副作用減少之安全產品。該等量可經調整以使得產品具有高功效，同時亦確保消費者安全且避免任何過量之活性劑。The inventors have found that the amount of active ingredients as described above provides beneficial effects of promoting sleep, including inducing sleep and/or maintaining sleep, while providing a safe product with reduced side effects. Such amounts can be adjusted to make the product highly effective while also ensuring consumer safety and avoiding any excess of active agents.

除以上描述之額外活性劑外，下文亦描述其他適合之額外活性成分。In addition to the additional active agents described above, other suitable additional active ingredients are also described below.

在一些實施例中，活性成分之組合進一步包含植物性活性成分。如本文所用，術語「植物性成分」或「植物性藥材」係指任何植物材料或真菌來源之材料，包括呈天然形式之植物材料及來源於天然植物材料之植物材料，諸如來自植物材料或經處理植物材料(例如經歷熱處理、醱酵、漂白或其他能夠改變材料之物理及/或化學性質之處理程序的植物材料)的萃取物或分離物。出於本揭露內容之目的，「植物性藥材」包括但不限於「草本材料」，係指產種子植物，該等植物不會發育持久的本質組織且通常因其藥用或感官特徵而具有價值(例如茶或草本茶)。可用於本揭露內容中的植物性材料可包含但不限於本文所闡述之化合物及來源中之任一者，包括其混合物。此類型的某些植物性材料有時稱為膳食補充劑、營養藥劑、「植物化學成分」或「功能食品」。已發現某些植物性藥材，如植物材料或其萃取物，用於傳統草藥醫學中，且將在本文中進一步描述。植物性藥材或植物性藥材來源之材料的非限制性實例包括假馬齒莧、木棉、羅勒、積雪草(Centella asiatica)、柴胡(Chai-hu)、櫻花、葉綠素、肉桂、柑橘、丁香、可可、蟲草、薑黃素、達米阿那(damiana)、心葉琉桑(Dorstenia arifolia)、香琉桑(Dorstenia odorata)、精油、桉樹、茴香、金英(Galphimia glauca)、薑、銀杏(Ginkgo biloba)、加納穀物(Grif.fonia simplicifolia)、大麻、漢麻、蛇麻(hop)、茉莉、小花山柰(Kaempferia parviflora)(泰國人參)、卡瓦胡椒(kava)、薰衣草、檸檬香草、檸檬草、甘草、葉黃素、抹茶、匙葉甘松(Nardostachys chinensis)、香堇菜(Viola odorata)之油基萃取物、胡椒薄荷、槲皮素、白藜蘆醇、天麻(Rhizoma gastrodiae)、厄瓜多爾茶(Guyasa)、抹茶、甜菜汁、紅景天(Rhodiola)、路易波士茶(rooibos)、玫瑰精油、迷迭香、扭曲松葉菊(Sceletium tortuosum)、五味子、黃芩、綠薄荷萃取物、甘松香油、萜烯、草本茶、薑黃、達米阿那(Turnera aphrodisiaca)、白桑、紫花馬蘭菊及瑪黛茶。如本文所描述，口服產品不含褪黑激素。In some embodiments, the combination of active ingredients further comprises a botanical active ingredient. As used herein, the term "botanical ingredient" or "botanical material" refers to any plant material or fungal-derived material, including plant material in natural form and plant material derived from natural plant material, such as extracts or isolates from plant material or processed plant material (e.g., plant material that has undergone heat treatment, fermentation, bleaching or other treatment procedures that can change the physical and/or chemical properties of the material). For the purposes of the present disclosure, "botanical material" includes but is not limited to "herbal material", which refers to seed-producing plants that do not develop persistent native tissues and are generally valued for their medicinal or sensory characteristics (e.g., tea or herbal tea). Botanical materials that can be used in the present disclosure may include but are not limited to any of the compounds and sources described herein, including mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals," or "functional foods." Certain botanicals, such as plant materials or extracts thereof, have been found to be used in traditional herbal medicine and are described further herein. Non-limiting examples of botanicals or botanical-derived materials include Bacopa ovata, Kapok, Basil,Centella asiatica , Chai-hu, cherry blossom, chlorophyll, cinnamon, citrus, clove, cocoa, cordyceps, curcumin, damiana,Dorstenia arifolia ,Dorstenia odorata , essential oils, eucalyptus, fennel,Galphimia glauca , ginger,Ginkgo biloba ,Griffonia simplicifolia , cannabis, hemp, hops, jasmine,Kaempferia parviflora , ) (Thai ginseng), kava, lavender, lemongrass, lemongrass, licorice, lutein, matcha, Nardostachys chinensis,Viola odorata oil-based extract, peppermint, quercetin, resveratrol,Rhizoma gastrodiae ,Guyasa , matcha, beet juice,Rhodiola , rooibos, rose essential oil, rosemary,Sceletium tortuosum , Schisandra, skullcap, spearmint extract, spikenard essential oil, terpenes, herbal tea, turmeric,Turnera aphrodisiaca , white mulberry, chamomile, and mate. As described herein, oral products do not contain melatonin.

在一些實施例中，活性成分之組合進一步包含紫花馬蘭菊，其為雛菊科中草本開花植物的一個屬，通常稱為金光菊屬。在存在之情況下，紫花馬蘭菊可以口服產品之約0.001%至約3重量%，且較佳口服產品之約0.01%至約1重量%之量存在。In some embodiments, the combination of active ingredients further comprises Rudbeckia rutaecarpa, which is a genus of herbaceous flowering plants in the family Asteraceae, commonly known as the genus Rudbeckia. Where present, Rudbeckia rutaecarpa can be present in an amount of about 0.001% to about 3% by weight of the oral product, and preferably about 0.01% to about 1% by weight of the oral product.

活性成分之組合可進一步包含選自以下之維生素：維生素A、維生素D、維生素E及維生素K，或其混合物。在一些較佳實施例中，活性成分之組合進一步包含維生素D，任擇地其量為口服產品之約0.00001重量%至約0.1重量%。The combination of active ingredients may further include a vitamin selected from the following: vitamin A, vitamin D, vitamin E and vitamin K, or a mixture thereof. In some preferred embodiments, the combination of active ingredients further includes vitamin D, optionally in an amount of about 0.00001% to about 0.1% by weight of the oral product.

活性成分之組合可進一步包含胺基酸，諸如選自由以下組成之群的胺基酸：丙胺酸、精胺酸、天冬醯胺、天冬胺酸、β-丙胺酸、半胱胺酸、麩醯胺酸、麩胺酸、甘胺酸、組胺酸、異白胺酸、白胺酸、離胺酸、甲硫胺酸、苯丙胺酸、脯胺酸、絲胺酸、蘇胺酸、色胺酸、酪胺酸、纈胺酸及羥脯胺酸。在一些實施例中，活性成分之組合包含L-甘胺酸。The combination of active ingredients may further comprise amino acids, such as amino acids selected from the group consisting of alanine, arginine, asparagine, aspartic acid, β-alanine, cysteine, glutamine, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine and hydroxyproline. In some embodiments, the combination of active ingredients comprises L-glycine.

在一些實施例中，活性成分之組合包含大麻鹼。大麻鹼可為大麻之衍生物或萃取物。大麻鹼係一類天然或合成化合物，其作用於細胞中的大麻鹼受體(亦即，CB1及CB2)，該等大麻鹼受體抑制腦釋放神經傳遞質。大麻鹼為環狀分子，其展現特定的特性，諸如容易穿越血腦障壁的能力。大麻鹼可天然存在於諸如大麻等植物(植物大麻鹼)、動物(內源大麻鹼)中，或人工製造(合成大麻鹼)。大麻物種表現至少85種不同的植物大麻鹼，且此等可分成亞類，包括大麻萜酚(cannabigerol)、大麻環萜酚(cannabichromene)、大麻二酚、四氫大麻酚、大麻酚及脫氫大麻二酚，以及其他大麻鹼。在一些實施例中，大麻鹼係選自由以下組成之群：大麻萜酚(CBG)、大麻環萜酚(CBC)、大麻二酚(CBD)、四氫大麻酚(THC)、大麻酚(CBN)及脫氫大麻二酚(CBDL)、大麻環酚(CBL)、次大麻酚(CBV)、四氫次大麻酚(THCV)、次大麻二酚(CBDV)、次大麻色酚(CBCV)、次大麻萜酚(CBGV)、大麻萜酚單甲醚(CBGM)、大麻橙花酸(cannabinerolic acid)、大麻二酚酸(CBDA)、大麻酚丙基變異體(CBNV)、大麻三酚(CBO)、四氫大麻酚酸(THCA)、四氫次大麻酚酸(THCV A)及其混合物。在一些實施例中，大麻鹼係或包含至少四氫大麻酚(THC)。在一些實施例中，大麻鹼係或包含至少大麻二酚(CBD)。In some embodiments, the combination of active ingredients includes cannabinoids. Cannabinoids can be derivatives or extracts of cannabis. Cannabinoids are a class of natural or synthetic compounds that act on cannabinoid receptors (i.e., CB1 and CB2) in cells, which inhibit the release of neurotransmitters from the brain. Cannabinoids are ring-shaped molecules that exhibit specific properties, such as the ability to easily cross the blood-brain barrier. Cannabinoids can occur naturally in plants such as cannabis (phytocannabinoids), animals (endogenous cannabinoids), or be artificially produced (synthetic cannabinoids). Cannabis species express at least 85 different phytocannabinoids, and these can be divided into subclasses, including cannabigerol, cannabichromene, cannabidiol, tetrahydrocannabinol, cannabinol, and dehydrocannabidiol, as well as other cannabinoids. In some embodiments, the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and dehydrocannabidiol (CBDL), cannabichromene (CBL), cannabinol (CBV), tetrahydrocannabinol (THCV), cannabichromene (CBDV), cannabichromene (CBCV), cannabigerol (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid (cannabinerolic acid), cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannatriol (CBO), tetrahydrocannabinolic acid (THCA), tetrahydrocannabinolic acid (THCV A) and mixtures thereof. In some embodiments, the cannabinoid is or comprises at least tetrahydrocannabinol (THC). In some embodiments, the cannabinoid is or comprises at least cannabidiol (CBD).

在一些實施例中，活性成分之組合包含佔口服產品之至少約0.001重量%，諸如在約0.001重量%至約10重量%範圍內，諸如約0.01重量%至約5重量%，諸如約0.1重量%至約2.5重量%，諸如佔口服產品之0.5重量%至約1重量%之量的大麻鹼(諸如大麻二酚)。In some embodiments, the combination of active ingredients comprises a cannabinoid (such as cannabidiol) in an amount of at least about 0.001% by weight of the oral product, such as in the range of about 0.001% to about 10% by weight, such as about 0.01% to about 5% by weight, such as about 0.1% to about 2.5% by weight, such as 0.5% to about 1% by weight of the oral product.

在一些實施例中，活性成分之組合包含電解質。電解質係含有離子之介質，其透過彼等離子之移動而導電。此包括溶解於諸如水之極性溶劑中的大多數可溶性鹽、酸及鹼。在溶解時，物質分成陽離子及陰離子，均勻地分散於整個溶劑中。在口服補液療法中，含有鈉鹽及鉀鹽之電解質飲料在由例如運動、過量飲酒、發汗、腹瀉、嘔吐、中毒或饑餓引起之脫水之後補充身體之水及電解質濃度。在一些實施例中，活性成分之組合包含電解質，任擇地，其中該電解質包含鈉鹽及/或鉀鹽。在存在之情況下，包括的電解質可為佔口服產品之0.01重量%至約30重量%，諸如口服產品之0.1重量%至約20重量%或約0.5重量%至約10重量%之量。In some embodiments, the combination of active ingredients includes an electrolyte. An electrolyte is a medium containing ions that conducts electricity by the movement of those ions. This includes most soluble salts, acids, and bases that dissolve in polar solvents such as water. Upon dissolution, the substance separates into cations and anions that are evenly dispersed throughout the solvent. In oral rehydration therapy, electrolyte drinks containing sodium and potassium salts replenish the body's water and electrolyte concentrations after dehydration caused by, for example, exercise, excessive drinking, sweating, diarrhea, vomiting, poisoning, or hunger. In some embodiments, the combination of active ingredients comprises an electrolyte, optionally wherein the electrolyte comprises a sodium salt and/or a potassium salt. Where present, the electrolyte may be included in an amount of 0.01% to about 30% by weight of the oral product, such as 0.1% to about 20% or about 0.5% to about 10% by weight of the oral product.

為避免疑問，本揭露內容明確設想上述端點之組合。此適用於本文所揭露之任一範圍。活性成分之比率For the avoidance of doubt, the present disclosure expressly contemplates combinations of the above endpoints. This applies to any range disclosed herein.Ratio of active ingredients

口服產品中活性成分之比率可經選擇以增加口服產品對消費者之作用。此為本揭露內容之特別有利的態樣。The ratio of active ingredients in an oral product can be selected to increase the effect of the oral product on the consumer. This is a particularly advantageous aspect of the present disclosure.

在一些實施例中，鎂或其鹽及總B族維生素以約250:1至約10:1，諸如約200:1至約25:1，較佳約200:1至約50:1之重量比存在。In some embodiments, magnesium or a salt thereof and total B vitamins are present in a weight ratio of about 250:1 to about 10:1, such as about 200:1 to about 25:1, preferably about 200:1 to about 50:1.

在一些實施例中，鎂或其鹽及人參以約10:1至約1:10，諸如約5:1至約1:5，較佳約5:1至約1:1之重量比存在。在一些實施例中，鎂或其鹽及人參以約10:1至約1:10，諸如約10:1至約1:5，較佳約10:1至約1:1之重量比存在。In some embodiments, magnesium or its salt and ginseng are present in a weight ratio of about 10: 1 to about 1: 10, such as about 5: 1 to about 1: 5, preferably about 5: 1 to about 1: 1. In some embodiments, magnesium or its salt and ginseng are present in a weight ratio of about 10: 1 to about 1: 10, such as about 10: 1 to about 1: 5, preferably about 10: 1 to about 1: 1.

在一些實施例中，鎂或其鹽及西番蓮以約10:1至約1:10，諸如約5:1至約1:5，較佳約5:1至約1:1之重量比存在。In some embodiments, magnesium or a salt thereof and passion flower are present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, preferably about 5:1 to about 1:1.

在一些實施例中，人參及總B族維生素以約100:1至約10:1，諸如約75:1至約15:1，較佳約50:1至約25:1之重量比存在。在一些實施例中，人參及總B族維生素以約50:1至約1:1，諸如約30:1至約2:1，較佳約25:1至約5:1之重量比存在。In some embodiments, ginseng and total B vitamins are present in a weight ratio of about 100: 1 to about 10: 1, such as about 75: 1 to about 15: 1, preferably about 50: 1 to about 25: 1. In some embodiments, ginseng and total B vitamins are present in a weight ratio of about 50: 1 to about 1: 1, such as about 30: 1 to about 2: 1, preferably about 25: 1 to about 5: 1.

在一些實施例中，人參及西番蓮以約10:1至約1:10，諸如約5:1至約1:5，較佳約3:1至約1:5之重量比存在。In some embodiments, ginseng and passion flower are present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, preferably about 3:1 to about 1:5.

在一些實施例中，西番蓮及總B族維生素以約100:1至約10:1，諸如約80:1至約15:1，較佳約75:1至約25:1之重量比存在。在一些實施例中，西番蓮及總B族維生素以約100:1至約10:1，諸如約80:1至約15:1，較佳約75:1至約20:1之重量比存在。In some embodiments, passion flower and total B vitamins are present in a weight ratio of about 100: 1 to about 10: 1, such as about 80: 1 to about 15: 1, preferably about 75: 1 to about 25: 1. In some embodiments, passion flower and total B vitamins are present in a weight ratio of about 100: 1 to about 10: 1, such as about 80: 1 to about 15: 1, preferably about 75: 1 to about 20: 1.

在一些實施例中，活性劑之組合可包括L-茶胺酸，且鎂或其鹽及L-茶胺酸可以約10:1至約1:10，諸如約10:1至約1:5，較佳約10:1至約1:1之重量比存在。在此類實施例中，人參及L-茶胺酸可以約10:1至約1:10，諸如約5:1至約1:5，較佳約2:1至約1:4之重量比存在。在此類實施例中，西番蓮及L-茶胺酸可以約10:1至約1:10，諸如約5:1至約1:5，較佳約3:1至約1:3之重量比存在。在此類實施例中，總B族維生素及L-茶胺酸可以約2:1至約1:1000，諸如約1:1至約1:500，較佳約1:2至約1:200之重量比存在。In some embodiments, the combination of active agents may include L-theanine, and magnesium or a salt thereof and L-theanine may be present in a weight ratio of about 10:1 to about 1:10, such as about 10:1 to about 1:5, preferably about 10:1 to about 1:1. In such embodiments, ginseng and L-theanine may be present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, preferably about 2:1 to about 1:4. In such embodiments, passionflower and L-theanine may be present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, preferably about 3:1 to about 1:3. In such embodiments, total B vitamins and L-theanine may be present in a weight ratio of about 2:1 to about 1:1000, such as about 1:1 to about 1:500, preferably about 1:2 to about 1:200.

在一些實施例中，活性劑之組合可包含洋甘菊萃取物，且鎂或其鹽及洋甘菊萃取物可以約50:1至約1:10，諸如約35:1至約1:1，較佳約25:1至約5:1之重量比存在。在此類實施例中，人參及洋甘菊萃取物可以約20:1至約1:5，諸如約15:1至約1:2，較佳約10:1至約1:1之重量比存在。在此類實施例中，西番蓮及洋甘菊萃取物可以約25:1至約1:5，諸如約20:1至約1:2，較佳約15:1至約1:1之重量比存在。在此類實施例中，總B族維生素及洋甘菊萃取物可以約2:1至約1:100，諸如約1:1至約1:50，較佳約1:2至約1:25之重量比存在。In some embodiments, the combination of active agents may include chamomile extract, and magnesium or a salt thereof and chamomile extract may be present in a weight ratio of about 50:1 to about 1:10, such as about 35:1 to about 1:1, preferably about 25:1 to about 5:1. In such embodiments, ginseng and chamomile extract may be present in a weight ratio of about 20:1 to about 1:5, such as about 15:1 to about 1:2, preferably about 10:1 to about 1:1. In such embodiments, passionflower and chamomile extract may be present in a weight ratio of about 25:1 to about 1:5, such as about 20:1 to about 1:2, preferably about 15:1 to about 1:1. In such embodiments, total B vitamins and chamomile extract may be present in a weight ratio of about 2:1 to about 1:100, such as about 1:1 to about 1:50, preferably about 1:2 to about 1:25.

在此類實施例中，活性劑之組合可進一步包含L-茶胺酸且L-茶胺酸及洋甘菊萃取物可以約25:1至約1:5，諸如約20:1至約1:2，較佳約15:1至約1:1之重量比存在。In such embodiments, the combination of active agents may further comprise L-theanine and the L-theanine and chamomile extract may be present in a weight ratio of about 25:1 to about 1:5, such as about 20:1 to about 1:2, preferably about 15:1 to about 1:1.

在一些實施例中，活性劑之組合可包含聖羅勒，且鎂或其鹽及聖羅勒可以約25:1至約1:5，諸如約10:1至約1:2，較佳約5:1至約1:1之重量比存在。在此類實施例中，人參及聖羅勒可以約10:1至約1:10，諸如約5:1至約1:5，較佳約4:1至約1:4之重量比存在。在此類實施例中，西番蓮及聖羅勒可以約10:1至約1:10，諸如約5:1至約1:5，較佳約4:1至約1:4之重量比存在。在此類實施例中，總B族維生素及聖羅勒可以約2:1至約1:1000，諸如約1:1至約1:500，較佳約1:2至約1:200之重量比存在。In some embodiments, the combination of active agents may include holy basil, and magnesium or its salt and holy basil may be present in a weight ratio of about 25:1 to about 1:5, such as about 10:1 to about 1:2, preferably about 5:1 to about 1:1. In such embodiments, ginseng and holy basil may be present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, preferably about 4:1 to about 1:4. In such embodiments, passionflower and holy basil may be present in a weight ratio of about 10:1 to about 1:10, such as about 5:1 to about 1:5, preferably about 4:1 to about 1:4. In such embodiments, total B vitamins and holy basil may be present in a weight ratio of about 2:1 to about 1:1000, such as about 1:1 to about 1:500, preferably about 1:2 to about 1:200.

在一些實施例中，活性劑之組合可包含L-茶胺酸及聖羅勒且L-茶胺酸及聖羅勒可以約10:1至約1:10，諸如約5:1至約1:5，較佳約4:1至約1:4之重量比存在。在此類實施例中，其他活性劑之重量比可根據以上實施例定義。In some embodiments, the combination of active agents may include L-theanine and holy basil and L-theanine and holy basil may be present in a weight ratio of about 10: 1 to about 1: 10, such as about 5: 1 to about 1: 5, preferably about 4: 1 to about 1: 4. In such embodiments, the weight ratio of other active agents may be defined according to the above embodiments.

在一些實施例中，活性劑之組合可包含洋甘菊萃取物及聖羅勒，且洋甘菊萃取物及聖羅勒可以約2:1至約1:1000，諸如約1:1至約1:100，較佳約1:2至約1:50之重量比存在。在此類實施例中，其他活性劑之重量比可根據以上實施例定義。In some embodiments, the combination of active agents may include chamomile extract and holy basil, and the chamomile extract and holy basil may be present in a weight ratio of about 2:1 to about 1:1000, such as about 1:1 to about 1:100, preferably about 1:2 to about 1:50. In such embodiments, the weight ratio of other active agents may be defined according to the above embodiments.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約50:1至約1:10；其中鎂或其鹽與B族維生素之總量之重量比為約250:1至約10:1；且任擇地其中人參與B族維生素之總量之重量比為約100:1至約10:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 50:1 to about 1:10; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 250:1 to about 10:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 100:1 to about 10:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:10；其中鎂或其鹽與B族維生素之總量之重量比為約250:1至約10:1；且任擇地其中人參與B族維生素之總量之重量比為約100:1至約10:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:10; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 250:1 to about 10:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 100:1 to about 10:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:10；其中鎂或其鹽與B族維生素之總量之重量比為約250:1至約10:1；且任擇地其中人參與B族維生素之總量之重量比為約50:1至約1:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:10; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 250:1 to about 10:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 50:1 to about 1:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約25:1至約1:5；其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約25:1；且任擇地其中人參與B族維生素之總量之重量比為約75:1至約15:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 25:1 to about 1:5; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 200:1 to about 25:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 75:1 to about 15:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約5:1至約1:5；其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約25:1；且任擇地其中人參與B族維生素之總量之重量比為約75:1至約15:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 5:1 to about 1:5; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 200:1 to about 25:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 75:1 to about 15:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約5:1至約1:5；其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約25:1；且任擇地其中人參與B族維生素之總量之重量比為約30:1至約2:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 5:1 to about 1:5; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 200:1 to about 25:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 30:1 to about 2:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:1；其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約50:1；且任擇地其中人參與B族維生素之總量之重量比為約50:1至約25:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:1; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 200:1 to about 50:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 50:1 to about 25:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:1；其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約50:1；且任擇地其中人參與B族維生素之總量之重量比為約25:1至約5:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:1; wherein the weight ratio of magnesium or a salt thereof to the total amount of B vitamins is about 200:1 to about 50:1; and optionally wherein the weight ratio of ginseng to the total amount of B vitamins is about 25:1 to about 5:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與B族維生素之總量之重量比為約250:1至約10:1；其中鎂或其鹽與西番蓮之重量比為約50:1至約10:1；且任擇地其中西番蓮與B族維生素之總量之重量比為約100:1至約10:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to the total amount of the B vitamins is from about 250:1 to about 10:1; wherein the weight ratio of magnesium or a salt thereof to passion flower is from about 50:1 to about 10:1; and optionally wherein the weight ratio of passion flower to the total amount of the B vitamins is from about 100:1 to about 10:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約25:1；其中鎂或其鹽與西番蓮之重量比為約25:1至約1:5；且任擇地其中西番蓮與B族維生素之總量之重量比為約80:1至約15:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to the total amount of the B vitamins is from about 200:1 to about 25:1; wherein the weight ratio of magnesium or a salt thereof to passion flower is from about 25:1 to about 1:5; and optionally wherein the weight ratio of passion flower to the total amount of the B vitamins is from about 80:1 to about 15:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約50:1；其中鎂或其鹽與西番蓮之重量比為約10:1至約1:1；且任擇地其中西番蓮與B族維生素之總量之重量比為約75:1至約25:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to the total amount of the B vitamins is from about 200:1 to about 50:1; wherein the weight ratio of magnesium or a salt thereof to passion flower is from about 10:1 to about 1:1; and optionally wherein the weight ratio of passion flower to the total amount of the B vitamins is from about 75:1 to about 25:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與B族維生素之總量之重量比為約200:1至約50:1；其中鎂或其鹽與西番蓮之重量比為約10:1至約1:1；且任擇地其中西番蓮與B族維生素之總量之重量比為約75:1至約20:1，其中B族維生素之組合如任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to the total amount of the B vitamins is from about 200:1 to about 50:1; wherein the weight ratio of magnesium or a salt thereof to passion flower is from about 10:1 to about 1:1; and optionally wherein the weight ratio of passion flower to the total amount of the B vitamins is from about 75:1 to about 20:1, wherein the combination of B vitamins is as described in any embodiment, wherein magnesium or a salt thereof is described in any embodiment above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中人參與B族維生素之總量之重量比為約100:1至約10:1；其中人參與西番蓮之重量比為約10:1至約1:10；且任擇地其中西番蓮與B族維生素之總量之重量比為約100:1至約10:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of the total amount of ginseng to the B vitamins is about 100:1 to about 10:1; wherein the weight ratio of ginseng to passion flower is about 10:1 to about 1:10; and optionally wherein the weight ratio of passion flower to the total amount of B vitamins is about 100:1 to about 10:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中人參與B族維生素之總量之重量比為約50:1至約1:1；其中人參與西番蓮之重量比為約10:1至約1:10；且任擇地其中西番蓮與B族維生素之總量之重量比為約100:1至約10:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of the total amount of ginseng to the B vitamins is about 50:1 to about 1:1; wherein the weight ratio of ginseng to passion flower is about 10:1 to about 1:10; and optionally wherein the weight ratio of passion flower to the total amount of B vitamins is about 100:1 to about 10:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中人參與B族維生素之總量之重量比為約75:1至約15:1；其中人參與西番蓮之重量比為約5:1至約1:5；且任擇地其中西番蓮與B族維生素之總量之重量比為約80:1至約15:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of the total amount of ginseng to the B vitamins is about 75:1 to about 15:1; wherein the weight ratio of ginseng to passion flower is about 5:1 to about 1:5; and optionally wherein the weight ratio of passion flower to the total amount of B vitamins is about 80:1 to about 15:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中人參與B族維生素之總量之重量比為約30:1至約2:1；其中人參與西番蓮之重量比為約5:1至約1:5；且任擇地其中西番蓮與B族維生素之總量之重量比為約80:1至約15:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of the total amount of ginseng to the B vitamins is about 30:1 to about 2:1; wherein the weight ratio of ginseng to passion flower is about 5:1 to about 1:5; and optionally wherein the weight ratio of passion flower to the total amount of B vitamins is about 80:1 to about 15:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中人參與B族維生素之總量之重量比為約50:1至約25:1；其中人參與西番蓮之重量比為約3:1至約1:3；且任擇地其中西番蓮與B族維生素之總量之重量比為約75:1至約25:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of the total amount of ginseng to the B vitamins is about 50:1 to about 25:1; wherein the weight ratio of ginseng to passion flower is about 3:1 to about 1:3; and optionally wherein the weight ratio of passion flower to the total amount of B vitamins is about 75:1 to about 25:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中人參與B族維生素之總量之重量比為約25:1至約5:1；其中人參與西番蓮之重量比為約3:1至約1:3；且任擇地其中西番蓮與B族維生素之總量之重量比為約75:1至約20:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of the total amount of ginseng to the B vitamins is about 25:1 to about 5:1; wherein the weight ratio of ginseng to passion flower is about 3:1 to about 1:3; and optionally wherein the weight ratio of passion flower to the total amount of B vitamins is about 75:1 to about 20:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約50:1至約1:10；其中鎂或其鹽與西番蓮之重量比為約50:1至約1:10；且任擇地其中人參與西番蓮之重量比為約10:1至約1:10，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 50:1 to about 1:10; wherein the weight ratio of magnesium or a salt thereof to passion flower is about 50:1 to about 1:10; and optionally wherein the weight ratio of ginseng to passion flower is about 10:1 to about 1:10, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:10；其中鎂或其鹽與西番蓮之重量比為約10:1至約1:10；且任擇地其中人參與西番蓮之重量比為約10:1至約1:10，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:10; wherein the weight ratio of magnesium or a salt thereof to passion flower is about 10:1 to about 1:10; and optionally wherein the weight ratio of ginseng to passion flower is about 10:1 to about 1:10, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約25:1至約1:5；其中鎂或其鹽與西番蓮之重量比為約25:1至約1:5；且任擇地其中人參與西番蓮之重量比為約5:1至約1:5，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 25:1 to about 1:5; wherein the weight ratio of magnesium or a salt thereof to passion flower is about 25:1 to about 1:5; and optionally wherein the weight ratio of ginseng to passion flower is about 5:1 to about 1:5, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:5；其中鎂或其鹽與西番蓮之重量比為約5:1至約1:5；且任擇地其中人參與西番蓮之重量比為約5:1至約1:5，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:5; wherein the weight ratio of magnesium or a salt thereof to passion flower is about 5:1 to about 1:5; and optionally wherein the weight ratio of ginseng to passion flower is about 5:1 to about 1:5, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:1；其中鎂或其鹽與西番蓮之重量比為約10:1至約1:1；且任擇地其中人參與西番蓮之重量比為約3:1至約1:3，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:1; wherein the weight ratio of magnesium or a salt thereof to passion flower is about 10:1 to about 1:1; and optionally wherein the weight ratio of ginseng to passion flower is about 3:1 to about 1:3, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參及(iv)西番蓮，其中鎂或其鹽與人參之重量比為約10:1至約1:1；其中鎂或其鹽與西番蓮之重量比為約5:1至約1:1；且任擇地其中人參與西番蓮之重量比為約3:1至約1:2，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, and (iv) passion flower, wherein the weight ratio of magnesium or a salt thereof to ginseng is about 10:1 to about 1:1; wherein the weight ratio of magnesium or a salt thereof to passion flower is about 5:1 to about 1:1; and optionally wherein the weight ratio of ginseng to passion flower is about 3:1 to about 1:2, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在以上實施例中之任一者中，口服產品可進一步包含(v) L-茶胺酸，其中鎂或其鹽與L-茶胺酸之重量比為約10:1至約1:10，較佳約10:1至約1:1。In any of the above embodiments, the oral product may further comprise (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to L-theanine is about 10:1 to about 1:10, preferably about 10:1 to about 1:1.

在以上實施例中之任一者中，口服產品可進一步包含(vi)洋甘菊萃取物，及/或(vii)聖羅勒，其中鎂或其鹽與洋甘菊萃取物之重量比為約50:1至約1:10，及/或其中鎂或其鹽與聖羅勒之重量比為約25:1至約1:5。In any of the above embodiments, the oral product may further comprise (vi) chamomile extract, and/or (vii) holy basil, wherein the weight ratio of magnesium or its salt to chamomile extract is about 50:1 to about 1:10, and/or wherein the weight ratio of magnesium or its salt to holy basil is about 25:1 to about 1:5.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參、(iv)西番蓮及(v) L-茶胺酸，其中鎂或其鹽與西番蓮之重量比為約50:1至約1:10；其中人參與西番蓮之重量比為約10:1至約1:10；且其中鎂或其鹽與L-茶胺酸之重量比為約10:1至約1:10，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passion flower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passion flower is about 50:1 to about 1:10; wherein the weight ratio of ginseng to passion flower is about 10:1 to about 1:10; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is about 10:1 to about 1:10, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參、(iv)西番蓮及(v) L-茶胺酸，其中鎂或其鹽與西番蓮之重量比為約10:1至約1:10；其中人參與西番蓮之重量比為約10:1至約1:10；且其中鎂或其鹽與L-茶胺酸之重量比為約10:1至約1:10，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passion flower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passion flower is about 10:1 to about 1:10; wherein the weight ratio of ginseng to passion flower is about 10:1 to about 1:10; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is about 10:1 to about 1:10, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參、(iv)西番蓮及(v) L-茶胺酸，其中鎂或其鹽與西番蓮之重量比為約25:1至約1:5；其中人參與西番蓮之重量比為約5:1至約1:5；且其中鎂或其鹽與L-茶胺酸之重量比為約10:1至約1:5，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passion flower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passion flower is about 25:1 to about 1:5; wherein the weight ratio of ginseng to passion flower is about 5:1 to about 1:5; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is about 10:1 to about 1:5, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參、(iv)西番蓮及(v) L-茶胺酸，其中鎂或其鹽與西番蓮之重量比為約5:1至約1:5；其中人參與西番蓮之重量比為約5:1至約1:5；且其中鎂或其鹽與L-茶胺酸之重量比為約10:1至約1:5，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passion flower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passion flower is about 5:1 to about 1:5; wherein the weight ratio of ginseng to passion flower is about 5:1 to about 1:5; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is about 10:1 to about 1:5, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在一些實施例中，口服產品包含活性成分之組合，該活性成分之組合包含：(i)鎂或其鹽、(ii) B族維生素之組合、(iii)人參、(iv)西番蓮及(v) L-茶胺酸，其中鎂或其鹽與西番蓮之重量比為約10:1至約1:1；其中人參與西番蓮之重量比為約3:1至約1:3；且其中鎂或其鹽與L-茶胺酸之重量比為約10:1至約1:1，其中B族維生素之組合如上文任一實施例中所描述，其中鎂或其鹽在上文任一實施例中描述，且其中該口服產品不含褪黑激素。In some embodiments, the oral product comprises a combination of active ingredients comprising: (i) magnesium or a salt thereof, (ii) a combination of B vitamins, (iii) ginseng, (iv) passion flower, and (v) L-theanine, wherein the weight ratio of magnesium or a salt thereof to passion flower is about 10:1 to about 1:1; wherein the weight ratio of ginseng to passion flower is about 3:1 to about 1:3; and wherein the weight ratio of magnesium or a salt thereof to L-theanine is about 10:1 to about 1:1, wherein the combination of B vitamins is as described in any of the embodiments above, wherein magnesium or a salt thereof is as described in any of the embodiments above, and wherein the oral product does not contain melatonin.

在以上實施例中之任一者中，口服產品可進一步包含(vi)洋甘菊萃取物，及/或(vii)聖羅勒，其中鎂或其鹽與洋甘菊萃取物之重量比為約50:1至約1:10，及/或其中鎂或其鹽與聖羅勒之重量比為約25:1至約1:5。In any of the above embodiments, the oral product may further comprise (vi) chamomile extract, and/or (vii) holy basil, wherein the weight ratio of magnesium or its salt to chamomile extract is about 50:1 to about 1:10, and/or wherein the weight ratio of magnesium or its salt to holy basil is about 25:1 to about 1:5.

在以上實施例中，人參較佳呈高麗參(韓國人參)存在。 添加劑In the above embodiments, ginseng is preferably present in the form of Korean ginseng.Additives

視所加工之口服產品的類型而定，該產品除包括活性成分之組合外，亦可包括一或多種額外組分。舉例而言，口服產品可進一步包含選自由以下組成之群的添加劑：調味劑、甜味劑、緩衝劑、酸化劑、增稠劑、填充劑、黏合劑、保濕劑、防腐劑、鹽、著色劑、口腔護理添加劑、崩解助劑、抗氧化劑、水或其混合物。在一些實施例中，該口服產品進一步包含一或多種選自由以下組成之群的添加劑：調味劑、甜味劑、酸化劑、增稠劑、填充劑、黏合劑、保濕劑、防腐劑及其混合物。填充劑Depending on the type of oral product being processed, the product may include one or more additional components in addition to the combination of active ingredients. For example, the oral product may further include an additive selected from the group consisting of flavorings, sweeteners, buffers, acidulants, thickeners, fillers, binders, humectants, preservatives, salts, colorants, oral care additives, disintegration aids, antioxidants, water, or mixtures thereof. In some embodiments, the oral product further includes one or more additives selected from the group consisting of flavorings, sweeteners, acidulants, thickeners, fillers, binders, humectants, preservatives, and mixtures thereof.Filler

視產品之形式而定，口服產品可包含填充劑。舉例而言，填充劑可履行多種功能，諸如增強某些感官特性，諸如質地及口感；增強產品之黏結性或可壓縮性；及其類似功能。Depending on the form of the product, oral products may contain fillers. For example, fillers can perform a variety of functions, such as enhancing certain organoleptic properties, such as texture and mouthfeel; enhancing the cohesiveness or compressibility of the product; and similar functions.

在一些實施例中，填充劑係多孔顆粒材料且以纖維素為主。舉例而言，填充劑或增積劑可為非菸草植物材料或其衍生物，包括來源於此類來源之纖維素材料。纖維素非菸草植物材料之實例包括穀粒(例如玉蜀黍、燕麥、大麥、黑麥、蕎麥及其類似物)、糖用甜菜(例如可購自International Fiber Corporation之FIBREX®牌填充劑)、麥麩纖維及其混合物。在一些實施例中，填充劑為選自由以下組成之群的纖維素材料：玉蜀黍纖維、燕麥纖維、大麥纖維、黑麥纖維、蕎麥纖維、糖用甜菜纖維、麥麩纖維、竹纖維、木漿纖維、棉纖維、柑桔渣纖維、禾草纖維、柳皮纖維、白楊纖維、可可纖維、其衍生物及其組合。在一些實施例中，填充劑為選自由以下組成之群的纖維素材料：糖用甜菜纖維、木漿纖維、竹纖維、其衍生物及其組合。In some embodiments, the filler is a porous particulate material and is mainly cellulose. For example, the filler or bulking agent can be a non-tobacco plant material or a derivative thereof, including cellulose materials derived from such sources. Examples of cellulose non-tobacco plant materials include cereals (e.g., corn, oats, barley, rye, buckwheat, and the like), sugar beets (e.g., FIBREX® brand fillers available from International Fiber Corporation), wheat gluten fibers, and mixtures thereof. In some embodiments, the filler is a cellulose material selected from the group consisting of corn fiber, oat fiber, barley fiber, rye fiber, buckwheat fiber, sugar beet fiber, gluten fiber, bamboo fiber, wood pulp fiber, cotton fiber, citrus pulp fiber, grass fiber, willow bark fiber, poplar fiber, cocoa fiber, derivatives thereof, and combinations thereof. In some embodiments, the filler is a cellulose material selected from the group consisting of sugar beet fiber, wood pulp fiber, bamboo fiber, derivatives thereof, and combinations thereof.

在一些實施例中，填充劑來源於木漿纖維。一種特別適合用於本文所描述之產品中的填充劑係微晶纖維素(「MCC」)。MCC可為合成或半合成的，或其可完全自天然纖維素獲得。MCC可選自由以下組成之群：AVICEL®級PH-100、PH-101、PH-102、PH-103、PH-105、PH-112、PH-113、PH-200、PH-300、PH-301、PH-302、VIVACEL®級101、102、12、20及EMOCEL®級50M及90M，以及其類似物及其混合物。In some embodiments, the filler is derived from wood pulp fibers. One filler particularly suitable for use in the products described herein is microcrystalline cellulose ("MCC"). MCC can be synthetic or semi-synthetic, or it can be obtained entirely from natural cellulose. MCC can be selected from the group consisting of AVICEL® grades PH-100, PH-101, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-301, PH-302, VIVACEL® grades 101, 102, 12, 20, and EMOCEL® grades 50M and 90M, and the like and mixtures thereof.

在一些實施例中，填充劑係非菸草植物材料或其衍生物。非菸草植物材料之衍生物的非限制性實例包括澱粉(例如來自馬鈴薯、小麥、稻穀、玉米)、天然纖維素及經改質之纖維素材料。潛在填充劑之額外實例包括麥芽糊精、右旋糖、碳酸鈣、磷酸鈣、乳糖、甘露糖醇、木糖醇及山梨糖醇。亦可使用此等填充劑之組合。In some embodiments, the filler is a non-tobacco plant material or a derivative thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starch (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulose materials. Additional examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of these fillers may also be used.

如本文所使用，「澱粉」可指來自任何來源之純澱粉、經改質澱粉或澱粉衍生物。澱粉典型地以顆粒狀形式存在於幾乎所有綠色植物中以及多種類型之植物組織及器官(例如種子、葉、根莖、根、塊莖、芽、果實、穀物及莖)中。澱粉在組成以及顆粒形狀及大小方面可不同。通常，來自不同來源之澱粉具有不同的化學及物理特徵。可基於澱粉材料賦予產品特定感官特性的能力，選擇特定澱粉包括在產品中。可使用來源於各種來源之澱粉。舉例而言，澱粉之主要來源包括穀物(例如稻穀、小麥及玉蜀黍)及根類蔬菜(例如馬鈴薯及木薯)。澱粉來源之其他實例包括橡樹果、竹芋、秘魯胡蘿蔔、香蕉、大麥、豆類(例如蠶豆、扁豆、綠豆、豌豆、鷹嘴豆)、麵包果、蕎麥、美人蕉、栗子、芋、片栗(katakuri)、野葛、馬蘭加(malanga)、粟、燕麥、酢漿草、波利尼西亞竹芋(Polynesian arrowroot)、西米、高粱、甘薯、鵝腳藜、黑麥、木薯、芋頭、菸草、荸薺及山藥。某些澱粉係經改質澱粉。經改質澱粉已經歷一或多種結構改良，通常經設計以改變其高熱特性。已藉由基因修飾開發出一些澱粉，且該等澱粉被視為「經改質」澱粉。獲得其他澱粉且隨後進行改質。舉例而言，經改質澱粉可為已經歷化學反應之澱粉，該等化學反應諸如為酯化、醚化、氧化、藉由酸催化或在鹼存在下氧化進行之解聚合(稀化)、漂白、轉醣化及解聚合(例如在催化劑存在下進行之糊精化)、交聯、酶處理、乙醯化、羥丙基化及/或部分水解。其他澱粉係藉由熱處理，諸如預膠凝化、糊精化及/或冷水膨脹法改質。某些經改質澱粉包括磷酸單澱粉、二澱粉甘油、用三偏磷酸鈉酯化之磷酸二澱粉、磷酸化磷酸二澱粉、乙醯化磷酸二澱粉、用乙酸酐酯化之乙酸澱粉、用乙酸乙烯酯酯化之乙酸澱粉、乙醯化己二酸二澱粉、乙醯化二澱粉甘油、羥丙基澱粉、羥丙基二澱粉甘油及辛烯基琥珀酸澱粉鈉。水As used herein, "starch" may refer to pure starch, modified starch, or starch derivatives from any source. Starch is typically found in granular form in almost all green plants and in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, buds, fruits, grains, and stems). Starch may differ in composition and particle shape and size. Typically, starches from different sources have different chemical and physical characteristics. Specific starches may be selected for inclusion in a product based on the ability of the starch material to impart specific organoleptic properties to the product. Starches from a variety of sources may be used. For example, major sources of starch include cereals (such as rice, wheat and corn) and root vegetables (such as potatoes and cassava). Other examples of sources of starch include acorns, arrowroot, Peruvian carrots, bananas, barley, legumes (such as broad beans, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, taro, katakuri, kudzu, malanga, millet, oats, oxalis, Polynesian arrowroot, sago, sorghum, sweet potatoes, quinoa, rye, cassava, taro, tobacco, water chestnuts and yams. Some starches are modified starches. Modified starch has undergone one or more structural modifications, usually designed to change its high thermal properties. Some starches have been developed by genetic modification and are considered "modified" starches. Other starches are obtained and subsequently modified. Modified starches may be starches that have undergone chemical reactions such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g. dextrinization in the presence of a catalyst), cross-linking, enzymatic treatment, acetylation, hydroxypropylation and/or partial hydrolysis, for example. Other starches are modified by heat treatments such as pregelatinization, dextrinization and/or cold water expansion. Some modified starches include phosphated monostarch, distarch glycerol, phosphated distarch esterified with sodium trimetaphosphate, phosphated distarch, acetylated phosphated distarch, acetic acid starch esterified with acetic anhydride, acetic acid starch esterified with vinyl acetate, acetylated adipate distarch, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol and sodium octenyl succinate.Water

在消費者使用產品之前，口服產品之水分含量(例如含水量)可根據所希望特性而變化。The moisture content (e.g., water content) of an oral product may be varied depending on the desired properties before the product is used by the consumer.

典型地，對於固體口服產品，在插入使用者之口中之前，含水量小於約50重量%且一般為該口服產品之約1重量%至約50重量%，例如約5重量%至約45重量%、約10重量%至約40重量%、約20重量%至約35重量%；包括該口服產品之至少約5重量%、至少約10重量%、至少約15重量%及至少約20重量%之水量。Typically, for solid oral products, the water content is less than about 50% by weight and generally about 1% to about 50% by weight of the oral product, such as about 5% to about 45% by weight, about 10% to about 40% by weight, about 20% to about 35% by weight, prior to insertion into the user's mouth; including at least about 5%, at least about 10%, at least about 15% and at least about 20% by weight of the oral product.

對於液體口服產品，含水量可較高且可為口服產品之至少約50重量%，諸如至少約60重量%，諸如至少約75重量%。較佳地，液體口服產品之含水量可為口服產品之至少約90重量%。較佳地，液體口服產品之含水量可為口服產品之約60重量%至約99.5重量%，諸如約75重量%至約99重量%，諸如約80重量%至約99重量%。調味劑For liquid oral products, the water content may be higher and may be at least about 50% by weight of the oral product, such as at least about 60% by weight, such as at least about 75% by weight. Preferably, the water content of the liquid oral product may be at least about 90% by weight of the oral product. Preferably, the water content of the liquid oral product may be from about 60% to about 99.5% by weight of the oral product, such as from about 75% to about 99% by weight, such as from about 80% to about 99% by weight.Flavoring

如本文所使用，術語「調味劑」(或「風味劑(flavour)」或「調味劑(flavourant)」)係指在地方法規准許的情況下可用於在用於成人消費者之產品中產生所希望味道、香氣或其他體感感覺之材料。可藉由調味劑改變之感官特徵的實例包括味道、口感、濕度、清涼/熱及/或香味/香氣。調味劑可為天然的或合成的，且由此賦予之調味劑的特徵可描述為(但不限於)新鮮、甜味、草本的、糖果型的、類花的、果味的或辛辣的。As used herein, the term "flavoring" (or "flavour" or "flavourant") refers to materials that can be used to produce a desired taste, aroma or other sensory sensation in products for adult consumers, where permitted by local regulations. Examples of sensory characteristics that can be altered by flavorings include taste, mouthfeel, wetness, coolness/heat and/or fragrance/aroma. Flavorings can be natural or synthetic, and the characteristics of the flavoring imparted thereby can be described as, but not limited to, fresh, sweet, herbal, confectionery-type, floral, fruity or spicy.

調味劑可選自由以下組成之群：天然存在之風味劑材料、植物性藥材、植物性藥材之萃取物、合成獲得的材料或其組合(例如菸草、大麻、歐亞甘草(licorice)(甘草)、繡球花、丁香酚、日本白皮木蘭葉(Japanese white bark magnolia leaf)、洋甘菊、葫蘆巴、丁香、楓樹、抹茶、薄荷醇、日本薄荷、大茴香籽(大茴香)、肉桂、薑黃、印度香辛料、亞洲香辛料、香草、冬青、櫻桃、漿果、紅莓、蔓越莓、覆盆子、草莓、桃、蘋果、橙、芒果、菠蘿、小柑橘(clementine)、檸檬、酸橙、熱帶水果、番木瓜、大黃、葡萄、榴蓮、火龍果、黃瓜、藍莓、桑椹、柑橘類水果、杜林標酒(Drambuie)、波旁威士忌(bourbon)、蘇格蘭威士忌(scotch)、威士忌(whiskey)、杜松子酒(gin)、龍舌蘭酒(tequila)、朗姆酒(rum)、綠薄荷、胡椒薄荷、薰衣草、蘆薈、小豆蔻、椰子、芹菜、卡藜皮、肉豆蔻、檀香木、佛手柑、天竺葵、阿拉伯茶(khat)、納斯瓦爾(naswar)、檳榔、水菸(shisha)、松樹、蜜精(honey essence)、玫瑰油、香草、檸檬油、橙油、橙花、櫻花、桂皮、香菜、干邑白蘭地(cognac)、茉莉、依蘭花(ylang-ylang)、鼠尾草、茴香、山葵、多香果、薑、芫荽、咖啡、大麻、來自薄荷屬任何物種之薄荷油、桉樹、八角大茴香、可可、檸檬草、路易波士茶、亞麻、銀杏、榛子、木槿、月桂、瑪黛茶(mate)、橙皮、玫瑰、茶(諸如綠茶或紅茶)、百里香、杜松、接骨木花、羅勒、月桂葉、小茴香、牛至草、辣椒粉、迷迭香、番紅花、檸檬皮、薄荷、紫蘇(beefsteak plant)、薑黃、芫荽葉(cilantro)、桃金娘、黑醋栗、甜椒、豆蔻皮(mace)、達米安(damien)、馬郁蘭(marjoram)、橄欖、檸檬羅勒、細香蔥、香菜、馬鞭草、香艾菊、檸檬烯、百里酚、莰烯)、增味劑、苦味受體位點阻斷劑、感覺受體位點活化劑或刺激劑、糖及/或代糖(例如蜂蜜、蔗糖素、乙醯磺胺酸鉀、阿斯巴甜糖、糖精、賽克拉美(cyclamate)、乳糖、蔗糖、葡萄糖、果糖、山梨糖醇或甘露糖醇)及其他添加劑，諸如木炭、葉綠素、礦物質、植物性藥材或口氣清新劑。該等調味劑可為模造物(imitation)、合成或天然成分或其摻合物。其可呈任何合適形式，例如諸如油之液體、諸如粉末之固體或凝膠。The flavoring agent may be selected from the group consisting of naturally occurring flavoring materials, botanicals, extracts of botanicals, synthetically derived materials, or combinations thereof (e.g., tobacco, cannabis, licorice (licorice), hydrangea, eugenol, Japanese white bark magnolia leaves, leaf), chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, aniseed (anise), cinnamon, turmeric, Indian spice, Asian spice, vanilla, wintergreen, cherry, berry, cranberry, cranberry, raspberry, strawberry, peach, apple, orange, mango, pineapple, clementine, lemon, lime, tropical fruit, papaya, rhubarb, grape, durian, pitaya, cucumber, blueberry, mulberry, citrus fruit, Drambuie , bourbon, scotch, whiskey, gin, tequila, rum, spearmint, peppermint, lavender, aloe, cardamom, coconut, celery, calendula, nutmeg, sandalwood, bergamot, geranium, khat, naswar, betel nut, shisha, pine, honey essence), rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom, cinnamon, coriander, cognac, jasmine, ylang-ylang, sage, fennel, horseradish, allspice, ginger, cilantro, coffee, cannabis, mint oil from any species of the genus Mentha, eucalyptus, star anise, cocoa, lemongrass, rooibos tea, flax, ginkgo, hazelnut, hibiscus, laurel, mate, orange peel, rose, tea (green or black), thyme, juniper, elderflower, basil, bay leaf, cumin, oregano, paprika, rosemary, saffron, lemon peel, mint, basil (beefsteak plant), turmeric, cilantro, myrtle, black currant, bell pepper, mace, damien, marjoram, olive, lemon basil, chives, coriander, verbena, tansy, limonene, thymol, camphene), flavor enhancers, bitter taste receptor site blockers, sensory receptor site activators or stimulators, sugars and/or sugar substitutes (e.g., honey, sucralose, acesulfame potassium, aspartame, saccharin, cyclamate, lactose, sucrose, glucose, fructose, sorbitol or mannitol) and other additives such as charcoal, chlorophyll, minerals, botanicals or breath fresheners. The flavoring agents may be imitations, synthetic or natural ingredients or blends thereof. They may be in any suitable form, for example liquids such as oils, solids such as powders or gels.

在一些實施例中，調味劑包含天然調味劑，諸如漿果(例如覆盆子、藍莓或草莓)、蜂蜜、柑橘(諸如檸檬、佛手柑、橙或酸橙)或其他植物性材料。In some embodiments, the flavoring comprises a natural flavoring such as berry (e.g., raspberry, blueberry, or strawberry), honey, citrus (e.g., lemon, bergamot, orange, or lime), or other botanical material.

在一些實施例中，調味劑包含薄荷醇、綠薄荷及/或胡椒薄荷。在一些實施例中，調味劑包含黃瓜、藍莓、柑橘類水果及/或紅莓之風味劑組分。在一些實施例中，調味劑包含丁香酚。在一些實施例中，調味劑包含自菸草萃取之風味劑組分。在一些實施例中，調味劑包含自大麻萃取之風味劑組分。In some embodiments, the flavoring comprises menthol, spearmint, and/or peppermint. In some embodiments, the flavoring comprises a flavoring component of cucumber, blueberry, citrus fruit, and/or cranberry. In some embodiments, the flavoring comprises eugenol. In some embodiments, the flavoring comprises a flavoring component extracted from tobacco. In some embodiments, the flavoring comprises a flavoring component extracted from cannabis.

在一些實施例中，除了香氣或味覺神經以外或代替香氣或味覺神經，調味劑亦可包含感覺劑，該感覺劑意欲實現通常化學誘導且藉由刺激第五顱神經(三叉神經)而感知的體感感覺，且此等感覺劑可包括提供加熱、冷卻、刺痛、麻木效果之試劑。適合之熱作用劑可為但不限於香草基乙基醚，且適合之冷卻劑可為但不限於桉油醇、WS-3。In some embodiments, in addition to or in place of aroma or taste nerves, flavoring agents may also include sensory agents that are intended to achieve somatosensory sensations that are usually chemically induced and perceived by stimulating the fifth cranial nerve (trigeminal nerve), and these sensory agents may include agents that provide heating, cooling, tingling, numbing effects. Suitable thermal agents may be, but are not limited to, vanillyl ethyl ether, and suitable cooling agents may be, but are not limited to, eucalyptol, WS-3.

在存在之情況下，調味劑可以口服產品之至多約10重量%，諸如至多約5重量%，諸如至多約1重量%之量包括在口服產品中。在一些實施例中，調味劑以約0.01重量%至約5重量%之量，較佳地以口服產品之約0.1重量%至約2.5重量%之量且更佳地以口服產品之約0.25重量%至約1重量%之量存在。黏合劑If present, the flavoring agent may be included in the oral product in an amount of up to about 10% by weight of the oral product, such as up to about 5% by weight, such as up to about 1% by weight. In some embodiments, the flavoring agent is present in an amount of about 0.01% to about 5% by weight, preferably about 0.1% to about 2.5% by weight of the oral product, and more preferably about 0.25% to about 1% by weight of the oral product.Binder

在一些實施例中，口服產品可進一步包含至少一種黏合劑。在某些實施例中，黏合劑(或黏合劑之組合)可以足以使該產品具有所希望之物理屬性及物理完整性的量用於該產品中。In some embodiments, the oral product may further comprise at least one binder. In certain embodiments, a binder (or a combination of binders) may be used in the product in an amount sufficient to give the product desired physical properties and physical integrity.

黏合劑可為有機或無機的，或其組合。代表性黏合劑包括纖維素衍生物、聚維酮、褐藻酸鈉、以澱粉為主之黏合劑、果膠、角叉菜膠、普魯蘭多糖(pullulan)、玉米蛋白及其類似物，以及其組合。產品中所用黏合劑之量可變化，但可為至多約30重量%，且某些實施例之特徵在於以口服產品之總重量計至少約0.1重量%，諸如約1重量%至約30重量%或約1重量%至約10重量%之黏合劑含量。Binders can be organic or inorganic, or a combination thereof. Representative binders include cellulose derivatives, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein and the like, and combinations thereof. The amount of binder used in the product can vary, but can be up to about 30% by weight, and certain embodiments are characterized by a binder content of at least about 0.1% by weight, such as about 1% to about 30% by weight or about 1% to about 10% by weight, based on the total weight of the oral product.

在一些實施例中，黏合劑包含纖維素衍生物。在某些實施例中，纖維素衍生物係纖維素醚(包括羧基烷基醚)，意謂纖維素結構中之一或多個羥基之氫經烷基、羥烷基或芳基置換的纖維素聚合物。此類纖維素衍生物之非限制性實例包括甲基纖維素、羥丙基纖維素(「HPC」)、羥丙基甲基纖維素(「HPMC」)、羥乙基纖維素及羧甲基纖維素(「CMC」)。在一些實施例中，纖維素衍生物係或包含HPC。在一些實施例中，纖維素衍生物係HPC與HPMC之組合。在一些實施例中，口服產品包含以口服產品之重量計約1%至約10%之纖維素衍生物(諸如HPC)，其中某些實施例包含以產品之重量計約1重量%至約5重量%之纖維素衍生物(諸如HPC)。保濕劑In some embodiments, the adhesive comprises a cellulose derivative. In certain embodiments, the cellulose derivative is a cellulose ether (including a carboxyalkyl ether), meaning a cellulose polymer in which one or more hydroxyl groups in the cellulose structure are replaced by an alkyl, hydroxyalkyl or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropyl cellulose ("HPC"), hydroxypropyl methyl cellulose ("HPMC"), hydroxyethyl cellulose and carboxymethyl cellulose ("CMC"). In some embodiments, the cellulose derivative is or comprises HPC. In some embodiments, the cellulose derivative is a combination of HPC and HPMC. In some embodiments, the oral product comprises about 1% to about 10% of a cellulose derivative (such as HPC) by weight of the oral product, with certain embodiments comprising about 1% to about 5% by weight of a cellulose derivative (such as HPC)by weight of the product.

在一些實施例中，口服產品包含至少一種保濕劑。可包括在產品中的適合保濕劑之實例包括但不限於甘油、1,2-丙二醇(丙二醇)、1,3-丙二醇、二丙二醇、山梨糖醇、木糖醇、甘露糖醇及其類似物。在一些實施例中，保濕劑係或包含甘油。在一些實施例中，口服產品包含甘油。在一些實施例中，保濕劑係或包含丙二醇。在一些實施例中，口服產品包含丙二醇。用於口服產品中的保濕劑之量可變化，但可為至多約5重量%，且某些實施例之特徵可在於佔口服產品至少約1重量%，諸如約2重量%至約5重量%之保濕劑含量。在一些實施例中，保濕劑(諸如甘油及/或丙二醇)可以口服產品之約0.01重量%至約25重量%，諸如口服產品之約0.1重量%至約20重量%，諸如口服產品之約0.5重量%至約15重量%，諸如口服產品之約1重量%至約10重量%，諸如口服產品之約5重量%至約10重量%之量存在。甜味劑In some embodiments, the oral product comprises at least one humectant. Examples of suitable humectants that may be included in the product include, but are not limited to, glycerol, 1,2-propanediol (propylene glycol), 1,3-propanediol, dipropylene glycol, sorbitol, xylitol, mannitol, and the like. In some embodiments, the humectant is or comprises glycerol. In some embodiments, the oral product comprises glycerol. In some embodiments, the humectant is or comprises propylene glycol. In some embodiments, the oral product comprises propylene glycol. The amount of humectant used in the oral product may vary, but may be up to about 5% by weight, and certain embodiments may be characterized by a humectant content of at least about 1% by weight of the oral product, such as about 2% to about 5% by weight. In some embodiments, humectants (such as glycerin and/or propylene glycol) may be present in an amount of about 0.01% to about 25% by weight of the oral product, such as about 0.1% to about 20% by weight of the oral product, such as about 0.5% to about 15% by weight of the oral product, such as about 1% to about 10% by weight of the oral product, such as about 5% to about 10% by weight of the oral product.Sweeteners

為了改良口服產品之感官特性，可添加一或多種甜味劑。甜味劑可為任何甜味劑或甜味劑之組合，呈天然或人造形式或者呈天然及人造甜味劑之組合形式。天然甜味劑之實例包括果糖、蔗糖、葡萄糖、麥芽糖、甘露糖、半乳糖、乳糖、甜菊、蜂蜜及其類似物。人工甜味劑之實例包括蔗糖素、異麥芽酮糖、麥芽糊精、糖精、阿斯巴甜、安賽蜜K (acesulfame K)、紐甜及其類似物。In order to improve the organoleptic properties of the oral product, one or more sweeteners may be added. The sweetener may be any sweetener or combination of sweeteners, in natural or artificial form or in the form of a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey and the like. Examples of artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, numetame and the like.

在一些實施例中，甜味劑包含一或多種糖醇。糖醇可以包括赤藻糖醇、阿拉伯糖醇、核糖醇、異麥芽酮糖醇、麥芽糖醇、甜醇、艾杜糖醇、甘露糖醇、木糖醇、乳糖醇、山梨糖醇或其組合。在一些實施例中，甜味劑係選自由以下組成之群：果糖、蔗糖、葡萄糖、麥芽糖、甘露糖、半乳糖、乳糖、甜菊、蜂蜜、蔗糖素、異麥芽酮糖、麥芽糊精、糖精、阿斯巴甜糖、安賽蜜K、紐甜、赤藻糖醇、阿拉伯糖醇、核糖醇、異麥芽酮糖醇、麥芽糖醇、甜醇、艾杜糖醇、甘露糖醇、木糖醇、乳糖醇、山梨糖醇及其混合物。In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols may include erythritol, arabitol, ribitol, isomalt, maltitol, sweet alcohol, iditol, mannitol, xylitol, lactitol, sorbitol or a combination thereof. In some embodiments, the sweetener is selected from the group consisting of: fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, numetide, erythritol, arabitol, ribitol, isomalt, maltitol, sweet alcohol, iditol, mannitol, xylitol, lactitol, sorbitol and a mixture thereof.

在一些實施例中，甜味劑係選自由以下組成之群：蔗糖素、安賽蜜K、阿斯巴甜糖、麥芽糊精、甘露糖醇、蔗糖及其混合物。較佳地，甜味劑可為蔗糖素及/或安賽蜜K。當存在於口服產品中時，甜味劑(諸如蔗糖素及/或安賽蜜K)可以口服產品之約0.001重量%至約5重量%，諸如約0.01重量%至約3重量%，較佳約0.01重量%至約1重量%之量存在。緩衝劑In some embodiments, the sweetener is selected from the group consisting of sucralose, acesulfame K, aspartame, maltodextrin, mannitol, sucrose, and mixtures thereof. Preferably, the sweetener may be sucralose and/or acesulfame K. When present in an oral product, the sweetener (such as sucralose and/or acesulfame K) may be present in an amount of about 0.001% to about 5% by weight of the oral product, such as about 0.01% to about 3% by weight, preferably about 0.01% to about 1% by weight.Buffer

可包括在口服產品中的適合緩衝劑之非限制性實例包括鹼金屬乙酸鹽、甘胺酸鹽、磷酸鹽、甘油磷酸鹽、檸檬酸鹽、碳酸鹽、碳酸氫鹽、硼酸鹽或其混合物。在存在緩衝劑之一些實施例中，緩衝劑係選自由以下組成之群：碳酸鈉、碳酸氫鈉、磷酸鈉、磷酸銨、磷酸二鈣、磷酸三鈣及其混合物。在一些實施例中，緩衝劑係碳酸氫鈉及/或碳酸鈉。在存在之情況下，緩衝劑(例如碳酸氫鈉及/或碳酸鈉)之含量可為以口服產品之重量計低於約5%；例如以口服產品之總重量計，約0.5%重量至約5重量%，諸如約0.75重量%至約4重量%、約0.75重量%至約3重量%或約1重量%至約2重量%。有機酸Non-limiting examples of suitable buffers that may be included in the oral product include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof. In some embodiments where a buffer is present, the buffer is selected from the group consisting of sodium carbonate, sodium bicarbonate, sodium phosphate, ammonium phosphate, dicalcium phosphate, tricalcium phosphate, and mixtures thereof. In some embodiments, the buffer is sodium bicarbonate and/or sodium carbonate. Where present, the buffer (e.g., sodium bicarbonate and/or sodium carbonate) may be present in an amount of less than about 5% by weight of the oral product; for example, about 0.5% by weight to about 5% by weight, such as about 0.75% by weight to about 4% by weight, about 0.75% by weight to about 3% by weight, or about 1% by weight to about 2% by weight, based on the total weight of the oral product.Organic Acid

在一些實施例中，產品包含有機酸。如本文所使用，術語「有機酸」係指以酸性特性為特徵之有機(亦即，以碳為主)之化合物。典型地，有機酸係相對較弱的酸(亦即，其在水存在下不會完全解離)，諸如羧酸(-CO₂H)或磺酸(-SO₂OH)。如本文所使用，提及有機酸意謂有意添加之有機酸。就此而言，相對於僅固有地作為另一混合物成分之一組分存在(例如可固有地存在於諸如菸草材料之類混合物成分中的少量有機酸)，有機酸可有意地作為特定混合物成分添加。在一些實施例中，一或多種有機酸係以純形式(亦即，以其游離酸、天然固體或液體形式)或以於例如水中之溶液形式添加。在一些實施例中，一或多種有機酸係以鹽形式添加。In some embodiments, the product comprises an organic acid. As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound characterized by acidic properties. Typically, an organic acid is a relatively weak acid (i.e., it does not completely dissociate in the presence of water), such as a carboxylic acid (-CO₂ H) or a sulfonic acid (-SO₂ OH). As used herein, reference to an organic acid means an intentionally added organic acid. In this regard, an organic acid may be intentionally added as a particular mixture component, as opposed to being inherently present as only a component of another mixture component (e.g., small amounts of an organic acid that may be inherently present in a mixture component such as tobacco material). In some embodiments, one or more organic acids are added in pure form (i.e., as their free acid, natural solid, or liquid form) or as a solution in, for example, water. In some embodiments, the one or more organic acids are added in the form of a salt.

在一些實施例中，有機酸係羧酸或磺酸。羧酸或磺酸官能基可連接至具有例如一至二十個碳原子(C₁-C₂₀)之任何烷基、環烷基、雜環烷基、芳基或雜芳基。在一些實施例中，有機酸係烷基、環烷基、雜環烷基、芳基或雜芳基羧酸或磺酸。In some embodiments, the organic acid is a carboxylic acid or a sulfonic acid. The carboxylic acid or sulfonic acid functional group can be attached to any alkyl, cycloalkyl, heterocycloalkyl, aryl or heteroaryl group having, for example, one to twenty carbon atoms (C₁ -C₂₀ ). In some embodiments, the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl or heteroaryl carboxylic acid or sulfonic acid.

在一些實施例中，有機酸係烷基羧酸。烷基羧酸之非限制性實例包括甲酸、乙酸、丙酸、辛酸、壬酸、癸酸、十一烷酸、十二烷酸、硬脂酸、油酸、亞麻油酸、次亞麻油酸及其類似物。在一些實施例中，有機酸係烷基磺酸。烷基磺酸之非限制性實例包括丙烷磺酸及辛烷磺酸。In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linolenic acid, linolenic acid, and the like. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propane sulfonic acid and octane sulfonic acid.

在一些實施例中，烷基羧酸或磺酸經一或多個羥基取代。非限制性實例包括乙醇酸、4-羥基丁酸及乳酸。In some embodiments, the alkyl carboxylic acid or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid.

在一些實施例中，有機酸可包括多於一個羧酸基團或多於一個磺酸基團(例如二個、三個或更多個羧酸基團)。非限制性實例包括草酸、反丁烯二酸、順丁烯二酸及戊二酸。在含有多個羧酸(例如二至四個羧酸基團)之有機酸中，一或多個羧酸基團可經酯化。非限制性實例包括琥珀酸單乙酯、反丁烯二酸單甲酯、檸檬酸單甲酯或檸檬酸二甲酯，及其類似物。In some embodiments, the organic acid may include more than one carboxylic acid group or more than one sulfonic acid group (e.g., two, three or more carboxylic acid groups). Non-limiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid. In organic acids containing multiple carboxylic acids (e.g., two to four carboxylic acid groups), one or more carboxylic acid groups may be esterified. Non-limiting examples include monoethyl succinate, monomethyl fumarate, monomethyl citrate, or dimethyl citrate, and the like.

在一些實施例中，有機酸可包括多於一個羧酸基團及一或多個羥基。此類酸之非限制性實例包括酒石酸、檸檬酸及其類似物。在一些較佳實施例中，有機酸係檸檬酸、檸檬酸鈉、檸檬酸鈣或其組合。In some embodiments, the organic acid may include more than one carboxylic acid group and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid, citric acid, and the like. In some preferred embodiments, the organic acid is citric acid, sodium citrate, calcium citrate, or a combination thereof.

在一些實施例中，有機酸係芳基羧酸或芳基磺酸。芳基羧酸及磺酸之非限制性實例包括苯甲酸、甲苯甲酸、水楊酸、苯磺酸及對甲苯磺酸。In some embodiments, the organic acid is an aryl carboxylic acid or an aryl sulfonic acid. Non-limiting examples of aryl carboxylic acids and sulfonic acids include benzoic acid, toluic acid, salicylic acid, benzenesulfonic acid and p-toluenesulfonic acid.

適合有機酸之額外非限制性實例包括2,2-二氯乙酸、2-羥基乙烷磺酸、2-側氧基戊二酸、4-乙醯胺基苯甲酸、4-胺基水楊酸、乙酸、己二酸、抗壞血酸(L)、天冬胺酸(L)、樟腦酸(+)、樟腦-10-磺酸(+)、羊蠟酸、羊油酸、羊脂酸、肉桂酸、環己胺磺酸、癸酸、十二烷基硫酸、乙烷-1,2-二磺酸、乙烷磺酸、甲酸、反丁烯二酸、半乳糖二酸、龍膽酸、葡糖庚酸、葡糖酸、葡糖醛酸、麩胺酸、甘油磷酸、乙醇酸、馬尿酸、異丁酸、乳糖酸、月桂酸、丙二酸、杏仁酸、甲烷磺酸、萘-1,5-二磺酸、萘-2-磺酸、油酸、棕櫚酸、雙羥萘酸、焦麩胺酸、癸二酸、硬脂酸及十一烯酸。Additional non-limiting examples of suitable organic acids include 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-hydroxyglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid (L), aspartic acid (L), camphoric acid (+), camphor-10-sulfonic acid (+), caprylic acid, caprylic acid, caprylic acid, cinnamic acid, cyclohexanesulfonic acid, capric acid, dodecyl sulfuric acid, ethyl ester, ethyl ester, succinic acid, succinic acid, decanoic acid, succinic ... 1,2-disulfonic acid, ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentianic acid, glucoheptanoic acid, gluconic acid, glucuronic acid, glutamine, glycerophosphoric acid, glycolic acid, hippuric acid, isobutyric acid, lactobionic acid, lauric acid, malonic acid, mandelic acid, methanesulfonic acid, naphthalene-1,5-disulfonic acid, naphthalene-2-sulfonic acid, oleic acid, palmitic acid, bis(hydroxynaphthoic acid), pyroglutamine, sebacic acid, stearic acid and undecylenic acid.

較佳地，有機酸係選自由以下組成之群：檸檬酸、蘋果酸、乳酸、苯甲酸、酒石酸及其混合物。在一些較佳實施例中，有機酸係或包含檸檬酸或其鹽。Preferably, the organic acid is selected from the group consisting of citric acid, malic acid, lactic acid, benzoic acid, tartaric acid and mixtures thereof. In some preferred embodiments, the organic acid is or comprises citric acid or a salt thereof.

在一些實施例中，有機酸係或包含無水檸檬酸。In some embodiments, the organic acid is or comprises anhydrous citric acid.

產品中存在之有機酸的量可變化。口服產品可包含以口服產品之總重量計約0.01重量%至約10重量%的以一或多種有機酸形式存在之有機酸(例如檸檬酸或其鹽)。在一些實施例中，口服產品包含以口服產品之總重量計至少約0.01重量%、至少約0.1重量%、約0.2重量%、約0.3重量%、約0.4重量%、約0.5重量%、約0.6重量%、約0.7重量%、約0.8重量%、約0.9重量%、約1重量%、約2重量%、約3重量%、約4重量%、約5重量%、約6重量%、約7重量%、約8重量%、約9重量%或至少約10重量%之有機酸。在一些較佳實施例中，口服產品包含以口服產品之重量計約0.01重量%至約5重量%有機酸(例如檸檬酸或其鹽)。舉例而言，口服產品包含佔口服產品之約0.1重量%至約2.5重量%之量的有機酸。在添加有機酸(例如無水檸檬酸)之鹽之情況下，重量百分比係基於游離酸之重量計算，不包括可能存在之任何相對離子。The amount of organic acid present in the product can vary. An oral product may include about 0.01% by weight to about 10% by weight of an organic acid (e.g., citric acid or a salt thereof) present in one or more organic acid forms, based on the total weight of the oral product. In some embodiments, the oral product includes at least about 0.01% by weight, at least about 0.1% by weight, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, about 0.9% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or at least about 10% by weight of an organic acid based on the total weight of the oral product. In some preferred embodiments, the oral product comprises about 0.01 wt % to about 5 wt % of an organic acid (e.g., citric acid or a salt thereof) based on the weight of the oral product. For example, the oral product comprises an organic acid in an amount of about 0.1 wt % to about 2.5 wt % of the oral product. In the case of adding a salt of an organic acid (e.g., anhydrous citric acid), the weight percentage is calculated based on the weight of the free acid, excluding any relative ions that may be present.

在某些實施例中，包括有機酸足以使產品具有約4.0至約9.0，諸如約4.5至約7.0或約5.5至約7.0、約4.0至約5.5或約7.0至約9.0的pH值。在一些實施例中，包括有機酸足以使產品具有約4.5至約6.5，例如約4.5、約5.0或約5.5至約6.0或約6.5的pH值。在一些實施例中，有機酸以足以使產品具有約5.5至約6.5，例如約5.5、約5.6、約5.7、約5.8、約5.9或約6.0至約6.1、約6.2、約6.3、約6.4或約6.5之pH值的數量提供。In certain embodiments, the organic acid is included sufficient to provide a product with a pH of about 4.0 to about 9.0, such as about 4.5 to about 7.0, or about 5.5 to about 7.0, about 4.0 to about 5.5, or about 7.0 to about 9.0. In some embodiments, the organic acid is included sufficient to provide a product with a pH of about 4.5 to about 6.5, such as about 4.5, about 5.0, or about 5.5 to about 6.0, or about 6.5. In some embodiments, the organic acid is provided in an amount sufficient to provide a product with a pH of about 5.5 to about 6.5, such as about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, or about 6.0 to about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5.

在其他實施例中，添加礦酸(例如鹽酸、硫酸、磷酸或其類似物)以將產品之pH值調至所希望的值。In other embodiments, a mineral acid (e.g., hydrochloric acid, sulfuric acid, phosphoric acid, or the like) is added to adjust the pH of the product to a desired value.

有機酸(例如檸檬酸)可以純形式(亦即，固體形式)或以於例如水中之溶液形式添加。在一些實施例中，有機酸係以50%水溶液形式添加。增稠劑The organic acid (e.g., citric acid) can be added in pure form (i.e., solid form) or as a solution in, for example, water. In some embodiments, the organic acid is added as a 50% aqueoussolution .

在一些實施例中，口服產品可包含增稠劑。適合增稠劑可包括水膠體，諸如三仙膠、瓜爾膠、蒟蒻膠、黃蓍膠及阿拉伯膠。舉例而言，三仙膠應理解為增稠劑，當在冷加工期間添加時(亦即，當不加熱時)，其使組成物稠化。In some embodiments, the oral product may include a thickener. Suitable thickeners may include hydrocolloids such as safflower gum, guar gum, konjac gum, tragacanth gum, and gum arabic. For example, safflower gum is understood to be a thickener that thickens the composition when added during cold processing (i.e., when not heated).

在存在之情況下，增稠劑(例如三仙膠)之含量可為口服產品之約0.001重量%至約5重量%且較佳為約0.01重量%至約1重量%。著色劑When present, thickeners (e.g., trimethicone) may be present in an amount of about 0.001% to about 5% by weight of the oral product and preferably about 0.01% to about 1% by weight.Coloring Agents

著色劑可以足以使該產品具有所希望之物理屬性的量使用。著色劑之實例包括各種染料及顏料，諸如焦糖色著色劑及二氧化鈦。亦可使用天然著色劑，諸如薑黃素、甜菜汁萃取物、螺旋藻；以及多種合成顏料。用於口服產品中的著色劑之量可變化，但當存在時，典型地為以口服產品之總重量計至多約3重量%，諸如約0.1重量%、約0.5重量%或約1重量%至約3重量%。其他添加劑Coloring agents may be used in an amount sufficient to impart the desired physical properties to the product. Examples of coloring agents include various dyes and pigments, such as caramel coloring agents and titanium dioxide. Natural coloring agents, such as curcumin, beet juice extract, spirulina; and a variety of synthetic pigments may also be used. The amount of coloring agent used in an oral product may vary, but when present, is typically up to about 3% by weight, such as about 0.1%, about 0.5%, or about 1% to about 3% by weight, based on the total weight of the oral product.Other additives

亦可使用其他成分，諸如防腐劑(例如山梨酸鉀)、崩解助劑(例如交聯羧甲基纖維素鈉、交聯聚維酮、羥基乙酸澱粉鈉、預膠凝化玉米澱粉及其類似物)及/或抗氧化劑。典型地，在使用時，此類成分以口服產品之至多約10%重量，例如至少約0.1重量%，諸如約0.5重量%至約10重量%之量使用。崩解助劑可以足以提供對口服產品所希望之物理屬性之控制，諸如藉由在調配物與水接觸時提供各種組分材料之物理完整性之損失及分散(例如藉由在與水接觸時發生膨脹)的量使用。Other ingredients such as preservatives (e.g., potassium sorbate), disintegration aids (e.g., sodium cross-linked carboxymethylcellulose, cross-linked povidone, sodium starch glycolate, pregelatinized corn starch, and the like) and/or antioxidants may also be used. Typically, when used, such ingredients are used in an amount of up to about 10% by weight of the oral product, such as at least about 0.1% by weight, such as about 0.5% to about 10% by weight. Disintegration aids may be used in an amount sufficient to provide control of the desired physical properties of the oral product, such as by providing loss of physical integrity and dispersion of the various component materials when the formulation is in contact with water (e.g., by swelling when in contact with water).

其他類型添加劑之實例包括對於具有較高水溶性之組成物選擇的水溶性相對較高的鋅鹽(例如葡糖酸鋅)；或對於具有減小之水溶性之組成物選擇的相對不可溶於水之鋅或鎂鹽(例如氧化鋅)；或其組合。參見例如頒予Mua等人之美國專利第9,237,769號、頒予Holton,Jr.等人之美國專利第7,861,728號、頒予Gao等人之美國專利申請公開案第2010/0291245號及頒予Holton, Jr.等人之美國專利申請公開案第2007/0062549號中所闡述的該等代表性組分、組分之組合、該等組分之相對量以及採用彼等組分之方式及方法，各案係以引用的方式併入本文中。此類額外添加劑之典型包括範圍可視添加劑之性質及功能以及最終產物之預期作用而變化，且示例範圍為以口服產品之總重量計至多約10重量% (例如約0.1重量%至約5重量%)。Examples of other types of additives include relatively water-soluble zinc salts (e.g., zinc gluconate) selected for compositions with higher water solubility; or relatively water-insoluble zinc or magnesium salts (e.g., zinc oxide) selected for compositions with reduced water solubility; or combinations thereof. See, for example, U.S. Patent No. 9,237,769 to Mua et al., U.S. Patent No. 7,861,728 to Holton, Jr. et al., U.S. Patent Application Publication No. 2010/0291245 to Gao et al., and U.S. Patent Application Publication No. 2007/0062549 to Holton, Jr. et al. for representative components, combinations of components, relative amounts of the components, and manners and methods of using the components, each of which is incorporated herein by reference. Typical inclusion ranges for such additional additives may vary depending on the nature and function of the additive and the intended effect of the final product, and an exemplary range is up to about 10 wt % (e.g., about 0.1 wt % to about 5 wt %) based on the total weight of the oral product.

在一些較佳實施例中，口服產品包含鋅或葡糖酸鋅。在一些實施例中，口服產品包含以口服產品計約0.001重量%至約5重量%，或約0.01重量%至約2重量%，較佳約0.01重量%至約0.1重量%之量的鋅或葡糖酸鋅。In some preferred embodiments, the oral product comprises zinc or zinc gluconate. In some embodiments, the oral product comprises zinc or zinc gluconate in an amount of about 0.001% to about 5% by weight, or about 0.01% to about 2% by weight, preferably about 0.01% to about 0.1% by weight, based on the oral product.

前述添加劑可一起(例如以添加劑調配物形式)使用或分開使用(例如各個添加劑組分可在最終產物之製備中所涉及之不同階段添加)。另外，前述類型之添加劑可以提供於最終產物或組成物中之形式囊封。例示性囊封添加劑描述於例如頒予Atchley之WO 2010/132444中，該案先前已以引用的方式併入本文中。 口服產品The aforementioned additives may be used together (e.g., in the form of an additive formulation) or separately (e.g., each additive component may be added at different stages involved in the preparation of the final product). In addition, the aforementioned types of additives may be provided in a form encapsulated in the final product or composition. Exemplary encapsulated additives are described, for example, in WO 2010/132444 to Atchley, which has been previously incorporated herein by reference.Oral Products

本文所描述之產品或組成物係經組態成供口服使用。如本文所使用，術語「經組態成供口服使用」意謂，該產品係以使得在使用期間使用者口中之唾液使該產品之一或多種組分(例如活性成分)進入使用者之口中的形式提供。在某些實施例中，該產品適合於透過使用者口中之黏膜、使用者之消化系統或二者將活性成分及任擇地調味劑遞送給使用者。在一些情況下，當使用該產品時，活性成分及任擇地調味劑可透過口中之黏膜吸收或透過消化道吸收。The products or compositions described herein are configured for oral use. As used herein, the term "configured for oral use" means that the product is provided in a form such that during use, saliva in the user's mouth causes one or more components of the product (e.g., active ingredients) to enter the user's mouth. In certain embodiments, the product is suitable for delivering the active ingredients and optionally flavorings to the user through the mucous membranes in the user's mouth, the user's digestive system, or both. In some cases, when the product is used, the active ingredients and optionally flavorings can be absorbed through the mucous membranes in the mouth or absorbed through the digestive tract.

在一些實施例中，口服產品包含佔口服產品至少約0.01重量%，諸如至少約0.1重量%或較佳至少約0.5重量%之量的活性成分之組合。In some embodiments, the oral product comprises a combination of active ingredients in an amount of at least about 0.01% by weight of the oral product, such as at least about 0.1% by weight or preferably at least about 0.5% by weight.

活性成分之組合可以約0.01重量%至約20重量%之量存在。舉例而言，活性成分之組合可以口服產品之約0.1重量%至約10重量%、較佳約0.5%至約5重量%之量存在。The combination of active ingredients can be present in an amount of about 0.01% to about 20% by weight. For example, the combination of active ingredients can be present in an amount of about 0.1% to about 10% by weight, preferably about 0.5% to about 5% by weight of the oral product.

口服產品可呈適於施用於人類或動物之口腔的任何形式。在一些實施例中，口服產品係呈固體、凝膠或液體形式之口服劑型。在一些實施例中，口服產品係固體口服劑型。本文所描述之口服產品可呈各種形式，包括凝膠劑、熔化物(melt)、錠劑、口含錠、散劑、小袋及液體(例如飲料)形式。在一些較佳實施例中，口服產品係液體口服劑型。液體口服劑型Oral products can be in any form suitable for administration to the oral cavity of a human or animal. In some embodiments, the oral product is an oral dosage form in the form of a solid, gel, or liquid. In some embodiments, the oral product is a solid oral dosage form. The oral products described herein can be in various forms, including gels, melts, tablets, lozenges, powders, sachets, and liquids (e.g., beverages). In some preferred embodiments, the oral product is a liquid oral dosage form.Liquid oral dosage form

在一些較佳實施例中，口服產品係呈液體劑型之形式。液體劑型適於經口攝入，由此其可稱為飲料，因為其可被使用者攝取(亦即，飲用)。In some preferred embodiments, the oral product is in the form of a liquid dosage form. The liquid dosage form is suitable for oral ingestion, whereby it can be referred to as a beverage because it can be ingested (i.e., drunk) by the user.

液體口服劑型可呈濃縮飲品形式；亦即，可例如以一口或數口快速攝入的飲品。將口服產品調配成濃縮飲品形式可為有利的，因為其提供適宜且易於使用之投予模式，在儲存(例如在冰箱或食櫥中)期間不佔用太多的空間且使用者可容易攜帶，因此可隨身攜帶。濃縮飲品亦可提供活性劑之高效遞送媒介物，藉此可將足以提供良好功效之位準的活性劑遞送給使用者，而無需攝入較大體積之液體。另外，濃縮飲品可經調配以具有令人愉快的味道。例如，對於使用者而言，飲用濃縮飲品可被認為要比吞咽錠劑更適口且更容易。Liquid oral dosage forms may be in the form of a concentrated drink; that is, a drink that can be taken quickly, for example, in one or a few gulps. Formulating oral products in the form of a concentrated drink can be advantageous because it provides a convenient and easy-to-use mode of administration, does not take up much space during storage (e.g., in a refrigerator or cupboard), and is easily portable to the user and can therefore be carried with them. Concentrated drinks can also provide an efficient delivery vehicle for the active agent, whereby a level of active agent sufficient to provide good efficacy can be delivered to the user without the need to ingest a larger volume of liquid. In addition, concentrated drinks can be formulated to have a pleasant taste. For example, drinking a concentrated drink may be considered more palatable and easier for the user than swallowing a tablet.

液體口服劑型亦可呈經若干口較慢攝入的較大飲料形式。液體口服劑型可具有約1 mL至約250 mL，諸如約1 mL至約200 mL之體積。液體口服劑型可具有約100 mL至約250 mL之體積且以諸如含液體之紙盒、杯、罐或瓶子之類包裝提供。The liquid oral dosage form may also be in the form of a larger drink that is ingested more slowly over several sips. The liquid oral dosage form may have a volume of about 1 mL to about 250 mL, such as about 1 mL to about 200 mL. The liquid oral dosage form may have a volume of about 100 mL to about 250 mL and be provided in a package such as a carton, cup, can or bottle containing the liquid.

液體口服劑型可具有約10 mL至約100 mL，諸如約25 mL至約75 mL之體積。在此類實施例中，液體口服劑型可被視為濃縮飲品。舉例而言，液體之體積可為約60 mL或約30 mL。此類形式在本揭露內容中為較佳的。The liquid oral dosage form may have a volume of about 10 mL to about 100 mL, such as about 25 mL to about 75 mL. In such embodiments, the liquid oral dosage form may be considered a concentrated drink. For example, the volume of the liquid may be about 60 mL or about 30 mL. Such forms are preferred in the present disclosure.

當呈液體口服劑型之形式時，口服產品可進一步包含佔口服產品之約50重量%至約99.9重量%之量的水。在一些實施例中，口服產品包含約75重量%至約99.9重量%、較佳約80重量%至約99.9重量%之量的水。When in the form of a liquid oral dosage form, the oral product may further include water in an amount of about 50% by weight to about 99.9% by weight of the oral product. In some embodiments, the oral product includes water in an amount of about 75% by weight to about 99.9% by weight, preferably about 80% by weight to about 99.9% by weight.

在存在之情況下，水可包括自來水、雨水、礦化水或蒸餾水。Where present, water may include tap water, rainwater, mineral water or distilled water.

液體口服劑型可包含佔口服產品之約0.1重量%至約15重量%之量的活性成分之組合及佔口服產品之約85重量%至約99.9重量%之量的水。液體口服劑型可包含佔口服產品之約0.5重量%至約12重量%之量的活性成分之組合及佔口服產品之約88重量%至約99.5重量%之量的水。Liquid oral dosage forms may include a combination of active ingredients in an amount of about 0.1% to about 15% by weight of the oral product and water in an amount of about 85% to about 99.9% by weight of the oral product. Liquid oral dosage forms may include a combination of active ingredients in an amount of about 0.5% to about 12% by weight of the oral product and water in an amount of about 88% to about 99.5% by weight of the oral product.

在一些實施例中，無褪黑激素之液體口服劑型中的活性成分之組合包含(i)鎂或其鹽；(ii)如上文所定義的B族維生素之組合；(iii)人參；(iv)西番蓮；及任擇地以下中之至少一者：(v) L-茶胺酸、(vi)洋甘菊萃取物及/或(vii)聖羅勒，其中鎂或其鹽在上文任一實施例中描述。無褪黑激素之液體口服劑型中的活性成分之組合可包含(i)鎂或其鹽；(ii)如上文所定義的B族維生素之組合；(iii)人參；(iv)西番蓮；及(v) L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述。無褪黑激素之液體口服劑型中的活性成分之組合可包含(i)鎂或其鹽；(ii)如上文所定義的B族維生素之組合；(iii)人參；(iv)西番蓮；及任擇地洋甘菊萃取物；及/或聖羅勒，其中鎂或其鹽在上文任一實施例中描述。無褪黑激素之液體口服劑型中的活性成分之組合可包含(i)鎂或其鹽；(ii)如上文所定義的B族維生素之組合；(iii)人參；(iv)西番蓮；(v) L-茶胺酸及任擇地，(vi)洋甘菊萃取物；及/或(vii)聖羅勒，其中鎂或其鹽在上文任一實施例中描述。在此等實施例中之各者中，B族維生素之組合可由維生素B2及維生素B6組成。In some embodiments, the combination of active ingredients in the liquid oral dosage form without melatonin comprises (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined above; (iii) ginseng; (iv) passion flower; and optionally at least one of the following: (v) L-theanine, (vi) chamomile extract and/or (vii) holy basil, wherein magnesium or a salt thereof is described in any of the embodiments above. The combination of active ingredients in the liquid oral dosage form without melatonin may comprise (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined above; (iii) ginseng; (iv) passion flower; and (v) L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above. The combination of active ingredients in the liquid oral dosage form without melatonin may include (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined above; (iii) ginseng; (iv) passion flower; and optionally chamomile extract; and/or holy basil, wherein magnesium or a salt thereof is described in any of the embodiments above. The combination of active ingredients in the liquid oral dosage form without melatonin may include (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined above; (iii) ginseng; (iv) passion flower; (v) L-theanine and optionally, (vi) chamomile extract; and/or (vii) holy basil, wherein magnesium or a salt thereof is described in any of the embodiments above. In each of these embodiments, the combination of B vitamins may consist of vitamin B2 and vitamin B6.

在以上實施例中之任一者中，液體口服劑型可進一步包含任擇地佔口服產品之約0.01重量%至約5重量%之量的纈草。舉例而言，纈草可以口服產品之約0.025%至約2.5重量%之量，較佳口服產品之約0.05%至約1重量%之量存在。替代地，液體口服劑型可不含纈草。In any of the above embodiments, the liquid oral dosage form may further include valveratrum, optionally in an amount of about 0.01% to about 5% by weight of the oral product. For example, valveratrum may be present in an amount of about 0.025% to about 2.5% by weight of the oral product, preferably about 0.05% to about 1% by weight of the oral product. Alternatively, the liquid oral dosage form may be free of valveratrum.

在一些實施例中，無褪黑激素之液體口服劑型中的活性成分之組合可基本上由以下組成：(i)鎂或其鹽；(ii)如上文所定義的B族維生素之組合；(iii)人參；(iv)西番蓮；(v) L-茶胺酸、(vi)洋甘菊萃取物；及(vii)聖羅勒，其中鎂或其鹽在上文任一實施例中描述。在此等實施例中之各者中，B族維生素之組合可由維生素B2及維生素B6組成。In some embodiments, the combination of active ingredients in the liquid oral dosage form without melatonin may consist essentially of: (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined above; (iii) ginseng; (iv) passion flower; (v) L-theanine, (vi) chamomile extract; and (vii) holy basil, wherein magnesium or a salt thereof is described in any of the embodiments above. In each of these embodiments, the combination of B vitamins may consist of vitamin B2 and vitamin B6.

在一些實施例中，無褪黑激素之液體口服劑型中的活性成分之組合可由以下組成：(i)鎂或其鹽；(ii)如上文所定義的B族維生素之組合；(iii)人參；(iv)西番蓮；(v) L-茶胺酸、(vi)洋甘菊萃取物；及(vii)聖羅勒，其中鎂或其鹽在上文任一實施例中描述。在此等實施例中之各者中，B族維生素之組合可由維生素B2及維生素B6組成。In some embodiments, the combination of active ingredients in the liquid oral dosage form without melatonin may consist of: (i) magnesium or a salt thereof; (ii) a combination of B vitamins as defined above; (iii) ginseng; (iv) passion flower; (v) L-theanine, (vi) chamomile extract; and (vii) holy basil, wherein magnesium or a salt thereof is described in any of the embodiments above. In each of these embodiments, the combination of B vitamins may consist of vitamin B2 and vitamin B6.

液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包含約50 mg至約800 mg，諸如約100 mg至約600 mg，較佳約200 mg至約500 mg之量的鎂或其鹽。Liquid oral dosage forms (e.g., in the form of concentrated drinks having a volume of 25 mL to 75 mL) may contain magnesium or a salt thereof in an amount of about 50 mg to about 800 mg, such as about 100 mg to about 600 mg, preferably about 200 mg to about 500 mg.

液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包含約0.1 mg至約10 mg，諸如約0.5 mg至約7.5 mg，較佳約1 mg至約5 mg或約1 mg至約7 mg之量的B族維生素之總量。Liquid oral dosage forms (e.g., in the form of concentrated drinks having a volume of 25 mL to 75 mL) may contain a total amount of B vitamins in an amount of about 0.1 mg to about 10 mg, such as about 0.5 mg to about 7.5 mg, preferably about 1 mg to about 5 mg or about 1 mg to about 7 mg.

液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包含約10 mg至約500 mg，諸如約25 mg至約300 mg，較佳約50 mg至約250 mg之量的人參。Liquid oral dosage forms (e.g., in the form of concentrated drinks having a volume of 25 mL to 75 mL) may contain ginseng in an amount of about 10 mg to about 500 mg, such as about 25 mg to about 300 mg, preferably about 50 mg to about 250 mg.

液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包含約10 mg至約500 mg，諸如約25 mg至約300 mg，較佳約50 mg至約250 mg之量的西番蓮。Liquid oral dosage forms (e.g., in the form of concentrated drinks having a volume of 25 mL to 75 mL) may contain passionflower in an amount of about 10 mg to about 500 mg, such as about 25 mg to about 300 mg, preferably about 50 mg to about 250 mg.

在存在之情況下，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包括約5 mg至約500 mg，諸如約25 mg至約400 mg，較佳約50 mg至約300 mg之量的L-茶胺酸。Where present, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) may include L-theanine in an amount of about 5 mg to about 500 mg, such as about 25 mg to about 400 mg, preferably about 50 mg to about 300 mg.

在存在之情況下，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包括約1 mg至約500 mg，諸如約5 mg至約250 mg，較佳約10 mg至約100 mg之量的洋甘菊萃取物。Where present, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) may include chamomile extract in an amount of about 1 mg to about 500 mg, such as about 5 mg to about 250 mg, preferably about 10 mg to about 100 mg.

在存在之情況下，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可包括約5 mg至約500 mg，諸如約25 mg至約400 mg，諸如約50 mg至約300 mg之量的聖羅勒。Where present, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) may include holy basil in an amount of about 5 mg to about 500 mg, such as about 25 mg to about 400 mg, such as about 50 mg to about 300 mg.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約50 mg至約800 mg之鎂或其鹽；(ii)約0.1 mg至約10 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約10 mg至約500 mg人參；(iv)約10 mg至約500 mg西番蓮；及任擇地(v)約5 mg至約500 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 10 mg to about 500 mg of ginseng; (iv) about 10 mg to about 500 mg of passionflower; and optionally (v) about 5 mg to about 500 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約100 mg至約600 mg之鎂或其鹽；(ii)約0.5 mg至約7.5 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約25 mg至約300 mg人參；(iv)約25 mg至約300 mg西番蓮；及任擇地(v)約25 mg至約400 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 25 mg to about 300 mg of ginseng; (iv) about 25 mg to about 300 mg of passionflower; and optionally (v) about 25 mg to about 400 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約200 mg至約500 mg之鎂或其鹽；(ii)約1 mg至約5 mg或約1 mg至約7 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約50 mg至約250 mg人參；(iv)約50 mg至約250 mg西番蓮；及任擇地(v)約50 mg至約300 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 200 mg to about 500 mg of magnesium or a salt thereof; (ii) about 1 mg to about 5 mg or about 1 mg to about 7 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 50 mg to about 250 mg of ginseng; (iv) about 50 mg to about 250 mg of passionflower; and optionally (v) about 50 mg to about 300 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約100 mg至約600 mg之鎂或其鹽；(ii)約0.1 mg至約10 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約10 mg至約500 mg人參；(iv)約10 mg至約500 mg西番蓮；及任擇地(v)約5 mg至約500 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 10 mg to about 500 mg of ginseng; (iv) about 10 mg to about 500 mg of passionflower; and optionally (v) about 5 mg to about 500 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約50 mg至約800 mg之鎂或其鹽；(ii)約0.5 mg至約7.5 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約10 mg至約500 mg人參；(iv)約10 mg至約500 mg西番蓮；及任擇地(v)約5 mg至約500 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 10 mg to about 500 mg of ginseng; (iv) about 10 mg to about 500 mg of passionflower; and optionally (v) about 5 mg to about 500 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約50 mg至約800 mg之鎂或其鹽；(ii)約0.1 mg至約10 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約25 mg至約300 mg人參；(iv)約10 mg至約500 mg西番蓮；及任擇地(v)約5 mg至約500 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 25 mg to about 300 mg of ginseng; (iv) about 10 mg to about 500 mg of passionflower; and optionally (v) about 5 mg to about 500 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約50 mg至約800 mg之鎂或其鹽；(ii)約0.1 mg至約10 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約10 mg至約500 mg人參；(iv)約25 mg至約300 mg西番蓮；及任擇地(v)約5 mg至約500 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 50 mg to about 800 mg of magnesium or a salt thereof; (ii) about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 10 mg to about 500 mg of ginseng; (iv) about 25 mg to about 300 mg of passion flower; and optionally (v) about 5 mg to about 500 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約200 mg至約500 mg之鎂或其鹽；(ii)約0.5 mg至約7.5 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約25 mg至約300 mg人參；(iv)約25 mg至約300 mg西番蓮；及任擇地(v)約25 mg至約400 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 200 mg to about 500 mg of magnesium or a salt thereof; (ii) about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 25 mg to about 300 mg of ginseng; (iv) about 25 mg to about 300 mg of passionflower; and optionally (v) about 25 mg to about 400 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約100 mg至約600 mg之鎂或其鹽；(ii)約1 mg至約5 mg或約1 mg至約7 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約25 mg至約300 mg人參；(iv)約25 mg至約300 mg西番蓮；及任擇地(v)約25 mg至約400 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) about 1 mg to about 5 mg or about 1 mg to about 7 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 25 mg to about 300 mg of ginseng; (iv) about 25 mg to about 300 mg of passionflower; and optionally (v) about 25 mg to about 400 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約100 mg至約600 mg之鎂或其鹽；(ii)約0.5 mg至約7.5 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約50 mg至約250 mg人參；(iv)約25 mg至約300 mg西番蓮；及任擇地(v)約25 mg至約400 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 50 mg to about 250 mg of ginseng; (iv) about 25 mg to about 300 mg of passion flower; and optionally (v) about 25 mg to about 400 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在一些實施例中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)包含：(i)約100 mg至約600 mg之鎂或其鹽；(ii)約0.5 mg至約7.5 mg的B族維生素之組合，其中B族維生素之組合如上文所定義；(iii)約25 mg至約300 mg人參；(iv)約50 mg至約250 mg西番蓮；及任擇地(v)約25 mg至約400 mg之L-茶胺酸，其中鎂或其鹽在上文任一實施例中描述，且產品不含褪黑激素。In some embodiments, a liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) comprises: (i) about 100 mg to about 600 mg of magnesium or a salt thereof; (ii) about 0.5 mg to about 7.5 mg of a combination of B vitamins, wherein the combination of B vitamins is as defined above; (iii) about 25 mg to about 300 mg of ginseng; (iv) about 50 mg to about 250 mg of passionflower; and optionally (v) about 25 mg to about 400 mg of L-theanine, wherein magnesium or a salt thereof is described in any of the embodiments above, and the product does not contain melatonin.

在以上實施例中之任一者中，L-茶胺酸可為所界定之量的活性劑之組合中的必備組分。In any of the above embodiments, L-theanine may be an essential component of the combination of active agents in the defined amounts.

在以上實施例中之任一者中，液體口服劑型(例如呈具有25 mL至75 mL之體積的濃縮飲品形式)可進一步包含：(vi)約1 mg至約500 mg，諸如約5 mg至約250 mg，較佳約10 mg至約100 mg洋甘菊萃取物及/或(vii)約5 mg至約500 mg，諸如約25 mg至約400 mg，較佳約50 mg至約300 mg聖羅勒。In any of the above embodiments, the liquid oral dosage form (e.g., in the form of a concentrated drink having a volume of 25 mL to 75 mL) may further comprise: (vi) about 1 mg to about 500 mg, such as about 5 mg to about 250 mg, preferably about 10 mg to about 100 mg of chamomile extract and/or (vii) about 5 mg to about 500 mg, such as about 25 mg to about 400 mg, preferably about 50 mg to about 300 mg of holy basil.

本發明人已發現，如以上所描述之活性成分之量促進睡眠，包括誘導睡眠及/或維持睡眠，同時提供副作用減少之安全產品。該等量可經調整以使得產品具有高功效，同時亦確保消費者安全且避免任何過量之活性劑。The inventors have found that the amount of active ingredients as described above promotes sleep, including inducing sleep and/or maintaining sleep, while providing a safe product with reduced side effects. Such amounts can be adjusted to make the product highly effective while also ensuring consumer safety and avoiding any excess of active agents.

在上述實施例中，人參較佳呈高麗參(韓國人參)存在。In the above embodiment, ginseng is preferably present in the form of Korean ginseng.

液體口服劑型可包括任何其他適合的添加劑。適合添加劑在上文有更詳細地描述，且本文所描述之所有添加劑皆可包括在液體口服劑型中。在一些實施例中，液體口服劑型可進一步包含選自由以下組成之群的添加劑：調味劑、甜味劑、酸化劑、增稠劑、保濕劑、防腐劑及其混合物。此等添加劑形式各自之實例描述於上文。固體口服劑型The liquid oral dosage form may include any other suitable additives. Suitable additives are described in more detail above, and all additives described herein may be included in the liquid oral dosage form. In some embodiments, the liquid oral dosage form may further comprise an additive selected from the group consisting of flavoring agents, sweeteners, acidulants, thickeners, humectants, preservatives, and mixtures thereof. Examples of each of these additive forms are described above.Solid Oral Dosage Forms

在一些實施例中，口服產品呈固體形式。如本文所使用，術語「固體」意謂該等產品在未藉由例如包裝等外部手段支撐時可實質上維持其物理形狀。因此，其被認為在室溫下為固體、固體狀、呈固體形式或呈固體狀形式。為避免疑問，固體產品在至多30℃下保持實質上固態。在一些實施例中，口服產品呈固體形式，諸如呈以下形式：鬆散的濕式鼻粉、鬆散的乾式鼻粉、團狀片、擠出或成型條帶、片、桿或棒、精細粉碎的研磨粉末、精細粉碎或研磨的粉末狀碎片及組分之聚結物、薄片狀碎片、模製加工片、薄膜、易溶於水或分散於水中之薄膜或條帶、膠囊樣材料、錠劑、口含錠。在一些實施例中，口服產品為錠劑或口含錠。在一些實施例中，口服產品呈濕式鼻粉或鼻菸形式，其可含有或可不含菸草。In some embodiments, the oral product is in solid form. As used herein, the term "solid" means that the product can substantially maintain its physical shape when not supported by external means such as packaging. Therefore, it is considered to be solid, solid-like, in solid form, or in solid-like form at room temperature. For the avoidance of doubt, a solid product remains substantially solid at a temperature of up to 30°C. In some embodiments, the oral product is in solid form, such as in the form of loose wet nasal powder, loose dry nasal powder, agglomerated tablets, extruded or molded strips, sheets, rods or sticks, finely crushed ground powders, finely crushed or ground powdered fragments and agglomerates of components, flaky fragments, molded processed tablets, films, films or strips that are easily soluble or dispersed in water, capsule-like materials, tablets, and buccal tablets. In some embodiments, the oral product is a tablet or a buccal tablet. In some embodiments, the oral product is in the form of a wet nasal powder or nasal tobacco, which may or may not contain tobacco.

本文所揭露之口服產品可形成為多種形狀，包括丸劑、錠劑、球體、條帶、薄膜、薄片、硬幣形、立方體、珠粒、卵形物、長橢圓形、圓柱形、豆形、棒狀或桿狀。該產品之橫截面形狀可變化，且示例橫截面形狀包括圓形、正方形、橢圓形、矩形及其類似形狀。此類形狀可使用諸如移動帶、夾、擠出機、造粒裝置、壓實裝置及其類似裝置之設備，以多種方式形成。The oral products disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, strips, films, flakes, coins, cubes, beads, ovals, oblongs, cylinders, beans, sticks, or rods. The cross-sectional shape of the product can vary, and example cross-sectional shapes include circles, squares, ellipses, rectangles, and the like. Such shapes can be formed in a variety of ways using equipment such as moving belts, clamps, extruders, granulating devices, compacting devices, and the like.

在一些實施例中，固體口服產品呈選自由以下組成之群的形式：熔化物、錠劑或口含錠。熔化物In some embodiments, the solid oral product is in a form selected from the group consisting of a melt, a tablet, or abuccal tablet.

在一些實施例中，該產品可為可熔化的，如例如頒予Cantrell等人之美國專利申請公開案第2012/0037175號中所論述，該案以全文引用的方式併入本文中。In some embodiments, the product may be meltable, as discussed, for example, in U.S. Patent Application Publication No. 2012/0037175 to Cantrell et al., which is incorporated herein by reference in its entirety.

如本文所使用，「熔化物」、「熔化」及「可熔化」係指該產品自固態變為液態的能力。亦即，當一種物質(例如本文所揭露之產品)通常藉由施加熱而自固態變為液態時，發生熔化。As used herein, "melt", "melt" and "meltable" refer to the ability of the product to change from a solid state to a liquid state. That is, melting occurs when a substance (such as the product disclosed herein) changes from a solid state to a liquid state, usually by applying heat.

對於如本文所揭露之產品施加熱係藉由使用者口中的內部溫度提供。因此，術語「可熔化」係指產品能夠在使用者之口中液化，此時該產品自固態變為液態，且意圖區分僅透過該產品內之黏結性喪失而在口腔中崩解的產品與僅在該產品之水溶性組分與水分相互作用時溶解於口腔中的產品。The application of heat to the products as disclosed herein is provided by the internal temperature of the user's mouth. Thus, the term "meltable" refers to a product that is capable of liquefying in the user's mouth when the product changes from a solid state to a liquid state, and is intended to distinguish between products that disintegrate in the oral cavity merely through a loss of cohesiveness within the product and products that dissolve in the oral cavity merely when the water-soluble components of the product interact with moisture.

一般而言，可熔化產品包含脂質。在一些實施例中，組成物包含脂質。脂質典型地為來源於動物或植物材料之脂肪、油或蠟物質(例如植物來源之脂肪)，且典型地主要包含三酸甘油酯以及較少量的游離脂肪酸及單酸甘油酯或二酸甘油酯。在某些實施例中，脂質在室溫(亦即，25℃)下為固體或半固體且在經歷使用者口腔之溫度時能夠至少部分液化(亦即，「熔化」)。示例植物來源之脂肪主要包含碳長度為約10至約26個碳原子、或約14至約20個碳原子、或約14至約18個碳原子的飽和或不飽和脂肪酸鏈(其中大多數在三酸甘油酯結構內結合)。In general, the meltable product comprises a lipid. In some embodiments, the composition comprises a lipid. The lipid is typically a fat, oil or waxy substance derived from an animal or plant material (e.g., a fat of plant origin), and typically comprises primarily triglycerides and relatively small amounts of free fatty acids and monoglycerides or diglycerides. In certain embodiments, the lipid is solid or semisolid at room temperature (i.e., 25° C.) and is capable of at least partially liquefying (i.e., “melting”) when subjected to the temperature of the user's mouth. Exemplary plant-derived fats primarily comprise saturated or unsaturated fatty acid chains (most of which are bound within a triglyceride structure) having a carbon length of about 10 to about 26 carbon atoms, or about 14 to about 20 carbon atoms, or about 14 to about 18 carbon atoms.

在一些實施例中，脂質包含油且特別是食品級油，包括分餾油。此類油包括但不限於植物油(例如巴西莓果油、杏仁油、莧菜油、杏油、蘋果籽油、摩洛哥堅果油、鱷梨油、巴巴蘇油、山毛櫸堅果油、本油(ben oil)、苦瓜油、黑籽油、黑醋栗籽油、琉璃苣籽油、婆羅洲牛油果油(borneo tallow nut oil)、葫蘆油(bottle gourd oil)、巴西堅果油、水牛葫蘆油、冬南瓜籽油、海角板栗油(cape chestnut oil)、芥花油、刺槐腰果油(carob cashew oil)、可可脂、蝨母子油(cocklebur oil)、椰子油、玉米油、科胡恩油(cothune oil)、芫荽籽油、棉籽油、椰棗籽油、地咖油(dika oil)、埃古斯籽油(egus seed oil)、月見草油、假亞麻油、亞麻籽油、葡萄籽油、葡萄柚籽油、榛果油、大麻油、木棉籽油、洋麻籽油、拉拉曼西亞油(lallemantia oil)、檸檬油、亞麻籽油、澳洲堅果油(macadamia oil)、瑪芙油(mafura oil)、馬魯拉油(marula oil)、白芒花籽油(meadowfoam seed oil)、蒙哥堅果油(mongongo nut oil)、芥末油(mustard oil)、尼日爾籽油(niger seed oil)、肉豆蔻脂(nutmeg butter)、秋葵籽油(okra seed oil)、橄欖油、橙油、棕櫚油、番木瓜籽油、花生油、山核桃油、紫蘇籽油、柿子籽油、巴西油桃木果油(pequi oil)、霹靂果油(pili nut oil)、松子油、開心果油、石榴籽油、罌粟籽油、巴卡斯果油(pracaxi oil)、李子仁油(prune kernel oil)、南瓜籽油、鵝腳藜油、小葵子油(ramtil oil)、菜籽油、米糠油、青刺果油(royle oil)、印加果油(sacha inchi oil)、紅花油、馬米果油(sapote oil)、油棕油(seje oil)、芝麻油、牛油樹脂(shea butter)、大豆油、葵花籽油、塔拉米拉油(taramira oil)、茶籽油、薊油、虎堅果油(tigernut oil)、菸籽油、番茄籽油、胡桃油、西瓜籽油、小麥胚芽油及其組合)、動物油(例如牛脂肪、水牛脂肪、綿羊脂肪、山羊脂肪、豬脂肪、豬油、駱駝脂肪、牛脂、液體人造奶油、魚油、魚肝油、鯨油、海豹油及其組合)以及礦物油。In some embodiments, the lipid comprises oil and particularly food grade oil, including fractionated oil. Such oils include, but are not limited to, vegetable oils (e.g., acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, ben oil, bitter melon oil, black seed oil, black currant seed oil, borage seed oil, borneo tallow nut oil, bottle gourd oil, brazil nut oil, buffalo gourd oil, winter squash seed oil, cape chestnut oil, canola oil, carob cashew oil, cocoa butter, cocklebur oil, coconut oil, corn oil, cothune oil, cilantro seed oil, cottonseed oil, coconut date seed oil, dika oil, egus seed oil, etc. oil), evening primrose oil, linseed oil, linseed oil, grapeseed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok seed oil, kenaf seed oil, lallemantia oil, lemon oil, linseed oil, macadamia oil, mafura oil, marula oil, meadowfoam seed oil, mongongo nut oil, mustard oil, niger seed oil, nutmeg butter, okra seed oil, olive oil, orange oil, palm oil, papaya seed oil, peanut oil, pecan oil, perilla seed oil, persimmon seed oil, pequi oil, pili nut oil, oil), pine nut oil, pistachio oil, pomegranate seed oil, poppy seed oil, pracaxi oil, prune kernel oil, pumpkin seed oil, quinoa oil, ramtil oil, rapeseed oil, rice bran oil, royle oil, sacha inchi oil, safflower oil, sapote oil, seje oil, sesame oil, shea butter, soybean oil, sunflower seed oil, taramira oil, tea seed oil, artichoke oil, tigernut oil oil), tobacco oil, tomato seed oil, walnut oil, watermelon seed oil, wheat germ oil, and combinations thereof), animal oils (e.g. beef fat, buffalo fat, sheep fat, goat fat, pork fat, lard, camel fat, tallow, liquid margarine, fish oil, cod liver oil, whale oil, seal oil, and combinations thereof), and mineral oils.

在某些實施例中，本揭露內容的植物來源之脂肪包括棕櫚油(包括分餾棕櫚油)、棕櫚仁油、大豆油、棉籽油及其混合物。在一個實施例中，脂質係棕櫚油及棕櫚仁油之摻合物。脂質可例如為氫化、部分氫化或未氫化的。脂質之示例實施例可以品牌名CEBES®、CISAO®或CONF AO®購自AarhusKarlshamn USA Inc。In certain embodiments, the plant-derived fats of the present disclosure include palm oil (including fractionated palm oil), palm kernel oil, soybean oil, cottonseed oil, and mixtures thereof. In one embodiment, the lipid is a blend of palm oil and palm kernel oil. The lipid may be, for example, hydrogenated, partially hydrogenated, or unhydrogenated. Exemplary embodiments of lipids may be purchased from AarhusKarlshamn USA Inc. under the brand names CEBES®, CISAO®, or CONF AO®.

脂質之熔點典型地為約29℃或更高，諸如為約29℃至約49℃、或約36℃至約45℃、或約38℃至約41℃。在一些實施例中，使用熔點小於約36℃之脂質會因產品儲存或操作期間可能熔化而不利。一種用於測定脂質熔點之測試係梅特勒滴點法(Mettler dropping point method) (ASTM D3954-15，蠟滴點之標準測試方法；ASTM International, West Conshohocken, PA, 2015, www.astm.org)。The melting point of the lipid is typically about 29° C. or higher, such as about 29° C. to about 49° C., or about 36° C. to about 45° C., or about 38° C. to about 41° C. In some embodiments, the use of a lipid with a melting point less than about 36° C. is disadvantageous because it may melt during storage or handling of the product. One test for determining the melting point of a lipid is the Mettler dropping point method (ASTM D3954-15, Standard Test Method for Wax Dropping Point; ASTM International, West Conshohocken, PA, 2015, www.astm.org).

當存在時，組成物內脂質之量可變化。在某些實施例中，脂質之量為以組成物之乾重計至少約10%、至少約20%或至少約30%。在某些實施例中，脂質之量為以乾重計小於約70%、小於約60%或小於約50%。示例脂質重量範圍包括以乾重計約10%至約70%，諸如以乾重計約35%至約50%。在一些實施例中，脂質之量佔總口服產品約35重量%、約40重量%、約45重量%或約50重量%。When present, the amount of lipid in the composition can vary. In certain embodiments, the amount of lipid is at least about 10%, at least about 20%, or at least about 30% by dry weight of the composition. In certain embodiments, the amount of lipid is less than about 70%, less than about 60%, or less than about 50% by dry weight. Example lipid weight ranges include about 10% to about 70% by dry weight, such as about 35% to about 50% by dry weight. In some embodiments, the amount of lipid is about 35%, about 40%, about 45%, or about 50% by weight of the total oral product.

在一些實施例中，口服產品包含脂質。在一個實施例中，脂質為選自由以下組成之群的油：棕櫚油、棕櫚仁油、大豆油、葵花籽油、棉籽油、椰子油及其組合，其中該油可為氫化、部分氫化或未氫化的。在一個實施例中，脂質係具有中等硬度的反式氫化之填充脂肪(filling fat)，諸如獲自AarhusKarlshamn USA Inc. (131 Marsh Street, Port Newark, NJ 07114)之Confao® 5。In some embodiments, the oral product comprises a lipid. In one embodiment, the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower seed oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or unhydrogenated. In one embodiment, the lipid is a trans-hydrogenated filling fat having a medium hardness, such as Confao® 5 available from AarhusKarlshamn USA Inc. (131 Marsh Street, Port Newark, NJ 07114).

在一些實施例中，呈可熔化形式之產品包含佔口服產品之約35重量%至約50重量%之量的脂質及佔口服產品之約35重量%至約55重量%之量的糖醇。在一些實施例中，糖醇係異麥芽酮糖醇、赤藻糖醇、山梨糖醇、阿拉伯糖醇、核糖醇、麥芽糖醇、甜醇、艾杜糖醇、甘露糖醇、木糖醇、乳糖醇或其組合。在一些實施例中，糖醇係或包含異麥芽酮糖醇。在一些實施例中，代糖可作為糖醇之替代或與一或多種糖醇組合使用。適合代糖包括阿洛酮糖、可溶性木薯纖維、菊糖及其組合。錠劑In some embodiments, the product in a meltable form comprises lipids in an amount of about 35% to about 50% by weight of the oral product and sugar alcohols in an amount of about 35% to about 55% by weight of the oral product. In some embodiments, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, tretol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is or comprises isomalt. In some embodiments, sugar substitutes may be used as a substitute for sugar alcohols or in combination with one or more sugar alcohols. Suitable sugar substitutes include allulose, soluble tapioca fiber, inulin, and combinations thereof.Tablets

在某些實施例中，產品呈壓縮或模製錠劑形式。例示性錠劑劑型重約250 mg至約1500 mg，諸如為約250 mg至約700 mg或約700 mg至約1500 mg。錠劑可具有多種形狀中之任一者，包括傳統的丸劑或錠劑形狀。In certain embodiments, the product is in the form of a compressed or molded tablet. Exemplary tablet dosage forms weigh from about 250 mg to about 1500 mg, such as from about 250 mg to about 700 mg or from about 700 mg to about 1500 mg. Tablets can have any of a variety of shapes, including traditional pill or tablet shapes.

一般而言，呈錠劑形式之產品包含葡萄糖-多醣摻合物及糖醇。在一些實施例中，葡萄糖-多醣摻合物係以產品之總重量計約35重量%至約50重量%之量存在；且糖醇係以產品之總重量計約30重量%至約45重量%之量存在。在一些實施例中，糖醇係異麥芽酮糖醇、赤藻糖醇、山梨糖醇、阿拉伯糖醇、核糖醇、麥芽糖醇、甜醇、艾杜糖醇、甘露糖醇、木糖醇、乳糖醇或其組合。在一些實施例中，糖醇係或包含異麥芽酮糖醇。In general, the product in tablet form comprises a glucose-polysaccharide blend and a sugar alcohol. In some embodiments, the glucose-polysaccharide blend is present in an amount of about 35% to about 50% by weight of the total weight of the product; and the sugar alcohol is present in an amount of about 30% to about 45% by weight of the total weight of the product. In some embodiments, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, sweet alcohol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is or comprises isomalt.

當呈錠劑形式時，產品可為可溶的。如本文所使用，術語「溶解(dissolve)」、「溶解(dissolving)」及「可溶」係指產品具有水溶性組分，該等水溶性組分與口腔中之水分相互作用且進入溶液中，由此引起產品逐漸攝入。根據一個態樣，可溶產品能夠在使用者之口中保持給定時段，直至其完全溶解。溶解速率可在約1分鐘或更短時間至約60分鐘之廣泛範圍內變化。舉例而言，快速釋放產品典型地在約2分鐘或更短時間，通常約1分鐘或更短時間(例如約50秒或更短時間、約40秒或更短時間、約30秒或更短時間、或約20秒或更短時間)內溶解及/或釋放一或多種所希望的組分(例如活性成分、風味劑及其類似物)。溶解可藉由任何手段進行，諸如熔化、機械破壞(例如咀嚼)、酶或其他化學降解，或藉由破壞產品各組分之間的相互作用。在其他實施例中，產品在產品於使用者之口中停留期間並不溶解。口含錠When in tablet form, the product may be soluble. As used herein, the terms "dissolve,""dissolving," and "soluble" refer to a product having water-soluble components that interact with the moisture in the oral cavity and go into solution, thereby causing gradual ingestion of the product. According to one aspect, a soluble product is capable of remaining in the user's mouth for a given period of time until it is completely dissolved. The rate of dissolution may vary over a wide range of about 1 minute or less to about 60 minutes. For example, rapid-release products typically dissolve and/or release one or more desired components (e.g., active ingredients, flavoring agents, and the like) in about 2 minutes or less, usually about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution may be accomplished by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or by disruption of interactions between the components of the product. In other embodiments, the product does not dissolve while the product is in the user's mouth.Buccal Tablets

在一些實施例中，本文所揭露之產品可呈經組態成供口服使用的可溶性口含錠產品形式。本發明的示例口含錠型產品具有口含錠、錠劑、舌下錠(microtab)或其他錠劑型產品形式。參見例如頒予Shaw之美國專利第4,967,773號、頒予Acharya之美國專利第5,110,605號、頒予Dam之美國專利第5,733,574號、頒予Santus之美國專利第6,280,761號、頒予Andersson等人之美國專利第6,676,959號、頒予Wilhelmsen之美國專利第6,248,760號及美國專利第7,374,779號，頒予Wilhelmsen之美國專利公開案第2001/0016593號、頒予Liu等人之美國專利公開案第2004/0101543號、頒予Mcneight之美國專利公開案第2006/0120974號、頒予Chau等人之美國專利公開案第2008/0020050號、頒予Gin等人之美國專利公開案第2009/0081291號及頒予Axelsson等人之美國專利公開案第2010/0004294號中所闡述的含菸鹼口含錠類型、口含錠調配物、口含錠型式及組態、口含錠特徵及用於調配或製造口含錠之技術，該等案以引用的方式併入本文中。In some embodiments, the products disclosed herein may be in the form of a soluble buccal tablet product configured for oral use. Exemplary buccal tablet products of the present invention have buccal tablets, lozenges, sublingual tablets (microtabs) or other tablet-type product forms. See, e.g., U.S. Patent No. 4,967,773 to Shaw, U.S. Patent No. 5,110,605 to Acharya, U.S. Patent No. 5,733,574 to Dam, U.S. Patent No. 6,280,761 to Santus, U.S. Patent No. 6,676,959 to Andersson et al., U.S. Patent Nos. 6,248,760 and 7,374,779 to Wilhelmsen, U.S. Patent Publication No. 2001/0016593 to Wilhelmsen, U.S. Patent No. 2002/0016597 to Liu et al. The types of nicotine oral tablets, oral tablet formulations, oral tablet forms and configurations, oral tablet features, and techniques for formulating or manufacturing oral tablets described in U.S. Patent Publication No. 2004/0101543 to McNeight, U.S. Patent Publication No. 2006/0120974 to Chau et al., U.S. Patent Publication No. 2008/0020050 to Chau et al., U.S. Patent Publication No. 2009/0081291 to Gin et al., and U.S. Patent Publication No. 2010/0004294 to Axelsson et al. are incorporated herein by reference.

口含錠產品一般被描述為「硬」的且以此方式與軟口含錠(亦即，丸粒)相區分。硬口含錠係呈非晶形狀態的糖及/或碳水化合物之混合物。儘管其由含水糖漿製成，但當糖漿在加工期間煮沸時，最初存在的水蒸發，由此使成品中之水分含量極低，諸如0.5重量%至1.5重量%。為獲得硬且無黏性之口含錠，熔化物之溫度一般應達到硬裂紋階段，且示例溫度範圍為149℃至154℃。Lozenge products are generally described as "hard" and in this way are distinguished from soft lozenges (i.e., pellets). Hard lozenges are mixtures of sugars and/or carbohydrates in an amorphous state. Although they are made from aqueous syrups, when the syrup is boiled during processing, the water initially present evaporates, resulting in a very low moisture content in the finished product, such as 0.5 to 1.5% by weight. To obtain hard and non-sticky lozenges, the temperature of the melt should generally reach the hard crack stage, and an exemplary temperature range is 149° C. to 154° C.

在一些實施例中，口含錠型產品可展現半透明性或透明性。產品所希望的透明性或半透明性可藉由任何已知方法定量。舉例而言，可使用光學方法，諸如比濁法(或濁度測定法)及比色法分別對產品之混濁度(光散射)及顏色(光吸收)進行定量。半透明性亦可利用目視檢查，藉由簡單地將產品放在光源下且確定光是否以漫射方式行進穿過材料或產品來確認。In some embodiments, the lozenge-type product may exhibit translucency or transparency. The desired transparency or translucency of the product may be quantified by any known method. For example, optical methods such as turbidimetry (or nephelometric method) and colorimetry may be used to quantify the turbidity (light scattering) and color (light absorption) of the product, respectively. Translucency may also be confirmed by visual inspection by simply placing the product under a light source and determining whether the light travels through the material or product in a diffuse manner.

除活性成分之組合外，本揭露內容之口含錠型產品亦可併入各種不同的添加劑，且可根據此項技術中通常已知的用於製備口含錠型產品之多種不同方法製備。示例組成物、產品及製備此類產品之方法將於下文詳述。In addition to the combination of active ingredients, the buccal tablet-type products of the present disclosure may also incorporate a variety of additives and may be prepared according to a variety of different methods commonly known in the art for preparing buccal tablet-type products. Exemplary compositions, products, and methods for preparing such products are described in detail below.

本揭露內容之口含錠產品典型地包括一種組成物，其包含小於約2重量%之量的活性成分之組合、至少約80重量%之量的代糖及糖醇糖漿。本文所論述之任何活性成分皆適合用作本文所提供之口含錠產品中的活性成分。在一些實施例中，活性成分可以液體形式或者以乾粉或顆粒形式提供。如上所指出，活性成分典型地係以產品之總重量計約0.1重量%至約10重量%，諸如約0.1重量%至約10重量%，諸如約0.1重量%、約0.5重量%、約1重量%、約1.5重量%、約2重量%、約2.5重量%、約3重量%、約3.5重量%、約4重量%或約4.5重量%至約5.5重量%、約6重量%、約6.5重量%、約7重量%、約7.5重量%、約8重量%、約8.5重量%、約9重量%、約9.5重量%或約10重量%之量存在。在一些實施例中，活性成分可以產品之總重量計小於約10重量%、小於約9重量%、小於約8重量%、小於約7重量%、小於約6重量%、小於約5重量%、小於約4重量%、小於約3重量%、小於約2重量%或小於約1重量%之量存在。The buccal tablet products of the present disclosure typically include a composition comprising a combination of active ingredients in an amount of less than about 2% by weight, a sugar substitute and a sugar alcohol syrup in an amount of at least about 80% by weight. Any active ingredient discussed herein is suitable for use as an active ingredient in the buccal tablet products provided herein. In some embodiments, the active ingredient can be provided in liquid form or in a dry powder or granular form. As noted above, the active ingredient is typically present in an amount of about 0.1% to about 10% by weight, such as about 0.1% to about 10% by weight, such as about 0.1%, about 0.5%, about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, or about 4.5% to about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, or about 10% by weight of the total weight of the product. In some embodiments, the active ingredient can be present in an amount of less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, or less than about 1% by weight of the total weight of the product.

在一些實施例中，口含錠產品包含代糖。代糖典型地以純、固體形式(例如顆粒或粉末形式)提供。在某些實施例中，代糖係乾燥的，包含極低含水量。舉例而言，代糖可包含小於約5重量%水、小於約3重量%水、小於約2重量%水或小於約1重量%水。在某些實施例中，代糖能夠形成玻璃狀基質。玻璃狀基質之形成通常以半透明/透明外觀為特徵。In some embodiments, the lozenge product comprises a sugar substitute. The sugar substitute is typically provided in a pure, solid form (e.g., granular or powdered form). In certain embodiments, the sugar substitute is dry and contains a very low water content. For example, the sugar substitute may contain less than about 5% by weight water, less than about 3% by weight water, less than about 2% by weight water, or less than about 1% by weight water. In certain embodiments, the sugar substitute is capable of forming a glassy matrix. The formation of a glassy matrix is generally characterized by a translucent/transparent appearance.

典型地，代糖實質上為非吸濕性的。非吸濕性材料典型地不吸收、吸附及/或保留來自空氣之大量水分。非吸濕性材料在暴露於濕度時可提供減小口含錠產品有黏性之傾向的益處。代糖可為任何無糖材料(亦即，不含蔗糖之材料)且可為天然的或合成產生的。本文所描述之產品中使用之代糖可為有營養的或無營養的。舉例而言，代糖通常為糖醇。根據本發明可能有用的糖醇包括但不限於赤藻糖醇、蘇糖醇、阿拉伯糖醇、木糖醇、核糖醇、甘露糖醇、山梨糖醇、甜醇、艾杜糖醇、異麥芽酮糖醇、麥芽糖醇、乳糖醇、聚葡糖醇及其混合物。舉例而言，在某些實施例中，糖醇係選自由以下組成之群：赤藻糖醇、山梨糖醇及異麥芽酮糖醇。口含錠產品中代糖之量可變化，但典型地為產品之至少約75重量%、至少約80重量%、至少約85重量%或至少約90重量%、或至少約95重量%。Typically, sugar substitutes are substantially non-hygroscopic. Non-hygroscopic materials typically do not absorb, adsorb and/or retain large amounts of moisture from the air. Non-hygroscopic materials can provide the benefit of reducing the tendency of oral tablet products to be sticky when exposed to humidity. Sugar substitutes can be any sugar-free material (i.e., a material that does not contain sucrose) and can be natural or synthetically produced. The sugar substitutes used in the products described herein can be nutritious or non-nutritious. For example, sugar substitutes are usually sugar alcohols. Sugar alcohols that may be useful according to the present invention include, but are not limited to, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, sweet alcohol, iditol, isomalt, maltitol, lactitol, polyglucitol and mixtures thereof. For example, in certain embodiments, the sugar alcohol is selected from the group consisting of erythritol, sorbitol, and isomalt. The amount of sugar substitute in the buccal tablet product may vary, but is typically at least about 75%, at least about 80%, at least about 85%, or at least about 90%, or at least about 95% by weight of the product.

在某些實施例中，代糖包含一或多種糖醇。舉例而言，在一個實施例中，代糖係異麥芽酮糖醇。In certain embodiments, the sugar substitute comprises one or more sugar alcohols. For example, in one embodiment, the sugar substitute is isomalt.

在一些實施例中，代糖係以下中之一或多者：阿洛酮糖、可溶性木薯纖維及菊糖。此類代糖可作為糖醇之替代或與一或多種糖醇組合使用。In some embodiments, the sugar substitute is one or more of the following: psicose, soluble tapioca fiber and inulin. Such sugar substitutes can be used as a substitute for sugar alcohols or in combination with one or more sugar alcohols.

在一些實施例中，本揭露內容之口含錠產品可包含糖漿，例如含糖之糖漿或糖醇糖漿。如本文所使用，「糖醇糖漿」意欲指糖醇於水中之濃稠溶液，其例如具有大於約40%固體，較佳具有大於約50%固體、大於約60%固體、大於約70%固體或大於約80%固體。典型地，糖醇糖漿之固體含量主要包含所提糖醇(亦即，麥芽糖醇糖漿通常包含以乾重計大於約80重量%、大於約85重量%或大於約90重量%的麥芽糖醇)。糖醇糖漿一般藉由加熱糖醇於水中之溶液且冷卻該混合物以得到黏性組成物來製備。所得到的糖漿典型地以相對較高的糖醇濃度及相對較高的穩定性(亦即，糖醇通常在例如室溫下不會自溶液結晶)為特徵。In some embodiments, the buccal tablet products of the present disclosure may include a syrup, such as a sugar-containing syrup or a sugar alcohol syrup. As used herein, "sugar alcohol syrup" is intended to refer to a concentrated solution of a sugar alcohol in water, for example, having greater than about 40% solids, preferably greater than about 50% solids, greater than about 60% solids, greater than about 70% solids, or greater than about 80% solids. Typically, the solid content of the sugar alcohol syrup comprises mainly the sugar alcohols mentioned (i.e., maltitol syrups typically comprise greater than about 80% by weight, greater than about 85% by weight, or greater than about 90% by weight of maltitol on a dry weight basis). Sugar alcohol syrups are generally prepared by heating a solution of a sugar alcohol in water and cooling the mixture to obtain a viscous composition. The resulting syrups are typically characterized by a relatively high sugar alcohol concentration and a relatively high stability (ie, the sugar alcohol generally does not crystallize from solution at, for example, room temperature).

糖漿，例如糖醇糖漿，理想地能夠影響熔化之代糖之再結晶。根據本揭露內容特別有用的一種示例糖醇糖漿係麥芽糖醇糖漿。亦可使用其他糖醇糖漿，包括但不限於玉米糖漿、金黃色糖漿(golden syrup)、糖蜜、木糖醇、甘露糖醇、甘油、赤藻糖醇、蘇糖醇、阿拉伯糖醇、核糖醇、甘露糖醇、山梨糖醇、甜醇、艾杜糖醇、異麥芽酮糖醇、乳糖醇及聚葡糖醇糖漿。此類糖醇糖漿可經製備或可自商業來源獲得。舉例而言，麥芽糖醇糖漿可購自如Corn Products Specialty Ingredients之類供應商。儘管糖醇糖漿可為較佳的，但在某些實施例中，可使用含糖糖漿代替糖醇糖漿或與糖醇糖漿組合。舉例而言，在一些實施例中，可使用玉米糖漿、金黃色糖漿及/或糖蜜。Syrups, such as sugar alcohol syrups, are ideally capable of affecting the recrystallization of the melted sugar substitute. An exemplary sugar alcohol syrup that is particularly useful according to the present disclosure is maltitol syrup. Other sugar alcohol syrups may also be used, including but not limited to corn syrup, golden syrup, molasses, xylitol, mannitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, sorbitol, tretol, iditol, isomalt, lactitol, and polyglucitol syrups. Such sugar alcohol syrups may be prepared or may be obtained from commercial sources. For example, maltitol syrup may be purchased from suppliers such as Corn Products Specialty Ingredients. Although sugar alcohol syrups may be preferred, in some embodiments, sugar-containing syrups may be used instead of or in combination with sugar alcohol syrups. For example, in some embodiments, corn syrup, golden syrup and/or molasses may be used.

添加至口含錠組成物混合物中的糖醇糖漿之量典型地為減慢呈熔化形式之代糖再結晶所需的量。應注意，視殘留成分之組成而定，可變化糖醇糖漿之量以確保再結晶足夠慢以提供具有所希望特徵(例如所希望的半透明性/透明性位準)之材料。因此，糖醇糖漿之量可變化，但典型地在佔口含錠產品混合物約0.1重量%至約2重量%，通常約0.5重量%至約1.5重量%範圍內，且更通常為約1重量%。在某些實施例中，糖醇糖漿之量較高，例如佔混合物多達約2重量%、佔混合物多達約5重量%、佔混合物多達約10重量%或佔混合物多達約20重量%。The amount of sugar alcohol syrup added to the oral tablet composition mixture is typically the amount required to slow down the recrystallization of the sugar substitute in molten form. It should be noted that, depending on the composition of the residual ingredients, the amount of sugar alcohol syrup can be varied to ensure that the recrystallization is slow enough to provide a material with desired characteristics (e.g., desired translucency/transparency level). Therefore, the amount of sugar alcohol syrup can vary, but is typically in the range of about 0.1% to about 2% by weight, typically about 0.5% to about 1.5% by weight, and more typically about 1% by weight of the oral tablet product mixture. In certain embodiments, the amount of sugar alcohol syrup is higher, such as up to about 2% by weight of the mixture, up to about 5% by weight of the mixture, up to about 10% by weight of the mixture, or up to about 20% by weight of the mixture.

代表性口含錠組成物及產品可併入以產品之總重量計約10重量%或更低的活性成分之組合、約0.01重量%至約2重量%的人造甜味劑、約1重量%至約5重量%的保濕劑、約1重量%至約5重量%的天然甜味劑、至少約80重量%的代糖、約0.1重量%至約10重量%的糖醇糖漿、至多約5重量%之量的一或多種調味劑及至多約3重量%之量的鹽。各成分之特定百分比及選擇將視所希望之風味、質地及其他特徵而變化。Representative lozenge compositions and products may incorporate a combination of active ingredients at about 10% or less by weight, about 0.01% to about 2% by weight of artificial sweeteners, about 1% to about 5% by weight of humectants, about 1% to about 5% by weight of natural sweeteners, at least about 80% by weight of sugar substitutes, about 0.1% to about 10% by weight of sugar alcohol syrups, one or more flavorings in an amount of up to about 5% by weight, and salt in an amount of up to about 3% by weight, based on the total weight of the product. The specific percentages and selections of each ingredient will vary depending on the desired flavor, texture, and other characteristics.

本揭露內容的呈口含錠形式之口服產品可含有各種量的水。除指定產品之最終形式外，在產品之消費者使用之前，本文所描述之口含錠的含水量可根據所希望特性及特徵在此類範圍內變化。舉例而言，口含錠型產品典型地具有在產品約0.1重量%至約5重量%範圍內之含水量。較佳地，在插入使用者之口中之前存在於單個產品單元內的口含錠產品之水分含量小於產品之約5重量%、小於約3重量%、小於約2重量%或小於約1重量%。在一些實施例中，本文所描述之口含錠產品的水分含量可在產品之約0.1重量%至約5重量%、約0.5重量%至約3重量%或約1重量%至約2重量%範圍內。散劑或袋裝產品The oral products in the form of buccal tablets of the present disclosure may contain various amounts of water. In addition to the final form of the specified product, the water content of the buccal tablets described herein may vary within such ranges according to the desired properties and characteristics before the consumer of the product uses it. For example, buccal tablet-type products typically have a water content in the range of about 0.1% by weight to about 5% by weight of the product. Preferably, the water content of the buccal tablet product present in a single product unit before insertion into the user's mouth is less than about 5% by weight of the product, less than about 3% by weight, less than about 2% by weight, or less than about 1% by weight. In some embodiments, the water content of the buccal tablet product described herein may be in the range of about 0.1% by weight to about 5% by weight, about 0.5% by weight to about 3% by weight, or about 1% by weight to about 2% by weight of the product.Powder or bagged products

在一些實施例中，口服產品可呈散劑形式。散劑可為自由流動之粉末。散劑可以鬆散形式包含在容器內，且因此可以與菸草鼻粉類似之形式使用，在此情況下，使用者自該容器拿起一撮粉末並將該粉末放入口腔中。替代地或另外，散劑可併入水分可滲透(例如唾液可滲透)之小袋中，與鼻菸型產品類似。袋裝產品可經組態成用於插入使用者之口腔中；亦即，其可為袋裝口服產品。In some embodiments, the oral product may be in the form of a powder. The powder may be a free-flowing powder. The powder may be contained in a container in loose form and may therefore be used in a manner similar to tobacco nasal powder, in which case the user takes a pinch of powder from the container and places the powder in the mouth. Alternatively or in addition, the powder may be incorporated into a moisture permeable (e.g., saliva permeable) pouch, similar to a snorting product. A bagged product may be configured for insertion into the user's mouth; that is, it may be a bagged oral product.

在一些實施例中，本揭露內容之產品呈袋裝口服產品形式。此類袋裝產品包含安置於水分可滲透容器(例如水可滲透小袋或唾液可滲透小袋)內的如本文所描述之口服產品。舉例而言，袋裝產品可包含併入唾液可滲透小袋內的呈粉末形式之口服產品。In some embodiments, the product of the present disclosure is in the form of a bagged oral product. Such bagged products include an oral product as described herein placed in a moisture permeable container (e.g., a water permeable pouch or a saliva permeable pouch). For example, the bagged product may include an oral product in powder form incorporated into a saliva permeable pouch.

此類呈水分可滲透小袋型式之組成物典型地藉由將一個含有組成物之小袋置放於人類個體/使用者之口中來使用。一般而言，該小袋以與一般使用濕式鼻粉產品相同的方式置放於使用者口腔中之某處，例如唇下方。小袋較佳地不進行咀嚼或吞服。接著，暴露於唾液使得其中的組成物之一些組分(例如活性成分及/或任何風味劑)穿過例如水分可滲透小袋並向使用者提供風味及滿足感，且使用者不需要吐出該組成物之任何部分。在使用/享受約10分鐘至約60分鐘，典型地約15分鐘至約45分鐘之後，大量組成物已被人類個體攝取，且可自人類個體之口中取出小袋進行處置。Such compositions in the form of water-permeable pouches are typically used by placing a pouch containing the composition in the mouth of a human individual/user. Generally speaking, the pouch is placed somewhere in the user's oral cavity, such as below the lip, in the same manner as a wet nasal powder product is generally used. The pouch is preferably not chewed or swallowed. Then, exposure to saliva allows some components of the composition therein (such as active ingredients and/or any flavoring agents) to pass through, for example, the water-permeable pouch and provide flavor and satisfaction to the user, and the user does not need to spit out any part of the composition. After about 10 minutes to about 60 minutes of use/enjoyment, typically about 15 minutes to about 45 minutes, a large amount of the composition has been ingested by the human individual, and the pouch can be removed from the mouth of the human individual for disposal.

在一些實施例中，小袋係唾液可滲透的。此意謂該小袋由唾液可滲透之小袋材料製成。口服袋裝產品中使用之小袋材料典型地係包含黏膠人造纖維(亦即，再生纖維素)及丙烯酸系聚合物的乾法黏合之非織物，該丙烯酸系聚合物充當非織物材料中之黏合劑且在小袋製造期間提供小袋之熱封。除黏膠纖維外，小袋材料亦可包含合成纖維(例如聚酯)。通常用於無煙之菸草袋的黏膠非織物材料與茶葉袋中使用之織物類似。非織物係既非編織亦非針織之織物。用於製造非織物材料之方法係此項技術中通常已知的。關於非織物之其他資訊見於「Handbook of Nonwovens」, S. Russel, Woodhead Pub I. Ltd.出版, 2007。在一些實施例中，小袋材料係羊毛絨材料。在一些實施例中，小袋材料係非織物材料。在一些實施例中，小袋材料係非織物羊毛絨材料。在一些實施例中，小袋材料包含黏膠，諸如黏膠人造纖維。在一些實施例中，小袋材料包含再生纖維素纖維。在一些實施例中，小袋材料包含聚酯纖維；該等聚酯纖維可構成小袋材料或可與黏膠(諸如再生纖維素纖維)之組合一起包括。In some embodiments, the pouch is permeable to saliva. This means that the pouch is made of a pouch material that is permeable to saliva. The pouch material used in oral pouch products is typically a dry-bonded nonwoven comprising viscose rayon (i.e., regenerated cellulose) and an acrylic polymer, which acts as an adhesive in the nonwoven material and provides heat sealing of the pouch during pouch manufacturing. In addition to viscose fibers, the pouch material may also include synthetic fibers (e.g., polyester). The viscose nonwoven material commonly used in smokeless tobacco bags is similar to the fabric used in tea bags. A nonwoven is a fabric that is neither woven nor knitted. Methods for making nonwoven materials are generally known in the art. Additional information about nonwovens can be found in "Handbook of Nonwovens", published by S. Russel, Woodhead Pub I. Ltd., 2007. In some embodiments, the pouch material is a wool fleece material. In some embodiments, the pouch material is a nonwoven material. In some embodiments, the pouch material is a nonwoven wool fleece material. In some embodiments, the pouch material comprises viscose, such as viscose rayon. In some embodiments, the pouch material comprises regenerated cellulose fibers. In some embodiments, the pouch material comprises polyester fibers; such polyester fibers may constitute the pouch material or may be included in combination with viscose, such as regenerated cellulose fibers.

在一些實施例中，小袋材料包含在製造期間提供對小袋之熱封的黏合劑。在一些實施例中，小袋材料包含丙烯酸黏合劑。在一些實施例中，小袋材料包含丙烯酸黏合劑與黏膠及/或聚酯纖維之組合。In some embodiments, the pouch material comprises an adhesive that provides a heat seal to the pouch during manufacture. In some embodiments, the pouch material comprises an acrylic adhesive. In some embodiments, the pouch material comprises a combination of an acrylic adhesive and viscose and/or polyester fibers.

用於製造無煙型菸草產品之類型的適合小包裝、小袋或容器可以商品名CatchDry、Ettan、General、Granit、Goteborgs Rape、Grovsnus White、Metropol Kaktus、Mocca Anis、Mocca Mint、Mocca Wintergreen、Kicks、Probe、Prince、Skruf及TreAnkrare獲得。該組成物可包含在小袋中且以用於製造習知鼻菸型產品之方式且使用製造習知鼻菸型產品之類型的組分包裝。該小袋提供一種類型的水分可滲透容器，其可被視為特徵與用於構造茶葉袋之網狀型材料類似。該組成物之組分易於透過小袋擴散且進入使用者口中。適合類型小袋之非限制性實例闡述於例如以下各案中：頒予Kjerstad之美國專利第5,167,244號及頒予Sebastian等人之美國專利第8,931,493號；以及頒予Sebastian等人之美國專利申請公開案第2016/0000140號、頒予Sebastian等人之美國專利申請公開案第2016/0073689號、頒予Chapman等人之美國專利申請公開案第2016/0157515號及頒予Sebastian等人之美國專利申請公開案第2016/0192703號，各案以引用的方式併入本文中。小袋可以個別小袋提供，或多個小袋(例如2、4、5、10、12、15、20、25或30個小袋)可連接或聯結在一起(例如以端對端方式)，使得能容易地自小袋之單件股或矩陣取下單一小袋或個別部分以供使用。Suitable small packages, pouches or containers of the type used to make smokeless tobacco products are available under the trade names CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. The composition may be contained in a pouch and packaged in a manner and using components of the type used to make a known snus-type product. The pouch provides a type of moisture permeable container that can be considered to be similar in characteristics to a mesh-type material used to construct tea bags. The components of the composition diffuse easily through the pouch and into the user's mouth. Non-limiting examples of suitable types of pouches are described, for example, in U.S. Patent Nos. 5,167,244 to Kjerstad and 8,931,493 to Sebastian et al., and U.S. Patent Application Publication No. 2016/0000140 to Sebastian et al., 2016/0073689 to Sebastian et al., 2016/0157515 to Chapman et al., and 2016/0192703 to Sebastian et al., each of which is incorporated herein by reference. The pouches may be provided as individual pouches, or a plurality of pouches (e.g. 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) may be connected or joined together (e.g. in an end-to-end manner) so that a single pouch or individual portion can be easily removed from a single strand or matrix of pouches for use.

示例小袋可由多種材料製成，且以此方式使得在使用者使用期間，該小袋經歷控制性分散或溶解。此類小袋材料可具有網狀、絲網、穿孔紙、可滲透織物形式或其類似形式。舉例而言，由網狀形式之米紙或穿孔米紙製成的小袋材料可溶解於使用者之口中。結果，小袋及組成物各自可在正常使用條件期間於使用者之口內經歷完全分散，且因此，該小袋及組成物皆可被使用者攝取。小袋材料之其他實例可使用水分散性成膜材料(例如黏合劑，諸如褐藻酸鹽、羧甲基纖維素、三仙膠、普魯蘭多糖及其類似物)以及彼等材料與諸如研磨纖維素材料(例如精細粒度之木漿)之類材料之組合來製造。較佳的小袋材料儘管為水分散性或可溶的，但仍可設計及製造成使得在正常使用條件下，在小袋經歷其物理完整性損失之時間之前，大量的組成物內含物滲透穿過小袋材料。必要時，可在小袋材料內併入或施加調味成分、崩解助劑及其他所希望組分。Example pouches can be made of a variety of materials in such a way that the pouch undergoes controlled dispersion or dissolution during use by the user. Such pouch materials can have a mesh, wire mesh, perforated paper, permeable fabric form, or the like. For example, a pouch material made of rice paper or perforated rice paper in a mesh form can dissolve in the user's mouth. As a result, the pouch and the composition can each undergo complete dispersion in the user's mouth during normal use conditions, and therefore, the pouch and the composition can be ingested by the user. Other examples of pouch materials can be made using water-dispersible film-forming materials (e.g., adhesives such as alginates, carboxymethyl cellulose, trisaccharides, pullulans, and the like) and combinations of such materials with materials such as ground cellulose materials (e.g., finely particled wood pulp). Preferred pouch materials, although water dispersible or soluble, can be designed and manufactured so that under normal use conditions, a substantial amount of the composition contents permeate through the pouch material before the pouch experiences a loss of its physical integrity. If necessary, flavoring ingredients, disintegration aids and other desired ingredients can be incorporated or applied to the pouch material.

各袋裝產品單元(例如小袋)內所包含之口服產品的量可變化。在一些實施例中，各小袋內組成物之重量係至少約50 mg，例如為約50 mg至約1 g (1,000 mg)，諸如為約100 mg至約900 mg，諸如為約200 mg至約800 mg，諸如為約500 mg至約700 mg。在一些較小實施例中，各小袋內組成物之重量可為約100 mg至約300 mg。對於較大實施例，各小袋內組成物之重量可為約300 mg至約700 mg。必要時，其他組分可包含在各小袋內。The amount of oral product contained in each bagged product unit (e.g., pouch) can vary. In some embodiments, the weight of the composition in each pouch is at least about 50 mg, such as about 50 mg to about 1 g (1,000 mg), such as about 100 mg to about 900 mg, such as about 200 mg to about 800 mg, such as about 500 mg to about 700 mg. In some smaller embodiments, the weight of the composition in each pouch can be about 100 mg to about 300 mg. For larger embodiments, the weight of the composition in each pouch can be about 300 mg to about 700 mg. If necessary, other components can be included in each pouch.

口服產品之水分含量可視提供組成物之型式而變化。在如上文所描述之一些實施例中，口服產品可呈濕式鼻粉或鼻菸形式及/或可以袋裝型式提供。在一些實施例中(例如對於鼻菸型產品)，組成物之水分含量(在將產品插入使用者之口中之前)可為口服產品之至少約20重量%，諸如至少30重量%，諸如至少40重量%，諸如至少50重量%。在一些實施例中(例如對於鼻菸型產品；例如非袋裝或袋裝之鼻菸產品)，組成物之水分含量(在將產品插入使用者之口中之前)可為口服產品之約20重量%至約70重量%，諸如約30重量%至約60重量%，諸如約40重量%至約55重量%。The moisture content of oral products can vary depending on the form in which the composition is provided. In some embodiments as described above, the oral product can be in the form of a wet nasal powder or nasal smoke and/or can be provided in a bagged form. In some embodiments (e.g., for nasal smoke type products), the moisture content of the composition (before the product is inserted into the user's mouth) can be at least about 20% by weight of the oral product, such as at least 30% by weight, such as at least 40% by weight, such as at least 50% by weight. In some embodiments (e.g., for nasal smoke type products; such as non-bagged or bagged nasal smoke products), the moisture content of the composition (before the product is inserted into the user's mouth) can be about 20% by weight to about 70% by weight of the oral product, such as about 30% by weight to about 60% by weight, such as about 40% by weight to about 55% by weight.

在一些實施例中，口服產品可為「乾燥」形式之鼻菸型或鼻粉型產品。在此類實施例中，口服產品之水分含量可不超過口服產品之約10重量%，諸如不超過約5重量%。舉例而言，水分含量可為口服產品之約0.1重量%至約10重量%，諸如約1重量%至約5重量%。In some embodiments, the oral product may be a "dry" form of a nasal smoke or nasal powder product. In such embodiments, the moisture content of the oral product may not exceed about 10% by weight of the oral product, such as not more than about 5% by weight. For example, the moisture content may be about 0.1% to about 10% by weight of the oral product, such as about 1% to about 5% by weight.

當呈袋裝口服產品形式時，口服產品典型地包含填充劑。填充劑可較佳地為選自上文所描述之適合材料的纖維素材料。在一些較佳實施例中，填充劑係或包含至少MCC。填充劑之量可變化，但以口服產品之總重量計，典型地為口服產品之至少約5重量%至約95重量%。在一些實施例中，填充劑(諸如纖維素材料，諸如MCC)可以口服產品之約5重量%至約95重量%，諸如約10重量%至約90重量%，諸如約15重量%至約85重量%，諸如約20重量%至約80重量%，諸如約25重量%至約75重量%，諸如約30重量%至約70重量%，諸如約35重量%至約65重量%，諸如約40重量%至約60重量%之量存在於口服產品中。在一些實施例中，填充劑(諸如纖維素材料，諸如MCC)可以該口服產品之約45重量%至約55重量%之量存在。 包裝When in the form of a bagged oral product, the oral product typically includes a filler. The filler can preferably be a cellulose material selected from the suitable materials described above. In some preferred embodiments, the filler is or includes at least MCC. The amount of the filler can vary, but based on the total weight of the oral product, it is typically at least about 5% by weight to about 95% by weight of the oral product. In some embodiments, fillers (such as cellulose materials, such as MCC) can be present in an oral product in an amount of about 5% to about 95% by weight, such as about 10% to about 90% by weight, such as about 15% to about 85% by weight, such as about 20% to about 80% by weight, such as about 25% to about 75% by weight, such as about 30% to about 70% by weight, such as about 35% to about 65% by weight, such as about 40% to about 60% by weight. In some embodiments, fillers (such as cellulose materials, such as MCC) can be present in an amount of about 45% to about 55% by weight of the oral product.Packaging

根據本文所描述之一些實施例，提供一種含有如本文所描述之口服產品的包裝。舉例而言，包裝可以含有呈粉末形式之口服產品。在此類實施例中，包裝可呈錫製或塑膠容器形式。替代地或另外，包裝可含有呈口含錠、錠劑或其類似物形式之口服產品。包裝可呈含有此類口服劑型之泡罩包裝、錫製或塑膠容器形式。According to some embodiments described herein, a package is provided containing an oral product as described herein. For example, the package can contain an oral product in powder form. In such embodiments, the package can be in the form of a tin or plastic container. Alternatively or in addition, the package can contain an oral product in the form of a lozenge, tablet, or the like. The package can be in the form of a blister pack, tin or plastic container containing such oral dosage forms.

根據本文所描述之一些實施例，提供一種含有至少一種如本文所描述之袋裝口服產品的包裝。本文所描述之袋裝產品可包裝在任何適合之內部包裝材料及/或外部容器內。亦參見例如以下中所闡述的用於無煙型產品之多種類型容器：頒予Henson等人之美國專利第7,014,039號、頒予Kutsch等人之美國專利第7,537,110號、頒予Kutsch等人之美國專利第7,584,843號、頒予Gelardi等人之美國專利第8,397,945號、頒予Thiellier之美國專利第D592,956號、頒予Patel等人之美國專利第D594,154號及頒予Bailey等人之美國專利第D625,178號；頒予Robinson等人之美國專利公開案第2008/0173317號、頒予Clark等人之美國專利公開案第2009/0014343號、頒予Bjorkholm之美國專利公開案第2009/0014450號、頒予Bellamah等人之美國專利公開案第2009/0250360號、頒予Gelardi等人之美國專利公開案第2009/0266837號、頒予Gelardi之美國專利公開案第2009/0223989號、頒予Thiellier之美國專利公開案第2009/0230003號、頒予Gelardi之美國專利公開案第2010/0084424號及頒予Bailey等人之美國專利公開案第2010/0133140號、頒予Bailey等人之美國專利公開案第2010/0264157號以及頒予Bailey等人之美國專利公開案第2011/0168712號，各案以引用的方式併入本文中。舉例而言，包裝可為含有多個袋裝口服產品之錫製或塑膠容器。According to some embodiments described herein, a package containing at least one bagged oral product as described herein is provided. The bagged product described herein can be packaged in any suitable inner packaging material and/or outer container. See also, for example, the various types of containers for smokeless products described in the following: U.S. Patent No. 7,014,039 to Henson et al., U.S. Patent No. 7,537,110 to Kutsch et al., U.S. Patent No. 7,584,843 to Kutsch et al., U.S. Patent No. 8,397,945 to Gelardi et al., U.S. Patent No. 8,397,945 to Thiellier et al., U.S. Patent No. 8,397,946 to Thiellier et al., U.S. Patent No. 8,397,947 to Thiellier et al., U.S. Patent No. 8,397,948 to Thiellier et al., U.S. Patent No. 8,397,949 to Thiellier et al., U.S. Patent No. 8,397,949 to Thiellier et al., U.S. Patent No. 8,397,949 to Thiellier et al., U.S. Patent No. 8,397,940 to Thiellier et al., U.S. Patent No. 8,397,941 to Thiellier et al., U.S. Patent No. 8,397,942 to Thiellier et al., U.S. Patent No. 8,397,943 to Thiellier et al., U.S. Patent No. 8,397,943 to Thiellier et al., U.S. Patent No. 8,397,940 to Thiellier et al., U.S. Patent No. 8,397,940 to Thiellier No. D592,956 to Patel et al., U.S. Patent No. D594,154 to Patel et al., and U.S. Patent No. D625,178 to Bailey et al.; U.S. Patent Publication No. 2008/0173317 to Robinson et al., U.S. Patent Publication No. 2009/0014343 to Clark et al., U.S. Patent Publication No. 2010/0014344 to Bjorkholm et al. U.S. Patent Application No. 2009/0014450, U.S. Patent Application No. 2009/0250360 to Bellamah et al., U.S. Patent Application No. 2009/0266837 to Gelardi et al., U.S. Patent Application No. 2009/0223989 to Gelardi, U.S. Patent Application No. 2009/023000 to Thiellier 3, U.S. Patent Publication No. 2010/0084424 to Gelardi and U.S. Patent Publication No. 2010/0133140 to Bailey et al., U.S. Patent Publication No. 2010/0264157 to Bailey et al., and U.S. Patent Publication No. 2011/0168712 to Bailey et al., each of which is incorporated herein by reference. For example, the packaging can be a tin or plastic container containing a plurality of bags of oral products.

在口服產品呈液體形式之一些較佳實施例中，提供一種含有液體口服劑型的呈瓶子或罐形式之包裝。包裝可為含有所希望體積之液體口服劑型的瓶子。方法In some preferred embodiments where the oral product is in liquid form, a package in the form of a bottle or can containing the liquid oral dosage form is provided. The package can be a bottle containing a desired volume of the liquid oral dosage form.Method

組成物之各種組分(例如活性成分及任何添加劑)組合之方式可變化。因此，具有例如粉末狀組成物組分之整體產品在本質上可相對較均勻(例如均質的)。可呈液體或乾燥固體形式之上述組分可在預處理步驟中混雜，隨後與該產品之任何剩餘組分混合，或僅與所有其他液體或乾燥成分混合在一起。The manner in which the various components of the composition (e.g., active ingredients and any additives) are combined may vary. Thus, the overall product having, for example, a powdered composition component may be relatively uniform in nature (e.g., homogeneous). The above components, which may be in liquid or dry solid form, may be mixed in a pre-treatment step and subsequently mixed with any remaining components of the product, or simply mixed together with all other liquid or dry ingredients.

產品之各種組分可使用此項技術中已知之任何混合技術或設備接觸、組合或混合在一起。使產品各成分緊密接觸的任何混合方法均可使用，諸如以葉輪或能夠攪動之其他結構為特徵的混合設備。混合設備之實例包括加料筒；調節圓筒或筒；液體噴霧設備；圓錐型摻合器；帶狀摻合器；可以FKM130、FKM600、FKM1200、FKM2000及FKM3000獲自Littleford Day, Inc.之混合器；Plough Share型混合圓筒；Hobart混合器；及其類似物。亦參見例如頒予Solomon等人之美國專利第4,148,325號、頒予Korte等人之美國專利第6,510,855號及頒予Williams之美國專利第6,834,654號中所闡述之方法類型，各案以引用的方式併入本文中。在一些實施例中，形成產品之組分係製備成使得其混合物可用於形成該產品之澱粉模製製程中。用於調配產品之方式及方法對於熟習此項技術者將為顯而易見的。參見例如頒予Solomon等人之美國專利第4,148,325號；頒予Korte等人之美國專利第6,510,855號；及頒予Williams之美國專利第6,834,654號、頒予Ridgway等人之美國專利第4,725,440號及頒予Bolder等人之美國專利第6,077,524號中所闡述之類型的方法，各案以引用的方式併入本文中。製備液體口服產品之方法The various components of the product may be contacted, combined or mixed together using any mixing technique or equipment known in the art. Any mixing method that brings the components of the product into intimate contact may be used, such as mixing equipment featuring an impeller or other structure capable of agitation. Examples of mixing equipment include a feed cylinder; a regulating cylinder or cylinders; a liquid spray device; a cone-type blender; a ribbon blender; mixers available from Littleford Day, Inc. as FKM130, FKM600, FKM1200, FKM2000 and FKM3000; a Plough Share type mixing cylinder; a Hobart mixer; and the like. See also the types of methods described in, for example, U.S. Patent Nos. 4,148,325 to Solomon et al., 6,510,855 to Korte et al., and 6,834,654 to Williams, each of which is incorporated herein by reference. In some embodiments, the components forming the product are prepared so that their mixture can be used in a starch molding process to form the product. The means and methods for formulating the product will be apparent to those skilled in the art. See, for example, U.S. Patent Nos. 4,148,325 to Solomon et al.; 6,510,855 to Korte et al.; and 6,834,654 to Williams, 4,725,440 to Ridgway et al., and 6,077,524 to Bolder et al., each of which is incorporated herein by reference.Methods of Preparing Liquid Oral Products

根據本文所描述之一些實施例，提供一種用於製備如本文所描述之口服產品的方法，該口服產品較佳呈液體形式，該方法包含以下步驟： (a)將活性成分組合， (b)使該等活性成分與水接觸，以及 (c)將該等活性成分與水混合以製備口服產品。According to some embodiments described herein, a method for preparing an oral product as described herein is provided, the oral product is preferably in liquid form, the method comprising the steps of:(a) combining active ingredients,(b) contacting the active ingredients with water, and(c) mixing the active ingredients with water to prepare the oral product.

活性成分之組合可如上文所描述。活性劑之組合亦可如下文關於「其他廣泛態樣」所描述。The combination of active ingredients may be as described above. The combination of active agents may also be as described below in relation to "other broad aspects".

活性成分可呈液體萃取物、液體油或粉末形式提供。當呈粉末形式時，步驟(c)可包含將活性成分與水混合，直至該等活性成分已溶解於水中。The active ingredients may be provided in the form of a liquid extract, a liquid oil or a powder. When in powder form, step (c) may comprise mixing the active ingredients with water until the active ingredients have dissolved in the water.

步驟(b)及/或步驟(c)可較佳地在環境溫度或室溫(20-25℃)下進行。替代地，可升高溫度以便幫助活性成分分散或溶解於水中。舉例而言，步驟(b)可包含使活性成分與水在約20-100℃，諸如約30-90℃或約40-80℃之溫度下接觸。步驟(b)可包含將活性成分與水在約20-100℃，諸如約30-90℃或約40-80℃之溫度下混合。Step (b) and/or step (c) may preferably be performed at ambient temperature or room temperature (20-25°C). Alternatively, the temperature may be elevated to aid in dispersing or dissolving the active ingredient in water. For example, step (b) may comprise contacting the active ingredient with water at a temperature of about 20-100°C, such as about 30-90°C or about 40-80°C. Step (b) may comprise mixing the active ingredient with water at a temperature of about 20-100°C, such as about 30-90°C or about 40-80°C.

該方法可包含在任何階段添加任何額外添加劑。舉例而言，可在活性成分與水組合之前及/或活性成分已與水組合之後，將任何添加劑添加至該等活性成分中。添加劑亦可在水與活性成分之組合接觸之前添加至水中。步驟(a)可包含將任何添加劑(例如酸化劑)與活性成分之組合相組合的任擇步驟。步驟(b)可包含使活性成分與水及添加劑接觸的任擇步驟。步驟(c)可包含將添加劑添加至混合物中且將該等添加劑與活性成分之組合及水混合的任擇步驟。The method may include adding any additional additives at any stage. For example, any additives may be added to the active ingredients before they are combined with water and/or after the active ingredients have been combined with water. Additives may also be added to the water before the water contacts the combination of active ingredients. Step (a) may include the optional step of combining any additives (e.g., acidulants) with the combination of active ingredients. Step (b) may include the optional step of contacting the active ingredients with water and additives. Step (c) may include the optional step of adding additives to the mixture and mixing the additives with the combination of active ingredients and water.

在一些實施例中，口服產品進一步包含一或多種選自以下之添加劑：增稠劑、有機酸或其混合物。在此類實施例中，可在添加活性成分之前，將該一或多種添加劑與水組合。任擇地，將該一或多種添加劑與水組合之步驟可包含加熱該組合，例如加熱至約60℃至約80℃之溫度，以實現該一或多種添加劑之溶解。其他添加劑，諸如甜味劑、保濕劑、著色劑或其類似物可在此階段添加或可在將活性成分與水組合之步驟期間及/或之後添加。In some embodiments, the oral product further comprises one or more additives selected from the group consisting of thickeners, organic acids, or mixtures thereof. In such embodiments, the one or more additives may be combined with water prior to adding the active ingredient. Optionally, the step of combining the one or more additives with water may comprise heating the combination, for example, to a temperature of about 60° C. to about 80° C., to effect dissolution of the one or more additives. Other additives, such as sweeteners, humectants, colorants, or the like may be added at this stage or may be added during and/or after the step of combining the active ingredient with water.

所得液體產品可呈活性成分於水中之溶液或分散液形式。製備錠劑產品之方法The resulting liquid product may be in the form of a solution or dispersion of the active ingredient in water.Method for preparing tablet products

在一些實施例中，產品呈壓縮丸粒(pellet)或錠劑形式。在一個實施例中，用於製造丸粒或錠劑之方法涉及先混合增量劑(例如EMDEX®)及活性成分。接著，添加其餘組成物成分(例如糖醇及任何其他所需組分，諸如黏合劑、著色劑、甜味劑、調味劑及其類似物)。任擇地，著色劑可在與該組成物之其餘組分混合之前，在獨立步驟中添加至一種組成物組分中。組成物之混合可使用任何混合裝置實現。接著，使用習知製錠技術將最終組成物壓縮成丸粒或錠劑形式，且任擇地包覆包衣。壓縮的組成物丸粒可藉由將包括任何相關調配物組分之組成物壓實成丸粒形式並任擇地用外塗層材料包覆各丸粒來產生。示例壓實裝置，諸如壓實壓機(compaction press)可以Colton 2216及Colton 2247自Vector Corporation獲得以及以1200i、2200i、3200、2090、3090及4090自Fette Compacting獲得。用於向壓實之丸粒狀組成物提供外塗層的裝置可以CompuLab 24、CompuLab 36、Accela-Cota 48及Accela-Cota 60自Thomas Engineering獲得。In some embodiments, the product is in the form of compressed pellets or tablets. In one embodiment, the method for making pellets or tablets involves first mixing an extender (e.g., EMDEX®) and an active ingredient. Then, the remaining composition ingredients (e.g., sugar alcohols and any other desired components, such as binders, colorants, sweeteners, flavorings, and the like) are added. Optionally, the colorant can be added to one composition component in a separate step before mixing with the remaining components of the composition. The mixing of the composition can be achieved using any mixing device. Then, the final composition is compressed into a pellet or tablet form using known tableting techniques and optionally coated. Compressed composition pellets can be produced by compacting a composition including any relevant formulation components into pellet form and optionally coating each pellet with an outer coating material. Exemplary compaction devices, such as compaction presses, are available from Vector Corporation as Colton 2216 and Colton 2247 and from Fette Compacting as 1200i, 2200i, 3200, 2090, 3090 and 4090. Devices for providing an outer coating to a compacted pelletized composition are available from Thomas Engineering as CompuLab 24, CompuLab 36, Accela-Cota 48 and Accela-Cota 60.

當存在時，包衣典型地包含成膜聚合物，諸如纖維素聚合物、任擇的塑化劑及任擇的調味劑、著色劑、鹽、甜味劑或本文所闡述之類型的其他添加劑。包衣組成物通常為水性的且可以使用此項技術中已知之任何丸粒或錠劑包衣技術(諸如鍋包衣)施加。示例成膜聚合物包括纖維素聚合物，諸如甲基纖維素、羥丙基纖維素(HPC)、羥丙基甲基纖維素(HPMC)、羥乙基纖維素及羧甲基纖維素。示例塑化劑包括單硬脂酸甘油酯及檸檬酸三乙酯之水溶液或乳液。額外的潛在包衣包括食品級蟲膠、諸如巴西棕櫚蠟之蠟及其組合。製備口含錠產品之方法When present, the coating typically comprises a film-forming polymer such as a cellulose polymer, an optional plasticizer, and optional flavorings, colorants, salts, sweeteners, or other additives of the type described herein. The coating composition is typically aqueous and can be applied using any pellet or tablet coating technique known in the art, such as pan coating. Exemplary film-forming polymers include cellulose polymers such as methylcellulose, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose, and carboxymethylcellulose. Exemplary plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potentialcoatings include food grade insecticide, waxes such as carnauba wax, and combinations thereof.

用於調配及製造如上文所描述之口含錠產品的方式及方法可變化。舉例而言，組成物可經由常用於製備經熬煮之硬糖果劑之任何方法製備。用於製備硬糖果劑之示例方法可見於例如LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell編輯, Leatherhead Food RA (1996年12月), 第21-44頁，該文獻以引用的方式併入本文中。The manner and method for formulating and manufacturing the buccal tablet product as described above can vary. For example, the composition can be prepared by any method commonly used to prepare boiled hard candies. Exemplary methods for preparing hard candies can be found in, for example, LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell, ed., Leatherhead Food RA (December 1996), pp. 21-44, which is incorporated herein by reference.

典型地，製備第一成分混合物。第一成分混合物之組成可變化；然而，其典型地包含代糖且可含有各種額外物質(例如糖醇糖漿、NaCl、防腐劑、其他甜味劑、水及/或調味劑)。在某些實施例中，其包含代糖、鹽及香草精。在其他實施例中，第一混合物包含代糖及糖醇糖漿。典型地，第一成分混合物不含活性成分；不過，在一些實施例中，活性成分可併入第一成分混合物中。Typically, a first component mixture is prepared. The composition of the first component mixture can vary; however, it typically includes a sugar substitute and may contain various additional substances (e.g., sugar alcohol syrup, NaCl, preservatives, other sweeteners, water and/or flavorings). In certain embodiments, it includes a sugar substitute, salt, and vanilla extract. In other embodiments, the first mixture includes a sugar substitute and a sugar alcohol syrup. Typically, the first component mixture does not contain an active ingredient; however, in some embodiments, an active ingredient can be incorporated into the first component mixture.

將第一成分混合物加熱，直至其熔化為止；隨後，將混合物加熱至或經過硬裂紋階段。在糖果製造中，將硬裂紋階段定義為經加熱的混合物之細絲(藉由在拇指與食指之間拉動冷卻糖漿之樣品獲得)變脆之溫度或嘗試模製糖漿引起開裂之溫度。根據本發明方法，實現硬裂紋階段之溫度可視產品混合物之特定構成而變化，但一般在約145℃與約170℃之間。典型地，該混合物不加熱至高於約171℃，此係焦糖化開始發生之溫度。在本揭露內容之方法中，混合物典型地加熱至硬裂紋階段溫度或更高溫度且接著使其冷卻。加熱可在大氣壓下或在真空下進行。典型地，本發明之方法係在大氣壓力下進行。The first ingredient mixture is heated until it melts; thereafter, the mixture is heated to or past the hard crack stage. In candy making, the hard crack stage is defined as the temperature at which threads of the heated mixture (obtained by pulling a sample of cooled syrup between the thumb and forefinger) become brittle or the temperature at which attempts to mold the syrup cause cracking. According to the method of the present invention, the temperature at which the hard crack stage is achieved can vary depending on the specific composition of the product mixture, but is generally between about 145°C and about 170°C. Typically, the mixture is not heated to above about 171°C, which is the temperature at which caramelization begins to occur. In the methods of the present disclosure, the mixture is typically heated to the hard crack stage temperature or higher and then allowed to cool. The heating can be carried out under atmospheric pressure or under vacuum. Typically, the method of the present invention is carried out under atmospheric pressure.

在一個示例實施例中，第一成分混合物包含高百分比之異麥芽酮糖醇且將混合物加熱至約143℃。一旦所有組分均溶解，則將溫度升高超過硬裂紋階段(例如，升高至約166℃)。將混合物加熱至此溫度且接著自加熱移開以使混合物冷卻。In one exemplary embodiment, the first ingredient mixture includes a high percentage of isomalt and the mixture is heated to about 143° C. Once all components are dissolved, the temperature is raised beyond the hard crack stage (e.g., to about 166° C.). The mixture is heated to this temperature and then removed from the heat to allow the mixture to cool.

在某些實施例中，活性成分及任擇地如上文所描述之額外組分(例如額外甜味劑、填充劑、調味劑及水)獨立地組合成第二混合物。典型地在第一成分混合物已自加熱移開後，將該第二混合物添加至第一成分混合物中。在一些實施例中，第二混合物之添加可僅在將加熱的第一成分混合物冷卻至預先確定之溫度(例如在某些實施例中冷卻至約132℃)之後進行。在某些實施例中，一或多種調味劑係在混合物即將添加至經加熱之第一成分混合物之前添加至第二混合物中。某些調味劑係揮發性的且因此，較佳地在混合物已略微冷卻之後添加。接著，使組合之混合物形成為所希望的形狀。在某些實施例中，將混合物直接倒入模具中，使其形成(例如輥軋或壓製)成所希望之形狀，或擠出。必要時，混合物可經擠出或射出模製。在某些實施例中，混合物在封閉系統中形成或擠出至具有所希望形狀之模具中，此可能需要降低溫度且可限制某些混合物組分之蒸發。舉例而言，此類系統可限制揮發性組分之蒸發，該等揮發性組分包括但不限於風味劑。本文亦意欲涵蓋其他產生口含錠之方法。In certain embodiments, the active ingredients and optionally additional components as described above (e.g., additional sweeteners, fillers, flavorings, and water) are independently combined into a second mixture. Typically, the second mixture is added to the first component mixture after the first component mixture has been removed from heating. In some embodiments, the addition of the second mixture can be performed only after the heated first component mixture has been cooled to a predetermined temperature (e.g., cooled to about 132° C. in certain embodiments). In certain embodiments, one or more flavorings are added to the second mixture before the mixture is added to the heated first component mixture. Some flavorings are volatile and therefore, are preferably added after the mixture has been slightly cooled. Then, the combined mixture is formed into a desired shape. In some embodiments, the mixture is poured directly into a mold, formed (e.g., rolled or pressed) into a desired shape, or extruded. If necessary, the mixture can be extruded or injection molded. In some embodiments, the mixture is formed or extruded into a mold having a desired shape in a closed system, which may require a reduction in temperature and may limit the evaporation of certain mixture components. For example, such a system may limit the evaporation of volatile components, including but not limited to flavoring agents. Other methods of producing buccal tablets are also intended to be covered herein.

與製造食品級口含錠產品(諸如本文所描述)相關之典型條件包括控制加熱及溫度(亦即，各種成分在製造期間所暴露之加熱的程度及製造環境之溫度)、水分含量(例如存在於個別成分內及最終組成物內之水分的程度)、製造環境內之濕度、氛圍控制(例如氮氣氛圍)、各種成分在製造製程期間所經歷之空氣流及其他類似類型之因素。另外，產品製造中所涉及之各種製程步驟可涉及某些溶劑及加工助劑之選擇、加熱及輻射之使用、冷藏及低溫條件、成分混合速率及類似因素。製造條件亦可因各種成分之形式(例如固體、液體或氣體)的選擇、固體形式成分之粒度或結晶性質、液體形式成分之濃度或其類似因素而進行控制。成分可藉由諸如擠出、壓縮、噴霧之類技術及其類似技術加工成所希望的組成物。Typical conditions associated with manufacturing food-grade lozenge products such as those described herein include controlling heat and temperature (i.e., the degree of heat to which the various ingredients are exposed during manufacturing and the temperature of the manufacturing environment), moisture content (e.g., the degree of moisture present in the individual ingredients and in the final composition), humidity within the manufacturing environment, atmosphere control (e.g., nitrogen atmosphere), air flow experienced by the various ingredients during the manufacturing process, and other similar types of factors. In addition, the various process steps involved in the manufacture of the product may involve the selection of certain solvents and processing aids, the use of heat and radiation, refrigeration and cryogenic conditions, ingredient mixing rates, and similar factors. Manufacturing conditions can also be controlled by the choice of the form (e.g., solid, liquid, or gas) of the various ingredients, the particle size or crystal properties of the ingredients in solid form, the concentration of the ingredients in liquid form, or the like. The ingredients can be processed into the desired composition by techniques such as extrusion, compression, spraying, and the like.

在某些實施例中，口含錠產品可為透明或半透明的。如本文所使用，「半透明」或「半透明性」係指允許某一位準的光以漫射方式行進穿過之材料。在某些實施例中，本揭露內容之口含錠產品可具有使得該材料可歸類為「透明」或展現「透明性」的較高程度澄清度，「透明」或「透明性」定義為材料允許光自由地穿過，而無顯著漫射。口含錠產品之澄清度係使得存在某一位準之半透明性，與不透明性(不透明性係指材料不能透過光)相對。In certain embodiments, the buccal tablet product may be transparent or translucent. As used herein, "translucent" or "translucency" refers to a material that allows a certain level of light to travel through it in a diffuse manner. In certain embodiments, the buccal tablet product of the present disclosure may have a high degree of clarity such that the material may be classified as "transparent" or exhibit "transparency", which is defined as a material that allows light to pass freely without significant diffusion. The clarity of the buccal tablet product is such that there is a certain level of translucency, as opposed to opacity, which refers to the inability of the material to transmit light.

透明性/半透明性可藉由此項技術中常用之任何手段確定；然而，其通常藉由在某一波長範圍內(例如約400-700 nm)的分光光度光透射率量測。替代地，可使用光學方法，諸如比濁法(或濁度測定法)及比色法分別對本文所提供之口含錠產品的混濁度(光散射)及顏色(光吸收)進行定量。半透明性亦可利用目視檢查，藉由簡單地將材料(例如萃取物)或產品放在光源下並確定光是否以漫射方式行進穿過該產品來確認。製備熔化物產品之方法Transparency/translucency may be determined by any means commonly used in the art; however, it is typically measured by spectrophotometric light transmittance over a range of wavelengths (e.g., about 400-700 nm). Alternatively, optical methods such as turbidimetry (or nephelometric methods) and colorimetry may be used to quantify the turbidity (light scattering) and color (light absorption), respectively, of the buccal tablet products provided herein. Translucency may also be confirmed by visual inspection by simply placing the material (e.g., an extract) or product under a light source and determining whether the light travels through the product in a diffuse manner.Methods of Preparing Melt Products

在一些實施例中，產品係呈可熔化形式。為製備可熔化產品，脂質典型地被加熱至略微高於熔化溫度，以使得脂質液化。任擇地，活性成分、調味劑及/或卵磷脂可在此階段添加至液化之脂質中。之後，可將液化脂質之全部或一部分與乾燥摻合物摻合且混合，直至產品達到所希望位準之均質性或直至實現所希望之紋理特性。對混合物進行研磨(例如在乾式輥磨機中)，直至粒度小於約20微米。將經研磨之異麥芽酮糖醇-棕櫚油與任何剩餘脂質組合，且在其中混合乾燥成分及調味劑。一般將基質升溫至流體稠度。In some embodiments, the product is in a fusible form. To prepare a fusible product, the lipid is typically heated to a temperature slightly above the melting temperature to liquefy the lipid. Optionally, active ingredients, flavorings, and/or lecithin may be added to the liquefied lipid at this stage. Afterwards, all or a portion of the liquefied lipid may be blended and mixed with a dry blend until the product reaches a desired level of homogeneity or until the desired texture properties are achieved. The mixture is ground (e.g., in a dry roller mill) until the particle size is less than about 20 microns. The ground isomalt-palm oil is combined with any remaining lipid, and dry ingredients and flavorings are mixed therein. The base is generally heated to a fluid consistency.

在一些實施例中，將糖醇(例如異麥芽酮糖醇)添加至混合碗中，且添加總脂質(例如熔化之棕櫚油)之一部分以及鹽及乳化劑。In some embodiments, a sugar alcohol (e.g., isomalt) is added to a mixing bowl, and a portion of the total lipid (e.g., melted palm oil) is added along with salt and an emulsifier.

在混合下添加額外脂質，直至形成黏著凝塊。將凝塊之混合物逐份轉移至3輥研磨機中且加工成小於50微米或約20微米之粒度。將精製之混合物轉移至混合碗中，且在混合下添加剩餘脂質。視需要，使混合物升溫以維持流體稠度。Add additional fat while mixing until a cohesive curd is formed. Transfer the curd mixture portionwise to a 3-roll grinder and process to a particle size of less than 50 microns or about 20 microns. Transfer the refined mixture to a mixing bowl and add the remaining fat while mixing. Warm the mixture as needed to maintain a fluid consistency.

在混合下，添加甜味劑、風味劑及一或多種活性成分。繼續混合，直至獲得均質組成物。使混合物靜置一段時間，諸如約10至15分鐘。可將組成物分成分散的部分，此諸如藉由將組成物倒入薄片狀結構中，冷卻且接著將該結構切割成個別部分，或藉由將組成物沉積至模具中且使其冷卻來實現。模具可為澱粉模具或無澱粉模具。在特定實施例中，模具係無澱粉的。Under mixing, sweeteners, flavors and one or more active ingredients are added. Mixing is continued until a homogenous composition is obtained. The mixture is allowed to stand for a period of time, such as about 10 to 15 minutes. The composition can be divided into discrete portions, such as by pouring the composition into a laminar structure, cooling and then cutting the structure into individual portions, or by depositing the composition into a mold and allowing it to cool. The mold can be a starch mold or a starch-free mold. In a specific embodiment, the mold is starch-free.

熔化物組成物可保持在模具(澱粉或無澱粉模具)中，保持預先確定的持續時間，諸如約1至約15分鐘，以使熔化物組成物冷卻且凝固。任擇地，含有熔化物產品之模具可藉由冷藏進行冷卻以加速凝固。The melt composition can be kept in the mold (starch or no-starch mold) for a predetermined duration, such as about 1 to about 15 minutes, to allow the melt composition to cool and solidify. Optionally, the mold containing the melt product can be cooled by refrigeration to accelerate solidification.

根據本揭露內容之其他態樣，可採用將最終熔化物產品擠出之擠出製程代替使用模具來製備熔化物產品。在一些情況下，呈漿液形式之熔化物組成物可形成為薄片且使其乾燥至例如含約15重量%至約25重量%水之水分含量，以形成呈能夠以物理方式操作之形式的黏性或其他糊狀材料。接著，可使用例如混合器將該材料切短或以其他方式切割成較小塊。接著，可將切短的材料透過擠出裝置擠成任何所希望的形狀/大小，包括可能很難或不可能用模具獲得的形狀。在一些情況下，擠出之產品接著可經乾燥以實現所希望之水分含量。類似類型之製程描述於例如頒予Smylie等人之美國專利第3,806,617號中，該案以全文引用的方式併入本文中。另外，熔化物組成物可與另一組成物一起經歷共擠出製程。According to other aspects of the present disclosure, an extrusion process in which the final melt product is extruded may be used instead of using a mold to prepare the melt product. In some cases, the melt composition in the form of a slurry may be formed into a sheet and dried to a moisture content of, for example, about 15% to about 25% by weight water to form a viscous or other pasty material in a form that can be physically manipulated. The material may then be chopped or otherwise cut into smaller pieces using, for example, a mixer. The chopped material may then be extruded through an extruder into any desired shape/size, including shapes that may be difficult or impossible to obtain with a mold. In some cases, the extruded product may then be dried to achieve the desired moisture content. Similar types of processes are described, for example, in U.S. Patent No. 3,806,617 to Smylie et al., which is incorporated herein by reference in its entirety. Additionally, the melt composition may be subjected to a co-extrusion process with another composition.

諸如桿及立方體之類形狀可藉由以下方式形成：首先透過具有所希望之橫截面(例如圓形或正方形)的模具擠出該材料且接著任擇地，將擠出之材料切割成所希望的長度。用於擠出菸草材料之技術及設備闡述於頒予Wursburg之美國專利第3,098,492號、頒予Tamol等人之美國專利第4,874,000號、頒予Graves等人之美國專利第25 4,880,018號、頒予Keritsis等人之美國專利第4,989,620號、頒予Luke等人之美國專利第5,072,744號、頒予White等人之美國專利第5,829,453號及頒予White等人之美國專利第6,182,670號中；各文獻以引用的方式併入本文中。適合使用之示例擠出設備包括食品或膠狀物擠出機，或工業用麵食擠出機，諸如得自意大利之Emiliomiti有限責任公司的型號TP 200/300。在一些情況下，單一機器能夠實現本文所描述之製程的多個步驟，諸如得自Buss AG之捏合機系統。Shapes such as rods and cubes can be formed by first extruding the material through a die having the desired cross-section (e.g., round or square) and then, optionally, cutting the extruded material into the desired lengths. Techniques and apparatus for extruding tobacco materials are described in U.S. Patent Nos. 3,098,492 to Wursburg, 4,874,000 to Tamol et al., 4,880,018 to Graves et al., 4,989,620 to Keritsis et al., 5,072,744 to Luke et al., 5,829,453 to White et al., and 6,182,670 to White et al.; each of which is incorporated herein by reference. Exemplary extrusion equipment suitable for use include food or gelatin extruders, or industrial pasta extruders, such as the Model TP 200/300 from Emiliomiti S.p.A. of Italy. In some cases, a single machine can perform multiple steps of the process described herein, such as the kneading machine system available from Buss AG.

儘管前述描述集中各產品單元皆均勻的組成物，但亦可在同一產品單元中利用具有不同特性之多種不同調配物形成產品。舉例而言，二種不同組成物可沉積於單一模具中以產生分層產品。又另外，可將二種不同的組成物共擠出以形成在整個橫截面上具有不同特徵的產品。此類方法可用於提供具有特徵在於不同溶解速率之二種不同組成物的產品，由此使該產品之第一部分以第一速率(例如較快速率)溶解且第二部分以較慢之第二速率溶解。製備袋裝口服產品之方法Although the foregoing description focuses on uniform compositions in each product unit, it is also possible to form products utilizing multiple different formulations having different properties in the same product unit. For example, two different compositions may be deposited in a single mold to produce a layered product. Still further, two different compositions may be co-extruded to form a product having different characteristics across a cross-section. Such methods may be used to provide a product having two different compositions characterized by different dissolution rates, whereby a first portion of the product dissolves at a first rate (e.g., a faster rate) and a second portion dissolves at a second, slower rate.Method of Preparing a Bag-Packed Oral Product

在產品呈袋裝口服產品形式時，該方法可包含以下步驟： (a)將活性成分組合； (b)使活性成分之組合與至少一種填充劑接觸以提供該口服產品。When the product is in the form of a bagged oral product, the method may include the following steps:(a) combining the active ingredients;(b) contacting the combination of active ingredients with at least one filler to provide the oral product.

活性成分之組合可如上文所描述。活性劑之組合亦可如下文關於「其他廣泛態樣」所描述。The combination of active ingredients may be as described above. The combination of active agents may also be as described below in relation to "other broad aspects".

在一些實施例中，步驟(b)包含將至少一種填充劑與活性成分之組合混合。在一些實施例中，活性成分之組合係呈固體形式(例如呈粉末形式)。活性成分之組合可直接與填充劑混合以提供該口服產品。在一些實施例中，活性成分之組合可在接觸填充劑之前溶解於親水性溶劑(例如水及/或醇)中。舉例而言，活性成分之組合可在與填充劑混合之前溶解於水或醇(例如乙醇或丙二醇)中。在此類實施例中，該方法可包含乾燥產品以便移除溶劑的步驟。舉例而言，產品可經由加熱、冷凍乾燥、噴霧乾燥或僅將該產品在室溫下靜置某一時段來進行乾燥。較佳地，乾燥步驟包含使產品在室溫下靜置1小時至48小時之時段以移除溶劑。In some embodiments, step (b) comprises mixing at least one filler with the combination of active ingredients. In some embodiments, the combination of active ingredients is in solid form (e.g., in powder form). The combination of active ingredients can be directly mixed with the filler to provide the oral product. In some embodiments, the combination of active ingredients can be dissolved in a hydrophilic solvent (e.g., water and/or alcohol) before contacting the filler. For example, the combination of active ingredients can be dissolved in water or alcohol (e.g., ethanol or propylene glycol) before mixing with the filler. In such embodiments, the method may include a step of drying the product to remove the solvent. For example, the product can be dried by heating, freeze drying, spray drying, or simply leaving the product at room temperature for a period of time. Preferably, the drying step comprises allowing the product to stand at room temperature for a period of 1 hour to 48 hours to remove the solvent.

接著，該方法可進一步包含使用如上文所描述之小袋材料將口服產品裝袋的步驟。用途Then, the method may further comprise thestep of bagging the oral product using the pouch material as described above.

根據本文所描述之一些實施例，提供活性成分之組合促進睡眠之用途，較佳地，活性劑之組合存在於口服產品中，其中活性成分之組合包含(i)鎂或其鹽；(ii)包含至少維生素B2及維生素B6之B族維生素之組合；(iii)人參；及(iv)西番蓮，其中活性成分之組合(及口服產品)不含褪黑激素。According to some embodiments described herein, a combination of active ingredients is provided for use in promoting sleep, preferably, the combination of active agents is present in an oral product, wherein the combination of active ingredients comprises (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising at least vitamin B2 and vitamin B6; (iii) ginseng; and (iv) passion flower, wherein the combination of active ingredients (and the oral product) does not contain melatonin.

在一些實施例中，用途包含藉由誘導及/或維持投予活性成分之組合之個體的睡眠來促進睡眠。用途可包含增加個體之放鬆。In some embodiments, the use comprises promoting sleep by inducing and/or maintaining sleep in a subject to which the combination of active ingredients is administered. The use may comprise increasing relaxation in a subject.

在一些實施例中，活性成分之組合如上文所定義。在此類實施例中，該組合可進一步包含如上文所描述之額外活性成分中之任一者。舉例而言，活性成分之組合可進一步包含以下中之至少一者：(v) L-茶胺酸；(vi)聖羅勒及/或(vii)洋甘菊萃取物。活性成分之組合可尤其進一步包含L-茶胺酸。In some embodiments, the combination of active ingredients is as defined above. In such embodiments, the combination may further comprise any of the additional active ingredients as described above. For example, the combination of active ingredients may further comprise at least one of the following: (v) L-theanine; (vi) holy basil and/or (vii) chamomile extract. The combination of active ingredients may in particular further comprise L-theanine.

替代地，活性成分之組合亦可如下文關於「其他廣泛態樣」中之任一者中所描述。Alternatively, the combination of active ingredients may also be as described below in any of the “other broad aspects”.

與先前已知之產品及/或安慰劑相比，活性成分之組合可提供改善之作用。The combination of active ingredients may provide an improved effect compared to previously known products and/or placebo.

在一些實施例中，活性成分之組合提供與安慰劑產品相比改善之睡眠促進，其中安慰劑產品不包括根據本發明之活性成分之組合。在一些實施例中，活性成分之組合與安慰劑產品相比進一步改善放鬆。In some embodiments, the combination of active ingredients provides improved sleep promotion compared to a placebo product, wherein the placebo product does not include a combination of active ingredients according to the present invention. In some embodiments, the combination of active ingredients further improves relaxation compared to a placebo product.

睡眠促進及/或放鬆之測定可根據本文實例中所描述及採用之方法。睡眠促進可例如使用PROMIS睡眠障礙問卷及/或PROMIS睡眠損傷問卷確定。PROMIS睡眠障礙問卷提供睡眠品質之量測，而PROMIS睡眠障礙問卷提供睡眠滿意度之量測；睡眠品質及睡眠滿意度之改善在睡眠促進之範疇內。在一些實施例中，根據PROMIS睡眠障礙及PROMIS睡眠損傷問卷，活性成分之組合可藉由改善睡眠品質及睡眠滿意度來促進睡眠。Determination of sleep promotion and/or relaxation can be according to the methods described and used in the examples herein. Sleep promotion can be determined, for example, using the PROMIS Sleep Disorder Questionnaire and/or the PROMIS Sleep Impairment Questionnaire. The PROMIS Sleep Disorder Questionnaire provides a measure of sleep quality, while the PROMIS Sleep Disorder Questionnaire provides a measure of sleep satisfaction; improvements in sleep quality and sleep satisfaction are within the scope of sleep promotion. In some embodiments, the combination of active ingredients can promote sleep by improving sleep quality and sleep satisfaction according to the PROMIS Sleep Disorder and PROMIS Sleep Impairment Questionnaires.

替代地或另外，可使用阿森斯失眠量表(Athens Insomnia Scale)測定睡眠促進；此量表提供不良睡眠位準之量測；不良睡眠位準降低或較低屬於睡眠促進之範疇內。在一些實施例中，根據阿森斯失眠量表，活性成分之組合可藉由降低不良睡眠位準來進一步促進睡眠。Alternatively or additionally, sleep promotion can be measured using the Athens Insomnia Scale; this scale provides a measure of the level of poor sleep; reduced or lower levels of poor sleep are within the scope of sleep promotion. In some embodiments, the combination of active ingredients can further promote sleep by reducing the level of poor sleep according to the Athens Insomnia Scale.

放鬆可使用STAI-S量表(例如STAI-S-SF)、積極及消極情感時間表(PANAS)、情緒狀態量表(較佳為POMS-SF)及/或感知壓力問卷(PSQ)測定。STAI-S量表提供狀態焦慮之量測；PANAS提供積極情感之量測；POMS提供情緒障礙之量測；且PSQ提供感知壓力之量測。更低狀態焦慮、增加之積極情感、更低情緒障礙及/或減少之感知壓力指示個體之放鬆。在一些實施例中，活性成分之組合進一步提供藉由STAI-S、PANAS、POMS及/或PSQ量測之放鬆。其他廣泛態樣Relaxation can be measured using the STAI-S scale (e.g., STAI-S-SF), the Positive and Negative Affect Schedule (PANAS), the Mood State Inventory (preferably POMS-SF), and/or the Perceived Stress Questionnaire (PSQ). The STAI-S scale provides a measure of state anxiety; the PANAS provides a measure of positive affect; the POMS provides a measure of emotional disturbance; and the PSQ provides a measure of perceived stress. Lower state anxiety, increased positive affect, lower emotional disturbance, and/or decreased perceived stress indicate relaxation in the individual. In some embodiments, the combination of active ingredients further provides relaxation as measured by the STAI-S, PANAS, POMS, and/or PSQ.Other Broad Aspects

根據本文所描述之一些實施例，提供一種無褪黑激素之口服產品，其包含活性成分之組合，其中活性成分之組合包含(i)鎂或其鹽；(ii)人參及(iii)西番蓮。替代地，提供一種無褪黑激素之口服產品，其包含活性成分之組合，該活性成分之組合包含(i)鎂或其鹽、(ii)西番蓮及(iii) L-茶胺酸。替代地，提供一種無褪黑激素之口服產品，其包含活性成分之組合，該活性成分之組合包含(i)鎂或其鹽、(ii)人參及(iii)西番蓮，其中活性劑任擇地進一步包含L-茶胺酸。在此類實施例中，B族維生素之組合並非必需要素。According to some embodiments described herein, a melatonin-free oral product is provided, comprising a combination of active ingredients, wherein the combination of active ingredients comprises (i) magnesium or a salt thereof; (ii) ginseng and (iii) passion flower. Alternatively, a melatonin-free oral product is provided, comprising a combination of active ingredients, wherein the combination of active ingredients comprises (i) magnesium or a salt thereof, (ii) passion flower and (iii) L-theanine. Alternatively, a melatonin-free oral product is provided, comprising a combination of active ingredients, wherein the combination of active ingredients comprises (i) magnesium or a salt thereof, (ii) ginseng and (iii) passion flower, wherein the active agent optionally further comprises L-theanine. In such embodiments, the combination of B vitamins is not a necessary element.

替代地，提供一種無褪黑激素之口服產品，其包含活性成分之組合，該活性成分之組合包含(i)鎂或其鹽；(ii)包含維生素B2及維生素B6之B族維生素之組合；(iii)西番蓮；及任擇地(iv) L-茶胺酸。替代地，活性成分之組合可包含(i)鎂或其鹽；(ii)包含維生素B2及維生素B6之B族維生素之組合；及(iii)西番蓮。換言之，活性劑之組合可包括西番蓮作為必需要素，但人參不是。Alternatively, a melatonin-free oral product is provided, comprising a combination of active ingredients comprising (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising vitamin B2 and vitamin B6; (iii) passionflower; and optionally (iv) L-theanine. Alternatively, the combination of active ingredients may comprise (i) magnesium or a salt thereof; (ii) a combination of B vitamins comprising vitamin B2 and vitamin B6; and (iii) passionflower. In other words, the combination of active agents may include passionflower as an essential element, but not ginseng.

包括上文所描述之鎂或其鹽、人參、西番蓮、B族維生素及L-茶胺酸(以及所有其他活性成分及/或添加劑)之形式及量的細節同等地適用於此類實施例且僅為簡潔起見不在此處重複。包括上文所描述之形式、量及組合的所有細節同等地適用於此實施例。上文所描述之方法及用途亦可同等地適用於上述實施例。實例The details including the forms and amounts of magnesium or its salts, ginseng, passion flower, B vitamins and L-theanine (and all other active ingredients and/or additives) described above are equally applicable to such embodiments and are not repeated here for the sake of brevity. All details including the forms, amounts and combinations described above are equally applicable to this embodiment. The methods and uses described above are also equally applicable to the above embodiments.Examples

本發明之態樣將藉由以下實例更完整地說明，該等實例係闡述用於說明本發明之某些態樣且不應解釋為對本發明之限制。The aspects of the present invention will be more fully described by the following examples, which are provided to illustrate certain aspects of the present invention and should not be construed as limiting the present invention.

實例1-液體劑型 製備含有以下成分的呈液體形式之口服產品：成分百分比量(wt%)水85-99.9鎂鹽(例如甘胺酸鎂或氧化鎂)0.01-20維生素B2、B60.001-2人參萃取物0.01-10西番蓮0.01-1Example 1 - Liquid Dosage Form An oral product in liquid form is prepared containing the following ingredients:ElementPercentage(wt%) water 85-99.9 Magnesium salts (such as magnesium glycinate or magnesium oxide) 0.01-20 Vitamin B2, B6 0.001-2 Ginseng Extract 0.01-10 Passionflower 0.01-1

口服產品每份服用量具有30 mL或60 mL體積。Oral products come in 30 mL or 60 mL servings.

將所有活性成分添加至水中，且攪拌所得混合物，直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有30 mL或60 mL液體。All active ingredients are added to water and the resulting mixture is stirred until a homogenous dispersion or clear solution is obtained. The product is then packaged in bottles, where each serving size contains 30 mL or 60 mL of liquid.

實例2-液體劑型 製備含有以下成分的呈液體形式之口服產品：成分百分比量(wt%)水85-99.9鎂鹽(例如甘胺酸鎂或氧化鎂)0.01-20維生素B2、B60.001-2人參萃取物0.01-10西番蓮0.01 - 1L-茶胺酸0.01-10Example 2 - Liquid Dosage Form An oral product in liquid form is prepared containing the following ingredients:ElementPercentage(wt%) water 85-99.9 Magnesium salts (such as magnesium glycinate or magnesium oxide) 0.01-20 Vitamin B2, B6 0.001-2 Ginseng Extract 0.01-10 Passionflower 0.01 - 1 L-Theanine 0.01-10

口服產品每份服用量具有30 mL或60 mL體積。Oral products come in 30 mL or 60 mL servings.

將所有活性成分添加至水中，且攪拌所得混合物，直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有30 mL或60 mL液體。All active ingredients are added to water and the resulting mixture is stirred until a homogenous dispersion or clear solution is obtained. The product is then packaged in bottles, where each serving size contains 30 mL or 60 mL of liquid.

實例3-液體劑型 製備含有以下成分的呈液體形式之口服產品：成分百分比量(wt%)水85-99.9鎂鹽(例如甘胺酸鎂或氧化鎂)0.1-10維生素B2、B60.005-0.5人參萃取物0.01-2.5西番蓮0.005-0.1Example 3 - Liquid Dosage Form An oral product in liquid form is prepared containing the following ingredients:ElementPercentage(wt%) water 85-99.9 Magnesium salts (such as magnesium glycinate or magnesium oxide) 0.1-10 Vitamin B2, B6 0.005-0.5 Ginseng Extract 0.01-2.5 Passionflower 0.005-0.1

口服產品每份服用量具有30 mL或60 mL體積。Oral products come in 30 mL or 60 mL servings.

將所有活性成分添加至水中，且攪拌所得混合物，直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有30 mL或60 mL液體。All active ingredients are added to water and the resulting mixture is stirred until a homogenous dispersion or clear solution is obtained. The product is then packaged in bottles, where each serving size contains 30 mL or 60 mL of liquid.

實例4-具有100:1重量比之鎂鹽與總B族維生素及5:1比率之鎂鹽與人參的液體劑型 製備含有以下成分的呈液體形式之口服產品： ● 水 ● 甘胺酸鎂或氧化鎂 ● 維生素B2、B6 ● 人參萃取物 ● 西番蓮Example 4 - Liquid Dosage Forms with a 100:1 weight ratio of magnesium salt to total B vitamins and a 5:1 ratio of magnesium salt to ginsengPrepare an oral product in liquid form containing the following ingredients:● Water● Magnesium glycinate or magnesium oxide● Vitamins B2, B6● Ginseng extract● Passionflower

鎂或其鹽之量為每份服用量約400 mg且人參之量為每份服用量約80 mg。維生素B6之量為每份服用量約2 mg且維生素B2之量為每份服用量約2 mg。口服產品每份服用量具有60 mL體積。The amount of magnesium or its salt is about 400 mg per serving and the amount of ginseng is about 80 mg per serving. The amount of vitamin B6 is about 2 mg per serving and the amount of vitamin B2 is about 2 mg per serving. The oral product has a volume of 60 mL per serving.

口服產品如實例1至3中所闡述來製備。Oral products were prepared as described in Examples 1 to 3.

該口服產品可進一步具有5:1之鎂鹽與西番蓮之重量比，意謂西番蓮以80 mg存在。結果為人參與西番蓮之重量比為1:1，且西番蓮與總B族維生素之重量比為20:1。The oral product may further have a weight ratio of magnesium salt to passion flower of 5:1, meaning passion flower is present at 80 mg. As a result, the weight ratio of ginseng to passion flower is 1:1, and the weight ratio of passion flower to total B vitamins is 20:1.

實例5-具有1:1重量比之人參與西番蓮及5:1重量比之鎂鹽與L-茶胺酸的包括L-茶胺酸的液體劑型 製備含有以下成分的呈液體形式之口服產品： ● 水 ● 甘胺酸鎂或氧化鎂 ● 維生素B2、B6 ● 人參萃取物 ● 西番蓮 ● L-茶胺酸Example 5 - Liquid dosage form including L-theanine with a 1:1 weight ratio of ginseng to passion flower and a 5:1 weight ratio of magnesium salt to L-theaninePrepare an oral product in liquid form containing the following ingredients:● Water● Magnesium glycinate or magnesium oxide● Vitamin B2, B6● Ginseng extract● Passion flower● L-theanine

鎂鹽之量為每份服用量約500 mg且L-茶胺酸之量為約100 mg。西番蓮之量為每份服用量約200 mg。人參之量為約200 mg。該口服產品每份服用量具有30 mL體積。The amount of magnesium salt is about 500 mg per serving and the amount of L-theanine is about 100 mg. The amount of passionflower is about 200 mg per serving. The amount of ginseng is about 200 mg. The oral product has a volume of 30 mL per serving.

該口服產品如實例1至3中所闡述來製備。鎂鹽與西番蓮之重量比為5:2，且鎂鹽與人參之重量比類似地為5:2。B族維生素之總量可為3.5 mg。The oral product is prepared as described in Examples 1 to 3. The weight ratio of magnesium salt to passion flower is 5:2, and the weight ratio of magnesium salt to ginseng is similarly 5:2. The total amount of B vitamins may be 3.5 mg.

實例6-包括洋甘菊萃取物之液體劑型 製備含有以下成分的呈液體形式之口服產品：成分百分比量(wt%)60 ml之示例量(wt%)水85-99.998鎂鹽0.1-101.0維生素B2、B60.004-0.50.005人參萃取物0.1-2.50.1西番蓮0.1-2.50.25洋甘菊萃取物0.01-10.03Example 6 - Liquid Dosage Formulations Including Chamomile Extract An oral product in liquid form was prepared containing the following ingredients:ElementPercentage(wt%)Example volume of60 ml(wt%) water 85-99.9 98 Magnesium salt 0.1-10 1.0 Vitamin B2, B6 0.004-0.5 0.005 Ginseng Extract 0.1-2.5 0.1 Passionflower 0.1-2.5 0.25 Chamomile Extract 0.01-1 0.03

口服產品每份服用量具有60 mL體積。The oral product has a serving size of 60 mL.

將所有活性成分以及調味劑、著色劑、增稠劑、酸化劑、防腐劑及甜味劑(以總重量%餘量至100 wt%之量)一起添加至水中，且攪拌所得混合物直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有60 mL液體。All active ingredients, as well as flavorings, coloring agents, thickeners, acidulants, preservatives and sweeteners (in an amount equal to 100 wt % of the total weight %) are added to water and the resulting mixture is stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, wherein each serving contains 60 mL of liquid.

實例7-包括洋甘菊萃取物及聖羅勒之液體劑型 製備含有以下活性成分的呈液體形式之口服產品：成分百分比量(wt%)60 ml之示例量(wt%)水85-99.997.5鎂鹽0.1-101.0維生素B2、B60.004-0.50.005人參萃取物0.1-2.50.1西番蓮0.1-2.50.25洋甘菊萃取物0.01-10.03聖羅勒0.1-2.50.5Example 7 - Liquid Dosage Formulations Including Chamomile Extract and Holy Basil An oral product in liquid form was prepared containing the following active ingredients:ElementPercentage(wt%)Example volume of60 ml(wt%) water 85-99.9 97.5 Magnesium salt 0.1-10 1.0 Vitamin B2, B6 0.004-0.5 0.005 Ginseng Extract 0.1-2.5 0.1 Passionflower 0.1-2.5 0.25 Chamomile Extract 0.01-1 0.03 Holy Basil 0.1-2.5 0.5

口服產品每份服用量具有60 mL體積。The oral product has a serving size of 60 mL.

將所有活性成分以及調味劑、著色劑、增稠劑、酸化劑、防腐劑及甜味劑(以總重量%餘量至100 wt%之量)一起添加至水中，且攪拌所得混合物直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有60 mL液體。All active ingredients, as well as flavorings, coloring agents, thickeners, acidulants, preservatives and sweeteners (in an amount equal to 100 wt % of the total weight %) are added to water and the resulting mixture is stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, wherein each serving contains 60 mL of liquid.

實例8-包括洋甘菊萃取物、聖羅勒及L-茶胺酸之液體劑型 製備含有以下成分的呈液體形式之口服產品：成分百分比量(wt%)60 ml之示例量(wt%)水85-99.997鎂鹽0.1-101.0維生素B2、B60.004-0.50.005人參萃取物0.1-2.50.1西番蓮0.1-2.50.25洋甘菊萃取物0.01-10.03聖羅勒0.1-2.50.5L-茶胺酸0.1-2.50.5Example 8 - Liquid Dosage Formulations Comprising Chamomile Extract, Holy Basil and L-Theanine An oral product in liquid form was prepared containing the following ingredients:ElementPercentage(wt%)Example volume of60 ml(wt%) water 85-99.9 97 Magnesium salt 0.1-10 1.0 Vitamin B2, B6 0.004-0.5 0.005 Ginseng Extract 0.1-2.5 0.1 Passionflower 0.1-2.5 0.25 Chamomile Extract 0.01-1 0.03 Holy Basil 0.1-2.5 0.5 L-Theanine 0.1-2.5 0.5

口服產品每份服用量具有60 mL體積。The oral product has a serving size of 60 mL.

將所有活性成分以及調味劑、著色劑、增稠劑、酸化劑、防腐劑及甜味劑(以總重量%餘量至100 wt%之量)一起添加至水中，且攪拌所得混合物直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有60 mL液體。All active ingredients, as well as flavorings, coloring agents, thickeners, acidulants, preservatives and sweeteners (in an amount equal to 100 wt % of the total weight %) are added to water and the resulting mixture is stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, wherein each serving contains 60 mL of liquid.

實例9-消費者測試結果Example 9 - Consumer Test Results

進行研究以比較根據實例8製備之口服產品與安慰劑(在無實例8之活性成分之情況下均勻調味之濃縮飲品)。進行盲法測試，其中一組參與者攝入實例8之濃縮飲品，而第二組參與者給予安慰劑產品。該研究研究液體劑型改善睡眠之作用。A study was conducted to compare an oral product prepared according to Example 8 with a placebo (a concentrated drink uniformly flavored without the active ingredient of Example 8). A blind test was conducted, with one group of participants taking the concentrated drink of Example 8 and a second group of participants being given a placebo product. The study investigated the effect of a liquid dosage form on improving sleep.

研究之主要結果為睡眠品質及滿意度，以及睡眠障礙及損傷；此結果係在每日攝入產品之後經由PROMIS睡眠問卷(患者報導結果量測資訊系統)量測。此為此項技術中睡眠度量之公認量度。次要量度為經由恢復性睡眠問卷之恢復性睡眠評分、經由阿森斯失眠量表之失眠嚴重度評分、經由POMS-SF之情緒狀態量表、經由狀態-特質焦慮問卷(STAI)之滿足感及經由感知壓力問卷之感知壓力評分。下表中展示該等方法及終點。The primary outcomes of the study were sleep quality and satisfaction, and sleep disturbance and impairment, measured by the PROMIS Sleep Questionnaire (Patient Reported Outcomes Measurement Information System) following daily product ingestion. This is a recognized measure of sleep measurement in this technology. Secondary measures were restorative sleep scores by the Restorative Sleep Questionnaire, insomnia severity scores by the Athens Insomnia Scale, mood state scale by the POMS-SF, satisfaction by the State-Trait Anxiety Inventory (STAI), and perceived stress scores by the Perceived Stress Questionnaire. The methods and endpoints are shown in the table below.

在研究之前(T0)及7天之後(T7)獲取基線，隨後14天每日攝入產品。在參與者就寢時間之前30分鐘，每日攝入一次服用量(一次濃縮飲品60 ml體積)。所有參與者完成每週反映性調查。此等量測提供有關液體劑型對睡眠之影響的評估。預期的消費者益處包括壓力減少、放鬆、變成「準備睡覺」、提供積極就寢時間儀式、得到恢復及品質睡眠以及更快地入睡。 評估以下因素：終點方法問卷中之問題數目頻率睡眠品質及滿意度 睡眠障礙及損傷PROMIS睡眠問卷16每週睡眠後疲勞 睡眠後情緒 睡眠後能量恢復性睡眠問卷11每週入睡 熟睡中 頻繁醒來/早醒 睡眠持續時間及品質 對每日功能之干擾阿森斯失眠量表8每週活力/友好/疲勞/憤怒/意識模糊/沮喪/緊張/TMD情緒狀態量表-SF40每週滿足感STAI-狀態-SF6每週壓力感知壓力問卷30書檔Baselines were obtained before (T0) and 7 days after (T7) the study, followed by daily product intake for 14 days. One serving (60 ml volume of one concentrated drink) was taken daily 30 minutes before the participant's bedtime. All participants completed weekly reflective surveys. These measures provide an assessment of the effects of the liquid dosage form on sleep. Expected consumer benefits include stress reduction, relaxation, becoming "ready for bed," providing a positive bedtime ritual, getting restorative and quality sleep, and falling asleep faster. The following factors were assessed:EndmethodNumber of questions in the questionnaireFrequency Sleep quality and satisfaction Sleep disorders and impairment PROMIS Sleep Questionnaire 16 Weekly Fatigue after sleep Emotion after sleep Energy after sleep Restorative Sleep Questionnaire 11 Weekly Frequent awakenings during deep sleep/early awakenings The duration and quality of sleep interfere with daily function Athens Insomnia Scale 8 Weekly Energetic/Friendly/Tired/Angry/Confused/Frustrated/Nervous/TMD Mood State Scale-SF 40 Weekly Satisfaction STAI-Status-SF 6 Weekly pressure Perceived stress questionnaire 30 Book Files

研究中之所有參與者(實例8產品n = 27，安慰劑產品n = 29)為年齡為18-45歲之健康成人，根據失眠症狀問卷，其並非臨床上失眠的，及/或自我報導為臨床上抑鬱的。All participants in the study (Example 8 product n = 27, placebo product n = 29) were healthy adults aged 18-45 years who were not clinically insomniac according to the Insomnia Symptom Questionnaire and/or self-reported as clinically depressed.

第7天為真正的每週反映基線，此係因為其確保參與者已一週未服用其他產品來促進睡眠或放鬆。獲得T7作為基線(亦即，各別圖中量表上之0)之以下結果： ● 滿足感(較低焦慮)-STAI-S-狀態-特質焦慮問卷(STAI)係特質及狀態焦慮之常用量度。其包含用於量測二個不同焦慮概念之獨立自我報導量表：狀態焦慮及特質焦慮。本實例中使用STAI-S量表；此由20個陳述組成且說明書要求參與者指出其在特定時刻感覺如何。STAI-S量表可用於確定由壓力程序誘發之焦慮強度的實際位準。攝入實例8產品之參與者報導與安慰劑相比在第14天及第21天較低位準之焦慮。此表明本發明之口服產品與安慰劑相比較高位準之滿足感或放鬆狀態。圖1中展示結果。 ● 睡眠品質-PROMIS睡眠障礙-PROMIS或患者報導結果量測資訊系統係監測身體、精神及社交健康之一組個性化量度。PROMIS工具藉由詢問多個問題量測參與者能夠執行之程度及其感受。PROMIS之「睡眠障礙」工具評估自我報導之對睡眠品質、睡眠深度及與睡眠相關之恢復的感知。此包括感知的入睡或保持睡眠困難及擔憂，以及對睡眠充足性及滿意度的感知。要求所有參與者每週回答問卷。使用8項簡表問卷。攝入實例8產品之參與者報導與安慰劑相比在第21天總體較低位準之睡眠障礙。圖2中展示結果。 ● 睡眠滿意度-PROMIS睡眠損傷-PROMIS之「睡眠損傷」工具評估在清醒時間期間與睡眠問題相關之自我報導的警覺性、嗜睡、疲勞及功能損傷。要求所有參與者每週回答問卷。使用8項簡表問卷。攝入實例8產品之參與者報導與安慰劑相比在第14天及第21天總體較低位準之睡眠損傷。圖3中展示結果。 ● 不良睡眠-阿森斯失眠量表(AIS)-AIS為八項問卷，其評估入睡、夜醒及晨醒、睡眠時間、睡眠品質、不適頻率及持續時間、由失眠經歷引起之痛苦及對每日功能之干擾。要求所有參與者每週回答問卷。攝入實例8產品之參與者報導與安慰劑相比在第14天及第21天總體較低位準之不良睡眠。圖4中展示結果。 ● 情緒障礙總分-情緒狀態量表(POMS)-POMS係一種用於評估短暫、不同的情緒狀態之心理評定量表。POMS係隨時間推移量測六個情緒波動維度的自我報導工具：緊張或焦慮、抑鬱或沮喪、憤怒或敵意、活力或活性、疲勞或慣性、意識模糊或迷惘，以得到情緒障礙總分之組合平均值。POMS-SF係指情緒狀態量表之「簡表」。要求所有參與者每週回答問卷。攝入實例8產品之參與者返回比攝入安慰劑之參與者低的評分。此表明本發明之口服產品與安慰劑相比產生較低情緒障礙。圖5中展示結果。Day 7 was a true weekly reflection baseline because it ensured that participants had not taken other products to promote sleep or relaxation for a week. The following results were obtained with T7 as the baseline (i.e., 0 on the scales in the respective figures): ● Satisfaction (lower anxiety) - STAI-S - The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It consists of separate self-report scales for measuring two different anxiety concepts: state anxiety and trait anxiety. The STAI-S scale was used in this example; this consists of 20 statements and the instructions ask participants to indicate how they felt at a specific moment. The STAI-S scale can be used to determine the actual level of anxiety intensity induced by stressful procedures. Participants who took the Example 8 product reported lower levels of anxiety on Day 14 and Day 21 compared to placebo. This indicates a higher level of satisfaction or relaxation with the oral product of the present invention compared to placebo. The results are shown in Figure 1.● Sleep Quality - PROMIS Sleep Disturbance - PROMIS or the Patient Reported Outcomes Measurement Information System is a set of personalized measures that monitor physical, mental and social health. The PROMIS tool measures how well participants are able to perform and how they feel by asking multiple questions. The PROMIS "Sleep Disturbance" tool assesses self-reported perceptions of sleep quality, sleep depth, and sleep-related recovery. This includes perceived difficulty and worry about falling asleep or staying asleep, as well as perceptions of sleep adequacy and satisfaction. All participants were asked to answer weekly questionnaires. An 8-item short-form questionnaire was used. Participants who took Example 8 products reported overall lower levels of sleep disturbances at Day 21 compared to placebo. Results are shown in Figure 2.● Sleep Satisfaction - PROMIS Sleep Impairment - The PROMIS "Sleep Impairment" tool assesses self-reported alertness, sleepiness, fatigue, and functional impairment associated with sleep problems during waking hours. All participants were asked to answer weekly questionnaires. An 8-item short-form questionnaire was used. Participants who took Example 8 products reported overall lower levels of sleep impairment at Days 14 and 21 compared to placebo. Results are shown in Figure 3.● Poor Sleep - Athens Insomnia Scale (AIS) - The AIS is an eight-item questionnaire that assesses sleep onset, night and morning awakenings, sleep duration, sleep quality, frequency and duration of discomfort, distress caused by insomnia experiences, and interference with daily functioning. All participants were asked to answer the questionnaire weekly. Participants who took the Example 8 product reported overall lower levels of poor sleep on Days 14 and 21 compared to placebo. The results are shown in Figure 4.● Total Mood Disturbance Score - The Inventory of Mood States Scale (POMS) - The POMS is a psychological rating scale used to assess transient, distinct mood states. POMS is a self-report instrument that measures six dimensions of mood fluctuations over time: tension or anxiety, depression or frustration, anger or hostility, vitality or activity, fatigue or inertia, and confusion or confusion to obtain a combined average of the total score of mood disturbance. POMS-SF refers to the "Short Form" of the Mood State Scale. All participants were asked to answer the questionnaire weekly. Participants who took the Example 8 product returned lower scores than those who took the placebo. This indicates that the oral product of the present invention produces lower mood disturbances compared to the placebo. The results are shown in Figure 5.

總體而言，觀測到與基線評分相比之正向作用，表明在攝入產品14天期間多個睡眠領域得到改善。有趣地，睡眠品質及滿意度與睡眠障礙及損傷之主要結果及多種次要結果顯示與基線相比之正面作用。次要結果包括增加位準之滿足感及較低情緒障礙，表明本發明之口服產品賦予放鬆，同時促進睡眠。在不受理論束縛之情況下，咸信本文所定義之活性成分之組合允許觀測到的促進睡眠之作用以及待實現之滿足感及/或更穩定之情緒。Overall, positive effects were observed compared to baseline scores, indicating that multiple sleep domains were improved during the 14-day period of product intake. Interestingly, the primary outcomes of sleep quality and satisfaction and sleep disturbances and impairment and various secondary outcomes showed positive effects compared to baseline. Secondary outcomes included increased levels of satisfaction and lower mood disturbances, indicating that the oral product of the present invention provides relaxation while promoting sleep. Without being bound by theory, it is believed that the combination of active ingredients defined herein allows the observed sleep-promoting effects as well as satisfaction and/or more stable mood to be achieved.

實例10-進一步消費者測試 製備含有以下成分的呈液體形式之口服產品：表A成分百分比量(wt%)60 ml之示例量(wt%)水85-99.997鎂鹽0.1-100.6維生素B2、B60.004-0.50.005人參萃取物0.1-2.50.2西番蓮0.1-2.50.25洋甘菊萃取物0.01-10.03聖羅勒0.1-2.50.5L-茶胺酸0.1-2.50.3表B成分百分比量(wt%)60 ml之示例量(wt%)水85-99.997.5GABA0.1-100.2維生素B2、B60.005-0.50.005人參萃取物0.1-2.50.2褪黑激素0.005-0.10.008洋甘菊萃取物0.025-10.03檸檬香草0.05-2.50.1L-茶胺酸0.1-2.50.05色胺酸0.05-2.50.08Example 10 - Further Consumer Testing An oral product in liquid form was prepared containing the following ingredients:TableAElementPercentage(wt%)Example volume of60 ml(wt%) water 85-99.9 97 Magnesium salt 0.1-10 0.6 Vitamin B2, B6 0.004-0.5 0.005 Ginseng Extract 0.1-2.5 0.2 Passionflower 0.1-2.5 0.25 Chamomile Extract 0.01-1 0.03 Holy Basil 0.1-2.5 0.5 L-Theanine 0.1-2.5 0.3TableBElementPercentage(wt%)Example volume of60 ml(wt%) water 85-99.9 97.5 GABA 0.1-10 0.2 Vitamin B2, B6 0.005-0.5 0.005 Ginseng Extract 0.1-2.5 0.2 Melatonin 0.005-0.1 0.008 Chamomile Extract 0.025-1 0.03 Lemongrass 0.05-2.5 0.1 L-Theanine 0.1-2.5 0.05 Tryptophan 0.05-2.5 0.08

各口服產品每份服用量具有60 mL體積。Each oral product serving size has a volume of 60 mL.

將來自表A或表B之活性成分以及調味劑、著色劑、增稠劑、酸化劑、防腐劑及甜味劑(以總重量%餘量至100 wt%之量)一起添加至水中，且攪拌所得混合物直至獲得均質分散液或澄清溶液。接著，將產品包裝於瓶子中，其中各份服用量含有60 mL液體。The active ingredients from Table A or Table B, as well as flavoring agents, coloring agents, thickeners, acidulants, preservatives and sweeteners (in an amount equal to 100 wt % of the total weight %) are added to water, and the resulting mixture is stirred until a homogeneous dispersion or clear solution is obtained. The product is then packaged in bottles, wherein each serving contains 60 mL of liquid.

進行研究以比較根據表A製備之口服產品與根據表B製備之口服產品及安慰劑(在無活性成分之情況下均勻調味之濃縮飲品)。進行盲法測試，其中一組參與者(n=60個/組)攝入根據表A製備之濃縮飲品，第二組參與者攝入根據表B製備之濃縮飲品，而第三組參與者給予安慰劑產品。該研究研究液體劑型改善睡眠之作用。A study was conducted to compare an oral product prepared according to Table A with an oral product prepared according to Table B and a placebo (a concentrated drink uniformly flavored without active ingredients). A blind test was conducted in which one group of participants (n=60/group) ingested a concentrated drink prepared according to Table A, a second group ingested a concentrated drink prepared according to Table B, and a third group was given a placebo product. The study investigated the effect of liquid dosage forms on improving sleep.

研究之主要結果為睡眠品質及滿意度，以及睡眠障礙及損傷；此結果係在每日攝入產品之後經由PROMIS睡眠問卷(患者報導結果量測資訊系統)量測。次要量度包括例如經由每日睡眠日記之自我報導睡眠量度、經由恢復性睡眠問卷之恢復性睡眠評分、經由阿森斯失眠量表之失眠嚴重度評分、經由積極及消極情感時間表(PANAS)及POMS-SF之情緒狀態量表、經由STAI-狀態-SF之滿足感及/或經由感知壓力問卷之感知壓力評分。方法及終點展示於下表中。The primary outcomes of the study were sleep quality and satisfaction, and sleep disturbance and impairment, measured by the PROMIS Sleep Questionnaire (Patient Reported Outcomes Measurement Information System) after daily product ingestion. Secondary measures included, for example, self-reported sleep measures by daily sleep diary, restorative sleep scores by the Restorative Sleep Questionnaire, insomnia severity scores by the Athens Insomnia Scale, mood state scales by the Positive and Negative Affect Schedule (PANAS) and POMS-SF, satisfaction by the STAI-State-SF, and/or perceived stress scores by the Perceived Stress Questionnaire. The methods and endpoints are shown in the table below.

在研究之前(T0)及7天之後(T7)獲取基線，隨後21天每日攝入產品。在參與者就寢時間之前30分鐘，每日攝入一次服用量(一次濃縮飲品60 ml體積)。所有參與者完成睡眠日記，其中項目在每天睡眠後早晨進行，且每週進行反映性調查。此等量測提供有關液體劑型對睡眠之影響的評估。預期的消費者益處與實例9相同。Baselines were obtained before the study (T0) and 7 days after (T7), followed by daily product intake for 21 days. A single dose (60 ml volume of a concentrated drink) was taken daily 30 minutes before the participant's bedtime. All participants completed a sleep diary with items taken in the morning after each sleep session and a reflective survey was conducted weekly. These measurements provide an assessment of the effects of the liquid dosage form on sleep. The expected consumer benefits are the same as in Example 9.

評估以下因素：終點方法頻率自我報導之睡眠量度睡眠日記 ●  熟睡中或醒來 ●  睡眠品質、情緒、警覺性每天早晨睡眠品質及滿意度 睡眠障礙及損傷PROMIS睡眠問卷每週睡眠後疲勞 睡眠後情緒 睡眠後能量恢復性睡眠問卷每週入睡 熟睡中 頻繁醒來/早醒 睡眠持續時間及品質 對每日功能之干擾阿森斯失眠量表每週積極情緒積極及消極情感時間表(PANAS)每週活力/友好/疲勞/憤怒/意識模糊/沮喪/緊張/TMD情緒狀態量表-SF每週滿足感STAI-狀態-SF每週壓力感知壓力問卷每週產品體驗(定性)自由文本+主題分析研究後Assess the following factors:EndmethodFrequency Self-reported sleep measures Sleep diary● Deep sleep or waking● Sleep quality, mood, alertness Every morning Sleep quality and satisfaction Sleep disorders and impairment PROMIS Sleep Questionnaire Weekly Fatigue after sleep Emotion after sleep Energy after sleep Restorative Sleep Questionnaire Weekly Frequent awakenings during deep sleep/early awakenings The duration and quality of sleep interfere with daily function Athens Insomnia Scale Weekly Positive emotions Positive and Negative Affect Schedule (PANAS) Weekly Energetic/Friendly/Tired/Angry/Confused/Frustrated/Nervous/TMD Mood State Scale-SF Weekly Satisfaction STAI-Status-SF Weekly pressure Perceived stress questionnaire Weekly Product Experience (Qualitative) Free text + topic analysis After the study

PROMIS、AIS、POMS-SF及STAI-狀態方法如上文針對實例9所描述。STAI-狀態-SF係指STAI-S之「簡表」，其中參與者提出六個陳述。The PROMIS, AIS, POMS-SF, and STAI-State methods were as described above for Example 9. STAI-State-SF refers to the "short form" of the STAI-S, in which participants make six statements.

積極及消極情感時間表(PANAS)係量測情緒及感情的使用最廣泛量表之一。量表包含20項，其中10項量測積極情感(例如激發、啟發)且10項量測消極情感(例如心煩、害怕)。在此研究中，僅量測積極情感。各項根據在1至5範圍內之五分李克特量表(Likert Scale)進行評定，以量測在指定時間範圍內已經歷情感之程度。The Positive and Negative Affect Schedule (PANAS) is one of the most widely used scales to measure emotions and feelings. The scale contains 20 items, 10 of which measure positive emotions (e.g., excitement, inspiration) and 10 items measure negative emotions (e.g., upset, fear). In this study, only positive emotions were measured. Each item is rated on a five-point Likert Scale ranging from 1 to 5 to measure the degree to which the emotion has been experienced within a specified time frame.

感知壓力問卷(PSQ)包括30項且經研發作為評估趨向於觸發或加劇疾病症狀之壓力性生活事件及情況的工具。在對睡眠週期之品質及一致性明顯有壓力的情況下，PSQ為用於評估睡眠障礙之根本原因的可能有用工具。The Perceived Stress Questionnaire (PSQ) consists of 30 items and was developed as a tool to assess stressful life events and situations that tend to trigger or exacerbate disease symptoms. In situations where stress about the quality and consistency of the sleep cycle is evident, the PSQ is a potentially useful tool for assessing the underlying causes of sleep disturbances.

研究中之所有參與者為年齡為18-45歲之健康成人，根據失眠症狀問卷，其未患臨床失眠，及/或自我報導為臨床上抑鬱的。All participants in the study were healthy adults aged 18-45 years who did not suffer from clinical insomnia and/or self-reported clinical depression according to the Insomnia Symptom Questionnaire.

亦針對睡眠障礙篩選所有參與者以確保其睡眠障礙加劇，但不滿足臨床臨限值。至少使用阿森斯失眠量表(AIS)自我報導睡眠障礙篩選。要求參與者具有8至14之間的平均AIS評分。AIS如上文針對實例9所描述。All participants were also screened for sleep disturbance to ensure that their sleep disturbance was exacerbated but did not meet clinical thresholds. At a minimum, the sleep disturbance screening was self-reported using the Athens Insomnia Scale (AIS). Participants were required to have an average AIS score between 8 and 14. The AIS was as described above for Example 9.

第7天為真正的每週反映基線，此係因為其確保參與者已一週未服用其他產品來促進睡眠或放鬆。Day 7 was a true weekly baseline because it ensured that participants had not taken other products to promote sleep or relaxation for a week.

本文所描述之各種實施例僅為了有助於瞭解及教示所主張之特徵而呈現。此等實施例僅作為實施例之代表樣品提供，且非窮盡性及/或排他性的。應瞭解，本文所描述之優點、實施例、實例、功能、特徵、結構及/或其他態樣不應視為限制如申請專利範圍所限定之本發明範疇或限制申請專利範圍的等效物，且可利用其他實施例且可進行修改而不脫離本發明之範疇。本發明之各種實施例可合適地包含以下、由以下組成或基本上由以下組成：除本文中特定描述之彼等者以外的所揭露元件、組件、特徵、部分、步驟、部件等之適當組合。另外，本揭露內容可包括目前未主張、但將來可能主張之其他發明。The various embodiments described herein are presented only to aid in understanding and teaching the claimed features. These embodiments are provided only as representative samples of embodiments and are not exhaustive and/or exclusive. It should be understood that the advantages, embodiments, examples, functions, features, structures and/or other aspects described herein should not be considered to limit the scope of the invention as defined by the scope of the patent application or the equivalents of limiting the scope of the patent application, and other embodiments may be utilized and modifications may be made without departing from the scope of the invention. The various embodiments of the present invention may suitably include, consist of, or consist essentially of appropriate combinations of disclosed elements, components, features, parts, steps, parts, etc. other than those specifically described herein. In addition, the present disclosure may include other inventions that are not currently claimed but may be claimed in the future.

(無)(without)

現將僅藉助於實例參考隨附圖式來描述本揭露內容之實施例，在該等圖式中：Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

圖1為來自實例9之圖，其展示在比較實例8之口服產品與安慰劑之消費者研究期間的狀態-特質焦慮調查表量測(STAI-S)結果。FIG. 1 is a graph from Example 9 showing the State-Trait Anxiety Inventory (STAI-S) results during a consumer study comparing the oral product to a placebo from Example 8.

圖2為來自實例9之圖，其展示在比較實例8之口服產品與安慰劑之消費者研究期間的PROMIS睡眠障礙量測結果。FIG. 2 is a graph from Example 9 showing the results of the PROMIS sleep disturbance measure during the consumer study comparing the oral product of Example 8 to a placebo.

圖3為來自實例9之圖，其展示在比較實例8之口服產品與安慰劑之消費者研究期間的PROMIS睡眠損傷量測結果。FIG. 3 is a graph from Example 9 showing the PROMIS sleep impairment measurement results during the consumer study comparing the oral product of Example 8 to a placebo.

圖4為來自實例9之圖，其展示在比較實例8之口服產品與安慰劑之消費者研究期間的阿森斯失眠量表(AIS)量測結果。FIG. 4 is a graph from Example 9 showing the Athens Insomnia Scale (AIS) measurement results during the consumer study comparing the oral product of Example 8 to a placebo.

圖5為來自實例9之圖，其展示在比較實例8之口服產品與安慰劑之消費者研究期間的情緒狀態量表(POMS)-簡表(SF)量測結果。FIG. 5 is a graph from Example 9 showing the results of the Positive and Negative Mood Scale (POMS)-Short Form (SF) measurement during the consumer study comparing the oral product and placebo of Example 8.

(無)(without)

Claims (25)

Translated fromChinese

一種無褪黑激素之口服產品，其包含活性成分之一組合，其中該組合包含： (i)鎂或其一鹽； (ii)包含至少維生素B2及維生素B6之B族維生素之一組合； (iii)人參； (iv)西番蓮(passionflower)； (v)洋甘菊萃取物。A melatonin-free oral product comprising a combination of active ingredients, wherein the combination comprises:(i) magnesium or a salt thereof;(ii) a combination of B vitamins including at least vitamin B2 and vitamin B6;(iii) ginseng;(iv) passionflower;(v) chamomile extract.如請求項1之無褪黑激素之口服產品，其中該(ii) B族維生素之組合由維生素B2及維生素B6組成。The melatonin-free oral product of claim 1, wherein the (ii) combination of B vitamins consists of vitamin B2 and vitamin B6.如請求項1或2中任一項之無褪黑激素之口服產品，其中包括在該活性劑之組合中的B族維生素之總量為按該組合之乾重計約0.01%至約5%，或該口服產品之約0.001重量%至約2重量%。The melatonin-free oral product of any one of claim 1 or 2, wherein the total amount of B vitamins included in the combination of active agents is about 0.01% to about 5% by dry weight of the combination, or about 0.001% to about 2% by weight of the oral product.如請求項1至3中任一項之無褪黑激素之口服產品，其中該鎂或其鹽以按該組合之乾重計約10%至約60%之一量存在，或其中該鎂或其鹽以該口服產品之約0.01重量%至約20重量%之一量存在。The melatonin-free oral product of any one of claims 1 to 3, wherein the magnesium or a salt thereof is present in an amount of about 10% to about 60% by dry weight of the composition, or wherein the magnesium or a salt thereof is present in an amount of about 0.01% to about 20% by weight of the oral product.如請求項1至4中任一項之無褪黑激素之口服產品，其中該人參以按該組合之乾重計約1%至約40%之一量存在，或其中該人參以該口服產品之約0.01重量%至約10重量%之一量存在。The melatonin-free oral product of any one of claims 1 to 4, wherein the ginseng is present in an amount of about 1% to about 40% by dry weight of the composition, or wherein the ginseng is present in an amount of about 0.01% to about 10% by weight of the oral product.如請求項1至5中任一項之無褪黑激素之口服產品，其中該西番蓮以按該組合之乾重計約1%至約40%之一量存在，或其中該西番蓮以該口服產品之約0.01重量%至約10重量%之一量存在。The melatonin-free oral product of any one of claims 1 to 5, wherein the passionflower is present in an amount of about 1% to about 40% by dry weight of the composition, or wherein the passionflower is present in an amount of about 0.01% to about 10% by weight of the oral product.如請求項1至6中任一項之無褪黑激素之口服產品，其中該鎂或其鹽及該人參以約50:1至約1:10之一重量比存在於該口服產品中，較佳其中該鎂或其鹽及該人參以約25:1至約1:5之一重量比存在於該口服產品中。A melatonin-free oral product as claimed in any one of claims 1 to 6, wherein the magnesium or its salt and the ginseng are present in the oral product in a weight ratio of about 50:1 to about 1:10, preferably wherein the magnesium or its salt and the ginseng are present in the oral product in a weight ratio of about 25:1 to about 1:5.如請求項1至7中任一項之無褪黑激素之口服產品，其中該鎂或其鹽及該B族維生素之總量以約250:1至約10:1之一重量比存在於該口服產品中，較佳其中該鎂或其鹽及該B族維生素之總量以約200:1至約25:1之一重量比存在於該口服產品中。A melatonin-free oral product according to any one of claims 1 to 7, wherein the total amount of the magnesium or a salt thereof and the B vitamins are present in the oral product in a weight ratio of about 250:1 to about 10:1, preferably wherein the total amount of the magnesium or a salt thereof and the B vitamins are present in the oral product in a weight ratio of about 200:1 to about 25:1.如請求項1至8中任一項之無褪黑激素之口服產品，其中該人參及該B族維生素之總量以約100:1至約10:1之一重量比存在於該口服產品中，較佳其中該人參及該B族維生素之總量以約75:1至約15:1之一重量比存在於該口服產品中。A melatonin-free oral product as claimed in any one of claims 1 to 8, wherein the total amount of ginseng and the B vitamins are present in the oral product in a weight ratio of about 100:1 to about 10:1, preferably wherein the total amount of ginseng and the B vitamins are present in the oral product in a weight ratio of about 75:1 to about 15:1.如請求項1至9中任一項之無褪黑激素之口服產品，其中該鎂或其鹽及該西番蓮以約50:1至約1:10之一重量比存在於該口服產品中，較佳其中該鎂或其鹽及該西番蓮以約25:1至約1:5之一重量比存在於該口服產品中。A melatonin-free oral product according to any one of claims 1 to 9, wherein the magnesium or a salt thereof and the passionflower are present in the oral product in a weight ratio of about 50:1 to about 1:10, preferably wherein the magnesium or a salt thereof and the passionflower are present in the oral product in a weight ratio of about 25:1 to about 1:5.如請求項1至10中任一項之無褪黑激素之口服產品，其中該人參及該西番蓮以約10:1至約1:10，較佳約5:1至約1:5之一重量比存在於該口服產品中。The melatonin-free oral product of any one of claims 1 to 10, wherein the ginseng and the passion flower are present in the oral product in a weight ratio of about 10:1 to about 1:10, preferably about 5:1 to about 1:5.如請求項1至11中任一項之無褪黑激素之口服產品，其中該活性成分之組合進一步包含(v) L-茶胺酸，任擇地其中該L-茶胺酸以按該組合之乾重計約1%至約40%之一量存在，或其中該L-茶胺酸以該口服產品之約0.01重量%至約10重量%之一量存在。A melatonin-free oral product as claimed in any one of claims 1 to 11, wherein the combination of active ingredients further comprises (v) L-theanine, optionally wherein the L-theanine is present in an amount of about 1% to about 40% by dry weight of the combination, or wherein the L-theanine is present in an amount of about 0.01% to about 10% by weight of the oral product.如請求項12之無褪黑激素之口服產品，其中該鎂或其鹽及該L-茶胺酸以約10:1至約1:10，較佳約10:1至約1:5之一重量比存在於該口服產品中。The melatonin-free oral product of claim 12, wherein the magnesium or a salt thereof and the L-theanine are present in the oral product in a weight ratio of about 10:1 to about 1:10, preferably about 10:1 to about 1:5.如請求項12或請求項13之無褪黑激素之口服產品，其中該西番蓮及該L-茶胺酸以約10:1至約1:10，較佳約5:1至約1:5之一重量比存在於該口服產品中。The melatonin-free oral product of claim 12 or claim 13, wherein the passionflower and the L-theanine are present in the oral product in a weight ratio of about 10:1 to about 1:10, preferably about 5:1 to about 1:5.如請求項1至14中任一項之無褪黑激素之口服產品，其中該洋甘菊萃取物以按該組合之乾重計約0.1%至約20%，或該口服產品之約0.001重量%至約10重量%之一量存在。The melatonin-free oral product of any one of claims 1 to 14, wherein the chamomile extract is present in an amount of about 0.1% to about 20% by dry weight of the composition, or about 0.001% to about 10% by weight of the oral product.如請求項1至15中任一項之無褪黑激素之口服產品，其中該鎂或其鹽及該洋甘菊萃取物以約50:1至約1:10，較佳約35:1至約1:1之一重量比存在於該口服產品中。The melatonin-free oral product of any one of claims 1 to 15, wherein the magnesium or a salt thereof and the chamomile extract are present in the oral product in a weight ratio of about 50:1 to about 1:10, preferably about 35:1 to about 1:1.如請求項1至16中任一項之無褪黑激素之口服產品，其中該口服產品包含佔該口服產品之約0.1重量%至約10重量%之量的該活性成分之組合。A melatonin-free oral product as claimed in any one of claims 1 to 16, wherein the oral product comprises the combination of active ingredients in an amount of about 0.1% to about 10% by weight of the oral product.如請求項1至17中任一項之無褪黑激素之口服產品，其進一步包含一或多種選自由以下組成之群的添加劑：一調味劑、甜味劑、酸化劑、增稠劑、填充劑、黏合劑、保濕劑、防腐劑及其混合物。The melatonin-free oral product of any one of claims 1 to 17, further comprising one or more additives selected from the group consisting of: a flavoring agent, a sweetener, an acidulant, a thickener, a filler, a binder, a humectant, a preservative, and a mixture thereof.如請求項1至18中任一項之無褪黑激素之口服產品，其中該口服產品係一液體劑型；任擇地其中該液體口服劑型具有約1 mL至約200 mL液體之一體積，任擇地其中該液體口服劑型具有約20 mL至約100 mL液體之一體積。A melatonin-free oral product as claimed in any one of claims 1 to 18, wherein the oral product is a liquid dosage form; optionally wherein the liquid oral dosage form has a volume of about 1 mL to about 200 mL of liquid, optionally wherein the liquid oral dosage form has a volume of about 20 mL to about 100 mL of liquid.如請求項1至19中任一項之無褪黑激素之口服產品，其中該口服產品進一步包含佔該口服產品之約50重量%至約99.9重量%之一量的水。The melatonin-free oral product of any one of claims 1 to 19, wherein the oral product further comprises water in an amount ranging from about 50% by weight to about 99.9% by weight of the oral product.如請求項19或請求項20之無褪黑激素之口服產品，其中該活性成分之組合包含： (i)鎂或其一鹽； (ii)至少維生素B2及維生素B6之一組合； (iii)人參； (iv)西番蓮； (v)洋甘菊萃取物；及 (vi) L-茶胺酸。An oral product without melatonin as claimed in claim 19 or claim 20, wherein the combination of active ingredients comprises:(i) magnesium or a salt thereof;(ii) a combination of at least vitamin B2 and vitamin B6;(iii) ginseng;(iv) passionflower;(v) chamomile extract; and(vi) L-theanine.如請求項1至21中任一項之無褪黑激素之口服產品，其中該口服產品係一液體劑型且包含： (i)約50 mg至約800 mg鎂或其一鹽； (ii)約0.1 mg至約10 mg之B族維生素之一組合，其中該組合包含至少維生素B2及維生素B6； (iii)約10 mg至約500 mg人參； (iv)約10 mg至約500 mg西番蓮； (v)約1 mg至約100 mg洋甘菊萃取物；及任擇地： (vi)約5 mg至約500 mg L-茶胺酸。An oral product without melatonin as claimed in any one of claims 1 to 21, wherein the oral product is a liquid dosage form and comprises:(i) about 50 mg to about 800 mg of magnesium or a salt thereof;(ii) about 0.1 mg to about 10 mg of a combination of B vitamins, wherein the combination comprises at least vitamin B2 and vitamin B6;(iii) about 10 mg to about 500 mg of ginseng;(iv) about 10 mg to about 500 mg of passionflower;(v) about 1 mg to about 100 mg of chamomile extract; and optionally:(vi) about 5 mg to about 500 mg of L-theanine.一種活性成分之組合促進人類或動物睡眠之用途，其中該活性成分之組合包含： (i)鎂或其一鹽； (ii)包含至少維生素B2及維生素B6之B族維生素之一組合； (iii)人參；及 (iv)西番蓮，且其中該活性成分之組合不含褪黑激素。A combination of active ingredients for promoting sleep in humans or animals, wherein the combination of active ingredients comprises:(i) magnesium or a salt thereof;(ii) a combination of B vitamins including at least vitamin B2 and vitamin B6;(iii) ginseng; and(iv) passion flower, and wherein the combination of active ingredients does not contain melatonin.如請求項23之用途，其中該活性成分之組合根據請求項1至22中之任一項來定義。The use of claim 23, wherein the combination of active ingredients is defined according to any one of claims 1 to 22.如請求項23或請求項24之用途，其中該促進睡眠包括誘導睡眠及維持睡眠中之至少一者。The use of claim 23 or claim 24, wherein the sleep promotion comprises at least one of inducing sleep and maintaining sleep.