技术领域technical field
本发明涉及一种复方莪术油凝胶剂及其制备方法，用于治疗阴道炎、宫颈糜烂等症的药物新剂型，具体地说是将原中国药典收载的复方莪术油栓剂改变为凝胶剂及该制剂的制备方法。The invention relates to a compound curcuma oil gel and a preparation method thereof, which is a new drug dosage form for treating vaginitis, cervical erosion and other diseases, specifically, the compound curcuma oil suppository recorded in the original Chinese Pharmacopoeia is changed into a gel agent and its preparation method.
背景技术Background technique
妇女阴道炎、宫颈糜烂等症是常见病、多发病，给患者带来了诸多痛苦，严重影响了广大妇女的身体健康。目前较常使用的治疗方法和使用的药物之一是用莪术油制成的复方莪术油栓剂。但莪术油本身具有易挥发、有臭味的性质，使其在存放过程中由于挥发或氧化分解而使疗效减失，而且其难闻的臭味也给患者带来了不便，同时栓剂融化后易流出，产生外溢。Women's vaginitis, cervical erosion and other diseases are commonly encountered diseases and frequently-occurring diseases, which have brought a lot of misery to patients and seriously affected the health of women in general. One of the more commonly used treatment method and the medicine used at present is the compound curcuma oil suppository made with Zedoary oil. But zedoary oil itself has the property of being volatile and smelly, so that its curative effect will be lost due to volatilization or oxidative decomposition during storage, and its unpleasant smell has also brought inconvenience to patients. Easy to flow out, resulting in overflow.
发明内容Contents of the invention
本发明所要解决的技术问题是针对现有技术中的上述不足之处，提供一种治疗广泛，见效快，既治标又治本，长期存放药效不减失且无难闻气味的复方莪术油凝胶剂及其制备方法。The technical problem to be solved by the present invention is to provide a compound zedoary oil congealed with extensive treatment, quick effect, both temporary and permanent cure, long-term storage without loss of efficacy and no unpleasant smell. Glue and its preparation method.
解决本发明技术问题所采用的技术方案是该复方莪术油凝胶剂在1000g的制剂中，药物成分包括：The technical solution adopted to solve the technical problems of the present invention is that the compound curcuma oil gel is in the preparation of 1000g, and the medicinal ingredients include:
硝酸益康唑 12.5gEconazole Nitrate 12.5g
莪术油 52.5mlCurcuma Oil 52.5ml
凝胶基质 1～30gGel base 1～30g
凝胶基质为卡波普、羧甲基纤维素钠(CMC-Na)、海藻酸钠中的一种或几种的混合凝胶基质。The gel matrix is one or a mixed gel matrix of carbopol, sodium carboxymethylcellulose (CMC-Na) and sodium alginate.
本发明提供的复方莪术油凝胶剂成分中还包括氢氧化钠、丙二醇、乙醇、聚山梨酯-80、山梨酸、焦亚硫酸钠、维生素E和去离子水，因此，本发明复方莪术油凝胶剂1000g的制剂中，成分配比范围为：Also include sodium hydroxide, propylene glycol, ethanol, polysorbate-80, sorbic acid, sodium pyrosulfite, vitamin E and deionized water in the composition of compound curcuma oil gel provided by the invention, therefore, compound curcuma oil gel of the present invention In the preparation of 1000g of dosage, the proportion range of ingredients is:
硝酸益康唑 12.5gEconazole Nitrate 12.5g
莪术油 52.5mlCurcuma Oil 52.5ml
凝胶基质 1～30gGel base 1～30g
氢氧化钠 0～4gSodium hydroxide 0～4g
丙二醇 10～50gPropylene glycol 10～50g
乙醇 20～100gEthanol 20～100g
聚山梨酯-80 10～50gPolysorbate-80 10～50g
山梨酸 1～4gSorbic acid 1～4g
焦亚硫酸钠 0.5～2gSodium metabisulfite 0.5～2g
维生素E 0.5-2gVitamin E 0.5-2g
去离子水 加至全量Deionized water Add to full amount
制成1000g，可分装于250只药用铝管中，每只4g。Made into 1000g, it can be divided into 250 medicinal aluminum tubes, each 4g.
上述组分中，辅料：氢氧化钠为pH调节剂，如果不调则凝胶不成型；丙二醇为增溶剂，保湿剂；乙醇为增溶剂，基质分散剂；聚山梨酯-80为乳化剂；山梨酸为防腐剂；焦亚硫酸钠为抗氧化剂；维生素E为抗氧化剂；去离子水为基质溶胀物质。Among the above components, excipients: sodium hydroxide is a pH regulator, if it is not adjusted, the gel will not form; propylene glycol is a solubilizer and a moisturizing agent; ethanol is a solubilizer and a matrix dispersant; polysorbate-80 is an emulsifier; Sorbic acid is a preservative; sodium metabisulfite is an antioxidant; vitamin E is an antioxidant; deionized water is a matrix swelling substance.
本发明复方莪术油凝胶剂的制备方法包括以下步骤：The preparation method of compound curcuma oil gel of the present invention comprises the following steps:
1、取配比量的凝胶基质，用丙二醇湿润，加适量蒸馏水，使充分溶胀，或加入用适量蒸馏水溶解的氢氧化钠，搅拌均匀，得无色透明凝胶基质；1. Take a proportioned amount of gel matrix, moisten it with propylene glycol, add an appropriate amount of distilled water to fully swell, or add sodium hydroxide dissolved in an appropriate amount of distilled water, and stir evenly to obtain a colorless and transparent gel matrix;
2、取配比量的莪术油，加入乙醇，混匀，再加入到用适量蒸馏水溶解的聚山梨酯-80溶液中，搅拌，使之乳化成乳白色的O/W型乳液；2. Take the proportioned amount of zedoary oil, add ethanol, mix well, then add it to the polysorbate-80 solution dissolved in an appropriate amount of distilled water, stir to make it emulsify into a milky white O/W emulsion;
3、取配比量的山梨酸、维生素E用乙醇溶解，焦亚硫酸钠用水溶解；3. Dissolve the proportioned amount of sorbic acid and vitamin E with ethanol, and dissolve sodium metabisulfite with water;
4、配比量的硝酸益康唑研细过80目筛；4. The proportioned amount of econazole nitrate is finely ground and passed through an 80-mesh sieve;
5、分别将2、3、4步骤所得物加入到步骤1的凝胶基质中，加蒸馏水至1000g，搅拌；5. Add the results of steps 2, 3, and 4 to the gel matrix in step 1, add distilled water to 1000g, and stir;
6、放置10-36小时使充分溶胀，搅拌均匀，分装，即得。6. Leave it for 10-36 hours to fully swell, stir evenly, and pack it separately.
本发明采用中西药结合的方式，以莪术油、硝酸益康唑等为主要成分，配合以其他辅料，制成凝胶剂。丙二醇为保湿剂，同时也为脂溶性成分的增溶剂、稳定剂；乙醇为脂溶性成分的增溶剂、乳化剂，也有利于凝胶剂形成，同时也是防腐剂；聚山梨酯-80为脂溶性成分的增溶剂，也是莪术油成乳的乳化剂；山梨酸为防腐剂；氢氧化钠起调节pH、调节凝胶稠度作用；焦亚硫酸钠、维生素E为抗氧剂，防止莪术油氧化变质；去离子水分散药物及基质，便于药物溶解及基质溶胀。与原制剂栓剂相比，制剂稳定，疗效高，无不良气味，方便使用，与子宫或阴道粘膜产生生物粘附，能使凝胶剂粘附于腔道内，在阴道内滞留性好，因此药物作用时间长，无刺激性、无异物感，药物因生物粘附性材料的作用而不易流出，无栓剂外溢产生，增强了疗效，同时，这些生物粘附材料在体内均能生物降解，无残留和毒副作用，方便使用，因而增强了疗效及患者依从性。同时，本发明采用乳化工艺对处方中莪术油进行乳化处理，增加了莪术油稳定性，减少了莪术油难闻的臭味，对阴道炎、宫颈糜烂等疾病的外用治疗，是一种很好的剂型。The invention adopts the method of combining Chinese and western medicines, uses zedoary oil, econazole nitrate, etc. as main components, and other auxiliary materials to prepare the gel. Propylene glycol is a humectant, but also a solubilizer and stabilizer for fat-soluble ingredients; ethanol is a solubilizer and emulsifier for fat-soluble ingredients, which is also conducive to the formation of gels and is also a preservative; polysorbate-80 is a fat The solubilizer of soluble components is also the emulsifier of zedoary oil into milk; sorbic acid is a preservative; sodium hydroxide can adjust pH and gel consistency; sodium metabisulfite and vitamin E are antioxidants to prevent zedoary oil from oxidative deterioration; Deionized water disperses the drug and the matrix to facilitate the dissolution of the drug and the swelling of the matrix. Compared with the original preparation suppository, the preparation is stable, has high curative effect, no bad smell, is convenient to use, and produces bioadhesion with the uterus or vaginal mucosa, which can make the gel adhere to the cavity and have good retention in the vagina. Therefore, the drug Long action time, no irritation, no foreign body sensation, the drug is not easy to flow out due to the action of bioadhesive materials, no suppository overflow occurs, and the curative effect is enhanced. At the same time, these bioadhesive materials can be biodegraded in the body without residue And toxic side effects, easy to use, thus enhancing the curative effect and patient compliance. Simultaneously, the present invention adopts the emulsification process to carry out emulsification treatment to the zedoary oil in the prescription, which increases the stability of the zedoary oil, reduces the unpleasant smell of the zedoary oil, and is a good external treatment for diseases such as vaginitis and cervical erosion. dosage form.
具体实施方式Detailed ways
本发明复方莪术油凝胶剂选用不同的凝胶基质时，1000g的制剂中，其凝胶基质用量分别为：一种凝胶基质单独使用时：卡波普为1～20g，羧甲基纤维素钠(CMC-Na)为10～30g，海藻酸钠为10～30g；两种凝胶基质混合使用时：如卡波普1～5g与CMC-Na5～15g。When the compound curcuma oil gel of the present invention selects different gel bases, in the preparation of 1000g, the dosage of the gel base is respectively: when a gel base is used alone: Carbopol is 1～20g, carboxymethyl fiber Sodium plain (CMC-Na) is 10-30g, and sodium alginate is 10-30g; when the two gel bases are used in combination: such as Carbopol 1-5g and CMC-Na 5-15g.
以下是本发明的非限定实施例：The following are non-limiting examples of the invention:
实施例1：Example 1:
每1000克复方莪术油凝胶剂制剂，按下列配方称取物料：Every 1000 grams of compound curcuma oil gel preparation, weigh materials according to the following formula:
硝酸益康唑 12.5gEconazole Nitrate 12.5g
莪术油 52.5mlCurcuma Oil 52.5ml
卡波普 15gCarbopol 15g
氢氧化钠 3gSodium Hydroxide 3g
丙二醇 25gPropylene Glycol 25g
乙醇 50gEthanol 50g
聚山梨酯-80 25gPolysorbate-80 25g
山梨酸 2gSorbic acid 2g
焦亚硫酸钠 0.5gSodium metabisulfite 0.5g
维生素E 0.5gVitamin E 0.5g
去离子水 加至全量Deionized water Add to full amount
将称取的原料按以下步骤制备本发明复方莪术油凝胶剂：Prepare the compound curcuma oil gel of the present invention by weighing the raw materials according to the following steps:
1、取卡波普，用丙二醇湿润，加适量蒸馏水，使充分溶胀，加入用适量蒸馏水溶解的氢氧化钠，搅拌均匀，得无色透明卡波普基质；1. Take Carbopol, moisten it with propylene glycol, add an appropriate amount of distilled water to fully swell, add sodium hydroxide dissolved in an appropriate amount of distilled water, and stir evenly to obtain a colorless and transparent Carbopol matrix;
2、取配比量的莪术油，加入乙醇，混匀，再加入到用适量蒸馏水溶解的聚山梨酯-80溶液中，搅拌，使之乳化成乳白色的O/W型乳液；2. Take the proportioned amount of zedoary oil, add ethanol, mix well, then add it to the polysorbate-80 solution dissolved in an appropriate amount of distilled water, stir to make it emulsify into a milky white O/W emulsion;
3、取配比量的山梨酸、维生素E用乙醇溶解，焦亚硫酸钠用水溶解；3. Dissolve the proportioned amount of sorbic acid and vitamin E with ethanol, and dissolve sodium metabisulfite with water;
4、硝酸益康唑研细过80目筛；4. Grind econazole nitrate and pass through an 80-mesh sieve;
5、分别将2、3、4步骤所得物加入到步骤1的凝胶基质中，加蒸馏水至1000g，搅拌，放置24小时使充分溶胀，搅拌，使均匀，制成1000g，可分装于250只药用铝管中，每只4g，即得。5. Add the results of steps 2, 3, and 4 to the gel matrix in step 1, add distilled water to 1000g, stir, let it sit for 24 hours to fully swell, stir to make it uniform, and make 1000g, which can be divided into 250 Only medicinal aluminum tube, each 4g, that is.
实施例2Example 2
每1000克复方莪术油凝胶剂制剂，按下列配方称取物料：Every 1000 grams of compound curcuma oil gel preparation, weigh materials according to the following formula:
硝酸益康唑 12.5gEconazole Nitrate 12.5g
莪术油 52.5mlCurcuma Oil 52.5ml
CMC-Na 30gCMC-Na 30g
丙二醇 25gPropylene Glycol 25g
乙醇 50gEthanol 50g
聚山梨酯-80 50gPolysorbate-80 50g
山梨酸 1gSorbic acid 1g
焦亚硫酸钠 1gSodium metabisulfite 1g
维生素E 0.5gVitamin E 0.5g
去离子水 加至全量Deionized water Add to full amount
将称取的原料按以下步骤制备本发明复方莪术油凝胶剂：Prepare the compound curcuma oil gel of the present invention by weighing the raw materials according to the following steps:
1、取CMC-Na，用丙二醇湿润，加适量蒸馏水，使充分溶胀，搅拌均匀，得无色透明羧甲基纤维素钠基质；1. Take CMC-Na, moisten it with propylene glycol, add an appropriate amount of distilled water to make it fully swell, and stir evenly to obtain a colorless and transparent sodium carboxymethyl cellulose matrix;
2、取配比量的莪术油，加入乙醇，混匀，再加入到用适量蒸馏水溶解的聚山梨酯-80溶液中，搅拌，使之乳化成乳白色的O/W型乳液；2. Take the proportioned amount of zedoary oil, add ethanol, mix well, then add it to the polysorbate-80 solution dissolved in an appropriate amount of distilled water, stir to make it emulsify into a milky white O/W emulsion;
3、取配比量的山梨酸、维生素E用乙醇溶解，焦亚硫酸钠用水溶解；3. Dissolve the proportioned amount of sorbic acid and vitamin E with ethanol, and dissolve sodium metabisulfite with water;
4、硝酸益康唑研细过80目筛；4. Grind econazole nitrate and pass through an 80-mesh sieve;
5、分别将2、3、4步骤所得物加入到上述CMC-Na基质中，加适量蒸馏水至1000g，搅拌，放置24小时使充分溶胀，搅拌，使均匀，制成1000g，可分装于250只药用铝管中，每只4g，即得。5. Add the results of steps 2, 3, and 4 to the above CMC-Na matrix, add an appropriate amount of distilled water to 1000g, stir, let it stand for 24 hours to fully swell, stir to make it uniform, and make 1000g, which can be divided into 250 Only medicinal aluminum tube, each 4g, that is.
实施例3Example 3
每1000克复方莪术油凝胶剂制剂，按下列配方称取物料：Every 1000 grams of compound curcuma oil gel preparation, weigh materials according to the following formula:
硝酸益康唑 12.5gEconazole Nitrate 12.5g
莪术油 52.5mlCurcuma Oil 52.5ml
海藻酸钠 20gSodium alginate 20g
丙二醇 25gPropylene Glycol 25g
乙醇 50gEthanol 50g
聚山梨酯-80 20gPolysorbate-80 20g
山梨酸 1.5gSorbic acid 1.5g
焦亚硫酸钠 1.5gSodium metabisulfite 1.5g
维生素E 0.5gVitamin E 0.5g
去离子水 加至全量Deionized water Add to full amount
将称取的原料按以下步骤制备本发明复方莪术油凝胶剂：Prepare the compound curcuma oil gel of the present invention by weighing the raw materials according to the following steps:
1、取海藻酸钠，用丙二醇湿润，加适量水，使充分溶胀，搅拌均匀，得无色透明海藻酸钠基质；1. Take sodium alginate, moisten it with propylene glycol, add appropriate amount of water to fully swell, stir evenly, and obtain a colorless and transparent sodium alginate matrix;
2、取配比量的莪术油，加入乙醇，混匀，再加入到用适量蒸馏水溶解的聚山梨酯-80溶液中，搅拌，使之乳化成乳白色的O/W型乳液；2. Take the proportioned amount of zedoary oil, add ethanol, mix well, then add it to the polysorbate-80 solution dissolved in an appropriate amount of distilled water, stir to make it emulsify into a milky white O/W emulsion;
3、取配比量的山梨酸、维生素E用乙醇溶解，焦亚硫酸钠用水溶解；3. Dissolve the proportioned amount of sorbic acid and vitamin E with ethanol, and dissolve sodium metabisulfite with water;
4、硝酸益康唑研细过80目筛；4. Grind econazole nitrate and pass through an 80-mesh sieve;
5、分别将2、3、4步骤所得物加入到上述CMC-Na基质中，加适量蒸馏水至1000g，搅拌，放置24小时使充分溶胀，搅拌，使均匀，制成1000g，可分装于250只药用铝管中，每只4g，即得。5. Add the results of steps 2, 3, and 4 to the above CMC-Na matrix, add an appropriate amount of distilled water to 1000g, stir, let it stand for 24 hours to fully swell, stir to make it uniform, and make 1000g, which can be divided into 250 Only medicinal aluminum tube, each 4g, that is.
实施例4Example 4
每1000克复方莪术油凝胶剂制剂，按下列配方称取物料：Every 1000 grams of compound curcuma oil gel preparation, weigh materials according to the following formula:
硝酸益康唑 12.5gEconazole Nitrate 12.5g
莪术油 52.5mlCurcuma Oil 52.5ml
卡波普 2gCarbopol 2g
CMC-Na 10gCMC-Na 10g
氢氧化钠 2gSodium Hydroxide 2g
丙二醇 25gPropylene Glycol 25g
乙醇 50gEthanol 50g
聚山梨酯-80 50gPolysorbate-80 50g
山梨酸 3gSorbic acid 3g
焦亚硫酸钠 0.5gSodium metabisulfite 0.5g
维生素E 0.5gVitamin E 0.5g
去离子水 加至全量Deionized water Add to full amount
将称取的原料按以下步骤制备本发明复方莪术油凝胶剂：Prepare the compound curcuma oil gel of the present invention by weighing the raw materials according to the following steps:
1、取卡波普、CMC-Na，用丙二醇湿润，加适量水，使充分溶胀，加入用适量蒸馏水溶解的氢氧化钠，搅拌均匀，得无色透明基质；1. Take Carbopol and CMC-Na, moisten it with propylene glycol, add appropriate amount of water to fully swell, add sodium hydroxide dissolved in appropriate amount of distilled water, stir evenly, and obtain a colorless and transparent matrix;
2、取配比量的莪术油，加入乙醇，混匀，再加入到用适量蒸馏水溶解的聚山梨酯-80溶液中，搅拌，使之乳化成乳白色的O/W型乳液；2. Take the proportioned amount of zedoary oil, add ethanol, mix well, then add it to the polysorbate-80 solution dissolved in an appropriate amount of distilled water, stir to make it emulsify into a milky white O/W emulsion;
3、取配比量的山梨酸、维生素E用乙醇溶解，焦亚硫酸钠用水溶解；3. Dissolve the proportioned amount of sorbic acid and vitamin E with ethanol, and dissolve sodium metabisulfite with water;
4、硝酸益康唑研细过80目筛；4. Grind econazole nitrate and pass through an 80-mesh sieve;
5、分别将2、3、4步骤所得物加入到上述CMC-Na基质中，加适量蒸馏水至1000g，搅拌，放置24小时使充分溶胀，搅拌，使均匀，制成1000g，可分装于250只药用铝管中，每只4g，即得。5. Add the results of steps 2, 3, and 4 to the above CMC-Na matrix, add an appropriate amount of distilled water to 1000g, stir, let it stand for 24 hours to fully swell, stir to make it uniform, and make 1000g, which can be divided into 250 Only medicinal aluminum tube, each 4g, that is.
| Application Number | Priority Date | Filing Date | Title |
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| CN 200510031138CN1803185A (en) | 2005-01-12 | 2005-01-12 | Compound zedoary turmeric oil gelata and its preparing method |
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| CN 200510031138CN1803185A (en) | 2005-01-12 | 2005-01-12 | Compound zedoary turmeric oil gelata and its preparing method |
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| CN1803185Atrue CN1803185A (en) | 2006-07-19 |
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| CN 200510031138PendingCN1803185A (en) | 2005-01-12 | 2005-01-12 | Compound zedoary turmeric oil gelata and its preparing method |
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| GB2445818A (en)* | 2006-09-15 | 2008-07-23 | Japan Atomic Energy Agency | Preparation of gels derived from carboxymethyl cellulose alkali metal salt |
| GB2445818B (en)* | 2006-09-15 | 2011-03-09 | Japan Atomic Energy Agency | Preparation of gels derived from carboxymethyl cellulose alkali metal salt |
| CN101157760B (en)* | 2006-09-15 | 2012-03-21 | 独立行政法人日本原子力研究开发机构 | Preparation of gel derived from alkali metal salt of carboxymethyl cellulose |
| CN102824598A (en)* | 2012-06-18 | 2012-12-19 | 韩昌志 | Compound Rhizoma Curcumae oil effervescent ointment, and preparation method and use method thereof |
| CN104224923A (en)* | 2014-07-07 | 2014-12-24 | 海南华拓天涯制药有限公司 | Tea tree essential oil antimicrobial gel for treating vaginal disease in gynecology |
| CN109453439A (en)* | 2019-01-22 | 2019-03-12 | 郑州乐迪生物科技有限公司 | A kind of mucosa protective agent and preparation method thereof for domestic animal artificial insemination |
| CN109453439B (en)* | 2019-01-22 | 2021-05-14 | 郑州乐迪生物科技有限公司 | Mucous membrane protective agent for artificial insemination of livestock and preparation method thereof |
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