【発明の詳細な説明】 産業上の利用分野 本発明は糖衣被覆錠剤に関し、詳しくは経時的な崩壊遅
延、着色あるいはひび割れ等を防止することのできるき
わめて安定なカラギーナン含有糖衣被覆錠剤に関するも
のである。TECHNICAL FIELD The present invention relates to a sugar-coated tablet, and more particularly to an extremely stable carrageenan-containing sugar-coated tablet capable of preventing disintegration delay, coloration, cracking or the like over time. .
従来技術 通常、糖衣被覆錠剤は、コーティングパン中で回転して
いる芯物質に適当な結合剤を含有する糖衣液と、タル
ク、炭酸カルシウム、酸化チタン等の散布剤及びビタミ
ンＢ１、ビタミンＣ等の活性物質を交互に施す方法ある
いはそれらの物質を一つにした糖衣懸濁液により糖衣を
施す方法により製造されている。2. Description of the Related Art Generally, sugar-coated tablets include a sugar-coating liquid containing a binder suitable for a core substance rotating in a coating pan, a spraying agent such as talc, calcium carbonate and titanium oxide, and vitamin B1 and vitamin C. It is manufactured by a method of applying the active substances alternately or by a method of applying a sugar coating with a suspension of sugar coating containing these substances as one.
上記の方法に於いて用いられる結合剤は衝撃強度を維持
あるいは増大させ、芯物質と糖衣被覆層との間の結合力
を高めるために添加されるものであり、一般にゼラチ
ン、アラビアゴム末、でんぷん等の天然高分子、ポリビ
ニルピロリドン(PVP)、ポリビニルアルコール（PVA）、
ポリエチレングリコール（PEG）等の合成高分子化合物
等が使用される。The binder used in the above method is added in order to maintain or increase impact strength and enhance the binding force between the core substance and the sugar coating layer. Generally, gelatin, gum arabic powder and starch are used. Natural polymers such as polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA),
A synthetic polymer compound such as polyethylene glycol (PEG) is used.
発明が解決しようとする問題点 上記の結合剤には種々の問題点が存在し、たとえばゼラ
チンは経時的に崩壊遅延をきたし、アラビアゴム末、で
んぷんは強度が充分でないため衝撃や温度変化に対して
ひびの発生率が高くなる。またPVP は色素との相互作用
があり、PVA はコーティングパンがあれ易く、パンから
はがれた被覆物質が芯物質につぶ状に付着し易く、また
PEG は不快な味がある等、いずれも満足できるものでは
ない。Problems to be Solved by the Invention There are various problems in the above-mentioned binder, for example, gelatin causes a delayed disintegration with time, and gum arabic powder and starch have insufficient strength, so that they are resistant to impact and temperature change. The incidence of cracks increases. In addition, PVP interacts with the pigment, PVA easily causes the coating pan to peel, and the coating material peeled off from the pan easily adheres to the core material in a crushed form.
PEG has an unpleasant taste and is not satisfactory.
問題を解決するための手段 本発明者等は鋭意研究を行った結果、結合剤としてカラ
ギーナンを使用すると上記の如き欠点を排除でき、した
がって重量変動が少なく、表面が平滑で、しかも機械的
強度が大であり、崩壊遅延、変色等の経時変化を伴わな
い良質な糖衣被覆が可能であることを見出した。Means for Solving the Problem As a result of intensive studies by the present inventors, the use of carrageenan as a binder can eliminate the above-mentioned drawbacks, and therefore the weight fluctuation is small, the surface is smooth, and the mechanical strength is low. It has been found that a large amount of sugar coating is possible, which is large and does not cause deterioration with time, such as disintegration delay and discoloration.
すなわち、本発明はガラギーナン含有糖衣被覆液にて被
覆を施した糖衣被覆錠剤に存する。That is, the present invention resides in a sugar-coated tablet which is coated with a galrageenan-containing sugar coating solution.
本発明に於いて用いられるカラギーナンはエーキューマ
（Eucheuma）、コンドラス（Chondrus)、イリダイヤ（I
ridaea）、ギガルティーナ（Gigartina）等の紅藻類よ
り抽出される天然多糖類（カッパ、イオタ、ラムダ）で
あり、ガラクトース、３，６−アンヒドロラクトースお
よびその硫酸エステルからなるものである。またその抽
出法についてはドラムドライ法、ゲルプレス法、アルコ
ール沈澱法等があるが、本発明においてはいずれの方法
によるカラギーナンでも自由に使用できる。Carrageenan used in the present invention is Eucheuma, Chondrus, Iridia (I
ridaea), Gigartina, and other natural algae extracted from red algae (kappa, iota, lambda), and consist of galactose, 3,6-anhydrolactose and its sulfate ester. The extraction method includes a drum dry method, a gel press method, an alcohol precipitation method and the like, but in the present invention, carrageenan by any method can be used freely.
本発明においてはカッパ、イオタ、ラムダカラギーナン
のいずれでも使用でき、一種または二種以上の混合物が
使用されるが、好ましくはイオタカラギーナンの比率が
１０〜１００重量％のカラギーナンが適している。In the present invention, any of kappa, iota and lambda carrageenan can be used, and one kind or a mixture of two or more kinds is used. Preferably, carrageenan having a ratio of iota carrageenan of 10 to 100% by weight is suitable.
結合剤使用時のショ糖とカラギーナンの濃度はショ糖３
０〜９０重量％、カラギーナン０．０１〜３重量％、好
ましくはショ糖４０〜７０重量％、カラギーナン０．１
〜１重量％である。なお、通常の結合剤、色素、散布
剤、活性物質等周知の物質を添加することは当然ながら
可能である。The concentration of sucrose and carrageenan when using the binder is sucrose 3
0-90% by weight, carrageenan 0.01-3% by weight, preferably sucrose 40-70% by weight, carrageenan 0.1
~ 1% by weight. In addition, it is naturally possible to add well-known substances such as ordinary binders, pigments, dusting agents and active substances.
糖衣工程は通常の方法により行なうことができ、得られ
た製剤は耐衝撃性にとみ、経時的な崩壊遅延、着色もき
わめて少ない。またまたカラギーナンは水、温水に可溶
なため調製も容易であり、散布剤、活性物質等を添加し
た糖衣懸濁液は分散性がよく、効率的に糖衣を施こすこ
とができる。The sugar coating step can be carried out by a usual method, and the obtained preparation has high impact resistance, delay of disintegration with time, and extremely little coloration. Further, carrageenan is soluble in water and warm water, so that it is easy to prepare, and a sugar coating suspension containing a spraying agent, an active substance and the like has good dispersibility and can be efficiently coated with sugar.
実施例 以下に実施例を示し本発明をさらに詳細に説明するが、
本発明はこれにより何ら限定されるものではない。EXAMPLES The present invention will be described in more detail below with reference to Examples.
The present invention is not limited thereby.
実施例１ カラギーナンMV-201（イオタ） （三菱アセテート株式会社製）０．５重量％ ショ糖 ４５．０ 〃 炭酸カルシウム ２０．０ 〃 酸化チタン ５．０ 〃 精製水 ２９．５ 〃 上記組成の糖衣懸濁液を調製し、直径約３０cmのコーテ
ィングパンに錠径８．０mm、１８０mg／Tの錠剤約８０
０ｇを入れ、パンを回転させながら上記糖衣被覆液約１
５ｇを注加し、液が十分に行きわたったら温風を送り入
んで乾燥する。この操作を繰り返し行った後、常法の操
作により１錠約２８０mgの白色の光沢のある糖衣被覆錠
剤が得られた。Example 1 Carrageenan MV-201 (Iota) (manufactured by Mitsubishi Acetate Co., Ltd.) 0.5 wt% sucrose 45.0 〃 calcium carbonate 20.0 〃 titanium oxide 5.0 〃 purified water 29.5 〃 sugar coating of the above composition A suspension was prepared, and a coating pan with a diameter of about 30 cm had a tablet diameter of 8.0 mm and 180 mg / T tablets about 80.
Add 0 g and rotate the pan to rotate the sugar coating solution above about 1
5 g is added, and when the liquid is sufficiently spread, warm air is blown in to dry. After repeating this procedure, a white coated glossy sugar-coated tablet (about 280 mg per tablet) was obtained by a conventional procedure.
この剤について硬度、衝撃試験、苛酷条件下での崩壊時
間および外観変化について試験を行った。結果は第１，
２，３および４表に示す通りであった。This agent was tested for hardness, impact test, disintegration time under severe conditions and appearance change. The result is the first
The results are shown in Tables 2, 3 and 4.
硬度は木屋式錠剤硬度計により糖衣層にひびが発生する
時の圧力を測定して求めた（第１表）。The hardness was determined by measuring the pressure when a crack was generated in the sugar coating layer using a Kiya type tablet hardness meter (Table 1).
衝撃試験はフライアビレーターを使用し、１回の試験に
錠剤２０錠を１５分間回転させた時に発生する欠けと、
ひび割れ発生錠数を測定した（第１表）。The impact test uses a fly aviator, and a chip that occurs when 20 tablets are rotated for 15 minutes in one test,
The number of cracked tablets was measured (Table 1).
崩壊時間の変化は、製造直後、ガラスびん中に５０℃で
３０日および６０日、６０℃で３０日保管後の崩壊時間
を常法により求めた（第２表）。The change in the disintegration time was determined by a conventional method immediately after the production, after the disintegration time was stored in a glass bottle at 50 ° C. for 30 days and 60 days and at 60 ° C. for 30 days (Table 2).
苛酷条件下での外観変化については、糖衣被覆錠剤をガ
ラスびんに入れ、５０℃で３０日および６０日、６０℃
で１５日および３０日保管した時のかつ変度を試験した
（第３表）。Regarding the appearance change under severe conditions, put sugar-coated tablets in a glass bottle, and at 50 ° C for 30 days and 60 days at 60 ° C.
And stored for 15 and 30 days and tested for variability (Table 3).
なお、さらにPTP 包装したものを４０℃、７５％RH で
１５日および３０日保管した時のひび割れを観察した
（第４表）。Further, cracks were observed when the PTP-packaged product was stored at 40 ° C. and 75% RH for 15 days and 30 days (Table 4).
比較例１ アラビアゴム末 １．０重量％ ゼラチン １．０ 〃 ショ糖 ４５．０ 〃 炭酸カルシウム ２０．０ 〃 酸化チタン ５．０ 〃 精製水 ２８．０ 〃 上記組成の糖衣懸濁液を調製し、実施例１と同様にして
糖衣被覆錠剤を得、この剤について硬度、衝撃試験、苛
酷条件下での崩壊時間および外観変化について試験を行
った。結果は第１，２，３および４表に示す通りであっ
た。Comparative Example 1 Gum arabic powder 1.0 wt% Gelatin 1.0 〃 Sucrose 45.0 〃 Calcium carbonate 20.0 〃 Titanium oxide 5.0 〃 Purified water 28.0 〃 A sugar coating suspension having the above composition was prepared. A sugar-coated tablet was obtained in the same manner as in Example 1. This agent was tested for hardness, impact test, disintegration time under severe conditions and appearance change. The results were as shown in Tables 1, 2, 3 and 4.
実施例２ カラギーナンMV-201（イオタ） （三菱アセテート株式会社製）０．２重量％ ショ糖 ４３．５ 〃 タルク ５．０ 〃 酸化チタン ２．０重量％ 無水リン酸水素カルシウム ２０．０ 〃 精製水 ２９．３ 〃 上記組成の糖衣懸濁液を用いて、実施例１と同様に白色
の光沢のある糖衣被覆錠剤を得、硬度の測定、衝撃試験
および崩壊時間の測定を行った。結果は第５および６表
に示す通りであった。 Example 2 Carrageenan MV-201 (Iota) (manufactured by Mitsubishi Acetate Co., Ltd.) 0.2 wt% sucrose 43.5 〃 talc 5.0 〃 titanium oxide 2.0 wt% anhydrous calcium hydrogen phosphate 20.0 〃 Purification Water 29.3 〃 Using the sugar-coated suspension having the above composition, white glossy sugar-coated tablets were obtained in the same manner as in Example 1, and the hardness, impact test and disintegration time were measured. The results were as shown in Tables 5 and 6.
比較例２ 実施例２のカラギーナンの替わりにアラビアゴム末１．
０重量％、ゼラチン１．０重量％を含有する糖衣懸濁液
で被覆した糖衣被覆錠剤を得、実施例２と同様の測定を
行った。結果は第５および６表に示す通りであった。Comparative Example 2 Instead of the carrageenan of Example 2, gum arabic powder 1.
A sugar-coated tablet coated with a sugar-coated suspension containing 0% by weight and 1.0% by weight of gelatin was obtained, and the same measurement as in Example 2 was performed. The results were as shown in Tables 5 and 6.
実施例３ 散布剤処方 炭酸カルシウム ８０．０重量％ タルク １５．０ 〃 酸化チタン ５．０ 〃 糖衣液処方 カラギーナンMV-201（イオタ） （三菱アセテート株式会社製）０．４ 〃 カラギーナンMV-101（カッパ） （三菱アセテート株式会社製）０．１ 〃 ショ糖 ６０．０ 〃 精製水 ３９．５ 〃 上記組成の散布剤および糖衣液をそれぞれ調製し、直径
約３０cmのコーティングパンに錠径8.0 mm、１８０mg／
T の錠剤約６００ｇを入れ、パンを回転しつつ糖衣液約
１５ｇを注加し、該液が十分錠剤をうるおした時、散布
液約３０ｇを加えて十分錠剤にいきわたった後、温風を
送って乾燥する。この操作を繰り返して行なった後、常
法により１錠約３００mgの白色の光沢のある糖衣被覆錠
剤を得、重量偏差、硬度の測定、衝撃試験、外観変化
（かつ変およびひび割れ）の測定を行った。結果は第
７，８および９表に示す通りであった。 Example 3 Spreading agent formulation Calcium carbonate 80.0% by weight Talc 15.0 〃 Titanium oxide 5.0 〃 Sugar coating liquid formulation Carrageenan MV-201 (Iota) (manufactured by Mitsubishi Acetate Co., Ltd.) 0.4 〃 Carrageenan MV-101 ( Kappa) (manufactured by Mitsubishi Acetate Co., Ltd.) 0.1〃 sucrose 60.0〃 purified water 39.5〃 Prepare a spraying agent and sugar coating solution having the above composition, and put a coating pan of about 30 cm in diameter and a tablet diameter of 8.0 mm, 180 mg /
Approximately 600 g of T tablets are put, about 15 g of sugar coating liquid is added while rotating the pan, and when the liquid is sufficiently moisturized, about 30 g of spraying liquid is added and thoroughly spread on the tablets, and then warm air is blown. To dry. After repeating this operation, a white glossy sugar-coated tablet (about 300 mg per tablet) was obtained by a conventional method, and weight deviation, hardness measurement, impact test, and appearance change (and change and cracking) were measured. It was The results were as shown in Tables 7, 8 and 9.
比較例３ 実施例３の両カラギーナンの替りにアラビアゴム末１．
０重量％、ゼラチン１．０重量％を含有した糖衣液を用
いる以外は実施例３と同様にして糖衣被覆錠剤を得、実
施例３と同様の測定を行った。結果は第７，８および９
表に示す通りであった。Comparative Example 3 Instead of both carrageenans of Example 3, gum arabic powder 1.
A sugar-coated tablet was obtained in the same manner as in Example 3 except that a sugar coating solution containing 0% by weight and 1.0% by weight of gelatin was used, and the same measurement as in Example 3 was performed. Results are 7, 8 and 9
It was as shown in the table.
発明の効果 各実施例および各比較例より明らかな如く、本発明によ
るカラギーナン含有糖衣被覆錠剤は、従来の糖衣被覆錠
剤に比しその糖衣の硬度、耐衝撃性にすぐれ、崩壊時間
が短かく、かつ変およびひび割れが少なく、糖衣被覆錠
剤としてきわめてすぐれたものである。 EFFECTS OF THE INVENTION As is clear from each example and each comparative example, the carrageenan-containing sugar-coated tablet according to the present invention has excellent sugar coating hardness, impact resistance, and short disintegration time as compared with a conventional sugar-coated tablet. Moreover, there is little change or cracking, and it is an excellent sugar-coated tablet.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP25094685AJPH0662400B2 (en) | 1985-11-11 | 1985-11-11 | Sugar-coated tablets |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP25094685AJPH0662400B2 (en) | 1985-11-11 | 1985-11-11 | Sugar-coated tablets |
| Publication Number | Publication Date |
|---|---|
| JPS62111917A JPS62111917A (en) | 1987-05-22 |
| JPH0662400B2true JPH0662400B2 (en) | 1994-08-17 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP25094685AExpired - LifetimeJPH0662400B2 (en) | 1985-11-11 | 1985-11-11 | Sugar-coated tablets |
| Country | Link |
|---|---|
| JP (1) | JPH0662400B2 (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6932861B2 (en) | 2000-11-28 | 2005-08-23 | Fmc Corporation | Edible PGA coating composition |
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| AU1195001A (en)* | 1999-10-11 | 2001-04-23 | Monsanto Company | Tablets coated with locust bean gum, guar gum or carrageenan gum |
| JP4759905B2 (en)* | 2002-09-10 | 2011-08-31 | 大正製薬株式会社 | Dragees |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6932861B2 (en) | 2000-11-28 | 2005-08-23 | Fmc Corporation | Edible PGA coating composition |
| Publication number | Publication date |
|---|---|
| JPS62111917A (en) | 1987-05-22 |
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