JPH08245372A - Capsule agent - Google Patents
Capsule agentInfo
- Publication number
- JPH08245372A JPH08245372A JP5216895A JP5216895A JPH08245372A JP H08245372 A JPH08245372 A JP H08245372A JP 5216895 A JP5216895 A JP 5216895A JP 5216895 A JP5216895 A JP 5216895A JP H08245372 A JPH08245372 A JP H08245372A
- Authority
- JP
- Japan
- Prior art keywords
- gelatin
- acid
- agar
- capsule
- capsules
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は医薬品、食品、化粧品な
どに用いられるカプセル剤に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to capsules used for medicines, foods, cosmetics and the like.
【０００２】[0002]
【従来の技術及びその課題】一般的に、カプセル剤は内
容物質をゼラチンを基剤とする皮膜で覆うことにより形
成される。BACKGROUND OF THE INVENTION Capsules are generally formed by coating the contents with a gelatin-based coating.
【０００３】ゼラチンを基剤とすることでカプセル剤は
胃内で速やかに溶解し、内容薬物を一挙に放出するため
に薬効の発現が早く速効性に優れる。しかし薬物が胃内
で一挙に放出されることで副作用が懸念される場合や、
薬効に持続性が求められる場合には問題となる。By using gelatin as a base, the capsule is rapidly dissolved in the stomach, and the content drug is released all at once. However, if the drug is released all at once in the stomach and there are concerns about side effects,
It becomes a problem when drug efficacy is required to be persistent.
【０００４】また、ゼラチンは融点が低いため、主に軟
カプセル剤において内容物が硬化油、ロウなどの高融点
の物質にした場合には、皮膜用ゼラチンゲルフィルムが
３５℃程度で溶解してしまうためこれ以上の温度で内容
物を加温することができず、内容物に制限を受けること
や、 高温多湿下において溶解し、互いに付着したり液
漏れを起こすこと等の問題があった。Further, since gelatin has a low melting point, when the contents of the soft capsules are high melting point substances such as hardened oil and wax, the gelatin gel film for coating dissolves at about 35 ° C. Therefore, the contents cannot be heated at a temperature higher than this, and there are problems that the contents are limited, and the contents melt under high temperature and high humidity and adhere to each other or cause liquid leakage.
【０００５】さらに、ゼラチンは粘弾性が強いため、一
般にセルフカットタイプ、ツイストオフタイプなどと呼
ばれる、主に外用剤に用いられ、使用時にカプセル剤の
一部を捻り切って内容物を放出して用いる軟カプセル剤
においては、吸湿などにより軟化した場合捻り切ること
が困難であった。Further, since gelatin has a strong viscoelasticity, it is generally used as an external preparation, which is generally called a self-cut type, twist-off type, etc., and when used, twists a part of the capsule to release the contents. It has been difficult to twist the soft capsule used when it is softened by moisture absorption or the like.
【０００６】上記徐放性の問題に対しては、皮膜に寒天
や水溶性高分子を配合する技術が知られている。（特開
昭５７−３２２３０、特開昭６３−２３８０１５、特開
平２−７８６１２、特開平５−３２５４３）With respect to the above-mentioned problem of sustained release, there is known a technique of incorporating agar or a water-soluble polymer into a film. (JP-A-57-32230, JP-A-63-238015, JP-A-2-78612, JP-A-5-32543)
【０００７】[0007]
【発明が解決しようとする課題】しかし、通常カプセル
剤に用いるところのアルカリ処理ゼラチンは寒天と完全
には相溶しないために、得られたカプセル剤は必ずしも
期待したようにゼラチンと寒天の両方の性質を併せ持つ
ものとはならない。またこれらを溶解したカプセル皮膜
用の水溶液は経時的に分離してしまい、品質が一定なカ
プセル剤を連続して得ることは困難であり、上記課題を
現実的に解決するには至っていない。However, since the alkali-treated gelatin, which is usually used for capsules, is not completely compatible with agar, the obtained capsules do not always have both gelatin and agar as expected. It does not combine properties. Further, the aqueous solution for the capsule film in which these are dissolved separates with time, and it is difficult to continuously obtain capsules of constant quality, and the above problems have not been practically solved.
【０００８】さらには経時的に皮膜の不溶化を起こし徐
々に崩壊時間が延長してしまう問題があった。Further, there is a problem that the coating becomes insoluble over time and the disintegration time is gradually extended.
【０００９】本願発明は、寒天とゼラチンの本来の性質
を具備した安定な皮膜を製造することにより、寒天とゼ
ラチンの混合皮膜の上記欠点を解決するためになされた
ものである。The present invention has been made to solve the above-mentioned drawbacks of the mixed film of agar and gelatin by producing a stable film having the original properties of agar and gelatin.
【００１０】[0010]
【課題を解決するための手段】本願発明者は、通常使用
されている寒天とアルカリ処理ゼラチンについて研究を
重ね、混合するゼラチンに酸処理ゼラチン、化学修飾ゼ
ラチンまたは両者の混合物を用いること、得られたカプ
セル剤が経時的に不溶化することを防止するためにはゼ
ラチン材料のすべてまたは一部を化学修飾ゼラチンとす
ること、および有機酸、アミノ酸、還元剤等のゼラチン
不溶化防止剤を配合することが有効であることを見出し
た。本願発明に係るカプセル剤は、寒天とゼラチンが完
全に相溶し、経時的に分離せずゼラチンと寒天の両方の
特質を併せ持ったカプセル剤であって、皮膜が経時的に
崩壊時間が延長することのない、品質が一定なカプセル
剤を提供するものである。The inventor of the present invention has conducted extensive studies on commonly used agar and alkali-processed gelatin, and obtained acid-processed gelatin, chemically modified gelatin, or a mixture of both, as the gelatin to be mixed. In order to prevent the capsules from becoming insoluble over time, all or part of the gelatin material should be chemically modified gelatin, and a gelatin insolubilizer such as an organic acid, an amino acid or a reducing agent should be added. It was found to be effective. The capsule according to the present invention is a capsule in which agar and gelatin are completely compatible with each other and do not separate over time, and have the characteristics of both gelatin and agar, and the disintegration time of the film increases over time. It provides a consistent quality capsule.
【００１１】ここにいう酸処理ゼラチンとはゼラチンの
原料であるコラーゲンを希塩酸、希硫酸などの酸性物質
にて加水分解し抽出したゼラチンをいい、コラーゲンを
石灰液等のアルカリ性物質にて加水分解し抽出したアル
カリ処理ゼラチンとは異なる。通常カプセル剤において
は主に透明性の高い、着色度が少ないなどの外観上の問
題や内容薬物との反応性の問題でアルカリ処理ゼラチン
が用いられる。The acid-processed gelatin referred to herein is gelatin extracted by hydrolyzing collagen, which is a raw material of gelatin, with an acidic substance such as dilute hydrochloric acid or dilute sulfuric acid. Collagen is hydrolyzed with an alkaline substance such as lime liquid. Different from the extracted alkali-processed gelatin. Usually, in capsules, alkali-processed gelatin is mainly used because of problems in appearance such as high transparency and low degree of coloring and reactivity with content drug.
【００１２】一方、化学修飾ゼラチンとはゼラチンのア
ミノ基と種々の物質を反応させ、ゼラチンの特性を変化
させたものをいい、コハク酸、フタル酸、酢酸などで反
応させて製造したものが一般的であるがこれに限定され
ない。また化学修飾ゼラチンであれば酸処理ゼラチンで
ある必要はなくアルカリ処理ゼラチンを化学修飾したも
のも使用できる。いずれのゼラチンもその物性に特に制
限はないが従来公知のカプセル製造機で製造するために
はゼリー強度１５０〜３００ブルームのものが好まし
い。On the other hand, chemically modified gelatin refers to one obtained by reacting an amino group of gelatin with various substances to change the characteristics of gelatin, and is generally produced by reacting with succinic acid, phthalic acid, acetic acid and the like. However, the present invention is not limited to this. Further, as long as it is chemically modified gelatin, it is not necessary to use acid-treated gelatin, and alkali-modified gelatin chemically modified can be used. The physical properties of any gelatin are not particularly limited, but those having a jelly strength of 150 to 300 bloom are preferable for production with a conventionally known capsule manufacturing machine.
【００１３】化学修飾されていない酸処理ゼラチンと化
学修飾ゼラチンを混合して使用することは化学修飾ゼラ
チンが酸処理ゼラチンの場合には問題なくどのような比
率で混合することも可能であるが化学修飾ゼラチンがア
ルカリ処理ゼラチンの場合には混合する比率によっては
混合液が白濁化するために注意が必要である。この場合
の酸処理ゼラチンとアルカリ処理修飾ゼラチンの比率は
４０：６０〜６０：４０が好ましい。ただしどちらのゼ
ラチンも５０％を越えると白濁化が強くなる傾向がある
のでより好ましくは５０：５０である。When the chemically modified acid-modified gelatin and the chemically modified gelatin are mixed and used, when the chemically modified gelatin is the acid-processed gelatin, it is possible to mix them at any ratio without any problem. When the modified gelatin is an alkali-processed gelatin, care must be taken because the mixed solution becomes cloudy depending on the mixing ratio. In this case, the ratio of acid-treated gelatin to alkali-treated modified gelatin is preferably 40:60 to 60:40. However, both gelatins are more preferably 50:50 because if they exceed 50%, the white turbidity tends to be strong.
【００１４】混合する寒天の種類は特に制限がないが、
徐放性のカプセル剤のようにカプセル剤の皮膜強度が必
要な場合には、ゼリー強度４００ｇ／ｃｍ2（日寒水
式）以上の高強度の寒天が好ましく、それ以外の用途で
はゼリー強度２００ｇ／ｃｍ2以下の加水分解寒天をも
使用可能である。The type of agar to be mixed is not particularly limited,
When the film strength of the capsule is required as in the case of sustained-release capsules, high-strength agar with a jelly strength of 400 g / cm 2 (Nissha water system) or higher is preferable, and jelly strength of 200 g / Hydrolyzed agar of cm 2 or less can also be used.
【００１５】寒天とゼラチンの混合比率はその目的と用
途で適宜選択すればよく特に限定されない。例えば崩壊
性を延長させるためにはゼラチン、寒天の混合物中寒天
の比率を５％以上、徐放性のカプセル剤を得るためには
１５％以上、セルフカットタイプのカプセル剤の捻り切
り性を向上せしめるのは２０％以上、カプセル剤の加工
時または保存時の耐熱性を向上させるためには１％以
上、カプセル剤同士の付着性を防止するためには５％以
上が効果的である。The mixing ratio of agar and gelatin may be appropriately selected depending on its purpose and application and is not particularly limited. For example, the ratio of agar in the mixture of gelatin and agar is 5% or more to prolong the disintegration property, 15% or more to obtain a sustained release capsule, and the twisting property of the self-cut type capsule is improved. The effective amount is 20% or more, the effective amount is 1% or more for improving the heat resistance of the capsule during processing or storage, and the effective amount is 5% or more for preventing the adhesion between the capsules.
【００１６】ゼラチン不溶化防止剤とは、有機酸、アミ
ノ酸、還元剤などをいいゼラチンの経時的な溶解性の劣
化を防止するものであれば特に限定されない。有機酸と
して具体的にはフマル酸、酒石酸、クエン酸、塩酸など
があり、アミノ酸として具体的には、アルギニン、グリ
シン、アスパラギン酸などがある。ここにいう還元剤と
は、ゼラチンを経時的に不溶化する成分であって、寒天
中に微量含まれるガラクトース、キシロースなどの還元
糖の性質を改質する成分をいう。具体的には、ヨウ化水
素、硫化水素、二酸化硫黄、亜硫酸塩等がある。これら
の不溶化防止剤は単独または組み合わせにより有効に作
用する。配合量は配合する物質によって異なるために特
に限定できないが寒天およびゼラチン混合物の固形分重
量に対し、例えば有機酸であるクエン酸の場合は０．５
〜５％、アミノ酸であるアスパラギン酸の場合は０．５
〜４％、還元剤である亜硫酸ナトリウムの場合は０．０
５％〜１％程度が良好である。The gelatin insolubilizer is an organic acid, an amino acid, a reducing agent or the like and is not particularly limited as long as it prevents deterioration of the solubility of gelatin over time. Specific examples of the organic acid include fumaric acid, tartaric acid, citric acid and hydrochloric acid, and specific examples of the amino acid include arginine, glycine and aspartic acid. The reducing agent mentioned here is a component that insolubilizes gelatin over time, and is a component that modifies the properties of reducing sugars such as galactose and xylose contained in agar in a trace amount. Specific examples include hydrogen iodide, hydrogen sulfide, sulfur dioxide, and sulfite. These insolubilizers act effectively alone or in combination. The amount to be blended differs depending on the substances to be blended, and therefore it is not particularly limited, but is 0.5 with respect to the solid content weight of the agar and gelatin mixture, for example, in the case of citric acid which is an organic acid.
~ 5%, 0.5 for amino acid aspartic acid
~ 4%, 0.0 for reducing agent sodium sulfite
About 5% to 1% is good.
【００１７】本発明のカプセル剤は、硬カプセル、軟カ
プセル、マイクロカプセルいずれにおいても常法の製造
方法を利用することができ、各種のカプセル剤を得るこ
とができる。例えば硬カプセル製造法としての成形ピン
浸漬法、軟カプセル製造法としてのロータリー法、滴下
法、マイクロカプセル製造法としてのコアセルベーショ
ン法などが有効に使用できる。また、カプセル剤の内容
物および皮膜中には従来公知のカプセル剤と同様、可塑
剤、着色剤、防腐剤、矯味剤、乳化剤などの添加物を配
合することができる。The hard capsules, soft capsules, and microcapsules of the present invention can be manufactured by a conventional method, and various capsules can be obtained. For example, a molding pin dipping method as a hard capsule manufacturing method, a rotary method as a soft capsule manufacturing method, a dropping method, and a coacervation method as a microcapsule manufacturing method can be effectively used. Further, additives such as a plasticizer, a coloring agent, a preservative, a corrigent, and an emulsifier can be blended in the contents and the film of the capsule as in the conventionally known capsules.
【００１８】[0018]
【実施例】本発明にかかるカプセル剤のうち軟カプセル
剤について、以下に比較実験例を挙げて詳細に説明す
る。これらは本発明の一例にすぎず、これらに限定され
るものではない。EXAMPLES Among the capsules according to the present invention, soft capsules will be described in detail below with reference to comparative experimental examples. These are merely examples of the present invention and are not limited thereto.
【００１９】１．検体 表１に示すとおりの原料を混合調合して比較例１〜２、
実施例１〜６の軟カプセル皮膜用溶液を調製した。つい
で該軟カプセル皮膜用溶液をライナー社製ロータリー式
軟カプセル製造機に仕込み、内容物を流動パラフィンと
したオーバル５型（一般的に使用される楕円球型のカプ
セル剤、以下同じ）の軟カプセル剤を製造した。1. Samples The raw materials as shown in Table 1 were mixed and mixed, and Comparative Examples 1 and 2,
The solutions for soft capsule coatings of Examples 1 to 6 were prepared. Then, the solution for forming a soft capsule film was charged into a rotary type soft capsule manufacturing machine manufactured by Liner Co., and the content was liquid paraffin, and an oval 5 type (generally used elliptic sphere type capsule, the same applies hereinafter) soft capsule. The agent was manufactured.
【００２０】[0020]
【表１】各実験に供する比較例１〜２、実施例１〜６の
カプセル皮膜用溶液の配合量 ２．崩壊試験 比較例１〜２、実施例１〜６の軟カプセル皮膜用溶液を
用いて製造したカプセル剤と、同検体をガラス製サンプ
ル瓶に１０個ずつ入れ密栓して４０℃の恒温槽中で３カ
月保存したものを日本薬局方規定の崩壊試験器中に入
れ、３６℃の精製水および日本薬局方第一液（ＰＨ約
１．２）および第二液（ＰＨ約６．８）中で溶解時間を
測定した。その結果を表２に示す。[Table 1] Compounding amounts of the capsule coating solutions of Comparative Examples 1-2 and Examples 1-6 used in each experiment 2. Disintegration test Capsules prepared using the solutions for soft capsule coatings of Comparative Examples 1 and 2 and Examples 1 to 6 and 10 samples of the same sample were placed in glass sample bottles and sealed tightly in a constant temperature bath at 40 ° C. The product stored for 3 months was placed in a disintegration tester prescribed by the Japanese Pharmacopoeia, and was placed in purified water at 36 ° C. and Japanese Pharmacopoeia first liquid (PH about 1.2) and second liquid (PH about 6.8). The dissolution time was measured. The results are shown in Table 2.
【００２１】[0021]
【表２】崩壊試験の結果 表２より明らかなように、本発明によるカプセル剤は、
従来法の比較例２と寒天の配合量が同じ実施例３でも崩
壊時間の延長効果が顕著に見られ、その崩壊性はＰＨに
依存しないことがわかった。このことから、生体内のさ
まざまなＰＨの状態に左右される事なく一定の崩壊性を
発現することが示唆される。[Table 2] Results of disintegration test As is clear from Table 2, the capsule according to the present invention is
Even in Comparative Example 2 of the conventional method and Example 3 in which the amount of agar was the same, the effect of extending the disintegration time was remarkably observed, and it was found that the disintegration property does not depend on PH. From this, it is suggested that a certain degree of disintegration is exhibited without being influenced by various states of PH in the living body.
【００２２】また実施例１、２、３の実験結果よりカプ
セル剤の崩壊性は酸処理ゼラチンと寒天の配合量に依存
することが解った。よってその配合量によって崩壊時間
が任意に調節できる。また、コハク酸で化学修飾された
ゼラチンを用いた検体である、実施例４、５、アスパラ
ギン酸を配合した検体である実施例６では保存前と比べ
て保存後の経時的崩壊時間の延長は見られない。よって
生体内のＰＨに影響されず任意に崩壊時間を設定できか
つ経時的に崩壊時間が延長することのないカプセル剤を
可能とし、特に経口医薬品等としてカプセル剤に適して
いる。From the experimental results of Examples 1, 2 and 3, it was found that the disintegration property of the capsule depends on the blending amount of acid-treated gelatin and agar. Therefore, the disintegration time can be arbitrarily adjusted by the blending amount. In addition, in Examples 4 and 5 which are samples using gelatin chemically modified with succinic acid and Example 6 which is a sample containing aspartic acid, the time-dependent disintegration time after storage is longer than that before storage. can not see. Therefore, it is possible to set a disintegration time which is not influenced by PH in the living body and which does not prolong disintegration time with time, and it is particularly suitable as a capsule as an oral drug.
【００２３】３．付着試験 比較例１〜２、実施例３のカプセル剤を１０個ずつガラ
ス製サンプル瓶に入れ、瓶口を開口した状態で４０℃、
７０％ＲＨの恒温恒湿槽中で２４時間保存し、室温に戻
した後、該サンプル瓶を以下の状態にして、落下した軟
カプセル剤の個数によって各検体の付着性を判定した。3. Adhesion test Ten capsules of each of Comparative Examples 1 and 2 and Example 3 were placed in a glass sample bottle, and the bottle mouth was opened at 40 ° C.
The sample was preserved in a thermo-hygrostat of 70% RH for 24 hours and returned to room temperature, and then the sample bottle was put in the following state, and the adhesiveness of each sample was determined by the number of soft capsules that had dropped.
【００２４】（ａ）サンプル瓶を静かに逆さにする。(A) Gently invert the sample bottle.
【００２５】（ｂ）ａの試験後サンプル瓶を静かに逆さ
にして机上１ｃｍから落とす。(B) After the test of a, the sample bottle is gently inverted and dropped from 1 cm on the desk.
【００２６】（ｃ）ｂの試験後サンプル瓶を静かに逆さ
にして机上３ｃｍから落とす。(C) After the test of (b), the sample bottle is gently inverted and dropped from 3 cm on the desk.
【００２７】（ｄ）ｃの試験後サンプル瓶を静かに逆さ
にして机上５ｃｍから落とす。(D) After the test of c, the sample bottle is gently inverted and dropped from 5 cm on the desk.
【００２８】結果を表３に示す。The results are shown in Table 3.
【００２９】[0029]
【表３】付着試験の結果 表３から明らかなように本発明に係るカプセル剤は、従
来のカプセル剤に比べて高温多湿下での保存においても
カプセル剤同士が付着しにくいというカプセル剤として
優れた性質を有するものである。[Table 3] Results of adhesion test As is clear from Table 3, the capsule according to the present invention has excellent properties as a capsule, in which the capsules do not easily adhere to each other even when stored under high temperature and high humidity, as compared with the conventional capsules.
【００３０】４．セルフカットタイプカプセル剤におけ
る捻り切り試験 比較例１〜２、実施例３の軟カプセル皮膜用溶液を、金
型をオーバル５型からセルフカット型に変更したライナ
ー社製ロータリー式軟カプセル製造機に仕込み、常法に
より、内容物が流動パラフィンのセルフカットタイプカ
プセル剤を製造した。該セルフカットタイプカプセル剤
及び、同検体をガラス製サンプル瓶に１０個ずつ入れ栓
をせずに３０℃、７５％ＲＨの恒温恒湿槽中に２４時間
保存したセルフカットタイプカプセル剤について各々５
カプセルずつ首部を捻り切り、その捻り切り易さによっ
て良好３ポイント、普通２ポイント、不良１ポイントの
得点を付与する試験を５名のパネラーにより行った。結
果を表４に示す。4. Twisting Test in Self-Cut Type Capsule Preparation The soft capsule coating solutions of Comparative Examples 1 and 2 and Example 3 were charged into a liner rotary rotary capsule manufacturing machine in which the mold was changed from Oval 5 to self-cut. A self-cut type capsule containing liquid paraffin as the content was manufactured by a conventional method. Five self-cut type capsules and five self-cut type capsules were placed in glass sample bottles, each of which was stored in a thermo-hygrostat at 30 ° C. and 75% RH for 24 hours without a stopper.
The neck of each capsule was twisted off, and a test was conducted by 5 panelists to give a score of good 3 points, normal 2 points, and bad 1 point according to the ease of twisting. The results are shown in Table 4.
【００３１】[0031]
【表４】セルフカットタイプカプセル剤における捻り切
り試験に結果 表４から明らかなように本発明によるカプセル剤は従来
法のそれと比較して明らかに捻り切り性が良好でそれは
高温多湿下で保存した場合も同様に効果が確かめられ
た。[Table 4] Results of twist-off test in self-cut type capsules As is clear from Table 4, the capsule according to the present invention has a clearly better twisting property than that of the conventional method, and the same effect was confirmed when it was stored under high temperature and high humidity.
【００３２】５．加温内容物充填試験 比較例１〜２、実施例３の軟カプセル皮膜用溶液をライ
ナー社製ロータリー式軟カプセル製造機に仕込み、内容
物をナタネ部分硬化油（融点４０℃）の加温融解物（温
度５０℃）として、オーバル５型の軟カプセル剤を製造
した後、目視で該カプセル剤２０個を観察し、不良を調
べた。結果を表５に示す。5. Warming Content Filling Test The solutions for soft capsule coatings of Comparative Examples 1 and 2 and Example 3 were placed in a rotary soft capsule manufacturing machine manufactured by Liner Co., and the contents were heated and melted with rapeseed partially hardened oil (melting point 40 ° C.). After manufacturing Oval 5 type soft capsules as a product (temperature: 50 ° C.), 20 capsules were visually observed to examine defects. The results are shown in Table 5.
【００３３】[0033]
【表５】加温内容物充填試験の結果 表５から明らかなとおり本発明のカプセル剤によれば従
来法では不可能であった高温に保たれた内容物でも、変
形や液漏れなどを起こすことなくカプセル加工が可能で
あった。[Table 5] Results of heated contents filling test As is clear from Table 5, according to the capsule of the present invention, even the contents kept at a high temperature, which was impossible by the conventional method, could be processed into capsules without causing deformation or liquid leakage.
【００３４】[0034]
【発明の効果】このように本願発明は、従来困難であっ
た寒天とゼラチンを完全に混合せしめたカプセル皮膜用
溶液を調整可能とし、寒天とゼラチンの双方の性質を十
分に併せ持った安定なカプセル剤であって、ゼラチンと
寒天との配合量によって任意の崩壊性を与えることはも
とより、ゼラチン、寒天の各々の特徴を任意に調節し希
望の性質を有するカプセル剤を提供することができる。INDUSTRIAL APPLICABILITY As described above, the present invention makes it possible to prepare a capsule coating solution in which agar and gelatin are completely mixed, which has been difficult in the past, and it is possible to prepare a stable capsule having properties of both agar and gelatin. It is possible to provide a capsule having desired properties by arbitrarily controlling the respective characteristics of gelatin and agar, as well as imparting an arbitrary disintegrating property depending on the blending amount of gelatin and agar.
【００３５】従って、任意に薬効の持続性を付与し、加
温内容物にも適応できる耐高温多湿性の軟カプセル剤の
実現を可能とした。Therefore, it has become possible to realize a high temperature and high humidity resistant soft capsule which is capable of arbitrarily imparting a sustained effect and adapted to a heated content.
【００３６】セルフカットタイプカプセル剤においても
寒天の脆さとゼラチンの粘弾性を併せ持つために良好な
捻り切り性を得ることができ、このタイプのカプセル剤
の利便性を向上させるものである。Even in the self-cutting type capsule, since the agar has the brittleness and the viscoelasticity of gelatin, good twisting property can be obtained, and the convenience of this type of capsule is improved.
【００３７】また経時的にその崩壊性が一定で品質が変
化しにくいという特徴を有するため、内容物の用途、目
的に対し最適の崩壊性を設定することができる。Further, since the disintegration property is constant over time and the quality is unlikely to change, the optimum disintegration property can be set for the intended use and purpose of the contents.
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ａ６１Ｋ 47/36 Ａ６１Ｋ 47/36 Ｄ 47/42 47/42 Ｄ //(Ａ６１Ｋ 47/36 47:42） ─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. 6 Identification code Internal reference number FI Technical display location A61K 47/36 A61K 47/36 D 47/42 47/42 D // (A61K 47/36 47: 42)
Claims (9)
てなるカプセル剤1. A capsule comprising acid-processed gelatin and agar as a film base.
してなるカプセル剤2. A capsule comprising chemically modified gelatin and agar as a film base.
びに寒天を皮膜基剤としてなるカプセル剤3. A capsule comprising acid-treated gelatin, chemically modified gelatin, and agar as a film base.
コハク酸、フタル酸、酢酸の内から選ばれた１種類以上
を反応させて得られた酸処理またはアルカリ処理ゼラチ
ンである請求項２、または請求項３のカプセル剤4. The chemically modified gelatin is an acid-treated or alkali-treated gelatin obtained by reacting the amino group of gelatin with one or more selected from succinic acid, phthalic acid and acetic acid. Capsule according to claim 3
請求項１から４のカプセル剤5. The capsule according to claim 1, wherein a gelatin insolubilizer is added to the film base.
項５のカプセル剤6. The capsule according to claim 5, wherein the gelatin insolubilizing agent is an organic acid.
求項５のカプセル剤7. The capsule according to claim 5, wherein the gelatin insolubilizing agent is an amino acid.
項５のカプセル剤8. The capsule according to claim 5, wherein the gelatin insolubilizing agent is a reducing agent.
の一部を捻り切り内容物を放出させて用いる請求項１か
ら８のカプセル剤9. The capsule preparation according to claim 1, which is mainly used as an external preparation and is used by twisting a part of the film to release the content when used.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP05216895A JP3493563B2 (en) | 1995-03-13 | 1995-03-13 | Capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP05216895A JP3493563B2 (en) | 1995-03-13 | 1995-03-13 | Capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH08245372A true JPH08245372A (en) | 1996-09-24 |
| JP3493563B2 JP3493563B2 (en) | 2004-02-03 |
Family
ID=12907305
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP05216895A Expired - Fee Related JP3493563B2 (en) | 1995-03-13 | 1995-03-13 | Capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3493563B2 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002326030A (en) * | 2001-05-02 | 2002-11-12 | Ogawa & Co Ltd | Method for preventing crosslinking of coating film of noncrosslinked gelatin capsule |
| JP2003192578A (en) * | 2001-12-27 | 2003-07-09 | Nonogawa Shoji Kk | Soft capsule |
| JP2006328044A (en) * | 2004-07-30 | 2006-12-07 | Wakunaga Pharmaceut Co Ltd | Composition for gelatin film, composition for capsule film, capsule film, capsular preparation using the same, and method for producing the capsular preparation |
| CN104812256A (en) * | 2013-04-15 | 2015-07-29 | 三生医药株式会社 | Disintegrable capsule, manufacturing method for same, and smoking equipment containing disintegrable capsule |
-
1995
- 1995-03-13 JP JP05216895A patent/JP3493563B2/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002326030A (en) * | 2001-05-02 | 2002-11-12 | Ogawa & Co Ltd | Method for preventing crosslinking of coating film of noncrosslinked gelatin capsule |
| JP2003192578A (en) * | 2001-12-27 | 2003-07-09 | Nonogawa Shoji Kk | Soft capsule |
| JP2006328044A (en) * | 2004-07-30 | 2006-12-07 | Wakunaga Pharmaceut Co Ltd | Composition for gelatin film, composition for capsule film, capsule film, capsular preparation using the same, and method for producing the capsular preparation |
| CN104812256A (en) * | 2013-04-15 | 2015-07-29 | 三生医药株式会社 | Disintegrable capsule, manufacturing method for same, and smoking equipment containing disintegrable capsule |
| US10015984B2 (en) | 2013-04-15 | 2018-07-10 | Sunsho Pharmaceutical Co., Ltd. | Disintegrable capsule, manufacturing method for same, and smoking device containing said disintegrable capsule |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3493563B2 (en) | 2004-02-03 |
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