JP2000044465A - Soft capsule agent - Google Patents
Soft capsule agentInfo
- Publication number
- JP2000044465A JP2000044465A JP11146245A JP14624599A JP2000044465A JP 2000044465 A JP2000044465 A JP 2000044465A JP 11146245 A JP11146245 A JP 11146245A JP 14624599 A JP14624599 A JP 14624599A JP 2000044465 A JP2000044465 A JP 2000044465A
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- Prior art keywords
- starch
- capsule
- soft capsule
- soft
- polyglucose
- 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.)
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Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は軟カプセル剤に関す
る。TECHNICAL FIELD The present invention relates to a soft capsule.
【０００２】[0002]
【従来の技術】従来、軟カプセル剤の皮膜成分として、
ゼラチン分子中のアミノ基を有機酸で修飾した修飾ゼラ
チンを基剤とするものが、特開昭55-106876 、特開昭55
-106877 で提案されている。この修飾ゼラチンを皮膜成
分の基剤とする軟カプセル剤にあっては、経口投与の医
用軟カプセル剤、健康食品用軟カプセル剤等においてそ
の投与時の皮膜の溶解時間を短くして溶解性（崩壊性）
を向上でき、浴用軟カプセル剤、口中清涼用軟カプセル
剤等においてカプセルの内容物に特にアルデヒド系物質
を含むような場合の投与持の皮膜の溶解性を保存中に悪
くすることを回避する不溶化防止性を向上できる。2. Description of the Related Art Conventionally, as a film component of a soft capsule,
Those based on a modified gelatin obtained by modifying an amino group in a gelatin molecule with an organic acid are disclosed in JP-A-55-106876 and JP-A-55-106876.
-106877. In the case of soft capsules containing this modified gelatin as the base of the film component, the dissolution time of the film at the time of its administration is shortened in oral soft medical capsules, health food soft capsules, etc. Disintegrable)
Insolubilization to prevent deterioration of the solubility of the coating film during storage when the contents of capsules particularly contain aldehyde-based substances in soft capsules for bathing, soft capsules for refreshing in the mouth, etc. Prevention can be improved.
【０００３】[0003]
【発明が解決しようとする課題】然しながら、修飾ゼラ
チンを皮膜成分の基剤とする軟カプセル剤にあっては、
以下の問題点がある。However, in a soft capsule containing modified gelatin as a base of a film component,
There are the following problems.
【０００４】カプセル剤を多湿な環境下においた場合
や、可塑剤であるグリセリンを多く入れた場合等に、カ
プセル剤の表面がべとつき、カプセル剤相互の付着や容
器との付着を生じ易い。When the capsules are placed in a humid environment or when a large amount of glycerin as a plasticizer is added, the surface of the capsules becomes sticky, and the capsules tend to adhere to each other or to the container.
【０００５】カプセル剤の内容物に特にポリエチレン
グリコールやプロピレングリコール、他の水溶性物質を
含んでいる場合等に、カプセル剤の製造工程の乾燥中も
しくは保存中にカプセル剤の皮膜に凹み等の変形を生
じ、皮膜強度を低下する虞れがある。[0005] When the content of a capsule contains polyethylene glycol, propylene glycol, or other water-soluble substances in particular, during drying or storage in the manufacturing process of the capsule, deformation of the capsule such as dents occurs. May occur and the film strength may be reduced.
【０００６】カプセル剤の保存中に、皮膜が褐色に変
色し、或いは内容物が光の照射により退色する。[0006] During storage of the capsule, the film turns brown or the contents fade due to light irradiation.
【０００７】本発明の課題は、軟カプセル剤において、
皮膜の溶解性と不溶化防止性を向上しながら、カプセル
剤相互もしくは容器との付着性を向上し、皮膜の変形を
防止し、皮膜の変色と内容物の退色を防止することにあ
る。An object of the present invention is to provide a soft capsule,
An object of the present invention is to improve the adhesiveness between capsules or containers while preventing the dissolution and insolubility of the coating, and to prevent the deformation of the coating, to prevent the discoloration of the coating and the fading of the contents.
【０００８】[0008]
【課題を解決するための手段】請求項１に記載の本発明
は、軟カプセル剤の皮膜成分として、ゼラチン分子中の
アミノ基を有機酸で修飾した修飾ゼラチンと、ポリグル
コース及びこれらの誘導体・加工物から選択される１種
以上とを含有するようにしたものである。Means for Solving the Problems The present invention according to claim 1 provides, as a film component of a soft capsule, a modified gelatin obtained by modifying an amino group in a gelatin molecule with an organic acid, polyglucose and derivatives thereof. And one or more selected from processed products.
【０００９】請求項２に記載の本発明は、請求項１に記
載の本発明において更に、ポリグルコースが澱粉である
ようにしたものである。According to a second aspect of the present invention, in the first aspect of the present invention, the polyglucose is starch.
【００１０】請求項３に記載の本発明は、請求項２に記
載の本発明において更に、澱粉が、コーンスターチ、米
澱粉、馬鈴薯澱粉、小麦澱粉、タピオカ澱粉、ワキシー
スターチのいずれか１以上であるようにしたものであ
る。[0010] According to a third aspect of the present invention, in the second aspect, the starch is any one or more of corn starch, rice starch, potato starch, wheat starch, tapioca starch, and waxy starch. It is like that.
【００１１】請求項４に記載の本発明は、請求項１〜３
のいずれかに記載の本発明において更に、ポリグルコー
スの加工物が、前記澱粉を水と共に加熱して得られる、
当該澱粉の一部又は全部をα化したものである。The present invention described in claim 4 is the first to third aspects of the present invention.
Further in the present invention according to any of the above, a processed product of polyglucose is obtained by heating the starch with water,
A part or all of the starch is pregelatinized.
【００１２】請求項５に記載の本発明は、請求項１に記
載の本発明において更に、ポリグルコースがセルロース
であるようにしたものである。According to a fifth aspect of the present invention, in the first aspect of the present invention, the polyglucose is cellulose.
【００１３】請求項６に記載の本発明は、請求項１〜５
のいずれかに記載の本発明において更に、修飾ゼラチン
がコハク酸ゼラチンであるようにしたものである。The present invention described in claim 6 provides the invention according to claims 1 to 5
In the present invention described in any of the above, the modified gelatin is succinic gelatin.
【００１４】[0014]
【作用】請求項１〜６の本発明によれば、下記〜の
作用がある。 軟カプセル剤の皮膜成分に含んだ修飾ゼラチンが、経
口投与の医用軟カプセル剤、健康食品用軟カプセル剤等
においてその投与時の皮膜の溶解時間を短くして溶解性
（崩壊性）を向上する。According to the present invention, there are the following functions. The modified gelatin contained in the film component of the soft capsule improves the solubility (disintegration) by shortening the dissolution time of the film at the time of administration in orally administered medical soft capsules and health food soft capsules. .
【００１５】軟カプセル剤の皮膜成分に含んだ修飾ゼ
ラチンが、浴用軟カプセル剤、口中清涼用軟カプセル剤
等においてカプセル内容物に特にアルデヒド系の物質を
含むような場合の使用時の皮膜の溶けにくさを回避する
不溶化防止性を向上する。[0015] When the modified gelatin contained in the film component of the soft capsule is used in a case where the content of the capsule particularly contains an aldehyde-based substance in a soft capsule for bathing, a soft capsule for refreshing in the mouth, etc., dissolution of the film when used. Improves the insolubilization prevention property of avoiding difficulties.
【００１６】軟カプセル剤の皮膜成分に含んだポリグ
ルコースが、カプセル剤を多湿な環境下においた場合
や、可塑剤であるグリセリンを多く入れた場合等に、カ
プセル剤の表面のべとつきを防止し、カプセル剤相互の
付着や容器との付着を防止する。The polyglucose contained in the film component of the soft capsule prevents the surface of the capsule from sticking when the capsule is placed in a humid environment or when a large amount of glycerin as a plasticizer is added. To prevent capsules from adhering to each other and to containers.
【００１７】軟カプセル剤の皮膜成分に含んだポリグ
ルコースが、カプセル剤の内容物に特にポリエチレング
リコールやプロピレングリコール、他の水溶性物質を含
んでいる場合等に、カプセル剤の製造工程の乾燥中もし
くは保存中にカプセル剤の皮膜に凹み等の変形が生ずる
ことを防止する。In the case where the polyglucose contained in the film component of the soft capsule contains, in particular, polyethylene glycol, propylene glycol or other water-soluble substances in the content of the capsule, for example, during the drying of the capsule manufacturing process. Alternatively, deformation of the capsule film such as dents during storage is prevented.
【００１８】軟カプセル剤の皮膜成分に含んだ修飾ゼ
ラチンが皮膜の不溶化を防止するとともに皮膜の褐色へ
の変色を防止する。同時に、軟カプセル剤の皮膜成分に
含んだポリグルコースが照射光を拡散させて内容物の退
色を防止する。The modified gelatin contained in the film component of the soft capsule prevents the film from being insolubilized and also prevents the film from discoloring to brown. At the same time, the polyglucose contained in the film component of the soft capsule diffuses the irradiation light to prevent the contents from fading.
【００１９】[0019]
【実施例】実施例１〜４として、それぞれ下記の如く
に、皮膜液と内容液を調製し、これらをカプセル充填機
により軟カプセル剤とした。EXAMPLES In Examples 1 to 4, a coating solution and a content solution were prepared as described below, and these were made into soft capsules by a capsule filling machine.
【００２０】 （実施例(1) ）（ビタミンＡＤＥ軟カプセル剤） １．皮膜液の調製 コハク酸ゼラチン 100 重量部 グリセリン 40 重量部 セキセル（旭フーズ（株）製）（※） 10 重量部 精製水 適量 （※）セキセルはセルロースと澱粉の混合物 上記各原料を65℃にて加熱溶解・分散させた後脱泡し
て、60℃における粘度が約30,000cPとなるように皮膜液
を調製した。Example (1) (Vitamin ADE Soft Capsule) Preparation of coating solution Gelatin succinate 100 parts by weight Glycerin 40 parts by weight Sexel (manufactured by Asahi Foods Co., Ltd.) (*) 10 parts by weight Purified water qs (*) Sexel is a mixture of cellulose and starch at 65 ° C After being dissolved and dispersed by heating, the mixture was defoamed to prepare a coating liquid so that the viscosity at 60 ° C. was about 30,000 cP.
【００２１】 ２．内容液の調製 ビタミンＥオイル 50 mg ビタミンＡＤオイル 2 mg 小麦胚芽油 198 mg[0021] 2. Preparation of content liquid Vitamin E oil 50 mg Vitamin AD oil 2 mg Wheat germ oil 198 mg
【００２２】３．カプセル充填 １、２で得られた皮膜液及び内容液を、ロータリー式カ
プセル充填機（例：特公昭61-12698、特開平5-51315 に
記載の装置）を用いて軟カプセルとし、長径約13mm、短
径約8mm 、内容量250mg のフットボール型（ＯＶＡＬ5
）のビタミンＡＤＥ含有軟カプセル剤を得た。3. Capsule filling The coating liquid and the contents liquid obtained in the steps 1 and 2 were converted into soft capsules using a rotary capsule filling machine (for example, a device described in JP-B-61-12698, JP-A-5-51315). , Football type (OVAL5)
) A soft capsule containing vitamin ADE was obtained.
【００２３】 （実施例(2) ）（カプセル入浴剤） １．皮膜液の調製 コハク酸ゼラチン 100 重量部 グリセリン 40 重量部 コーンスターチ 10 重量部 精製水 適量 上記各原料を65℃にて加熱溶解・分散させた後脱泡し
て、60℃における粘度が約30,000cPとなるように皮膜液
を調製した。(Example (2)) (Capsule bath agent) Preparation of coating solution Gelatin succinate 100 parts by weight Glycerin 40 parts by weight Corn starch 10 parts by weight Purified water Appropriate amount After heating and dissolving and dispersing each of the above ingredients at 65 ° C, defoaming, the viscosity at 60 ° C is about 30,000 cP. Thus, a coating solution was prepared.
【００２４】 ２．内容液の調製 流動パラフィン 55 ％ ミリスチン酸イソプロピル 20 ％ ＰＯＥソルビタンジオレート 15 ％ 水溶性色素（法定色素赤色 2号） 微量 精製水 少量（ 5％以下） ラベンダー香料（アルデヒド含有） 適量 Ｌ−メントール 5 ％ スクワラン 5 ％ 上記各原料を撹拌溶解して内容液を調製した。[0024] 2. Preparation of liquid contents Liquid paraffin 55% Isopropyl myristate 20% POE sorbitandiolate 15% Water-soluble dye (legal dye red No. 2) Trace amount Purified water Small amount (5% or less) Lavender flavor (containing aldehyde) L-menthol 5% Squalane 5% The above materials were stirred and dissolved to prepare a content solution.
【００２５】３．カプセル充填 １、２で得られた皮膜液及び内容液を、ロータリー式カ
プセル充填機（例：特公昭61-12698、特開平5-51315 に
記載の装置）を用いて軟カプセルとし、直径約2.5cm 、
内容量7,000mg（ＲＯＵＮＤ160）のカプセル入浴剤を得
た。3. Capsule filling The coating liquid and the contents liquid obtained in the steps 1 and 2 were converted into soft capsules using a rotary capsule filling machine (for example, a device described in JP-B-61-12698, and JP-A-5-51315), and a diameter of about 2.5 cm ,
A capsule bath with a content of 7,000 mg (ROUND 160) was obtained.
【００２６】 （実施例(3)）（口中清涼用シームレスカプセル） １．皮膜液の調製 コハク酸ゼラチン 100 重量部 グリセリン 25 重量部 Ｄ−ソルビトール液（70％） 15 重量部 コーンスターチ 5 重量部 精製水 適量 上記各原料を70℃にて加熱しながら撹拌を続け、60℃に
おける粘度が約70cPになるように皮膜液を調製した。(Example (3)) (Seamless capsule for refreshing the mouth) Preparation of coating solution Gelatin succinate 100 parts by weight Glycerin 25 parts by weight D-sorbitol solution (70%) 15 parts by weight Corn starch 5 parts by weight Purified water Appropriate amount Continue stirring at 70 ° C while heating each of the above ingredients at 70 ° C. A coating solution was prepared so as to have a viscosity of about 70 cP.
【００２７】 ２．内容液の調製 レモンライム香料（アルデヒド含有） 70 ％ Ｌ−メントール 10 ％ 基剤油（ＭＣＴ；中鎖脂肪酸トリグリセリド等） 20 ％ 上記各原料を撹拌溶解し、内容液を得た。[0027] 2. Preparation of Content Liquid Lemon-lime flavor (containing aldehyde) 70% L-menthol 10% Base oil (MCT; medium-chain fatty acid triglyceride, etc.) 20% Each of the above raw materials was stirred and dissolved to obtain a content liquid.
【００２８】３．カプセル充填 １、２で得られた皮膜液及び内容液を用い、滴下式シー
ムレスカプセル充填機（例：特公昭36-3700 記載の装
置）にてカプセル化し、直径 4mmφ、内容量30mgの口中
清涼用シームレスカプセルを得た。3. Capsule filling Using the coating liquid and contents liquid obtained in 1 and 2, it is encapsulated with a drip-type seamless capsule filling machine (eg: the device described in Japanese Patent Publication No. 36-3700) and used for cooling in the mouth with a diameter of 4 mmφ and a content of 30 mg. A seamless capsule was obtained.
【００２９】（実施例(4) ） １．皮膜液の調製 実施例(2) と同様の皮膜液を使用(Embodiment (4)) Preparation of coating liquid Use the same coating liquid as in Example (2).
【００３０】 ２．内容液の調製 ポリエチレングリコール400 360mg 精製水 40mg 上記各原料を撹拌溶解して、内容液を調製した。[0030] 2. Preparation of Content Solution Polyethylene glycol 400 360 mg Purified water 40 mg The above-mentioned raw materials were stirred and dissolved to prepare a content solution.
【００３１】３．カプセル充填 １、２で得られた皮膜液及び内容液を、ロータリー式カ
プセル充填機（例：特公昭61-12698、特開平5-51315 に
記載の装置）を用いて軟カプセルとし、長径18mm、短径
7mm 、内容量400mg （ＯＢＬＯＮＧ8 ）の軟カプセル剤
（プラセボ）を得た。比較例１−(1) 〜(4) 、比較例２
−(1) 〜(4) 、比較例３−(1) 〜(4) として、表１の軟
カプセル剤を製造した。3. Capsule filling The coating liquid and the contents liquid obtained in 1 and 2 were converted into soft capsules using a rotary capsule filling machine (for example, an apparatus described in JP-B-61-12698, JP-A-5-51315). Minor axis
A soft capsule (placebo) having a size of 7 mm and a content of 400 mg (OBLONG8) was obtained. Comparative Examples 1- (1) to (4), Comparative Example 2
-(1) to (4) and Comparative Examples 3- (1) to (4), soft capsules shown in Table 1 were produced.
【００３２】[0032]
【表１】 [Table 1]
【００３３】実施例１〜４、比較例１−(1) 〜(4) 、比
較例２−(1) 〜(4) 、比較例３−(1) 〜(4) の軟カプセ
ル剤について評価し、以下の結果を得た。The soft capsules of Examples 1-4, Comparative Examples 1- (1)-(4), Comparative Examples 2- (1)-(4) and Comparative Examples 3- (1)-(4) were evaluated. Then, the following results were obtained.
【００３４】崩壊試験Disintegration test
【表２】 [Table 2]
【００３５】表２の崩壊試験結果によれば、本発明の実
施例(1) にあっては、軟カプセル剤の皮膜成分に含んだ
修飾ゼラチンが、経口投与の医用軟カプセル剤等におい
てその投与時の皮膜の溶解時間を短くして溶解性（崩壊
性）を向上することが認められる。According to the disintegration test results shown in Table 2, in Example (1) of the present invention, the modified gelatin contained in the film component of the soft capsule was administered in the oral soft medical capsule and the like. It is recognized that the dissolution time of the film at the time is shortened to improve the solubility (disintegration).
【００３６】溶解試験Dissolution test
【表３】 [Table 3]
【００３７】表３の溶解試験結果によれば、本発明の実
施例(2) 、(3) にあっては、軟カプセル剤の皮膜成分に
含んだ修飾ゼラチンが、浴用軟カプセル剤、口中清涼剤
用軟カプセル剤等においてカプセル内容物に特にアルデ
ヒド系の物質を含むような場合の投与持の皮膜の溶解性
を保存中に悪くすることを回避する不溶化防止性を向上
することが認められる。According to the results of the dissolution test shown in Table 3, in Examples (2) and (3) of the present invention, the modified gelatin contained in the film component of the soft capsule was replaced with the soft capsule for bath and the refreshing in the mouth. In soft capsules and the like, it has been found that the insolubilization preventing property for avoiding the deterioration of the solubility of the coating film during storage when the contents of the capsule particularly contain an aldehyde-based substance is improved.
【００３８】付着試験Adhesion test
【表４】 [Table 4]
【００３９】表４の付着試験結果によれば、本発明の実
施例(1) 、(2) 、(3) にあっては、軟カプセル剤の皮膜
成分に含んだポリグルコース（澱粉やセルロース等の上
位概念）が、カプセル剤を多湿な環境下においた場合
や、可塑剤であるグリセリンを多く入れた場合等に、カ
プセル剤の表面のべとつきを防止し、カプセル剤相互の
付着や容器との付着を防止することが認められる。According to the adhesion test results in Table 4, in Examples (1), (2) and (3) of the present invention, polyglucose (starch, cellulose, etc.) contained in the film component of the soft capsule was used. When the capsule is placed in a humid environment, or when a large amount of glycerin, which is a plasticizer, is used, the sticky surface of the capsule is prevented, and the capsules adhere to each other or adhere to the container. It is noted that adhesion is prevented.
【００４０】変形試験Deformation test
【表５】 [Table 5]
【００４１】表５の変形試験結果によれば、本発明の実
施例(4) にあっては、軟カプセル剤の皮膜成分に含んだ
ポリグルコースが、カプセル剤の内容物に特にポリエチ
レングリコールやプロピレングリコール、他の水溶性物
質を含んでいる場合等に、カプセル剤の製造工程の乾燥
中もしくは保存中にカプセル剤の皮膜に凹み等の変形が
生ずることを防止することが認められる。According to the deformation test results shown in Table 5, in Example (4) of the present invention, polyglucose contained in the film component of the soft capsule was added to the contents of the capsule, especially polyethylene glycol or propylene. When glycol or other water-soluble substances are contained, it is recognized that the capsule film is prevented from being deformed such as dents during drying or storage in the capsule manufacturing process.
【００４２】耐光試験 室内にて蛍光灯の光を１日当たり10時間、40日間に渡っ
て照射した。その前後の実施例(2) 及び比較例１−(2)
〜３−(2) の各カプセルの外観を観察結果を示す。Light resistance test The room was irradiated with light from a fluorescent lamp for 10 hours per day for 40 days in a room. Example (2) before and after that and Comparative Example 1- (2)
The results of observation of the appearance of each capsule of (3)-(2) are shown.
【００４３】[0043]
【表６】 [Table 6]
【００４４】表６の耐光試験結果によれば、本発明の実
施例(2) にあっては、軟カプセル剤の皮膜成分に含んだ
修飾ゼラチンが皮膜の不溶化を防止するとともに皮膜の
褐色への変色を防止する。同時に、軟カプセル剤の皮膜
成分に含んだポリグルコースが照射光を拡散させて内容
物の退色を防止することが認められる。According to the results of the light resistance test shown in Table 6, in Example (2) of the present invention, the modified gelatin contained in the film component of the soft capsule prevents the film from being insolubilized and changes the color of the film to brown. Prevents discoloration. At the same time, it is recognized that the polyglucose contained in the film component of the soft capsule diffuses the irradiation light to prevent discoloration of the contents.
【００４５】本発明における澱粉の配合量の適正範囲、
採用できる澱粉の種類、α化澱粉等の適用性を調査すべ
く、実施例Ａ（Ａ1、Ａ2）、Ｂ（Ｂ1〜Ｂ4）、Ｃ（Ｃ1
〜Ｃ3）、Ｄ（Ｄ1〜Ｄ3）により、皮膜液を調製し、こ
の皮膜液を用いた軟カプセル剤を製造し、それらの各実
施例で得た軟カプセル剤の付着防止効果を官能検査（手
で触った感触）を行ない、表１１の評価結果を得た。The proper range of the amount of starch in the present invention,
Examples A (A1, A2), B (B1 to B4), C (C1) were used to investigate the types of starch that can be used and the applicability of pregelatinized starch.
To C3) and D (D1 to D3) to prepare a coating solution, produce soft capsules using the coating solution, and carry out a sensory test on the effect of preventing the soft capsules obtained in each of the examples from adhering. Touch feeling by hand) was performed, and the evaluation results in Table 11 were obtained.
【００４６】（実施例Ａ）、（表７、表１１） 実施例Ａ（Ａ1、Ａ2）は、本発明の軟カプセル剤の皮膜
成分として用いられる澱粉の適正配合量について、コー
ンスターチを澱粉の代表例として確認した。(Example A), (Tables 7 and 11) In Example A (A1, A2), corn starch was used as a representative of starch to determine the proper amount of starch used as a film component of the soft capsule of the present invention. Confirmed as an example.
【００４７】この結果、澱粉の配合量は、コハク酸ゼラ
チンに対し重量比で少なくとも2〜100％とするとき、本
発明の作用効果を維持でき、適正となることが認められ
る。As a result, it is recognized that the action and effect of the present invention can be maintained when the amount of the starch is at least 2 to 100% by weight relative to the gelatin succinate, and the starch becomes appropriate.
【００４８】[0048]
【表７】 [Table 7]
【００４９】（実施例Ｂ）（表８、表１１、表１２） 実施例Ｂ（Ｂ1〜Ｂ4）は、本発明に適用できる澱粉の種
類の拡張について確認した。(Example B) (Table 8, Table 11, Table 12) In Example B (B1 to B4), the types of starch applicable to the present invention were confirmed to be expanded.
【００５０】この結果、澱粉としては、コーンスターチ
に限らず、米澱粉、馬鈴薯澱粉、タピオカ澱粉、ワキシ
ースターチを採用できる。また、小麦澱粉も採用でき
る。これらの各種澱粉を採用したとき、本発明の作用効
果を維持できる。As a result, the starch is not limited to corn starch, but may be rice starch, potato starch, tapioca starch, or waxy starch. Also, wheat starch can be employed. When these various starches are employed, the effects of the present invention can be maintained.
【００５１】[0051]
【表８】 [Table 8]
【００５２】尚、本発明に採用できる各種澱粉の組成、
粒径を示せば表１２の通りである。ここで、コーンスタ
ーチはうるち種とうもろこしを原料とし、ワキシー（コ
ーン）スターチはもち種とうもろこしを原料とするもの
である。The composition of various starches that can be used in the present invention,
Table 12 shows the particle size. Here, corn starch is a raw material of rice corn and waxy (corn) starch is a material of rice corn.
【００５３】（実施例Ｃ）（表９、表１１） 実施例Ｃ（Ｃ1〜Ｃ3）は、各種澱粉（実施例Ｃではコー
ンスターチを用いた）を全部又は部分的にα化した澱粉
である、α化澱粉と部分α化澱粉の本発明への適用性を
確認した。(Example C) (Tables 9 and 11) Example C (C1 to C3) is a starch obtained by fully or partially pregelatinizing various starches (corn starch was used in Example C). The applicability of pregelatinized starch and partially pregelatinized starch to the present invention was confirmed.
【００５４】尚、「α化澱粉」「部分α化澱粉」は、澱
粉を水と共に加熱して、全部又は一部をα化した後、こ
れを乾燥して得られる粉末状又は粒状のものであり、当
該状態で市販されている。そして、澱粉のα化とは、澱
粉を水と共に加熱することにより糊状のゾル溶液とし、
澱粉を変性させることである。The "pregelatinized starch" and the "partially pregelatinized starch" are powdery or granular materials obtained by heating starch together with water to partially or partially gelatinize the starch and then drying it. Yes, it is commercially available in that state. And the pregelatinization of starch is to make starch-like sol solution by heating starch with water,
It is to modify starch.
【００５５】この結果、α化澱粉を用いた実施例Ｃ1で
は、付着防止効果が十分でなく、変色防止効果も十分で
ない（皮膜が透明になるため）と思われる。但し、本発
明の澱粉として、α化澱粉、部分α化澱粉を採用したと
きにも、本発明の基本的な作用効果は維持できる。ま
た、これらの実施例Ｃ1、Ｃ2においては、α化澱粉の増
粘効果により、コハク酸ゼラチン（あるいは一般処方に
おけるゼラチン）の一部をα化澱粉で代替できる可能性
がある。As a result, in Example C1 using pregelatinized starch, it is considered that the effect of preventing adhesion and the effect of preventing discoloration are not sufficient (because the film becomes transparent). However, even when pregelatinized starch or partially pregelatinized starch is employed as the starch of the present invention, the basic effects of the present invention can be maintained. In these Examples C1 and C2, there is a possibility that a part of gelatin succinate (or gelatin in a general formulation) can be replaced by gelatinized starch due to the thickening effect of gelatinized starch.
【００５６】[0056]
【表９】 [Table 9]
【００５７】（実施例Ｄ）（表１０、表１１） 実施例Ｄ（Ｄ1〜Ｄ3）では、各種澱粉（コーンスター
チ、ワキシースターチ、タピオカ澱粉）又はこれらの混
合物を使用し、その皮膜調製段階で予め水と共に加熱す
ることにより、α化した澱粉を用いることとした。この
結果、本発明の澱粉として、皮膜調製時にα化した澱粉
を採用したときにも、本発明の基本的な作用効果は維持
できる。また、これらの実施例Ｄ1〜Ｄ3においては、α
化澱粉の増粘効果により、コハク酸ゼラチン（あるいは
一般処方のゼラチン）の一部をα化澱粉で代替できる可
能性がある。(Example D) (Tables 10 and 11) In Example D (D1 to D3), various starches (corn starch, waxy starch, tapioca starch) or a mixture thereof were used, and they were prepared in advance in the film preparation stage. By heating with water, pregelatinized starch was used. As a result, the basic action and effect of the present invention can be maintained even when starch pregelatinized at the time of preparing the film is employed as the starch of the present invention. In Examples D1 to D3, α
Due to the thickening effect of the gelatinized starch, there is a possibility that a part of gelatin succinate (or gelatin of general formula) can be replaced with gelatinized starch.
【００５８】[0058]
【表１０】 [Table 10]
【００５９】[0059]
【表１１】 [Table 11]
【００６０】[0060]
【表１２】 [Table 12]
【００６１】[0061]
【発明の効果】以上のように本発明によれば、軟カプセ
ル剤において、皮膜の溶解性と不溶化防止性を向上しな
がら、カプセル剤相互もしくは容器との付着性を向上
し、皮膜の変形を防止し、皮膜の変色と内容物の退色を
防止することができる。As described above, according to the present invention, in a soft capsule, while improving the solubility and insolubility prevention of the film, the adhesion between the capsules and the container is improved, and the deformation of the film is reduced. It is possible to prevent discoloration of the film and discoloration of the contents.
Claims (6)
チンと、 ポリグルコース及びこれらの誘導体・加工物から選択さ
れる１種以上とを含有することを特徴とする軟カプセル
剤。Claims: 1. A soft capsule comprising, as a film component, a modified gelatin obtained by modifying an amino group in a gelatin molecule with an organic acid, and at least one selected from polyglucose and derivatives and processed products thereof. Soft capsules characterized by the following.
載の軟カプセル剤。2. The soft capsule according to claim 1, wherein the polyglucose is starch.
薯澱粉、小麦澱粉、タピオカ澱粉、ワキシースターチの
いずれか１以上である請求項２記載の軟カプセル剤。3. The soft capsule according to claim 2, wherein the starch is at least one of corn starch, rice starch, potato starch, wheat starch, tapioca starch, and waxy starch.
水と共に加熱して得られる、当該澱粉の一部又は全部を
α化したものである請求項１〜３のいずれかに記載の軟
カプセル剤。4. The soft capsule according to any one of claims 1 to 3, wherein the processed product of polyglucose is obtained by heating the starch together with water and partially or entirely pregelatinized the starch. Agent.
項１記載の軟カプセル剤。5. The soft capsule according to claim 1, wherein the polyglucose is cellulose.
請求項１〜５いずれかに記載の軟カプセル剤。6. The soft capsule according to claim 1, wherein the modified gelatin is succinic gelatin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11146245A JP2000044465A (en) | 1998-05-28 | 1999-05-26 | Soft capsule agent |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP16283098 | 1998-05-28 | ||
| JP10-162830 | 1998-05-28 | ||
| JP11146245A JP2000044465A (en) | 1998-05-28 | 1999-05-26 | Soft capsule agent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2000044465A true JP2000044465A (en) | 2000-02-15 |
Family
ID=26477127
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP11146245A Withdrawn JP2000044465A (en) | 1998-05-28 | 1999-05-26 | Soft capsule agent |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000044465A (en) |
Cited By (14)
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|---|---|---|---|---|
| JP2001335481A (en) * | 2000-03-22 | 2001-12-04 | Eisai Co Ltd | Soft capsule containing vitamin e at high concentration |
| 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 |
| KR20030070798A (en) * | 2002-02-26 | 2003-09-02 | 주식회사 국순당 | Method for preparation of micoencapsulated lipid soluble antioxidant coated by polysaccharides and proteins |
| JP2004010546A (en) * | 2002-06-07 | 2004-01-15 | Cardinal Health Japan 408 Kk | Soft capsule disintegratable in oral cavity |
| JP2006328038A (en) * | 2004-07-30 | 2006-12-07 | Wakunaga Pharmaceut Co Ltd | Composition for capsule film, capsule film, capsular preparation using the same, and method for producing the capsular preparation |
| US7867513B2 (en) | 2004-02-17 | 2011-01-11 | Eisai R&D Management Co., Ltd. | Soft capsule |
| WO2011080647A2 (en) | 2009-12-28 | 2011-07-07 | Pfizer Inc. | Gelatin capsules and gelatin compositions for forming capsule coating |
| JP2015059106A (en) * | 2013-09-19 | 2015-03-30 | 富士カプセル株式会社 | Soft capsule coating |
| JP2015193579A (en) * | 2014-03-31 | 2015-11-05 | 小林製薬株式会社 | Gelatine capsule agent and production method thereof |
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| KR20160114400A (en) * | 2015-03-24 | 2016-10-05 | 아주대학교산학협력단 | Preparation method of coating solution comprising rice starch and coating solution prepared thereby method |
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-
1999
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001335481A (en) * | 2000-03-22 | 2001-12-04 | Eisai Co Ltd | Soft capsule containing vitamin e at high concentration |
| 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 |
| KR20030070798A (en) * | 2002-02-26 | 2003-09-02 | 주식회사 국순당 | Method for preparation of micoencapsulated lipid soluble antioxidant coated by polysaccharides and proteins |
| JP2004010546A (en) * | 2002-06-07 | 2004-01-15 | Cardinal Health Japan 408 Kk | Soft capsule disintegratable in oral cavity |
| US7867513B2 (en) | 2004-02-17 | 2011-01-11 | Eisai R&D Management Co., Ltd. | Soft capsule |
| JP2006328038A (en) * | 2004-07-30 | 2006-12-07 | Wakunaga Pharmaceut Co Ltd | Composition for capsule film, capsule film, capsular preparation using the same, and method for producing the capsular preparation |
| 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 |
| WO2011080647A2 (en) | 2009-12-28 | 2011-07-07 | Pfizer Inc. | Gelatin capsules and gelatin compositions for forming capsule coating |
| JP2016514724A (en) * | 2013-06-28 | 2016-05-23 | ハンミ ファーム． シーオー．， エルティーディー． | Oral soft capsule formulation containing dutasteride |
| JP2015059106A (en) * | 2013-09-19 | 2015-03-30 | 富士カプセル株式会社 | Soft capsule coating |
| JP2015193579A (en) * | 2014-03-31 | 2015-11-05 | 小林製薬株式会社 | Gelatine capsule agent and production method thereof |
| KR20160114400A (en) * | 2015-03-24 | 2016-10-05 | 아주대학교산학협력단 | Preparation method of coating solution comprising rice starch and coating solution prepared thereby method |
| KR101690864B1 (en) * | 2015-03-24 | 2016-12-28 | 아주대학교산학협력단 | Preparation method of coating solution comprising rice starch and coating solution prepared thereby method |
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| JP2021042174A (en) * | 2019-09-12 | 2021-03-18 | 中日本カプセル 株式会社 | Soft capsule film, method for producing soft capsule film, and soft capsule |
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