JP2005176744A - Film composition of capsule - Google Patents

Film composition of capsule Download PDF

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JP2005176744A
JP2005176744A JP2003423615A JP2003423615A JP2005176744A JP 2005176744 A JP2005176744 A JP 2005176744A JP 2003423615 A JP2003423615 A JP 2003423615A JP 2003423615 A JP2003423615 A JP 2003423615A JP 2005176744 A JP2005176744 A JP 2005176744A
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carrageenan
capsule
dextrin
weight
gelatin
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JP4242266B2 (en
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Takashi Kondo
隆 近藤
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Sansho Pharmaceutical Co Ltd
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Sansho Pharmaceutical Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To develop gelatin alternatives as a gelling agent from the mad cow disease problem, allergic problems and problems on religions, and the like. <P>SOLUTION: A gelatin-free film composition of capsules derived from a cow comprises carrageenans as a gelling agent and dextrins as a film base. In the gelatin-free film composition of capsule, ι-carrageenan and κ-carrageenan are formulated in a weight ratio of (1:0.5) to (1:10) as carrageenans and carrageenans are formulated in an amount of 1-50 pts. wt. based on 100 pts. wt. dextrin. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、雑貨・食品・化粧品・医薬部外品・医薬品等の分野に適用されるカプセル剤皮組成物に関するものである。   The present invention relates to a capsule skin composition applied in the fields of sundry goods, foods, cosmetics, quasi drugs, pharmaceuticals and the like.

ソフトカプセルやハードカプセルの剤皮には、製造・保管時には形状安定性や内容物の保存安定性が求められ、その一方で使用時には速やかな崩壊性が求められている。従って、上記の点を総合的に考慮して、主に牛由来のゼラチンがゲル化剤及び膜基剤として使用されている。
それに対して、昨今では、狂牛病問題やアレルギー上の問題等から牛由来ゼラチンに代わる物の開発が求められている。
For capsules of soft capsules and hard capsules, shape stability and storage stability of contents are required during production and storage, while rapid disintegration is required during use. Accordingly, in consideration of the above points, gelatin derived from cattle is mainly used as a gelling agent and a film base.
On the other hand, in recent years, development of a substitute for bovine-derived gelatin has been required due to problems such as mad cow disease and allergies.

それに対応して、種々のゼラチンフリーの剤皮が提案されている。例えば、特許文献1には、ゲル化剤がカッパカラギーナン、膜基剤がデキストリンからなるカプセル剤皮が開示されている。
しかしながら、デキストリンの脆さ、カッパカラギーナンの硬さ等の問題がある。
Correspondingly, various gelatin-free coatings have been proposed. For example, Patent Document 1 discloses a capsule skin in which a gelling agent is kappa carrageenan and a membrane base is dextrin.
However, there are problems such as brittleness of dextrin and hardness of kappa carrageenan.

WO00/10538公報WO00 / 10538

それ故、本発明は、上記課題を解決する、新規なゼラチンフリーのカプセル剤皮組成物を提供することを目的とする。   Therefore, an object of the present invention is to provide a novel gelatin-free capsule skin composition that solves the above problems.

それ故、本発明者は、前記課題の解決を目指し鋭意検討を重ねた結果、デキストリン類を主成分とし、それにカッパカラギーナンとイオタカラギーナンとを特定の重量比で配合させることにより、満足できるカプセル剤皮組成物が得られることを見出し、本発明のカプセルの剤皮組成物を提案するに至った。本発明の組成物は、特にソフトカプセルに有用であることが確認されている。
これは、カッパカラギーナンとイオタカラギーナンを特定の重量比で配合させることにより、二重らせんの結晶領域と非晶領域とが適度に存在することになり、カプセル皮膜としての強度に適した剛性と柔軟性を有するものと考えられる。
また、ソフトカプセル成形時に必要なヒートシート性を持たせるためにはゾル−ゲル変性能が不可欠であるが、デキストリンは水溶解性が高いのでカラギーナンのゾル−ゲル変性能(即ち、網目構造形成能)を阻害し難く、少量のカラギーナンでも十分なフィルム形成能を発揮しているものと考えられる。
Therefore, as a result of intensive studies aimed at solving the above-mentioned problems, the present inventor is satisfied with capsules containing dextrins as a main component and kappa carrageenan and iota carrageenan in a specific weight ratio. It has been found that a skin composition can be obtained, and has come to propose a capsule skin composition of the present invention. The compositions of the present invention have been found to be particularly useful for soft capsules.
This is because by combining kappa carrageenan and iota carrageenan at a specific weight ratio, the crystalline region and the amorphous region of the double helix are present appropriately, and the rigidity and flexibility suitable for the strength as a capsule film It is thought that it has nature.
In addition, sol-gel modification performance is indispensable for providing heat sheet properties necessary for soft capsule molding, but dextrin has high water solubility, so carrageenan sol-gel modification performance (ie, network structure forming ability). It is considered that sufficient film-forming ability is exhibited even with a small amount of carrageenan.

上記の課題を解決する本発明のカプセル剤皮組成物は、ゲル化剤としてのカラギーナン類と膜基剤としてのデキストリンを含み、カラギーナン類としてカッパカラギーナンとイオタカラギーナンとが1:0.5〜1:10の重量比で配合され、且つデキストリン100重量部に対してカラギーナン類が1〜50重量部配合されており、牛由来ゼラチンフリーであることを特徴とするものである。   The capsule skin composition of the present invention that solves the above problems includes carrageenan as a gelling agent and dextrin as a membrane base, and kappa carrageenan and iota carrageenan are 1: 0.5 to 1 as carrageenans. The carrageenan is blended in an amount of 10 by weight and 1 to 50 parts by weight of carrageenan per 100 parts by weight of dextrin, and is free of bovine-derived gelatin.

本発明のカプセル剤皮組成物をカプセル皮膜として用いてカプセルを製造すると、カプセル成形、割れ、強度、透明性、ガスバリヤー性に関しては従来のゼラチン系カプセルと同等の皮膜特性が得られ、更に、付着性に関してはゼラチン系カプセルを上回る皮膜特性が得られる。   When capsules are produced using the capsule skin composition of the present invention as a capsule film, film properties equivalent to those of conventional gelatin-based capsules can be obtained with respect to capsule molding, cracking, strength, transparency, and gas barrier properties. With respect to adhesion, film properties superior to gelatin capsules can be obtained.

先ず、原料を説明する。
(1)ゲル化剤
カラギーナン類を用いる。
カラギーナンは硫酸基をもつガラクタンの一種であり、紅藻類のスギノリやツノマタに存在していることが知られている。カラギーナンとしては、イオタカラギーナン、カッパカラギーナン、ラムダカラギーナンの3種類が知られているが、構造やゲル化特性が異なることが報告されている。
本発明では、カラギーナン類としてカッパカラギーナンとイオタカラギーナンを併用する。
カッパカラギーナンのみを配合すると、硬く脆い皮膜となり好ましくない。また、イオタカラギーナンのみを配合すると、カプセルが吸湿したときの剛性を保つことが出来なく好ましくない。
First, raw materials will be described.
(1) Gelling agent Carrageenans are used.
Carrageenan is a type of galactan having a sulfate group and is known to exist in red alga Suginori and Tsunomata. Three types of carrageenan are known, iota carrageenan, kappa carrageenan, and lambda carrageenan, but it has been reported that the structure and gelation characteristics are different.
In the present invention, kappa carrageenan and iota carrageenan are used in combination as carrageenans.
When only kappa carrageenan is blended, a hard and brittle film is not preferable. Moreover, when only iota carrageenan is blended, rigidity when the capsule absorbs moisture cannot be maintained, which is not preferable.

カッパカラギーナンとイオタカラギーナンとを1:0.5〜1:10の重量比で併用する。この範囲で併用することにより、最適な共存効果を得ることができる。
現在では、カラギーナンは種類毎分別された精製品として市販されており、本発明ではそれを使用することができる。また、イオタカラギーナンとカッパカラギーナンとが混合されたものも市販されているが、重量比が分かれば、それらも本発明では使用できることは言うまでもない。
Kappa carrageenan and iota carrageenan are used in a weight ratio of 1: 0.5 to 1:10. By using together in this range, the optimal coexistence effect can be obtained.
At present, carrageenan is commercially available as a refined product sorted by type and can be used in the present invention. A mixture of iota carrageenan and kappa carrageenan is also commercially available, but it goes without saying that if the weight ratio is known, they can also be used in the present invention.

(2)膜基剤
デキストリン類を用いる。
デキストリン類は澱粉を加熱処理、酵素処理、酸処理等の処理に供して分解した澱粉分解物であり、澱粉とは異なりゲル化能が無く、冷水にも可溶性があり、透明なフィルム形成能を有している。
デキストリンとしては、従来から、白色デキストリンや黄色デキストリンが知られている。また、構造的には、直鎖と環状のデキストリンが知られている。
本発明のデキストリン類は、特に限定するものではないが、好ましくは環状デキストリンである。環状デキストリンの中でも、高度分岐環状デキストリンが好ましく、このような高度分岐環状デキストリンの一例としては、分子内に環状構造を1つ持ち、環状部分に多数のグルカン鎖(16〜100個程度のグルコース)が結合しており、平均重合度が2,000〜3,000程度の還元末端を含まないものが、江崎グリコ株式会社から商品名「クラスターデキストリン(CCD)(登録商標)」として販売されている。
(2) Membrane base Use dextrins.
Dextrins are starch degradation products that are decomposed by subjecting starch to heat treatment, enzyme treatment, acid treatment, etc. Unlike starch, it has no gelling ability, is soluble in cold water, and has a transparent film-forming ability. Have.
Conventionally, white dextrin and yellow dextrin are known as dextrin. Structurally, linear and cyclic dextrins are known.
The dextrins of the present invention are not particularly limited, but are preferably cyclic dextrins. Among the cyclic dextrins, highly branched cyclic dextrins are preferable, and one example of such highly branched cyclic dextrins has one cyclic structure in the molecule and a large number of glucan chains (about 16 to 100 glucose) in the cyclic part. Is bonded to Ezaki Glico Co., Ltd. under the trade name "Cluster Dextrin (CCD) (registered trademark)". .

環状デキストリンは非直鎖状の分子配列を有するので、配合すると一般のデキストリンより空間占有率が低く、その分だけカラギーナンの網目構造が形成され易くなり、結果としてカプセルの皮膜強度と透明性と付着性が一層向上するものと考えられる。   Cyclic dextrin has a non-linear molecular arrangement, so when blended, it has a lower space occupancy than ordinary dextrin, and a network structure of carrageenan is easily formed, and as a result, capsule film strength, transparency and adhesion This is considered to improve the performance further.

好ましくは、デキストリン類100重量部に対してカラギーナン類は1〜50重量部配合する。この範囲で併用すると、最適な共存効果を得ることができる。   Preferably, 1 to 50 parts by weight of carrageenans are added to 100 parts by weight of dextrins. When used in this range, the optimum coexistence effect can be obtained.

(3)その他の多糖類等
ガスバリヤー性を向上させるために、更に、プルランをデキストリン100重量部に対して20重量部を上限として配合してもよい。
プルランは水溶性の多糖類であり、黒酵母によって細胞外に産生されることが知られており、これを少量配合することでガスバリヤー性を改善することができる。カプセル剤皮によっては内容物の酸化による変性を防止することが求められることから、カプセルの用途に応じて適宜配合すればよい。
更に、澱粉(天然澱粉及び変性(改質)澱粉)も、デキストリン100重量部に対して100重量部以下で含ませても良い。例えば、ハードカプセルはソフトカプセルより膜が薄く、元々硬質であることから、強度を高めるために、澱粉を透明性、不溶解性が起こらない範囲内で、含ませても良いであろう。
また、魚ゼラチン、ニワトリゼラチン、豚ゼラチン、コラーゲンペプタイド等を配合して、カプセル強度、艶等を高めることが出来る。
このように、皮膜成分として(牛由来)ゼラチンを配合しなければ、上記した狂牛病問題やアレルギー及び宗教上の問題等を解決できよう。
(3) Other polysaccharides, etc. In order to improve gas barrier properties, pullulan may be further blended up to 20 parts by weight with respect to 100 parts by weight of dextrin.
Pullulan is a water-soluble polysaccharide and is known to be produced extracellularly by black yeast, and the gas barrier property can be improved by adding a small amount thereof. Depending on the capsule skin, it is required to prevent the contents from being denatured by oxidation.
Further, starch (natural starch and modified (modified) starch) may be contained in an amount of 100 parts by weight or less based on 100 parts by weight of dextrin. For example, since a hard capsule has a thinner film than a soft capsule and is originally hard, starch may be contained within a range where transparency and insolubility do not occur in order to increase strength.
Further, fish gelatin, chicken gelatin, pork gelatin, collagen peptide and the like can be blended to increase capsule strength, gloss and the like.
Thus, if no gelatin (cattle derived) gelatin is blended as a film component, the above-mentioned mad cow disease problems, allergies and religious problems can be solved.

(4)可塑剤等
必要に応じて、可塑剤として、従来から知られたグリセリン、ソルビトール、マルチトール、エチレングリコール等を適宜配合してもよい。可塑剤の配合量は、乾燥物基準として、可塑剤の種類によっては当てはまらない可能性はあるが好ましくは10〜60重量%である。
その他、金属封鎖剤として、クエン酸、酒石酸、乳酸、リン酸、酢酸、グルコン酸、エチレンジアミン四酢酸、メタリン酸又はそれらの塩あるいはグリシンなどを配合できる。また、通常の牛ゼラチンカプセルと同様、皮膜着色剤、矯味剤、甘味剤、保存剤、香料なども配合できる。
(4) Plasticizer, etc. Conventionally known glycerin, sorbitol, maltitol, ethylene glycol and the like may be appropriately blended as a plasticizer as necessary. The blending amount of the plasticizer is preferably 10 to 60% by weight, although it may not be applied depending on the kind of the plasticizer on the dry matter basis.
In addition, citric acid, tartaric acid, lactic acid, phosphoric acid, acetic acid, gluconic acid, ethylenediaminetetraacetic acid, metaphosphoric acid or salts thereof, glycine, or the like can be blended as a sequestering agent. In addition, a film coloring agent, a corrigent, a sweetening agent, a preservative, a fragrance, and the like can be blended in the same manner as normal bovine gelatin capsules.

次に製造方法について説明する。
基本的には、従来のゼラチン系ソフトカプセルやハードカプセル用の製造機械をそのまま利用して同様な手法で製造できる。
Next, a manufacturing method will be described.
Basically, it can be manufactured in the same manner using a conventional gelatin soft capsule or hard capsule manufacturing machine as it is.

ソフトカプセルの製造
中鎖脂肪酸トリグリセリドをカプセル内容物として、回転金型式カプセル充填機を用いて打ち抜き法にてフットボール型のソフトカプセル(膜厚0.3mm)を製造した。
従来品1以外は加熱溶解時(即ち、皮膜液時)の粘度が30000±1000cpsとなるよう脱イオン水の量を決定した。
カプセル皮膜液及びカプセル皮膜となる剤皮組成物の重量比は以下の通りである。
なお、デキストリンは通常の環状部分を有さない白色デキストリンであり、HP化タピオカ澱粉はヒドロキシプロプル化タピオカ澱粉のことである。
Production of Soft Capsule Using a medium chain fatty acid triglyceride as the capsule content, a football type soft capsule (film thickness: 0.3 mm) was produced by a punching method using a rotary mold type capsule filling machine.
Except for the conventional product 1, the amount of deionized water was determined so that the viscosity at the time of dissolution by heating (that is, at the time of the coating solution) was 30000 ± 1000 cps.
The weight ratio of the capsule film solution and the coating composition that becomes the capsule film is as follows.
In addition, dextrin is a white dextrin which does not have a normal cyclic part, and HP-ized tapioca starch is a hydroxypropylated tapioca starch.

Figure 2005176744
Figure 2005176744

試験方法及び結果
1.カプセル成形
既存の回転金型式充填機を使用して、カプセル成形を60分行い、良品のみの収率(%)を以下に示した。
Test method and results Capsule molding Using an existing rotary mold filling machine, capsule molding was performed for 60 minutes, and the yield (%) of only good products was shown below.

Figure 2005176744
Figure 2005176744

2.割れ
完成したカプセルを、デシケータ中で減圧乾燥(700mmHG)し、モンサント硬度試験器(最大硬度:30kg)によって破壊硬度(kg)を測定した。30kgでも割れなかったものは、30kg以上とした。
2. Cracking The completed capsules were dried under reduced pressure (700 mmHG) in a desiccator, and the fracture hardness (kg) was measured with a Monsanto hardness tester (maximum hardness: 30 kg). Those that did not break even at 30 kg were set at 30 kg or more.

Figure 2005176744
Figure 2005176744

3.透明性
完成したカプセルを、30℃・75RH%の恒温槽に1ヶ月間保管し、透明性について目視にて比較した。
3. Transparency The completed capsules were stored in a thermostatic bath at 30 ° C. and 75 RH% for 1 month, and the transparency was compared visually.

Figure 2005176744
Figure 2005176744

4.ガスバリヤー性
ソフトカプセルのカプセル皮膜に対応する厚さ0.1mmの乾燥皮膜を作成し、JIS K 7126「プラスチックフィルム及びシートの気体透過度試験方法」A法により酸素透過度を測定し比較した。
4). Gas barrier property A dry film having a thickness of 0.1 mm corresponding to the capsule film of the soft capsule was prepared, and the oxygen permeability was measured and compared according to JIS K 7126 “Method for testing gas permeability of plastic film and sheet” A method.

Figure 2005176744
Figure 2005176744

5.付着性
完成したカプセル20粒を、50℃の恒温槽に24時間密栓して静置保存(6号ガラス瓶を使用)し、その後6号ガラス瓶を逆さまにするあるいは所定の高さから落下することによって瓶内で底から落下するカプセル数の累積を算出した。
5). Adhesion Twenty capsules completed are sealed in a 50 ° C thermostatic chamber for 24 hours and stored (using a No. 6 glass bottle), and then the No. 6 glass bottle is turned upside down or dropped from a predetermined height. The cumulative number of capsules falling from the bottom in the bottle was calculated.

Figure 2005176744
Figure 2005176744

上記より、本発明品は、デキストリンの脆さ、カッパカラギーナンの硬さ、イオタカラギーナンの柔軟性及び付着性、澱粉特有の不透明化と言った、原料に由来して比較品や従来品が抱えていた欠点を見事に解消した画期的なものであることが確認された。   From the above, the product of the present invention has comparative products and conventional products derived from raw materials such as dextrin brittleness, kappa carrageenan hardness, iota carrageenan flexibility and adhesion, and starch-specific opacification. It was confirmed that it was an epoch-making thing that solved the shortcomings.

本発明のカプセル剤皮組成物は、従来のゼラチン系カプセル剤皮組成物の代替物となり得る。   The capsule skin composition of the present invention can be a substitute for a conventional gelatin capsule skin composition.

Claims (5)

ゲル化剤としてのカラギーナン類と膜基剤としてのデキストリン類を含み、
カラギーナン類としてカッパカラギーナンとイオタカラギーナンとが1:0.5〜1:10の重量比で配合され、且つデキストリン100重量部に対してカラギーナン類が1〜50重量部配合されていることを特徴とする牛由来ゼラチンフリーのカプセル剤皮組成物。
Including carrageenans as gelling agents and dextrins as membrane bases,
As a carrageenan, kappa carrageenan and iota carrageenan are blended at a weight ratio of 1: 0.5 to 1:10, and 1 to 50 parts by weight of carrageenan is blended with respect to 100 parts by weight of dextrin. A bovine-derived gelatin-free capsule skin composition.
皮膜成分として植物性成分のみを含むことを特徴とする請求項1に記載のカプセル剤皮組成物。 The capsule skin composition according to claim 1, comprising only a vegetable component as a film component. デキストリンが環状デキストリンであることを特徴とする請求項1または2に記載のカプセル剤皮組成物。   The capsule skin composition according to claim 1 or 2, wherein the dextrin is a cyclic dextrin. デキストリン100重量部に対してプルランを20重量部以下含むことを特徴とする請求項1から3のいずれかに記載のカプセル剤皮組成物。   The capsule skin composition according to any one of claims 1 to 3, comprising 20 parts by weight or less of pullulan per 100 parts by weight of dextrin. デキストリン100重量部に対して澱粉を100重量部以下含むことを特徴とする請求項1から4のいずれかに記載のカプセル剤皮組成物。   The capsule skin composition according to any one of claims 1 to 4, comprising 100 parts by weight or less of starch with respect to 100 parts by weight of dextrin.
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JP2006056789A (en) * 2004-08-17 2006-03-02 Oyo Seikagaku Kenkyusho Capsule film composition
JP2008088111A (en) * 2006-10-02 2008-04-17 Nakanihon Capsule Co Ltd Composition for film
JP2009173607A (en) * 2008-01-28 2009-08-06 Sansho Pharmaceutical Co Ltd Film composition of capsule and capsule
WO2012070577A1 (en) * 2010-11-22 2012-05-31 富士カプセル株式会社 Soft capsule coating
JP5149465B2 (en) * 2010-11-22 2013-02-20 富士カプセル株式会社 Soft capsule film
JP2013040217A (en) * 2010-11-22 2013-02-28 Fuji Capsule Kk Soft capsule coating
CN103059348A (en) * 2011-10-24 2013-04-24 三生医药株式会社 Capsule skin membrane composition
WO2014209964A1 (en) 2013-06-25 2014-12-31 R.P. Scherer Technologies, Llc Shell-forming compositions for soft capsules and soft capsules
CN104311887A (en) * 2014-09-19 2015-01-28 江苏崇尚生物科技有限公司 Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule
CN114424823A (en) * 2022-01-20 2022-05-03 江苏海王健康生物科技有限公司 A soft capsule containing natural extract for reducing blood lipid, and its preparation method

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006056789A (en) * 2004-08-17 2006-03-02 Oyo Seikagaku Kenkyusho Capsule film composition
JP2008088111A (en) * 2006-10-02 2008-04-17 Nakanihon Capsule Co Ltd Composition for film
JP2009173607A (en) * 2008-01-28 2009-08-06 Sansho Pharmaceutical Co Ltd Film composition of capsule and capsule
WO2012070577A1 (en) * 2010-11-22 2012-05-31 富士カプセル株式会社 Soft capsule coating
JP5149465B2 (en) * 2010-11-22 2013-02-20 富士カプセル株式会社 Soft capsule film
JP2013040217A (en) * 2010-11-22 2013-02-28 Fuji Capsule Kk Soft capsule coating
CN103059348A (en) * 2011-10-24 2013-04-24 三生医药株式会社 Capsule skin membrane composition
WO2014209964A1 (en) 2013-06-25 2014-12-31 R.P. Scherer Technologies, Llc Shell-forming compositions for soft capsules and soft capsules
CN104311887A (en) * 2014-09-19 2015-01-28 江苏崇尚生物科技有限公司 Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule
CN114424823A (en) * 2022-01-20 2022-05-03 江苏海王健康生物科技有限公司 A soft capsule containing natural extract for reducing blood lipid, and its preparation method

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