JP4797211B2 - Film forming composition for soft capsule - Google Patents

Description

  The present invention relates to a film-forming composition for soft capsules suitable for forming a soft capsule and a soft capsule formed using the composition.

Soft capsules are widely used in fields such as pharmaceuticals and foods. Gelatin is widely used as a main component constituting the shell of such soft capsules, and gelatin is mainly produced from beef bone and pig skin. However, vegetarians, Muslims who ban pork, and Hindus who sacred cows may take or eat soft capsules containing gelatin from such cows or pigs. There is a problem that can not be.
Furthermore, gelatin produced from bovine bones always remains uneasy about safety against mad cow disease, and gelatin produced from other than cattle and pigs cannot obtain the strength required for capsules, and from cattle and pigs. There is a problem that the cost performance is poor compared to the manufactured gelatin and the cost is high.
On the other hand, vegetable capsules formed by forming a soft capsule shell without using gelatin are known (for example, Patent Documents 1, 2, and 3). Since such vegetable capsules are made of plant-derived components, problems resulting from the use of cattle and pig-derived gelatin do not occur. However, soft capsules using gelatin usually insolubilize over time, making it difficult for the inner solution to elute out of the capsule, whereas vegetable capsules are less likely to insolubilize over time as capsules. Although it has the advantage of functioning stably, it has been found that there are problems in workability and capsule shell strength when manufacturing capsules.

Specifically, unmodified starch (rice starch, corn starch) has a high viscosity, and it is difficult to mix starch with a gelling agent or plasticizer. It was. Even if corn starch is decomposed to dextrin by enzyme treatment, which is one of the physical treatments, the strength of the capsules made is very weak and cannot withstand distribution, and the capsule strength is extremely reduced over time was there.
Therefore, a vegetable capsule having excellent properties as a soft capsule is desired.

Special table 2003-504326 gazette Special table 2008-519075 gazette JP 2005-176744 A

An object of this invention is to provide the film formation composition for soft capsules which has components other than gelatin as a main component.
An object of this invention is to provide the soft capsule which has the shell formed with the said film formation composition for soft capsules.

In the present invention, among various starches, acid-decomposed waxy corn starch is suitable as an alternative to gelatin, and when combined with a gelling agent and a plasticizer, forms a shell with excellent properties for soft capsules. It was made based on the knowledge that it is possible.
That is, the present invention provides a film-forming composition for soft capsules comprising (A) acid-decomposed waxy corn starch, (B) a gelling agent and (C) a plasticizer.
The present invention also provides a soft capsule comprising a shell formed of the composition and a capsule filler contained in the shell.

  According to the present invention, it is possible to provide a soft capsule shell that does not use any animal-derived gelatin raw material and a soft capsule that contains a capsule filler in the shell. The soft capsule having a shell formed from the film-forming composition for soft capsules of the present invention has excellent properties in terms of physical strength, disintegration, odor, taste, color, and blocking properties, and has excellent temporal stability. is there. In addition, when carrageenan is used as the gelling agent (B), it can be encapsulated without using metal salts (sodium salt, potassium salt, calcium salt) generally required for carrageenan gelation. There is an advantage that a strong film can be formed.

There are dent species and waxy species in corn, and the component (A) used in the present invention targets starch (starch) obtained from waxy species. Waxy corn, also called glutinous corn, is essentially 100% amylopectin starch without amylose. The acid-decomposed waxy corn starch used in the present invention includes acid-hydrolyzed waxy corn starch and acid-roasted waxy corn starch. For example, starch obtained from waxy corn has an inorganic acid or an organic acid such as sulfuric acid. And a part of the starch structure is decomposed under temperature conditions of 10 ° C to 160 ° C. Of these, those having a carboxyl group content of 0.1% by mass or less are preferred. Moreover, it is preferable that the viscosity in 80 degreeC when preparing to 20 mass% aqueous solution is 5-100 mPa * S. Such a viscosity can be measured using a rotor No. 1 using a BM viscometer (VISCO-BM type, manufactured by Tokimec Co., Ltd.). Acid-decomposed waxy corn starch can be obtained from the market, for example, as WS-10 (manufactured by Matsutani Chemical Industry).
Particularly preferred acid-decomposed waxy corn starch has a viscosity of 5 to 50 mPa · S, more preferably 10 to 20 mPa · S when measured under the above conditions.
The amount of the acid-decomposed waxy corn starch of the component (A) in the film-forming composition for soft capsules of the present invention (in the dry weight or in the component excluding water) is preferably 10 to 60% by mass, and further 25 It is preferably ˜60% by mass.

As the gelling agent of component (B) used in the present invention, carrageenan (iota-carrageenan, kappa-carrageenan, lambda-carrageenan), agar, gum arabic, gellan gum, native gellan gum, pullulan, pectin, glucomannan, locust bean gum , Guar gum, gellan gum, cellulose, konjac gum, fur celeran, tara gum, alginic acid and tamarind gum. Among these, one or a mixture of two or more selected from carrageenan (iota-carrageenan, kappa-carrageenan, lambda-carrageenan), agar, gum arabic, gellan gum, native gellan gum, pullulan, pectin and glucomannan is preferable. Of these, iota-carrageenan alone, kappa-carrageenan alone, or a mixture thereof is particularly preferred.
The amount of the gelling agent of component (B) in the film-forming composition for soft capsules of the present invention (in the dry weight or in the component excluding water) is preferably 8 to 30% by mass, and more preferably 10 to 24%. It is preferable that it is mass%.

As the plasticizer of component (C) used in the present invention, glycerin, sorbitol, maltitol, propylene glycol, polyethylene glycol, sugar alcohol, lactitol, polyalkylene glycol, monosaccharide, disaccharide, oligosaccharide, isomaltoligosaccharide, diethylene glycol Glycerol monoacetate, glycerol diacetate, glycerol triacetate, invert sugar, corn syrup and 1,2-propylene glycol or a mixture of two or more thereof. Among these, one or a mixture of two or more selected from glycerin, sorbitol, maltitol, propylene glycol, polyethylene glycol, sugar alcohol, lactitol, polyalkylene glycol, monosaccharide, disaccharide, oligosaccharide, and isomaltoligosaccharide is preferable. . Among these, glycerin, sorbitol, polyethylene glycol or a mixture thereof is particularly preferable.
The amount of the plasticizer of the component (C) in the film-forming composition for soft capsules of the present invention (in the dry weight or in the component excluding water) is preferably 5 to 65% by mass, and further 10 to 60% by mass. %, Particularly 15 to 50% by mass is preferred.

The film-forming composition for soft capsules of the present invention can further contain (D) a buffer. Examples of the buffering agent include sodium salt, potassium salt, calcium salt and the like, and sodium phosphate is preferable.
The amount of the buffer of component (D) in the film-forming composition for soft capsules of the present invention (in the dry weight or in the component excluding water) is preferably 0.2 to 5% by mass, and more preferably 1 to It is preferably 4% by mass.
However, in the present invention, when carrageenan is used as the gelling agent of component (B), it is necessary to use a buffer such as sodium salt, potassium salt or calcium salt generally required for gelation of carrageenan. This is preferable because the property can be excluded. In this case, it is preferable to use (A) acid-decomposed waxy corn starch / (B) gelling agent at a ratio of 1/1 to 4/1 (mass ratio).
The film-forming composition for soft capsules of the present invention can further contain colorants such as colorant dyes and pigments, flavoring agents, preservatives, etc., but preferably does not contain gelatin at all.

When forming the shell for soft capsules using the film-forming composition for soft capsules of the present invention, 40 to 110 parts by weight of water is added and mixed per 100 parts by weight of the film-forming composition for soft capsules of the present invention. The film is preferably formed by a conventional method so that the thickness of the film is 0.1 to 1.0 mm. Seamless capsules can also be formed using the soft capsule film-forming composition of the present invention.
The soft capsule of the present invention can be filled with slurry, oil, or the like as a capsule filler.
Next, the present invention will be described with reference to examples.

これらは、いずれも、松谷化学工業，江崎グリコ株式会社，日本コーンスターチ株式会社より販売されている。
酸分解ワキシコーンスターチWS-10の粘度を以下の方法で測定した。
スターチ（WS-10）80gに対し320gの精製水を加え80℃の温浴で溶解し20％溶液を調製した。温浴に入れたままスターチ温度を80℃に保ち，No1ローターを接続したBM粘度計（VISCO-BM型、株式会社トキメック製）を用いて測定したところ、粘度は12〜16ｍPa・Sであった。 Table 1 shows the starches used in Examples and Comparative Examples and components related thereto.
Table 1

These are all sold by Matsutani Chemical Industry, Ezaki Glico Co., Ltd., and Nippon Corn Starch Co., Ltd.
The viscosity of the acid-decomposed waxy corn starch WS-10 was measured by the following method.
To 80 g of starch (WS-10), 320 g of purified water was added and dissolved in a warm bath at 80 ° C. to prepare a 20% solution. The viscosity was 12 to 16 mPa · s as measured using a BM viscometer (VISCO-BM type, manufactured by Tokimec Co., Ltd.) connected to a No1 rotor while keeping the starch temperature at 80 ° C. while placed in a warm bath.

Example 1
Purified water was added in the range of 40 to 110 parts per 100 parts by mass of the film-forming composition for soft capsules having the composition shown in Table 2 to prepare a capsule-capable viscosity. Subsequently, rapeseed oil was filled as a filler, and soft capsules were prepared by a roll die type encapsulation machine.
Table 2

Comparative Examples 1 and 2
In Comparative Examples 1 and 2, rice starch (WR-1) and corn starch (purified and dried sterilized corn starch) were used in place of the acid-decomposed starch (WS-10) in the composition shown in Table 2 of Example 1, respectively. As a result of encapsulating in the same manner as in Example 1, in Comparative Examples 1 and 2, a coating solution was prepared with a viscosity so high that the preparation equipment was damaged even when purified water was added in the range of 40 to 110 parts. could not.
Comparative Examples 3-5
In Comparative Examples 3 to 5, instead of the acid-decomposed starch (WS-10) in the composition shown in Table 2 of Example 1, cluster dextrin (derived from waxy corn: Comparative Example 3) and enzyme-treated dextrin (paindex # 100: Comparative Example 4) and an enzyme-treated dextrin (MAX1000: Comparative Example 5) were used to prepare an encapsulation in the same manner as in Example 1.

About Example 1 and Comparative Examples 3-5, the film strength of the obtained capsule and its temporal stability were measured by the following methods.
Burst test Load is expressed in kg when one capsule is loaded and cracked using the following burst tester.
Capsule size: 9.5 Oblong
Film thickness: About 0.5mm (0.4-0.6mm)
Burst tester: Kiyama hardness tester (1600-E type: manufactured by Fujiwara Seisakusho Co., Ltd.)
Disintegration was measured by the Japanese Pharmacopoeia 14th revised edition disintegration test. The time for the drug solution filled in the capsule to elute and the time for the capsule film to completely dissolve is shown.
The results are summarized in Table 3.

表３の結果から、本発明のソフトカプセル用フィルム形成組成物を用いて調製したソフトカプセル（実施例１）は、破裂試験における物理的強度が比較例３〜５に比べ非常に強いが、崩壊性には実質的な差違がないことがわかる。
又、４０℃に３ヶ月放置した後に、同様の試験を行った。結果を表４に示すが、物理的強度と崩壊性はともに優れた特性を維持していた。
比較例３〜５では４０℃保存により物理的強度の悪化が見られたが実施例１では悪化は見られなかった（データが有る）。 Table 3

From the results of Table 3, the soft capsules (Example 1) prepared using the film-forming composition for soft capsules of the present invention have a very strong physical strength in the burst test compared to Comparative Examples 3 to 5, but are disintegratable. Shows that there is no substantial difference.
The same test was carried out after leaving at 40 ° C. for 3 months. The results are shown in Table 4, and both physical strength and disintegration maintained excellent characteristics.
In Comparative Examples 3 to 5, physical strength was deteriorated by storage at 40 ° C., but in Example 1, no deterioration was observed (there is data).

Table 4

表５の結果から、本発明のソフトカプセル用フィルム形成組成物を用いて調製したソフトカプセル（実施例１）は、臭気、味、色及びブロッキング性の全てについて優れたものであるが、比較例３では非常に強いカラメル臭とカラメルの味がし、カラメル臭は喫食のさいに食感を損なう場合があるとの問題がある。比較例４は、カラメル臭とカラメルの味は弱いが透明度が悪く暗く見えるとの問題がある。比較例５は、透明度が悪く暗く見え、又カプセル同士のくっ付きが強く包装をする際に問題がおこる可能性がある。 Table 5 shows the results of examining characteristics such as the appearance of the soft capsules prepared in Example 1 and Comparative Examples 3 to 5.
Table 5 Capsule properties

From the results in Table 5, the soft capsules (Example 1) prepared using the film-forming composition for soft capsules of the present invention are excellent in all of odor, taste, color and blocking property. There is a problem that the caramel odor has a very strong caramel odor and caramel taste, and the caramel odor may impair the texture during eating. Comparative Example 4 has a problem that the caramel smell and the caramel taste are weak, but the transparency is poor and looks dark. The comparative example 5 has poor transparency and looks dark, and the sticking between the capsules is strong, which may cause problems when packaging.

実施例２で得られたソフトカプセルの物理的強度を、実施例１で得られたソフトカプセルの物理的強度と比較して、表７に示す。 Example 2
Soft capsules were prepared in the same manner as in Example 1 using the composition shown in Table 6 except that Na phosphate as a buffering agent was removed from the film-forming composition for soft capsules of Example 1.
Table 6

The physical strength of the soft capsule obtained in Example 2 is shown in Table 7 in comparison with the physical strength of the soft capsule obtained in Example 1.

表７の結果から、本発明によれば、緩衝剤であるリン酸Naを用いなくても、物理的強度の優れたソフトカプセルが得られることがわかる。又、表３と表７の結果の比較から、実施例２は開口時間が実施例１より早く、ソフトカプセルの利点の１つである崩壊性の速さがより優れている。 Table 7

From the results in Table 7, it can be seen that according to the present invention, soft capsules having excellent physical strength can be obtained without using Na phosphate, which is a buffer. Moreover, from the comparison of the results of Table 3 and Table 7, Example 2 has a faster opening time than Example 1, and the disintegration speed, which is one of the advantages of the soft capsule, is more excellent.

Claims (8)

(A) Acid-decomposed waxy corn starch, (B) Gelatinizer selected from the group consisting of carrageenan, agar, gum arabic, pullulan, pectin and glucomannan , and (C) a soft capsule characterized by containing a plasticizer Film-forming composition.   The composition according to claim 1, wherein (A) the acid-decomposed waxy corn starch has a viscosity at 80 ° C of 5 to 100 mPa · S when prepared in an aqueous solution having a concentration of 20% by mass.   (B) The composition according to claim 1 or 2, wherein the gelling agent is carrageenan.   (C) The composition according to any one of claims 1 to 3, wherein the plasticizer is glycerin, sorbitol, polyethylene glycol or a mixture thereof.   (D) The composition of any one of Claims 1-4 which further contains a buffering agent.   The composition according to claim 5, wherein the buffer (D) is a sodium salt, potassium salt or calcium salt.   The composition according to any one of claims 1 to 4, which does not contain a buffer.   A soft capsule comprising a shell formed of the composition according to any one of claims 1 to 7, and a capsule filler accommodated in the shell.