JPH04145017A - Gelatin capsule composition - Google Patents

Abstract

PURPOSE:To provide a gelatin capsule composition containing a water-swelling component, having excellent shape-retainability and solubility and safe to human body. CONSTITUTION:A water-swelling component preferably selected from clay minerals (e.g. bentonite or montmorillonite), starch and water-absorbing resins (e.g. polyacrylic acid salt or CMC) is compounded in an amount of 0.1-10 wt.% (based on total composition) to a composition produced by using gelatin as main component and adding glycerol and water as a plasticizer. Compounding of an organic acid such as malic acid, tartaric acid or lactic acid to the composition is preferable to attain improved effect. If necessary, the composition is further compounded with colorant, preservative and ultraviolet absorber. The composition keeps its original solubility even by being left standing at room temperature or high temperature over a long period.

Description

Detailed Description of the Invention [Field of Industrial Application] The present invention is a gelatin capsule composition containing a water-swellable component, which has excellent shape retention stability and solubility, and is safe for the human body. For example, it is used in the fields of pharmaceuticals, quasi-drugs, cosmetics, foodstuffs, and miscellaneous goods.

[Prior art]

In the fields of pharmaceuticals, quasi-drugs, cosmetics, foodstuffs, and miscellaneous goods, gelatin capsules are used as outer shells for preserving the contents and for ease of use.

The composition of the gelatin capsules used is usually gelatin as a main component, with glycerin and water added to a plasticizer, and the gelatin capsules are processed, molded and dried and used as the shell of the seratin capsules.

Such capsule shells can be used for pharmaceuticals, quasi-drugs, cosmetics,
When used in foodstuffs and miscellaneous goods, important factors are not only preservation and retention of contents and ease of use, but also excellent solubility even after long-term storage. For this reason,
Capsules used for the above purpose are required to have shape retention stability and capsule solubility that do not deteriorate.

Conventional capsule shells include specific shells, such as modephite gelatin in which the amino group in the seratin molecule is blocked with an organic acid, disclosed in JP-A-55-138457, and JP-A-61-1.
There is one that uses succinated seratin 86314. However, apart from these special coatings, no coatings with excellent or sufficient solubility have been known.

For example, if a capsule is placed in a sealed glass or plastic container and left at room temperature or high temperature for a long period of time, the solubility will deteriorate or it will not dissolve at all.

[Problem to be solved by the invention]

In view of the above circumstances, the inventors of the present invention have conducted intensive research to determine whether capsules with excellent solubility can be obtained even if left at room temperature or high temperature for a long period of time, and have found that if a water-swellable component is used, the above problems will be solved. The present invention has been completed based on the discovery that the problem can be solved.

[Means to solve the problem]

That is, the present invention provides a gelatin capsule composition characterized by containing a water-swellable component.

Hereinafter, the configuration of the present invention will be explained in detail.

As the water-swellable component used in the present invention, one or more selected from clay minerals, starch, and water-absorbing resins are particularly suitable from the viewpoint of solubility.

Clay minerals are silicate minerals belonging to the genus smectite, and include magnesium aluminum silicate, bentonite, montmorillonite, saponite, synthetic sodium magnesium silicate, synthetic magnesium aluminate metasilicate, etc., and may be either natural or synthetic. But that's fine. Examples of starch include those obtained from wheat, rice, corn, potato, and the like. Examples of super absorbent resins include polyacrylates, isobutylene-maleic acid copolymers, starch-acrylic acid graft copolymers, vinyl acetate-acrylic acid ester copolymers, and polyethylene, which absorb more than 10 times its own weight of water. Examples include oxide type and carboxymethyl cellulose type.

These water-swellable ingredients are arranged in the gelatin network structure of the gelatin capsule composition, and when swallowed in the mouth like oral medicine or health food or dissolved in hot water, the gelatin network structure is arranged. It gradually destroys and dissolves.

The water-swellable component is suitably added to the gelatin capsule composition of the present invention in an amount of 0.1 to 10% by weight based on the total amount of the seratin capsule composition. If it is less than 0.1% by weight, the power to destroy the network structure of seratin is weak and the dissolution promoting effect is also weak. If it exceeds 10% by weight, the network structure of gelatin will become weak and the shape retention stability will deteriorate.

In addition to the above-mentioned essential ingredients, it is preferable to combine organic acids such as malic acid, tartaric acid, lactic acid, and succinic acid in the seratin capsule composition of the present invention in terms of effectiveness.

〔Effect of the invention〕

The gelatin capsule composition of the present invention has excellent shape retention stability and solubility.

〔Example〕

Next, the present invention will be explained in more detail based on comparative examples and examples. The present invention is not limited to these examples. All compounding amounts are weight %.

Comparative Examples and Examples were obtained by the following manufacturing methods.

<Manufacturing method> (a) Method for dissolving seratin In the case of a comparative example, gelatin, glycerin, and water are placed in a jacket-type pot, and boiling water is passed through the jacket to bring the temperature of the pot to 7.
The gelatin was dissolved by heating to 0°C and stirring. Thereafter, it was degassed and the temperature was lowered and maintained at 60°C.

In the case of the example, a water-swellable component was blended in addition to the above-mentioned blended components.

(b) Formation and encapsulation of gelatin The dissolved gelatin is kept at 60°C and left to stand day and night, and then formed into a sheet on a roller.The sheet is fed to a cylindrical molding die roll of a rotary fully automatic soft capsule forming machine. By rotating in both directions, the mold is molded one after the other, and at the same time, the liquid is filled by a pump. Molding is completed as soon as the content liquid reaches a specified amount. At this time, the temperature necessary for adhesion is applied to the sheet by the shaped segments, and the capsules are adhered by the pressure of the die roll. The movements of the die roll and filling pump are completely linked, and there is no loss of liquid content or air getting into the capsule. Furthermore, the operating accuracy of the filling pump is within 3% due to variations in the amount of filling, and high yields can be achieved.

(c) Content liquid The content liquid was a mixture of rose fragrance dissolved in isopropyl myristate and was included in the capsule.

(d) Capsule moisture adjustment The capsules obtained in (b) were left in a room at a temperature of 22° C. and a humidity of 30%, and dried until the moisture content of the capsule film became 3 to 12% to obtain a final sample.

Note that the blending amounts in Comparative Examples and Examples are the blending amounts at the time of preparation and are not the blending amounts in the final sample after moisture adjustment.

Comparative Example 1 (1) Gelatin (2) Glycerin (3) Tap water manufacturing method 40% 20% 40% (1) to (3) were placed in a pot in order, and the above manufacturing methods (a), (b), and (c) were prepared. According to (d), capsules (fl) were prepared.

Comparative Example 2 (1) Gelatin (2) Glycerin (3) Tap water (4) Yellow dye No. 1 (5) Methylparaben (6) 2-hydroxy-4 methoxybenzophenone 40% 20% Appropriate amount 0.001% 0°1% 0.1% Production methods (1) to (6) were charged in order into a pot, and encapsulated according to the production methods (a), (b), (c), and (d).

Example 1 (1) Gelatin (2) Glycerin 40% 20% (3) Appropriate amount of tap water (4)
Polyacrylic acid water absorbent resin 0.1% (
Palcas 500B (manufactured by Taiyo Kagaku Co., Ltd.) Production methods (1) to (4) were placed in a pot in order, and encapsulated according to the production methods (a), (b), (c), and (d).

Example 2 (1) Gelatin (2) Glycerin (3) Tap water (4) Yellow pigment No. 1 (5) Synthetic silicic acid 40% 20% Appropriate amount 0.001% Thorium 5% Magnesium production method (11-(5) ) were charged in order into a pot and encapsulated according to the manufacturing methods (a), (b), (c), and (d) above.

Example 3 1) Seratin 40%2
) Glycerin 20% 3) Tap water appropriate amount 4) Yellow pigment 1
No. 0. (101%5) Methylparaben 0.1%6) 2-hydroxy-4 methoxybenzophenone 0.1% (7)
Synthetic Metasilicate Aluminate 10% Magnesium Production Method (11 to (7)) were charged in order into a pot and encapsulated according to the production methods (a), (b), (c), and (d).

Example 4 (11 Gelatin (2) Glycerin (3) Tap water (4) Amount of barley starch % Production methods (1) to (4) were placed in a pot in order, and the production methods (A), (B), and (H) ) (d).

Example 5 (1) Gelatin 40
% (2) Glycerin (POE 3 mol) 20
% (3) Appropriate amount of tap water (4
) Cornstarch 1% (
5) Malic acid 1%
Manufacturing methods (1) to (5) were charged in order into a pot, and encapsulated according to the manufacturing methods (a), (b), (c), and (d).

Example 6 (1) Gelatin (2) Glycerin (3) Tap water 40% 20% Appropriate amount (4) Synthetic metasilicate aluminate 1% sodium (5) Cornstarch 1
% Production Methods (1) to (5) were charged into a pot in order, and encapsulated according to the production methods (a), (b), (c), and (d).

The samples obtained in Comparative Example 1.2 and Examples 1 to 6 were evaluated using the following evaluation methods for (11) shape stability of capsules and (2) solubility of capsules.

Capsule shape/stability Samples were left at temperatures of 0° C., 25° C. and 40° C. for one month, and the shape of the capsules was visually observed. The evaluation was based on the following evaluation criteria.

1: No change at all 2: Slight deformation of the solder is observed 3: Slight deformation is observed 4: Significant deformation is observed 5: Solubility samples of capsules with misshapen shapes were heated at 0°C, 25°C and 40°C. The sample was left at a temperature of 38° C. for 8 months, then stirred 120 times per minute at a water temperature of 38° C., and the degree of dissolution was sensory evaluated.

The evaluation was based on the following evaluation criteria.

1: Dissolves in 1-3 minutes 2: Dissolves in 4-7 minutes 3: Dissolves in 8-11 minutes 4: Dissolves in 12-15 minutes 5: hardly dissolves The results are shown in Tables 1 and 2.

Table 1 (Shape stability of capsules) (Hereinafter in the margin) (Hereinafter in the margins) Table (Solubility of capsules) As is clear from the comparative examples and examples, the gelatin capsule composition of the present invention has less deformation and dissolution. Excellent in sex.

Claims (2)

[Claims] (1) A gelatin capsule composition characterized by containing a water-swellable component. (2) Claim 1 containing a pigment, a preservative, and an ultraviolet absorber
gelatin capsule composition.