JPH0565222A - Film containing pullulan blended therein for capsule and capsule - Google Patents

Abstract

PURPOSE:To obtain a soft capsule, capable of stably enclosing a readily oxidiza ble substance, exhibiting easy solubility and withstanding a production method according to a punching method by blending a capsule film substrate such as gelatin, agar or carrageenan with pullulan. CONSTITUTION:A film containing pullulan (natural neutral polysaccharides which contain maltotriose that is a trimer of glucose repeatedly bound through alpha-1,6-glucoside bonds and are useful as a food) blended therein for a capsule is obtained by blending a capsule film substrate such as gelatin, agar or carrageenan with the pullulan in an amount of about 5-10% based on the total weight of the film. A readily oxidizable substance such as eicopapentaenoic acid, docosahexaenoic acid or beta-carotene can stably be contained by using the film containing the blended therein to afford the capsule. The resultant capsule is excellent in solubility in the stomach and capable of rapidly exhibiting effect of the medicine. Even if a soft capsule is produced by a punching method such as a flat plate or rotary die, the bonded surface is firm and there is no fear of leaking liquid contents and breaking the bonded surface, etc., with time.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pullulan-containing film for capsules and a capsule for soft capsules or hard capsules used in pharmaceuticals, health foods, cosmetics and the like.

[0002]

2. Description of the Related Art In general, a film of a soft capsule or a hard capsule is formed of a water-soluble film agent component such as gelatin, agar and carrageenan. The soft capsule is manufactured by encapsulating the contents with a soft capsule film obtained by gelling a film base consisting of gelatin, water, and a plasticizer. Further, the hard capsule is produced by, for example, attaching an aqueous gelatin solution around the mold and drying the mixture to fill the content in the hard capsule film formed.

[0003]

The above-mentioned conventional capsule film has the following problems. (1) Many of icosapentaenoic acid (hereinafter abbreviated as EPA), docosahexaenoic acid (hereinafter abbreviated as DHA), β-carotene, and the like, which are generally said to be effective in preventing adult diseases, are included in the molecule. Since it has a double bond of, it is a substance that is extremely easily oxidized. Moreover, since these substances have peculiar off-tastes and off-flavors, they cannot be blended in ordinary foods as they are. Therefore, it is generally used as a health food enclosed in a soft capsule. Further, a method of encapsulating in a soft capsule and then adding to a food is also known. (JP-A-60-102138, JP-B-60-66935, JP-A-2-203741)
However, although these methods can cover the off taste and the offensive odor, they cannot completely prevent the oxidation of the contents and have a problem that the peroxide value increases with time. (2) Capsules used for pharmaceuticals and health foods generally have good solubility in the stomach after ingestion, and it is required that the drug effect possessed by the contents be promptly developed, so that the solubility of the capsules is improved. This is originally an important issue for capsules. (3) In order to produce a soft capsule by a punching method such as a flat plate method or a rotary die method, for example, two soft capsules obtained by gelling a film base consisting of gelatin, water and a plasticizer. The contents are pressed into the space between the films, and the molds are cut off to bond the films to each other for molding. Increasing the adhesiveness of the film at this time improves the stability of the soft capsule over time. That is, it is an important issue for soft capsules in the sense of preventing liquid leakage of contents and cracking of the adhesive surface. Then,
An object of the present invention is to provide a capsule in which substances that are extremely easily oxidized, such as EPA, DHA, and β-carotene, are stably encapsulated with little increase in peroxide value over time. or,
An object of the present invention is to provide a capsule having good solubility and capable of rapidly exhibiting the drug effect of the content. A further object of the present invention is to provide a soft capsule which is manufactured by a punching method so that the adhesive surface of the soft capsule is strengthened so that there is no liquid leakage of contents over time, cracking of the adhesive surface and the like.

[0004]

The present inventors have focused on various properties of pullulan and have incorporated pullulan into a capsule film base such as gelatin, agar, and carrageenan. Here, pullulan is a natural neutral polysaccharide in which maltotriose, which is a glucose trimer, is repeatedly bound by α-1,6 glucoside bonds, and in Japan, like starch, it is approved as a food with no restrictions on use. Has been done. In the present invention, for example, a commercially available product from Hayashibara Shoji Co., Ltd. under the name "Pullulan PF-20" can be used.

The amount of pullulan to be added to the capsule film base is not particularly limited, but as the amount of pullulan is increased, the capsule film becomes more opaque and the capsule surface loses its gloss. Therefore, it is preferably 1% to 15%, particularly preferably 5% to 1% of the total weight of the capsule film after production.
It is 0%. If it is less than 1%, the effect is not sufficiently exhibited for any purpose of the present invention, and if it is 15% or more, the capsule film becomes opaque and the surface of the capsule loses its gloss. However, for any of the purposes of the present invention, the greater the amount of pullulan compounded, the more remarkable the effect.

No special means is required to prepare the pullulan-containing film for capsules and capsules of the present invention, and both the soft capsule 1 and the hard capsule are prepared by a conventional method for preparing a coating solution and a capsule manufacturing method. You can Further, for the purpose of preventing the oxidation of the content 2 of the capsule in the present invention, a method of coating the capsule containing the easily oxidizable substance with an ordinary film formulation with an aqueous solution of pullulan is also effective. .

[0007]

Example As a film formulation, 10 parts by weight of pullulan was added to a film base comprising 100 parts by weight of gelatin, 30 parts by weight of glycerin and 100 parts by weight of water. The rotary film of the punching method, which is one of the methods for producing the soft capsule 1 from this compound film.
Oval 5 type (OVAL 5 type) soft capsule 1 was produced by a die-type production method. Pullulan is Hayashibara Shoji Co., Ltd.
"Pullulan PF-20" of No. Further, as the content liquid 2, refined sardine oil (peroxide value 0.1 (meq / kg) (milliequivalent / kg) EPA content 12.5% and DHA content 10.5% was used.

Comparative Example Gelatin 100 as a film formulation
A soft base capsule was manufactured by using the same content liquid as the above-mentioned manufacturing method with a film base comprising 1 part by weight, 30 parts by weight of glycerin, and 100 parts by weight of water. In short, it does not contain pullulan.

(Experiment 1) 50 capsules of No. 6 sample bottle were taken for each of the soft capsules of the above-mentioned Examples and Comparative Examples, and stored in a thermostat bath at 40 ° C. for 1 week with the peroxide value. Was measured and compared with the value before storage. It is shown in Table 1.

[0010]

[Table 1]

As shown in Table 1 above, the soft capsules of the examples were superior to the soft capsules of the comparative example in that the peroxide value of the contents was less increased.

(Experiment 2) The soft capsules of the above Examples and Comparative Examples were subjected to a disintegration test according to the Japanese Pharmacopoeia for each 6 capsules. The results are shown in Table 2.

[0013]

[Table 2]

As shown in Table 2 above, the soft capsules of Examples were shorter in disintegration time and superior in solubility than the soft capsules of Comparative Example.

(Experiment 3) The central portions of the soft capsules of the above-mentioned Examples and Comparative Examples were cut as shown in FIG. 1, and the thickness of each portion A to D was measured with a stereoscopic microscope. However, A and B show an adhesion part, and C and D show a film part. The measurement results are shown in Table 3.

[0016]

[Table 3]

From Table 3 above, the soft capsules of the examples were substantially thicker in thickness than the soft capsules of the comparative example, while the thickness of the adhesive portion was significantly thicker. This suggests that the soft capsules of the examples are less likely to cause leakage of the content liquid and cracking of the capsules over time due to poor adhesion as compared with the soft capsules of the comparative examples. There is.

[0018]

(1) In the present invention, EPA, DHA, β-
It is possible to obtain a capsule in which an easily oxidizable substance such as carotene is stably encapsulated with little increase in peroxide value over time. (2) It is possible to obtain a capsule having good solubility and capable of rapidly exhibiting the drug effect of the content. (3) It is possible to obtain a soft capsule which is produced by a punching method by strengthening the adhesive surface of the soft capsule, which is free from leakage of contents over time, cracking of the adhesive surface and the like.

[Brief description of drawings]

FIG. 1 is a longitudinal sectional view of a soft capsule preparation according to the present invention manufactured by a rotary die manufacturing method.

[Explanation of symbols]

 1 Soft capsule 2 Content liquid

Claims (4)

[Claims] 1. A pullulan-containing film for capsules, characterized in that pullulan is added to the film base. 2. A capsule in which the content of an easily oxidizable substance is encapsulated by a pullulan-containing film. 3. An easily soluble capsule containing the contents encapsulated by a pullulan-containing film. 4. A capsule having a pullulan-containing film encapsulated therein, the soft capsule having a strong adhesive surface produced by a punching method.