JPH07179334A - Production of capsule and capsule agent - Google Patents

Abstract

PURPOSE:To obtain a capsule agent capable of eliminating problems such as cost of packaging or handling of the capsule without losing the gloss of the capsule surface by preventing the capsule from sticking to a container or mutual sticking. CONSTITUTION:This capsule agent. is obtained by forming a coating layer 2 of zein on the outer lateral surface of a capsule 1 and filling contents 3 such as a medicine, a quasi-drug, a cosmetic or a healthful food in the capsule 1.

Description

Detailed Description of the Invention

[0001]

[Industrial applications]

The present invention relates to a method for producing capsules and capsules, and more particularly to a method for producing soft capsules and capsules used for medicines, quasi drugs, cosmetics, health foods and the like.

[0003]

[Prior art]

[0004] Capsules are easy to use because the additives and the manufacturing method can be easily selected, and the odor of substances filled in the capsules and the unpleasant taste and irritation upon oral ingestion can be prevented. Therefore, it is widely used.

[0005]

[Problems to be Solved by the Invention]

[0006] Capsules using capsules, especially soft capsules, can be filled with oily or suspended chemicals, but they absorb moisture under high humidity conditions, so that the soft capsules adhere to the container or soften. There is a drawback that capsules adhere to each other.

Therefore, in general, 1 soft capsule is used.
They are individually packaged.

In some cases, the soft capsules are not individually packaged due to bottling or the like, but in that case, the above-mentioned adhesion disorder is present.

Therefore, capsules using capsules,
Especially for soft capsules, packaging will be expensive,
In addition, it also affects transportation, handling, and quality control, making it difficult to handle.

Conventionally, as a technique for preventing adhesion of capsules, there has been one disclosed in Japanese Patent Laid-Open No. 2221/1990.

In this technique, an inorganic calcium salt and a natural calcium agent are mixed in a gelatin film, or the film thickness is increased by gelatin mixed with these calcium agents.

However, the technique described in Japanese Patent Laid-Open No. 2221/1990 has a drawback that the gloss of the capsule surface is lost.

Therefore, there has been a demand for a technique for preventing the adhesion of the capsules, thereby solving the problems of the packaging cost, the handling of the capsules, and the like, and not losing the gloss of the capsule surface.

[0014]

[Means for Solving the Problems]

As a result of earnest studies to solve the above problems, the present inventors found that the adhesion of capsules to each other or to the container was
In particular, soft capsules are manufactured by drying the water content of the skin to about 10% or less, but when the gelatin of the base material comes into contact with the high humidity atmosphere, the surface absorbs moisture and the content of the soft capsules is about 40 to 50%.
This is because the water content of the capsules makes it easier to adhere. Therefore, it is considered that adhesion can be prevented by coating the surface of the capsule with a natural substance that has less hygroscopicity and is highly safe to form a film. As a result of studying the above, it was found that zein solvent-extracted from corn gluten meal achieves the above object, and the present invention has been completed.

Means for solving the problems of the present invention are as follows.

First, a capsule having a coating layer of zein on the outer surface.

Secondly, a method for producing a capsule, in which zein is coated on a capsule base before molding, and the capsule layer is formed so that the coating layer is on the outer surface.

Thirdly, a method for producing a capsule preparation, in which zein is coated in a capsule shape and a coating layer is formed on the outer surface.

Zein is contained in an amount of 1 to 25% by weight and alcohol is used in an amount of 70 to 100% by volume.

As the coating agent, various oils and fats such as shellac and beeswax, various water-soluble polymer substances such as hydroxypropyl cellulose, hardened oil,
Casein and the like can be considered, but corn protein zein, which is a safe and inexpensive natural product, is preferable here.

As zein, those produced from corn gluten meal by a general production method and those produced by subjecting corn gluten meal to acid treatment with absolute ethanol and hydrochloric acid followed by solvent extraction are used.

The general production method is to extract corn gluten meal with isopropyl alcohol, add hexane to this solution to remove oils and fats, and then transfer the isopropyl alcohol extract into water to precipitate zein. (LC SWALLEN et al. INDU
STREAL AND ENGINEERING CH
EMISTRY 33 (3), 1941 and T.W. P.
FORBATH et al. CHEMICAL ENGINEE
RING 1957).

The capsules according to the present invention may be prepared by spraying an alcohol solution of zein on the surface of the gelatin base during the production of the gelatin base for soft capsules, or by using a conventional soft capsule. , By immersing in an alcohol solution of zein, or spraying an alcohol solution of zein on the surface of the soft capsule, except for coating the surface with zein, according to the conventional method for producing a soft capsule, or Hard capsules (not filled with contents) manufactured by a conventional method are immersed in an alcohol solution of zein, or sprayed on the surface with an alcohol solution of zein, or the like.

The capsules coated with zein in this way were equivalent to the conventional capsules in hygroscopicity, but the adhesiveness was clearly improved, and the gloss was enhanced as compared with that before coating. .

Further, since zein becomes difficult to permeate oxygen when forming a film, it is possible to prevent oxidization of the substance to be filled due to oxygen, in addition to preventing mutual adhesion.

[0027]

[Example 1]

FIG. 1 is a sectional view of an embodiment of the capsule of the present invention.

The soft capsule shown in FIG. 1 has a coating layer 2 made of zein formed on the outer surface of a capsule 1.

The inside of the capsule 1 is filled with a content 3 such as a drug, a quasi drug, a cosmetic, and a health food in a powdery, granular, liquid, or mud-like state.

Next, a method for manufacturing the above soft capsule will be described.

(1) Production of zein

Lyophilized corn gluten meal 100
To 9 g, 1000 ml of 99.5% ethanol was added, 10 g of concentrated hydrochloric acid was added, and the mixture was allowed to stand overnight.

After removing ethanol by suction filtration,
Further, it was washed with ethanol and dried at 60 ° C. overnight.

To 100 g of this dried product, 1000 ml of 90% ethanol was added, and the mixture was extracted at 55 ° C. for 1 hour and then left at room temperature for 3 hours or more and cooled.

After that, the extract was obtained by suction filtration.

The extract was concentrated by a rotary evaporator to a solid content of about 10%, and the concentrate was spray-dried to obtain powder zein.

(2) Preparation of coating solution of zein

3 g of the zein produced in the above (1) was placed in an appropriate container, moistened with a small amount of 95% ethanol, and kneaded well.

After this, 95% ethanol was added to 60
It was dissolved while heating to 0 ° C. to make a total volume of 100 ml.

(3) Coating of zein

The zein coating solution prepared in the above (2) was put in a mist, sprayed on a commercially available soft capsule, and then dried under warm air of 40 ° C. or lower to form a coating layer of zein on the outer surface. A soft capsule preparation according to the present invention was obtained.

After that, the soft capsule according to the present invention was dried in a desiccator containing silica gel for 2 to 3 days.

(4) Control area

As a control, a commercially available soft capsule without zein coating was dried in the same manner as above.

Even when compared with the control soft capsules, the surface gloss of the soft capsules according to the present invention was not hindered by the zein coating, but rather enhanced by the coating agent.

[0047]

Example 2

For hard capsules, an alcohol solution of zein was coated on the outer surface of a commercially available hard capsule (content not filled) in the same manner as in Example 1 to form a coating layer. Obtained.

[0049]

[Test Example 1]

(1) Production of gelatin soft capsule base

50 g to 25 g gelatin in a suitable container
Slightly warm water (40 ° C) was added and left overnight to moisten, then dissolved at 40 ° C and dissolved by adding 25 g of glycerin,
Made uniform.

This solution was spread on a flat plate and gelled to obtain a gelatin soft capsule base.

(2) Coating of zein

The zein coating solution prepared in (2) of Example 1 was sprayed onto the gelatin soft capsule base obtained in (1) above while warm.

Alternatively, the gelatin soft capsule base obtained in (1) above, which was air-dried overnight, was sprayed with the coating solution of zein prepared in (2) of Example 1 to be laminated, and then overlaid by inverting. Except for the zein coating solution,
It was dried with warm air at 40 ° C or lower.

These were further air dried at room temperature for 2-3 days.

Thus, the surface of the gelatin soft capsule base was coated with zein.

(3) Adhesion test

As a control, a gelatin soft capsule base not coated with zein was dried, taken out from the petri dish, and cut into two pieces, and the mutual adhesion was examined.

Further, the gelatin soft capsule base obtained in the above (2) was dried, taken out from the petri dish, cut into two, and the mutual adhesion was examined.

As a result, the gelatin soft capsule control bases in the control group were well adhered to each other.

In contrast, the gelatin soft capsule base coated with zein did not adhere to each other at all.

(4) Consideration

From the above test, it was possible to prevent the soft capsule base from adhering to the container or to the mutual side by coating the surface of the soft capsule base with an alcohol solution of zein.

Therefore, it is possible to prevent adhesion even in the capsules produced by using this base material.

The coating of zein can be carried out in two ways, that is, when the capsule base is manufactured or when it is applied to a molded preparation.

[0067]

[Test Example 2]

As a group of the present invention, the soft capsule preparation coated with zein obtained in Example 1 above, and as a control group,
Regarding soft capsules that are not coated with zein,
The following tests were conducted respectively.

(1) Test preparation

In each of the present invention group and the control group, 10 soft capsules were randomly placed in separate glass sample bottles, and the temperature was 30 ° C. and the relative humidity (RH) was maintained with the bottle mouth opened. The sample was stored in a 99% constant temperature and humidity chamber for 24 hours, and then the glass sample bottle was taken out from the constant temperature and humidity chamber and returned to room temperature.

(2) Overturning test

Each glass sample bottle prepared in (1) above was placed on a desk with the bottle mouth directly above, and it was laid sideways on the desk so that the bottle mouth faced directly to the side.

Then, the number (cumulative value) of the soft capsules dropped from the inner wall of each glass sample bottle at that time was counted.

As a result, the control group was 0, whereas the present invention group was 5.

(3) Drop test

Each of the glass sample bottles prepared in (1) above was lifted up to a height of 1 cm above the desk with the bottle mouth directly below, and then dropped onto the desk.

Then, the number (cumulative value) of the soft capsules dropped from the inner wall of each glass sample bottle at that time was counted.

Similarly, when the object is lifted up to a height of 3 cm or 5 cm from the desk and then dropped on the desk,
The number of soft capsules (cumulative value) was counted.

Table 1 shows the results of the above-mentioned overturning test and drop test.

[0080]

[Table 1]

As is clear from the results shown in Table 1, the coating of zein could prevent the attachment of the capsules.

The hard capsule obtained in Example 2 was tested in the same manner as in Test Example 2, and as a result, it was found that mutual adhesion could be prevented.

[0083]

[Test Example 3]

As the group of the present invention, the soft capsule preparation coated with zein obtained in Example 1 above, and as the control group,
Regarding soft capsules that are not coated with zein,
The following tests were conducted respectively.

That is, a disintegration test was carried out (n = 6) in artificial gastric juice at a temperature of 37 ° C. based on the Japanese Pharmacopoeia disintegration test method.

The results are shown in Table 2.

[0087]

[Table 2]

[0088]

[Test Example 4]

As the group of the present invention, the soft capsule preparation coated with zein obtained in Example 1 above, and as the control group,
Regarding soft capsules that are not coated with zein,
The following tests were conducted respectively.

After each soft capsule was thoroughly dried in a desiccator containing silica gel, the initial weight of each of the 5 soft capsules was measured and then placed on a petri dish, and the temperature and relative humidity (R
H) The sample was allowed to stand at 99%, and after 5 hours and 23 hours, the moisture absorption amount was continuously measured (n = 5).

The results are shown in Table 3.

The numerical values of the amount of moisture absorption in Table 3 are average values ±
The standard deviation is shown.

[0093]

[Table 3]

According to the results shown in Table 3, the moisture absorption amount is the same regardless of the presence or absence of zein coating, and therefore it is found that the moisture absorption and desorption of water vapor from the atmosphere in the gelatin film is not prevented by the zein coating. did.

[0095]

【The invention's effect】

According to the present invention, by preventing the adhesion of the capsules, the problems such as the packaging cost and the handling of the capsules can be solved, and the gloss of the capsule surface is not lost.

That is, according to the present invention, zein, which is a highly safe vegetable protein, is used to prevent the capsules, particularly the soft capsules, from sticking to each other, simplifying the packaging, reducing the cost, and encapsulating the capsules. It is possible to maintain the quality such as preventing the content of the agent from being oxidized, and it is possible to industrially manufacture a capsule.

[Brief description of drawings]

FIG. 1 is a sectional view of an embodiment of a capsule of the present invention.

[Explanation of symbols]

 1 capsule 2 coating layer 3 contents

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Yoshinori 23, Nishishinmachi, Yoshida-cho, Obu-shi, Aichi

Claims (3)

[Claims] 1. A capsule having a coating layer of zein on the outer surface. 2. A method for producing a capsule, wherein zein is coated on a capsule base before capsule formation, and the capsule layer is formed so that the coating layer is on the outer surface. 3. A method for producing a capsule, wherein zein is coated in a capsule shape, and a coating layer is formed on the outer surface.