JPH08169817A - Capsule - Google Patents

Abstract

PURPOSE: To obtain a capsule having excellent thermostability and high storage stability, by using a straight-chain β-1,3-glucan or a substance containing it as a film-forming base of the capsule. CONSTITUTION: This capsule comprises a straight-chain β-1,3-gulcan alone or the straight-chain β-1,3-gulcan and gelatin as a film-forming base. The capsule is coated with a film comprising the straight-chain β-1,3-gulcan or coated with a film containing the straight-chain β-1,3-gulcan. The capsule is usable in the field of medicine, food, cosmetic and health food. The straight-chain β-1,3-gulcan is a gelatinizing agent having a high thermal coagulating properties and produces a hard gel having high heat resistance and a degree of extremely low solubility when heated to a high temperature of >=80 deg.C. Consequently, since the straight-chain β-1,3-gulcan is used as a coating film for a capsule or for coating a capsule, thermostability in capsule processing is improved and wax requiring heating in the processing can be used as contents.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to capsules used in the fields of medicines, foods, cosmetics, health foods and the like.

[0002]

2. Description of the Related Art Conventionally, the film base of these capsules is
Gelatin, which has excellent solubility and fast-acting properties, is mainly used.

[0003]

However, since gelatin-based capsules do not have heat resistance,
During manufacturing, it is difficult to process the contents heated to 40 ° C or higher into capsules, and since the solubility is high, dissolution in the stomach cannot be controlled, and sustained release or enteric property may be imparted. It was difficult. In addition, since the manufactured capsules have a high hygroscopic property, they easily stick to each other during the packaging work or stick to the container during storage. At high temperatures, the contents may leak.

[0004]

According to the present invention, a straight-chain β-1,3-glucan, or one containing it, is used as a film base of a capsule, or a film base of a capsule is used. This is done in order to solve the above problems by coating a capsule.

The linear β-1,3-glucan in the present invention means a microorganism (Alcaligenes faecalis var. Myxogenes
Etc.) refers to a heat-coagulable fermentable polysaccharide. Generally, what is marketed as curdlan can be used.

There are soft capsules, hard capsules, microcapsules, and the like as the types of capsules, and their manufacturing methods are different. The soft capsule preparation method includes a punching / dropping method, the hard capsule preparation method includes a pin dipping method, and the microcapsule preparation method includes a coacervation method / spray drying method.

The capsule according to the present invention comprises a dropping method among the above-mentioned soft capsule preparation methods, a hard capsule preparation method,
Regarding the method for producing the microcapsule, it can be produced by using the conventional apparatus as it is. Linear β- in this case
The blending amount of 1,3-glucan is not particularly limited, and can be appropriately blended depending on the properties of the intended capsule. Specifically, for the purpose of preventing adhesion of capsules, 1 to 3 of linear β-1,3-glucan is added to the capsule film base.
5%, 1 to 10% for the purpose of improving heat resistance, and 1 to 100% for the purpose of imparting sustained-release property are preferably blended.

On the other hand, in the punching method (rotary method) of the soft capsule manufacturing methods, a film base composed only of linear β-1,3-glucan is not suitable for manufacturing capsules. The device diagram of the punching method is as shown in FIG. 1, and two films F made of a water-soluble polymer having a thickness of about 0.8 mm are continuously faced between the rolls of the die roll D from different directions facing each other. Be guided. On the other hand, from the content supply device B including the segment C and the constant amount supply device A, a fixed amount of content per capsule is intermittently injected between the two heated films F, and While being punched by the die provided on the die roll D, the segment C
Thus, the film F is heat-sealed to form the soft capsule product E containing the contents. Therefore, the heat-sealing property is an essential condition for encapsulation in the film F, but the film made of the linear β-1,3-glucan lacks the property and cannot be prepared by the single formulation. Then, the inventors of the present application examined various film-forming substances mixed with linear β-1,3-glucan, and found that the addition of gelatin, which is a water-soluble polymer having good heat-sealing property, was effective. . In this case, the blending amount of the linear β-1,3-glucan may be appropriately selected according to the purpose, but it is preferable to use gelatin because the condition that the film F has good heat sealability is required. To 1 to 10
%.

Further, the temperature of the segment C at this time is adjusted to 35 to 45 ° C. in the case of a usual gelatin film, but in the case of this method, it depends on the blending amount of the linear β-1,3-glucan. It is necessary to adjust appropriately, and the range is 4
It is preferable to adjust in the range of 5 to 60 ° C.

When the linear β-1,3-glucan is coated on the outside of the capsule film, the linear β-1,3-glucan of the linear β-1,3-glucan can be prepared by rolling a certain amount of the capsule in a coating pan, for example. It can be carried out by a method of spraying a dispersed solution such as water or an organic solvent on the surface of the capsule. It is also possible to immerse the capsule in the above dispersion solution, pull it up, and then dry it. In this case as well, the concentration of the linear β-1,3-glucan aqueous dispersion is not limited, but from the viewpoint of workability, it is preferable that the viscosity of the linear β-1,3-glucan dispersion is low, Specifically 1 to 1
0% is desirable.

If necessary, the capsule of the present invention can be used in the film, contents, and coating film in the same manner as in conventional capsules, such as plasticizers, colorants, light-shielding agents, preservatives, flavoring agents, emulsifiers, etc. Can be added.

[0012]

[Functions and effects] Linear β-1,3-glucan is a heat-coagulable gelling agent, and when heated to a temperature of 80 ° C or higher, a hard gel with high heat resistance and poor solubility can be formed. By using it as a film or capsule coating, the heat resistance during capsule processing is improved, and wax, hardened oil, etc. that require heating during processing can be used as the content. Regarding storage stability, mutual adhesion, container adhesion, leakage of contents, etc. will be eliminated even under high temperature and high humidity, and improvement in storage stability can be expected. On the other hand, when a capsule is taken as a drug or the like, other components in the capsule film are dissolved, but the linear β-1,3-glucan remains in a matrix form, and the capsule is used to control the solubility. Sustained release can be imparted.

When the capsule is coated with the linear β-1,3-glucan dispersion, a heat-resistant film of linear β-1,3-glucan is formed on the surface of the capsule, and the capsule film is formed. The same effect as when the straight-chain β-1,3-glucan was blended therein could be provided.

[0014]

EXAMPLES Hereinafter, one example of the present invention will be described in detail with reference to examples and experimental examples.

Example 1 A coating solution for producing soft capsules was prepared according to the coating formulation shown in Table 1. As for the sample A, the film formulation shown in Table 1 was mixed and dissolved in a usual manner, and then the viscosity was adjusted to 18,000 cps (6
The temperature was adjusted to 0 ° C.) to obtain a film liquid for producing a soft capsule. For sample B, linear β-1,3-glucan was added to a part of the water used, dispersed by high speed stirring using a cutter mixer, and gelatin and glycerin were dissolved in the remaining water and mixed and dissolved. After that, the viscosity is 18,000 cps
It was adjusted to (60 ° C.) to obtain a film liquid for producing a soft capsule.

[0016]

[Table 1] The following is an example of the formulation of the capsule coating solution of the samples A and B to be subjected to the relationship test between the temperature of the filling material and the capsule manufacturing. Experimental Example 1 Using the coating liquids “Sample A” and “Sample B” obtained in Example 1, an oval 5 type (of commonly used ellipsoidal sphere type) was used in a liner rotary capsule manufacturing apparatus. Capsule, same as below) was produced. At that time, the temperature of the vegetable oil to be filled was appropriately changed to perform the filling. As shown in Table 2, it was found that the capsule according to the present invention can form a capsule even when the filling material is at a high temperature and is excellent in heat resistance during processing, as compared with the conventional product.

[0017]

[Table 2] Relationship between filling material temperature and capsule manufacturing test results [Explanation of evaluation symbols] O ... Like the usual capsules, molding and filling could be performed well.

Δ: There was some deformation after filling, but it was possible to manufacture.

X: Liquid leakage occurred immediately after filling, and production was impossible.

Example 2 By the same film formulation as shown in Table 3, the film liquids "Sample 1" to "Sample 5" for producing soft capsules were prepared in the same manner as in Example 1. Using the obtained coating solution, an oval 5 type vegetable oil-containing soft capsule was manufactured with a rotary capsule manufacturing device manufactured by Liner. At that time, the temperature of the vegetable oil to be filled was normal temperature.

"Sample 6" is a film-coated capsule, which has a linear concentration of 8% linear β-1,3-
Dip the capsule of Sample 1 in an aqueous dispersion of glucan,
Obtained by hot-air drying.

[0022]

[Table 3] Caps of Specimen 1 to Specimen 5 to be subjected to disintegration time comparison experiment and adhesion test Experimental Example 2 The capsules of Samples 1 to 6 obtained in Example 2 were used as the first
2 A disintegration test was conducted according to the revised Japanese Pharmacopoeia. As shown in Table 4, the longer the disintegration time, the longer the linear β-1,3-glucan content. This suggests that the solubility can be imparted to the capsule by the amount of the linear β-1,3-glucan added. In addition, Sample 6 showed the longest disintegration as compared with the other samples.

[0023]

[Table 4] Comparative test results of disintegration time Experimental Example 3 In order to test the adhesion condition of the capsule under high temperature and high humidity, 10 balls of each of Sample 1 to Sample 6 were put into a No. 6 standard sample bottle, and 4
After storing at 0 ° C., 75% Rh and 30 ° C., 100% Rh in an open state for 24 hours, the following operation was performed, and the cumulative number of capsules dropped from the sample bottle after the operation was recorded.

1. Gently invert the sample bottle on the desk.

After the operation of 2.1, the sample bottle is dropped from a height of 1 cm on the desk.

After the operation of 3.2, the sample bottle is dropped from the height of 3 cm on the desk.

After the operation of 4.3, the sample bottle is dropped from the height of 5 cm on the desk.

The results are shown in Table 5, and the adhesion to the sample bottle and the mutual adhesion of the capsules to each other are linear β-1,3-
It was found that the improvement was observed in accordance with the increase of the glucan content.

[0029]

[Table 5] Adhesion test results

[0030]

As described above, the capsule according to the present invention utilizes the heat-coagulability of the linear β-1,3-glucan and uses it for the capsule base or capsule film. INDUSTRIAL APPLICABILITY As described above, the invention of the present application provides a capsule having a high melting point substance that can be used as a content due to improved heat resistance, and has high storage stability even under high temperature and high humidity. In addition, a sustained-release property can be optionally imparted to the capsule for administration.

On the other hand, when such an effect is coated on a capsule, linear β-1,3- is formed on the surface of the capsule.
A heat-resistant film of glucan was formed, and the same effect as when the straight-chain β-1,3-glucan was blended in the capsule film could be imparted.

[Brief description of drawings]

 A formulation example of the cell agent coating solution is shown below.

FIG. 1 Main part of rotary type capsule manufacturing device

[Explanation of symbols]

 A. Quantitative supply device (pump) B. Content supply device C. Segment D. Die roll E. Capsule F. Film (capsule film material)

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[Procedure amendment]

[Submission date] March 13, 1995

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be corrected] 0022

[Correction method] Change

[Correction content]

[0022]

[Table 3] Experimental Example 2 The capsules of Samples 1 to 6 obtained in Example 2 were used as the first
2 A disintegration test was conducted according to the revised Japanese Pharmacopoeia. As shown in Table 4, the longer the disintegration time, the longer the linear β-1,3-glucan content. This suggests that the solubility can be imparted to the capsule by the amount of the linear β-1,3-glucan added. In addition, Sample 6 showed the longest disintegration as compared with the other samples.

Claims (3)

[Claims] 1. A capsule containing straight-chain β-1,3-glucan as a film base. 2. A capsule comprising a film base containing straight chain β-1,3-glucan and gelatin. 3. A capsule comprising a film of linear β-1,3-glucan or a film containing linear β-1,3-glucan.