JP7044360B2 - Coating agent for hard capsules and manufacturing method of hard capsules using it - Google Patents

Description

The present invention relates to a coating agent for hard capsules used for coating hard capsules used in the fields of foods such as health foods or functional foods, pharmaceuticals, etc., and a method for producing a hard capsule using the same.

In order to impart enteric properties to hard capsules used in health foods and pharmaceuticals, an enteric film is formed on hard capsules (also referred to as "hard capsules"). This type of enteric-coated capsule generally separates an empty hard capsule into a cap and body to fill the body with the contents, then reattaches the body and cap to provide an enteric coating over the entire perimeter of the capsule. Manufactured by spraying the agent and drying with warm air.

However, in the above-mentioned manufacturing method, since the coating agent is continuously sprayed and dried, there is a problem that the contents filled in the capsule are inactivated by a load such as heat. Further, if the coating fails, the entire capsule filled with the contents must be discarded, which causes a problem of large loss.

Therefore, in Patent Document 1, an enteric coating agent is sprayed on an empty hard capsule in which the cap and the body are bonded in a semi-locked state, and the cap and the body are dried with warm air to form an enteric film in advance, and then the hard capsule. There has been proposed a technique of separating the cap and the body, filling the body with the contents, and connecting the body and the cap in a locked state by sandwiching a part of the enteric film in the gap between the body and the cap.

Japanese Patent Application Laid-Open No. 2003-325642

Generally, as an enteric coating agent, a shellac solution obtained by dissolving shellac in a solvent such as alcohol is used. However, as described in Patent Document 1, an enteric coating film is formed in advance on an empty hard capsule using a shellac solution, and the obtained capsule is supplied to a capsule filling device so that the body side is downward. When an attempt was made to separate the cap and the body by pulling out with a vacuum, there was a risk that the two would be difficult to separate and a capsule could not be filled with the contents.

Therefore, the present invention has been made in view of the above-mentioned points, and an object thereof is to provide a coating agent for hard capsules capable of improving the separability between a cap and a body of a hard capsule having an enteric coating film formed in advance. It is an object of the present invention to provide a method for efficiently producing a hard capsule by improving the separability between a cap and a body.

In order to solve the above problems, the coating agent for hard capsules of the present invention contains shellac and a coating film softening component, and has a solid content of 45 to 70% by weight of shellac and 10 to 35% by weight of the coating film softening component. contains. By forming a coating film on the hard capsule with this coating agent, the separability between the cap and the body of the capsule supplied to the capsule filling device is remarkably improved, and the contents can be smoothly filled.

It is also preferable that the above-mentioned coating film softening component is a glycerin fatty acid ester. As a result, a suitable component is selected as the coating film softening component.

Further, the method for producing a hard capsule of the present invention is a film forming step of applying or spraying the above-mentioned coating agent for hard capsule to an empty hard capsule composed of a cap and a body and drying the coating film to form a coating film on the empty hard capsule. It also has a separation step of separating the cap and the body of an empty hard capsule on which a coating film is formed, and a filling step of filling the body with the contents. This makes it possible to efficiently manufacture a hard capsule even in a manufacturing method in which a coating film is formed in advance on an empty hard capsule and then the contents are filled.

According to the present invention, it is possible to provide a coating agent for hard capsules having the following excellent effects.
(1) For a hard capsule having an enteric coating film formed in advance, the separability between the cap and the body can be improved, and the contents can be smoothly filled.
(2) Efficient production of hard capsules can be realized.

It is a photograph which shows the separation state of the hard capsule in Example 1 of this invention. It is a photograph which shows the separation state of the hard capsule in the comparative example 1 of this invention.

The coating agent for hard capsules of the present invention contains shellac and a coating film softening component, and contains 45 to 70% by weight of shellac and 10 to 35% by weight of the coating film softening component as solid content. This coating agent is used to form a coating film on an empty hard capsule. The hard capsule refers to a hard capsule composed of a cap and a body, and includes those formed of any known material such as gelatin, HPMC or pullulan. Further, the capsule mechanism includes a mechanism equipped with all fitting mechanisms such as a lock method and a snap fit method. The contents to be filled in the capsule are not particularly limited, and any foods such as health foods or functional foods, and any foods used in the field of pharmaceuticals and the like can be filled.

The shellac used in the present invention is a kind of natural resin, and is a substance obtained by purifying and processing the resinous secretions of Laccifer lacca and several kinds of scale insects closely related thereto. In the coating agent of the present invention, shellac is preferably contained in an amount of 45 to 70% by weight, more preferably 50 to 70% by weight, as a solid content. As the shellac, various commercially available shellac-containing products can be used, and the shellac is not particularly limited. -N811 (both products of Gifu Seratsuki Seisakusho Co., Ltd.), rack glaze 32E (products of Japan Shellac Industry Co., Ltd.) and the like can be mentioned.

Further, the coating film softening component used in the present invention is preferably contained in the coating agent in an amount of 10 to 35% by weight, more preferably 10 to 30% by weight, as a solid content. The coating film softening component may be any component that can soften the formed coating film, and specifically, a glycerin fatty acid ester is preferable. The glycerin fatty acid ester is not particularly limited, but is preferably used as a food additive. As an example, acetate monoglyceride, lactic acid monoglyceride, citric acid monoglyceride, diacetyl tartrate monoglyceride, succinic acid monoglyceride, polyglycerin fatty acid ester, and polyglycerin condensation Examples thereof include linoseic acid ester.

The coating agent of the present invention may further contain other components as a solid content. Other components include celluloses such as HPC, HPMC, MC, HEC, CMEC, HPMCP that stabilize the coating film, fats and oils, pH adjusters, starches, paraffins, sweeteners such as sugars, coloring agents, and fragrances. And so on.

In the coating agent of the present invention, the solvent of the solid content of shellac and the softening component of the coating film is preferably an alcohol solvent capable of dissolving shellac, and examples thereof include ethanol, methanol and isopropanol, but from the viewpoint of safety. Therefore, ethanol is particularly preferable. The mixing ratio of the solvent contained in the coating agent is preferably 70 to 90% by weight, more preferably 80 to 90% by weight.

The coating of the hard capsule with the coating agent of the present invention can be performed by using a breathable coating device, a fluidized bed coating device, or the like, but any method or device can be used as long as a coating film can be formed on the entire outer circumference of the hard capsule. Can be coated. The coating film is formed by spraying or applying the coating agent of the present invention to a hard capsule and then drying it to volatilize a solvent such as ethanol.

When the hard capsule on which the coating film is formed is separated into the cap and the body, the separation can be performed by using a device provided with a mechanism for separating the cap and the body of the capsule. Generally, a capsule filling device is used, and after the capsule is inserted into the capsule holder, the capsule body is pulled out from the body side of the holder by a vacuum device, so that the capsule is separated into a cap and a body. The separated body is filled with the contents and reattached to the cap to obtain the desired hard capsule.

Next, the action of the coating agent of the present invention will be described. When the inventor coats the hard capsule with a coating agent consisting only of shellac and ethanol, the coating agent is sprayed on the boundary portion between the cap and the body to form a powder pool, which is more a film than the other parts. I found that the thickness was getting bigger. Therefore, the inventor presumed that when the body of the capsule is pulled out from the body side of the capsule holder, the portion having a large film thickness becomes a resistance and the body is difficult to be pulled out. Since the coating film of the present invention contains a coating film softening component, the coating film has ductility, so that when the body of the capsule is pulled out in a vacuum, the powder pool portion having a large film thickness becomes plastic. It is considered that the body portion can be pulled out smoothly because the coating film becomes smooth due to the flow or the coating film becomes flexible.

Hereinafter, examples and comparative examples of the present invention will be shown, but the present invention is not limited to these examples.

The tests related to Examples and Comparative Examples were carried out by the following methods.
1. 1. Preparation of coating agent for hard capsules The coating agents used in the following Examples and Comparative Examples are ethanol (specific alcohol 99 degree primary fermentation; product of Nippon Alcohol Sales Co., Ltd.) and ethanol solution of purified cellac (Drack EAS-315; Co., Ltd.). Gifu Seratuku Seisakusho products, including 19.5% by weight of purified cellac, 3.9% by weight of hydroxypropyl cellulose, 2.1% by weight of sodium acetate, 1% of processed edible fats and oils and 73.5% by weight of ethanol), Prescribed glycerin fatty acid ester (Myverset 9-45K; Kerry Bio-Science product, containing 99.91% by weight of glycerin fatty acid ester, 0.07% by weight of mixed tocopherol and 0.02% by weight of citric acid as ingredients) Prepared by mixing in proportion.

2. 2. Coating on an empty hard capsule As an empty hard capsule, a hard capsule made of HPMC with a weight of 72.7 mg and a capacity of 0.49 mL (QUALI-V®-N HPMC Capsule No. 1; Qualicaps Co., Ltd.) Product) was used. 100 g of this empty hard capsule was charged into a breathable coating device (HICOATER (registered trademark) HCT-30; a product of Freund Sangyo Co., Ltd.), and the entire outer circumference of the hard capsule was coated with various coating agents. The coating conditions are an intake temperature of about 55 ° C., a capsule temperature of 37 to 40 ° C., a spray speed of 1.5 g / min, a spray pressure of 0.11 MPa, and a pan rotation speed of 15 rpm. Coating was applied until the weight was 25 mg. In this way, an empty hard capsule on which the coating film was formed was obtained.

3. 3. Separability of hard capsules on which a coating film is formed An empty hard capsule on which a coating film is formed as described above is placed in a capsule filling machine (CAP8 (registered trademark) capsule filling machine; a product of Capsgel Japan Co., Ltd.). I put it in. The charged capsule was held in a capsule holder having 420 holes for holding the capsule in a structure in which ring-shaped holders were stacked on the top and bottom. After 420 capsules were held in the capsule holder, the body side of the capsule was pulled out from below the hole of the ring holder on the body side (lower side) with a vacuum device. The tensile pressure of the vacuum device was 15 to 20 kPa. Regarding the separation status of the capsule cap and body after the withdrawal process, visually check the state of the cap side capsule holder and the body side capsule holder, record the number of capsules separated into the cap and body as the number of separations, and separate the capsules. Gender was evaluated.

[Example 1]
Add 200 g of purified celac ethanol solution (Drack EAS-315; Gifu Seratsk Manufacturing Co., Ltd. product) to 294 g of ethanol (specific alcohol 99 degree first grade fermentation; product of Japan Alcohol Trading Co., Ltd.) and dissolve by stirring at room temperature with a stirrer. did. To this, 6 g of a glycerin fatty acid ester (Myverset 9-45K; a product of Kerry Bio-Science) was added and dissolved by stirring to obtain a coating agent used in Example 1. The components contained in this coating agent and their blending ratios are as shown in Example 1 of Table 1 below. This coating agent was used to test coating on empty hard capsules and the separability of hard capsules on which a coating film was formed. The results are shown in Table 1 and FIG. 1 below.

[Example 2]
Add 200 g of purified celac ethanol solution (Drack EAS-315; Gifu Seratsk Manufacturing Co., Ltd. product) to 275 g of ethanol (specific alcohol 99 degree first grade fermentation; product of Japan Alcohol Trading Co., Ltd.) and dissolve by stirring at room temperature with a stirrer. did. To this, 25 g of a glycerin fatty acid ester (Myverset 9-45K; a product of Kerry Bio-Science) was added and dissolved by stirring to obtain a coating agent used in Example 2. The components contained in this coating agent and their blending ratios are as shown in Example 2 of Table 1 below. This coating agent was used to test coating on empty hard capsules and the separability of hard capsules on which a coating film was formed. The results are shown in Table 1 below.

[Comparative Example 1]
Add 200 g of purified celac ethanol solution (Drack EAS-315; Gifu Seratsk Manufacturing Co., Ltd. product) to 300 g of ethanol (specific alcohol 99 degree first grade fermentation; product of Japan Alcohol Trading Co., Ltd.) and dissolve by stirring at room temperature with a stirrer. Then, the coating agent used in Comparative Example 1 was obtained. The components contained in this coating agent and their blending ratios are as shown in Comparative Example 1 in Table 2 below. This coating agent was used to test coating on empty hard capsules and the separability of hard capsules on which a coating film was formed. The results are shown in Table 2 and FIG. 2 below.

[Comparative Example 2]
Add 200 g of purified celac ethanol solution (Drack EAS-315; Gifu Seratsk Manufacturing Co., Ltd. product) to 297 g of ethanol (specific alcohol 99 degree first grade fermentation; product of Japan Alcohol Trading Co., Ltd.) and dissolve by stirring at room temperature with a stirrer. did. To this, 3 g of a glycerin fatty acid ester (Myverset 9-45K; a product of Kerry Bio-Science) was added and dissolved by stirring to obtain a coating agent used in Comparative Example 2. The components contained in this coating agent and their blending ratios are as shown in Comparative Example 2 in Table 2 below. This coating agent was used to test coating on empty hard capsules and the separability of hard capsules on which a coating film was formed. The results are shown in Table 2 below.

According to the results of Examples 1 and 2 and Comparative Examples 1 and 2, the separation ratio of the cap and the body of the hard capsule is remarkably improved by containing a certain ratio of the glycerin fatty acid ester blended in the coating agent in terms of solid content. I understand. Specifically, by using a coating agent containing 10% by weight or more of glycerin fatty acid ester in terms of solid matter, the separation ratio between the capsule cap and the body becomes 100%, and the contents to an empty hard capsule without loss. It was clarified that the filling of the above can be performed (Examples 1 and 2). As shown in FIG. 1, in Example 1, since the capsule is surely separated into the cap and the body, the capsule cap is housed in the hole of the ring holder on the cap side (upper side), and the capsule body is on the body side. It is housed in the hole of the (lower) ring holder.

On the other hand, with a coating agent containing no glycerin fatty acid ester or a small amount of the glycerin fatty acid ester, the capsule cap and the body were not separated, and the separation ratio was 0% (Comparative Examples 1 and 2). As shown in FIG. 2, in Comparative Example 1, since the capsule was not separated at all, the body portion of the capsule is visible below the ring holder on the cap side (upper side).

From these facts, by blending the glycerin fatty acid ester with the coating agent in a predetermined ratio, the coating film becomes plastic, and the coating film formed thicker than the other parts at the boundary between the capsule cap and the body becomes plastic. It was considered that the separability between the cap and the body was improved by smoothing by the flow or by providing flexibility in the coating film. The amount of the glycerin fatty acid ester to be added to the coating agent may exceed 35% by weight as a solid content, but if the amount is too large, the moldability of the coating film may be affected. It was considered that 10 to 35% by weight of the solid content was particularly suitable.

The present invention is not limited to the above-described embodiments or examples, and various design-modified forms within the scope of the invention described in the claims are also included in the technical scope. ..

Claims (3)

A coating agent for hard capsules containing shellac and glycerin fatty acid ester , and containing 45 to 70% by weight of shellac and 10 to 35% by weight of glycerin fatty acid ester as solid content. The coating agent for hard capsules according to claim 1 , wherein the shellac is contained in an amount of 45% by weight or more and less than 70% by weight as a solid content . A film forming step of applying or spraying the coating agent for hard capsules according to claim 1 or 2 onto an empty hard capsule composed of a cap and a body and drying the empty hard capsule to form a coating film on the empty hard capsule.
The separation step of separating the cap and the body of the empty hard capsule on which the coating film is formed,
A method for producing a hard capsule, comprising a filling step of filling the body with contents.

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