JP6843376B2 - Capsule coating composition and capsule - Google Patents

Description

The present invention relates to a capsule film composition having improved disintegration property and a capsule using the same.

Generally, gelatin and a plasticizer are used as the film base material of the capsule. Gelatin is a hydrolyzate of collagen and is a substance that improves moldability by imparting gelling properties. A polyhydric alcohol such as glycerin or sorbitol is used as the plasticizer, and the film strength and the capsule strength are improved by imparting elasticity. However, in the capsule molded by the capsule film composition obtained by mixing gelatin and a plasticizer, the gelatin and the like constituting the capsule react with the components in the content to form a crosslinked structure, and water over time. There was a problem that the disintegration property of the film was lowered. In particular, when a material containing polyphenols or unsaturated fatty acids is included as the capsule content, the problem is remarkable.

Conventionally, capsule film compositions disclosed in Patent Documents 1 and 2 have been known. Patent Documents 1 and 2 prevent a decrease in the disintegration property of a capsule by blending an organic acid, vitamin C, and lecithin into the capsule film composition.

JP-A-59-39834 Japanese Unexamined Patent Publication No. 2011-77986

However, in the present technical field, a further effect of suppressing the decrease in the disintegration property of the capsule has been required.
An object of the present invention is to provide a capsule film composition having improved disintegration property and a capsule using the same.

The present invention has been made based on the finding that the disintegration property of a capsule can be improved by using a compound having a mercapto group.
In order to achieve the above object, one aspect of the present invention is a capsule film composition containing gelatin, a plasticizer, and a compound having a mercapto group, which has the mercapto group in the capsule film composition. The compound is characterized by a capsule film composition in which 0.15 mmol or more is blended with respect to 100 g of gelatin.

As the compound having a mercapto group, a natural material containing at least one selected from cysteine, glutathione, cysteamine, and coenzyme A may be used. In the capsule film composition, the compound having a mercapto group may be blended in an amount of 35 mmol or less with respect to 100 g of gelatin.

In another aspect of the present invention, the capsule coating composition comprises a capsule containing a material containing polyphenols or unsaturated fatty acids.

According to the present invention, the disintegration property of the capsule can be improved.

Hereinafter, embodiments in which the capsule film composition of the present invention is embodied will be described. Gelatin, which is the main component of the capsule film composition of the present embodiment, is a heat-decomposed product of collagen derived from cattle, pigs, fish, birds, etc., and is unique in that it has film-forming and gelling properties. It is a substance. That is, gelatin is excellent in moldability, for example, capsule moldability and film-forming property because it is excellent in fluidity even in a high concentration aqueous solution of, for example, about 40% by weight. Therefore, capsules using gelatin as a film base material can suitably protect the contents thereof. Further, since gelatin has a gelling property that reversibly undergoes a sol-gel transition depending on the temperature, the capsule can be easily molded by utilizing the sol-gel transition. As the gelatin, any of acid-treated gelatin, alkali-treated gelatin, peptide gelatin and the like can be used. Of these specific examples of gelatin, only one type may be used alone, or two or more types may be used in combination. The gelatin content can be appropriately set from the viewpoint of improving moldability and strength, but the lower limit of the gelatin content in the solid content other than water of the capsule film composition is preferably 30% by mass or more. More preferably, it is 40% by mass or more. By setting it to 30% by mass or more, the strength can be further improved. The upper limit of the gelatin content is preferably 90% by mass or less, more preferably 80% by mass or less in the solid content. By setting the content to 90% by mass or less, the moldability can be further improved.

The plasticizer is formulated to further improve the flexibility of the capsules obtained by the capsule coating composition. Examples of the plasticizer include polyhydric alcohols and sugars. Examples of polyhydric alcohols include sugar alcohols, glycerins, and glycols. Specific examples of sugar alcohols include erythritol, maltitol, mannitol, sorbitol, xylitol, cyclitol, alditol, reduced starch syrup, and the like. Specific examples of glycerins include glycerin, diglycerin, polyglycerin and the like. Specific examples of glycols include ethylene glycol, polyethylene glycol, isopentyldiol, propylene glycol, dipropylene glycol, 1,3-butylene glycol and the like. Specific examples of saccharides include glucose, fructose, sucrose and the like. Of the specific examples of these plasticizers, only one type may be used alone, or two or more types may be used in combination. Among these, glycerin is preferably applied from the viewpoint of improving the strength.

The content of the plasticizer can be appropriately set from the viewpoint of improving moldability and flexibility, but the lower limit of the content of the plasticizer in the solid content is preferably 10% by mass or more, more preferably 20% by mass. That is all. By setting the lower limit of the content to 10% by mass or more, the flexibility can be further improved. The upper limit of the content of the plasticizer in the solid content is preferably 50% by mass or less, more preferably 40% by mass or less. By setting the upper limit of the content to 50% by mass or less, the moldability can be further improved.

The lower limit of the content of the plasticizer with respect to 100 parts by mass of gelatin is preferably 20 parts by mass or more, more preferably 30 parts by mass or more. By setting the lower limit of the content to 20 parts by mass or more, the flexibility can be further improved. The upper limit of the content of the plasticizer with respect to 100 parts by mass of gelatin is preferably 65 parts by mass or less, and more preferably 55 parts by mass or less. By setting the lower limit of the content to 65 parts by mass or less, the moldability can be further improved.

The compound having a mercapto group is blended in order to suppress the reaction between the capsule film component and the inclusion component and improve the disintegration property of the capsule. Specific examples of the compound having a mercapto group include cysteine, glutathione, cysteamine, coenzyme A, derivatives thereof and the like. Specific examples of the coenzyme A derivative include acetyl CoA, succinyl CoA, and the like. Of the specific examples of these compounds having a mercapto group, only one type may be used alone, or two or more types may be used in combination. Among these, cysteine and glutathione are preferably applied from the viewpoint of having a high effect of suppressing the disintegration delay of the capsule film composition and being easily available.

The compounding form of the compound having a mercapto group is not particularly limited, and for example, a natural material containing a compound having a mercapto group may be blended, and an extract obtained by extraction treatment from such a natural material may be blended. , Refined products and the like may be applied. Further, the compound itself having a mercapto group obtained from a biochemical product, a chemically synthesized product, a commercially available product, or the like may be blended. Examples of natural materials containing a large amount of cysteine include red pepper, garlic, onions, broccoli, Brussels sprouts, oats, wheat germ, yeast or plants having an increased content of cysteine, and the like. Examples of natural materials containing a large amount of glutathione include spinach, cabbage, pumpkin, liver, cod, yeast with an increased content of glutathione, and plants.

The lower limit of the content of the compound having a mercapto group in the capsule film composition is 0.15 mmol or more, preferably 0.4 mmol or more, and more preferably 0.8 mmol or more with respect to 100 g of gelatin. By blending 0.15 mmol or more with respect to 100 g of gelatin, the reaction between the capsule film component and the encapsulating component can be suppressed, and the decrease in the disintegration property of the capsule can be further suppressed.

The upper limit of the content of the compound having a mercapto group in the capsule film composition is appropriately set, but is preferably 35 mmol or less, more preferably 25 mmol or less, based on 100 g of gelatin. By blending 35 mmol or less with respect to 100 g of gelatin, it is possible to suppress a decrease in the sheet moldability of the capsule film composition or the moldability during the production of capsules.

An appropriate amount of water may be added to the capsule film composition of the present embodiment at the time of production. The amount of water added during production is appropriately set in consideration of the ratio of solid components, type, viscosity, mixing property, production equipment, drying efficiency of the film, and the like. The lower limit of the amount of water added to 100 parts by mass of the solid content of the capsule film composition is preferably 30 parts by mass or more, more preferably 45 parts by mass or more, and further preferably 60 parts by mass or more. On the other hand, the upper limit of the amount of water added is preferably 200 parts by mass or less, more preferably 150 parts by mass or less, and further preferably 100 parts by mass or less.

Next, the action and production method of the capsule film composition of the present embodiment will be described.
In the method for producing a capsule film composition of the present embodiment, a step of first blending the above-mentioned various raw materials and uniformly kneading them at a predetermined temperature (preferably heating conditions) to obtain a raw material mixed solution (prepared solution) is performed. Next, it can be manufactured by molding it into a sheet using a known manufacturing apparatus and passing it through a step of drying.

Further, as a method for producing a capsule using the capsule film composition of the present embodiment, a known method can be appropriately adopted. Further, the capsule film composition is not limited to the film for soft capsules, and may be applied to a film for hard capsules, a film for seamless capsules, and the like. For example, when the capsule film composition of the present embodiment is applied to a soft capsule, it comprises a step of producing a soft capsule film formulation and a step of molding the soft capsule film formulation into a sheet and including a filling component. As the encapsulation step of the filling component, for example, a punching method capable of encapsulating a relatively large amount of contents with high production efficiency can be adopted. The punching method is a method of producing a gel-like sheet from the soft capsule film preparation solution and punching it into a capsule shape with a mold. More specifically, a rotary die method in which a soft capsule is molded while filling the contents can be mentioned. The rotary die method is a molding method in which a gel-like sheet is punched out by rotation of two cylindrical molded die rolls and at the same time an internal solution is filled by a pump, and the joint of the capsule is crimped by the pressure and heat of the die roll. It is a method of sealing. The rotary die method can be carried out by a known device, for example, a rotary die type capsule filling machine.

The field to which the capsule film composition of the present embodiment is applied is not particularly limited, and can be preferably applied in each field of foods and drinks, pharmaceuticals, cosmetics and the like. Further, the capsule filling component contained in the capsule film composition may be a liquid or a solid such as a powder. In addition, the contents to be filled (encapsulated) in capsules are not particularly limited, and are food ingredients such as health foods, foods for specified health use, foods with functional claims, supplements, and pharmaceuticals for the purpose of exerting specific effects. Examples include various active ingredients such as ingredients and cosmetic ingredients.

Specific examples of the contents are not particularly limited, but for example, polyphenols, unsaturated fatty acids, natural materials containing these components, and the like are preferably applied. Examples of polyphenols include flavonoids and phenolic acids. Specific examples of unsaturated fatty acids include polyunsaturated fatty acids of ω3 fatty acids such as α-linolenic acid, stearidonic acid, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA), linolenic acid, γ-linolenic acid, and arachidonic acid. Examples thereof include polyunsaturated fatty acids of ω6 fatty acids, oleic acid which is a monounsaturated fatty acid of ω9 fatty acids, and the like. Specific examples of natural materials include plants such as vegetables, fruits and seeds, animals such as placenta and liver, microorganisms such as yeast, lactic acid bacteria and spirulina, beekeeping products such as propolis and royal jelly, and their extract components and various fermentations. Examples include food and fish oil. These materials are particularly liable to react with the components constituting the capsule film composition, and the disintegration property of the capsule with respect to water is lowered with time. Since the capsule film composition of the present embodiment contains a compound having a mercapto group, it is possible to suppress the reaction between polyphenols and unsaturated fatty acids and the components constituting the capsule film composition. Thereby, polyphenols or unsaturated fatty acids can be filled in the capsule and stored without lowering the disintegration property of the capsule film.

The effects exhibited by this embodiment will be described below.
(1) The capsule film composition of the present embodiment contains gelatin, a plasticizer, and a compound having a mercapto group. Therefore, the disintegration property of the capsule with respect to water can be improved.

Conventionally, the capsule film composition has a problem that it reacts with a component in the content to form a crosslinked structure, and its disintegration property with water decreases with time. For example, when a polyphenol-containing material or an unsaturated fatty acid is included as the content, the delay in disintegration of the film is particularly remarkable. Even when a polyphenol-containing material or an unsaturated fatty acid is applied as the content, the disintegration property of the capsule with respect to water can be improved.

(2) In the capsule film composition of the present embodiment, a compound having a mercapto group is blended in an amount of 0.15 mmol or more with respect to 100 g of gelatin. Therefore, it is possible to effectively exert the effect of suppressing the decrease in the disintegration property of the capsule with respect to water.

(3) In the capsule film composition of the present embodiment, when the compounding amount of the compound having a mercapto group is 35 mmol or less with respect to 100 g of gelatin, the film-forming property when molding the capsule film composition into a sheet, or It is possible to suppress a decrease in moldability when molding into a capsule shape. More specifically, it is possible to suppress an increase in the viscosity of the preparation liquid when the capsule film composition is prepared.

The above embodiment may be changed as follows.
-Capsules that are molded or filled with contents may be packaged and stored in a packaging form such as bottled packaging, PTP packaging, or pouch.

-The film thickness of the capsule film composition is appropriately set according to the purpose and application of the capsule. For example, the film thickness of the capsule film composition is preferably 0.1 mm or more, more preferably 0.4 mm or more, still more preferably 0.7 mm or more. On the other hand, the film thickness of the capsule film composition is preferably 2 mm or less, more preferably 1.5 mm or less, still more preferably 1.2 mm or less. By defining the film thickness of the capsule film composition within such a range, moldability and strength retention can be further improved.

-The shape of the capsule molded by the capsule film composition is not particularly limited, and examples thereof include an elliptical shape, an oblong shape, a spherical shape, a drop shape, a teardrop shape, and a triangular shape in terms of cross-sectional shape or outer shape.

-The capsule film composition may appropriately contain other known additives usually used for producing the capsule film composition, as long as the effects of the present invention are not impaired.

Hereinafter, the above-described embodiment will be described in more detail with reference to test examples, but the present invention is not limited thereto. Hereinafter, Example 13 will be replaced with Reference Example 13.
<Test Example 1: Disintegration test of capsule film composition>
(Manufacturing of capsule film composition)
Capsule film compositions containing each of the components shown in Tables 1 and 2 were prepared. The numerical value in the column indicating each component in each table indicates the content of the component in the column, and the unit thereof is parts by mass. The content of the yeast extract in Table 1 indicates the blending amount of the raw material itself shown in Table 2.

Specifically, first, raw materials other than gelatin shown in Table 1 were added to water (hot water), and if necessary, the mixture was thoroughly stirred while being dissolved in a 70 ° C. water bath. Next, gelatin was added, stirred, heated to 80 ° C. to dissolve, and then defoamed to prepare a viscous soft capsule film preparation solution. Next, by a film molding process using a control coater (manufactured by Imoto Seisakusho Co., Ltd.), the soft capsule film preparation solution is molded into a sheet having a thickness of 1.0 mm and allowed to stand to dry until the film moisture becomes about 10% by mass. As a result, a sheet-shaped capsule film composition was produced. The test pieces of each example were obtained by cutting the sheet into 1 cm squares.

(Collapse test)
First, put a soft capsule content liquid containing a high amount of bilberry extract (43.4% by mass of vegetable oil, 8.4% by mass of a mixture of emulsifier and honeybee, 48.2% by mass of bilberry extract powder: 100% by mass in total) in a chalet. Each test piece was immersed and stored in a constant temperature bath at 50 ° C. Next, after 4 days or 7 days, each test piece was taken out and the chemical solution on the surface was wiped off. Next, hot water at 70 ° C. and a test piece were placed in a beaker, and the mixture was stirred with a stirrer at 900 rpm for 7 minutes.

The residue of the insoluble matter of the test piece after stirring for 7 minutes with a stirrer was visually observed and evaluated according to the following criteria. ◎ when there is no insoluble matter, ○ when a small amount of insoluble matter residue (for example, fine filamentous insoluble matter) is observed, △ when a slightly large amount of insoluble matter residue (for example, yarn-like insoluble matter) is observed. The case where a large amount of insoluble matter (for example, a film-like insoluble matter) was observed was marked with x. The results are shown in Table 1.

(Evaluation of film properties (viscosity))
Conventionally, if the viscosity of the formulation is reduced or the surface is sticky immediately after the sheet is made, the film strength may be insufficient and the capsule may be cut or the shape may be lost when the capsule is molded with the rotary die type capsule filling machine. In some cases, the adhesive strength may be weakened or the capsule moldability may be lowered. According to the configuration of the present embodiment, it is possible to suppress the stickiness of the film surface and shorten the drying time of the sheet surface by suppressing the decrease in the viscosity of the preparation solution which is considered to be generated by the hydrolysis of gelatin or the like.

The viscosity of the film formulation and the stickiness of the surface immediately after the sheet-like film was formed were confirmed, and the film properties were evaluated according to the following criteria. When the viscosity of the film formulation is sufficient and the sheet surface is not sticky, the viscosity of the film formulation is reduced, but when the sheet surface is not sticky, the viscosity of the film formulation is significantly reduced. , The case where the sheet surface is sticky is marked with x. The results are shown in Table 1.

As shown in each example of Table 1, it was confirmed that the disintegration property was improved by adding the compound having a mercapto group to the capsule film composition. In Comparative Example 3 in which 1 part by mass of vitamin C, which is known to exhibit reducing property like the compound having a mercapto group, was added instead of the compound having a mercapto group, the effect of improving the disintegration property was not obtained. .. In addition, deterioration of film properties was observed.

<Test Example 2: Disintegration and film-forming test when glutathione content is changed>
A test piece composed of a capsule film composition containing each component shown in Table 3 was produced. As the method for producing the test piece, the same method as in Test Example 1 was adopted. Using each test piece, a disintegration test was conducted in the same manner as in Test Example 1 above. The results are shown in Table 3.

(Evaluation of film forming property)
The film-forming property when molding into a sheet having a thickness of 1.0 mm was evaluated according to the following criteria. ○ when the fluidity of the formulation is good and a uniform sheet can be molded, △ when the fluidity of the formulation is low, but △ when a uniform sheet can be molded, the formulation becomes highly viscous and uniform. The case where a simple sheet cannot be molded was marked with x. The results are shown in Table 3.

As shown in Table 3, it was confirmed that when the glutathione content was 0.098 mmol / gelatin 100 g, no disintegration property was obtained. On the other hand, when the glutathione content was 39 mmol / 100 g of gelatin, it was confirmed that disintegration property was obtained, but good film formation property was not obtained.

<Test Example 3: Disintegration test when the type of contents is changed>
The disintegration test was performed by changing the type of the content liquid of the soft capsule in which the test piece was immersed. Intrasoft capsule solutions containing each of the components shown in Table 4 were prepared. The numerical value in the column indicating each component in Table 4 indicates the content of the component in the column, and the unit thereof is mass%. As the test piece to be used, the test piece obtained from the capsule film composition of Example 1 and Comparative Example 1 was used. Other test methods were carried out in the same manner as in the disintegration test of Test Example 1. The results are shown in Table 4.

As shown in Table 4, even if the contents are propolis extract (polyphenol-containing composition) and DHA (unsaturated fatty acid), the disintegration property is improved by using the capsule film composition of this example. It was confirmed that

<Test Example 4: Disintegration test when molded into capsules>
After molding the capsule from the sheet-shaped capsule film composition, the disintegration property of the capsule was evaluated. Using each of the capsule film compositions of Example 1 and Comparative Example 1 prepared in Test Example 1, soft capsules were produced by a rotary die method. OVAL-6 was used as the mold. Using a rotary die-type capsule filling machine (manufactured by Sankyo Co., Ltd.), a soft capsule having a film thickness of 1.0 mm was prepared while containing 300 mg of the soft capsule content liquid containing a high amount of bilberry extract used in Test Example 1 as the content. The soft capsules of each example prepared were stored in a constant temperature / humidity bath at 40 ° C. and 75% RH. Capsule disintegration was evaluated for each capsule before storage, for a storage period of 2 weeks, and for 1 month according to the method shown below.

(Capsule disintegration)
The procedure was carried out in accordance with the 6.09 disintegration test method described in the general test method of the 16th revision of the Japanese Pharmacopoeia. However, water was used as the test solution. As a collapse tester, NT-20HS manufactured by Toyama Sangyo Co., Ltd. was used. One capsule of each example was put into a test solution (900 mL), and an auxiliary plate was placed in a glass tube to perform the test. The test time was measured, and if it did not disintegrate within 120 minutes from the start of the test, it was regarded as "insoluble". The results are shown in Table 5.

As shown in Table 5, it was confirmed that the disintegration property was improved even when the capsule film composition of Example 1 was actually molded into a soft capsule.

Next, the technical ideas that can be grasped from the above-described embodiment and other examples will be added below together with their effects.
(A) The capsule film composition in which the compound having a mercapto group is blended as yeast or yeast extract. According to the configuration of (a), it is easy to obtain and the applicability of living body ingestion can be further improved.

Claims (3)

A capsule coating composition containing gelatin, a plasticizer, and at least one selected from cysteine, glutathione, and cysteamine as compounds having a mercapto group.
A capsule film composition in which the compound having a mercapto group is blended in 0.15 mmol or more and 35 mmol or less with respect to 100 g of gelatin. The capsule film composition according to claim 1, wherein the compound having a mercapto group is a natural material containing at least one selected from cysteine, glutathione, and cysteamine. A capsule containing a material containing polyphenols or unsaturated fatty acids according to the capsule film composition according to claim 1 or 2.