JP5588134B2 - Capsule film - Google Patents

Description

  The present invention relates to a capsule film, a capsule using the capsule film, and a capsule manufacturing method.

  Capsules are used in a wide range of fields such as pharmaceuticals, foods, and cosmetics. The most widely used capsule base is gelatin. Gelatin capsules are inexpensive and non-toxic and exhibit excellent mechanical strength, disintegration, and the like. On the other hand, however, since gelatin is made from animals such as cattle, pigs and fish, there has been a problem that it has a peculiar animal odor.

In addition, a colorant is usually blended in the capsule from the viewpoint of imparting light-shielding properties, suppressing light change (discoloration, decomposition, etc.) of the capsule contents, and masking the contents. Coloring the capsule is also important from the viewpoint of providing distinctiveness and reducing accidental ingestion when ingested. Examples of the colorant used in the capsule include pigments such as titanium oxide, synthetic pigments such as tar pigments, and natural pigments such as carotenoid pigments, flavonoid pigments, and caramel pigments. In particular, titanium oxide and caramel color having excellent heat resistance and light resistance are widely used.
However, according to current Japanese laws and regulations, not only pigments and synthetic dyes, but also natural dyes must be labeled with additives. With the recent trend toward consumer health, there is an increasing demand for products that do not require additive labeling, and there is a demand for capsule films that have excellent light-shielding properties even without the addition of colorants. is there.

On the other hand, Tochu is a deciduous woody tree that is classified as a genus of a family belonging to the genus Eucommia and is a vine that reaches a height of 20 m. Tochu's bark and leaves are widely used as pharmaceuticals and food ingredients. A variety of effects are known for Tochu, for example, Tochu Naka has been shown to suppress hypertension (Non-patent Document 1), suppress hyperlipidemia (Patent Document 1), decrease serum VLDL, and reduce the incidence of cerebrovascular disorders (Non-patent Document 1). Patent Document 2) has been reported to have effects such as improvement of type 1 diabetes (insulin-dependent diabetes) (Non-patent Document 3). In addition, it has been reported that Tochu has a deodorizing effect on mercaptans and the like (Patent Document 2).
However, there has been no report of blending a processed product into a capsule film.

Japanese Patent No. 3435415 JP 2005-289952 A

Health Sciences 2005; vol. 21, no. 2: 198-210 Abstracts of Japanese Society of Nutrition and Food 52; 1998: 260 Diabetes Research and Clinical Practice 2005; 67: 22-28

  The present invention has been made in view of the above-described conventional problems and actual situations, and has an object to provide a capsule film that reduces gelatin-specific animal odor and has excellent light-shielding properties and a capsule using the capsule film. To do.

  The present inventor has conducted various studies to solve the problem, and as a result, if the processed starch is coexisted with the capsule film containing gelatin, the animal odor peculiar to gelatin is reduced, and the capsule film has light shielding properties. The present invention was completed by finding that it can be applied and useful for masking the capsule contents and suppressing light changes (discoloration, decomposition, etc.) of the contents due to transmitted light.

That is, this invention solves the said subject with the capsule membrane | film | coat characterized by containing gelatin and a processed product.
Moreover, this invention solves the said subject with the capsule obtained using the said capsule membrane | film | coat.
Further, the present invention provides the above-mentioned problem by a capsule manufacturing method, wherein the contents are filled in a capsule formed with a capsule film containing gelatin and a processed product, or encapsulated with the capsule film. It has been solved.

  ADVANTAGE OF THE INVENTION According to this invention, the capsule membrane | film | coat using the capsule membrane | film | coat with which the animal odor peculiar to gelatin, ie, gelatin odor, was reduced, and was excellent in light-shielding property can be provided. Since the capsule obtained by the present invention does not require an additive label, it meets the needs of consumers who desire a product that does not contain an additive.

The gelatin used in the present invention is produced, for example, by heating and extracting crude collagen obtained by treating with skin, bone, tendon, etc. of cattle, pigs, chickens, fish, etc., and treating with acid or alkali. Used. Further, gelatin hydrolyzate, oxygen decomposed product, gelatin derivatives such as acylated gelatin, and the like can also be used.
The jelly strength of gelatin is preferably from 100 to 300 g, particularly preferably from 120 to 270 g. The jelly strength can be measured according to JIS K-6503 (2001).

  The gelatin content in the capsule film may be appropriately examined in consideration of the mechanical strength of the capsule, the uniformity of the film at the time of molding, etc., but is preferably 50 to 85% by mass, particularly 65 to 80% by dry mass. Mass% is preferred.

  The processed product used in the present invention is a crushed product of Eucommia ulmoides oliver (including both coarse powder and fine powder), an extract obtained by extracting the solvent with a solvent, a diluted solution thereof, a concentrated solution, Dry powder, granules or pastes are included. A commercially available product may be used as the Tochu processed product, and the Tochu extract may be obtained through the extraction process described later.

The use site of Tochu is not particularly limited and can be appropriately selected. Examples thereof include leaves, bark, fruits, seeds, petiole, xylem, roots, rhizomes and the like. These can be used alone or in combination of two or more. Among these, it is preferable to use leaves from the viewpoint of reducing gelatin odor and imparting light shielding properties.
When extracting, these may be used as they are or may be subjected to pretreatment such as pulverization, cutting and drying.

The extraction method may be any of immersion, decoction, leaching, reflux extraction, supercritical extraction, ultrasonic extraction, microwave extraction, and the like.
As the extraction solvent, either a polar solvent or a nonpolar solvent can be used, and these can also be mixed and used. For example, water; alcohols such as methanol, ethanol, propanol and butanol; polyhydric alcohols such as ethylene glycol, propylene glycol and butylene glycol; ketones such as acetone and methyl ethyl ketone; esters such as methyl acetate and ethyl acetate; tetrahydrofuran Linear and cyclic ethers such as diethyl ether; polyethers such as polyethylene glycol; halogenated hydrocarbons such as dichloromethane, chloroform and carbon tetrachloride; hydrocarbons such as hexane, cyclohexane and petroleum ether; benzene and toluene Aromatic hydrocarbons such as; pyridines; supercritical carbon dioxide; oils, waxes, oils such as rapeseed oil, olive oil, soybean oil, etc., and these can be used alone or in combination of two or more. It is also possible to carry out repeatedly changed. Of these, water and alcohols are preferably used. Examples of water include tap water, purified water, distilled water, and ion exchange water.

  For extraction, for example, 1 to 50 parts by mass of a solvent is used per 1 part by mass of Tochu Nakaba, and it is immersed or heated to reflux at room temperature (25 ° C.) to 100 ° C. for 5 minutes to several hours, preferably 30 to 60 minutes. preferable.

  The Tochu extract used in the present invention may be a crude product as long as it conforms to food and pharmaceutical acceptable standards and exhibits the effects of the present invention. These purities may be increased by appropriately combining known separation and purification methods. Examples of the purification means include organic solvent precipitation, centrifugation, ultrafiltration membrane, high performance liquid chromatograph, column chromatograph and the like.

  It is preferable that geniposide acid is contained in the Tochu extract, and in the present invention, the geniposide acid concentration in the Tochu extract is preferably 6 to 100 mg / g, particularly preferably 20 to 80 mg / g. The geniposide acid concentration can be measured, for example, by the high performance liquid chromatograph method described in the examples below.

  The content of the processed product in the capsule film is preferably 1 part by mass or more with respect to 100 parts by mass of gelatin in terms of dry mass, from the viewpoint of reducing gelatin odor and imparting light shielding properties, and further 5 to 40 parts by mass, 8-20 mass parts is especially preferable. If the content of the processed product is more than 40 parts by mass, the viscosity becomes high and bubbles tend to remain in the film.

In the capsule film of the present invention, various additives used for the capsule film, for example, water-soluble polymers other than gelatin, plasticizers, preservatives, water activity lowering agents, pH adjusters and the like are blended as necessary. be able to.
Examples of the plasticizer include glycerin, sorbitol, propylene glycol, polyethylene glycol and the like. The content of the plasticizer in the capsule film is preferably 20 to 50 parts by mass, particularly preferably 30 to 40 parts by mass with respect to 100 parts by mass of gelatin from the viewpoint of flexibility.

  The capsule film can be produced according to a conventional method. For example, gelatin, a processed product, and further, if necessary, various additives may be stirred and dispersed in water, stirred and dissolved at 55 to 98 ° C., and then vacuum degassed. At this time, it is preferable to use the Tochu processed product after it is dissolved in water and filtered. As a filtration means, any of suction filtration, vacuum filtration, pressure filtration, centrifugal filtration, and natural filtration may be used. Further, a sieving means similar to the filtering means may be employed instead of a filter.

  A capsule can be obtained by forming the capsule film into a predetermined shape and drying it. Examples of the capsule include a soft capsule and a hard capsule, and among them, the soft capsule is preferable because the range in which the film thickness can be adjusted is wide.

  The shape of the capsule is not particularly limited, and examples thereof include an oval (football) type, an oblong (long ellipse) type, and a round (spherical) type.

The timing of forming the capsule film and filling the contents varies depending on the type of capsule, but for example, the capsule may be filled with the contents or encapsulated with the capsule film.
For example, soft capsules can be produced by a conventionally used method for producing soft capsules, such as a punching method using a rotary fully automatic soft capsule filling machine, a flat plate method, a dropping method, or the like.

  The capsule of the present invention can be used for various uses such as pharmaceuticals, quasi drugs, foods, and cosmetics, and the composition of the capsule contents is appropriately determined according to the use. The content may be in the form of a solution, a suspension, a paste, a powder, a granule or the like.

  Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited to these examples.

<Raw material>
The following materials were used.
Gelatin: manufactured by Nippi Co., Ltd., pig skin-derived acid-treated gelatin Glycerin: manufactured by Sakamoto Pharmaceutical Co., Ltd., food additive grade Tochu Nakaba extract: manufactured by Kobayashi Pharmaceutical Co., Ltd., powder raw material, geniposide acid concentration of 60 mg / g or more Caramel Dye: Food additive grade “BD-2” manufactured by Senba Saccharification Co., Ltd.

<Measurement of geniposide acid concentration>
The sample is filtered, diluted as appropriate, and a high-performance liquid chromatograph is used, and a packed column (YMC-Pack ODS-A, φ6 mm × 15 cm, manufactured by YMC Co., Ltd.) for octadecyl group-introduced liquid chromatograph is attached. , And measured at a flow rate of 1.0 ml / min. The mobile phase was a mixture of water, methanol and phosphoric acid, and the UV detector wavelength was 245 nm.

Example 1
(1) Preparation method After the Tochu Nakaba extract was dissolved in water, the solution residue was removed by natural sieving with a 75 μm sieve. After stirring and dispersing gelatin, glycerin, chunakaba extract (calculated in terms of dry mass) and caramel pigment in water in the amounts shown in Table 1, each sample was dissolved with stirring at 60 to 70 ° C., vacuum degassed, and sample 1-13 was obtained. Each sample was uniformly spread to a thickness of about 1 mm using a thin-layer chromatograph applicator and dried for 24 hours to obtain a film-like soft capsule film.

(2) Measurement of light-shielding property The light-shielding property of the soft capsule film obtained in the above (1) was measured using “absorbance with respect to air when the film thickness is 1 mm at a wavelength of 555 nm” as an index.
After measuring the thickness (D) [mm] of each film, the absorbance (A) was measured using “Spectrophotometer V-530 manufactured by JASCO Corporation” with air as a blank. Since the absorbance is proportional to the optical path length (8th edition Food Additives Official Manual (Yodogawa Shoten), page B-83 <16. UV-Vis Absorbance Measurement Method>), the absorbance value (A) is calculated from the optical path length (A). = Film thickness (D)) to correct for film thickness error.
The results are shown in Table 1.

  As is apparent from Table 1 above, it can be seen that light-shielding properties can be imparted by blending the nakanaka leaf extract. The light shielding property improves as the blending amount of the chunaka leaf extract increases. In particular, the transmittance of visible light is about 10% when the blending amount of the chunaka leaf extract is 5 parts by mass or more with respect to 100 parts by mass of gelatin. Thus, excellent light shielding properties can be obtained. On the other hand, when the blending amount of the chunaka leaf extract is increased, the viscosity becomes high and bubbles tend to remain in the film. Therefore, the blending amount of the chunaka leaf extract is 40 parts by mass or less, particularly 5 to 40 parts by mass. Was preferred.

Example 2
(1) Preparation Method In the same manner as in Example 1, the amounts of gelatin, glycerin, chunaka leaf extract (in terms of dry mass), and caramel color shown in Table 2 were each stirred and dispersed in water, followed by stirring at 70 ° C. Then, it was dissolved and vacuum degassed to obtain a capsule film. Using these capsule films, a rotary type fully automatic soft capsule filling machine was used to produce a vegetable oil-containing soft capsule (Test Example 1-13).

(2) Evaluation of gelatin odor 6 expert panels evaluated the “gelatin odor” of each soft capsule in accordance with the following evaluation criteria, and determined the average. The results are shown in Table 2. The “gelatin odor” means “a gelatinous animal odor”.
[Evaluation criteria for gelatin odor]
3: Strongly feel the gelatin odor 2: Feel the gelatin odor 1: Feel a little gelatin odor 0: Do not feel the gelatin odor

  As is apparent from Table 2, it can be seen that the gelatin odor is reduced by blending the nakanaka leaf extract. The reduction effect is exhibited as the blending amount of the chunaka leaf extract is increased. In particular, when the chunaka leaf extract is 1 part by mass or more, particularly 5 parts by mass or more with respect to 100 parts by mass of gelatin, a sufficient reduction effect is obtained. It was.

Claims (6)

Wherein gelatin, and in that it contains 1 to 40 parts by weight per 100 parts by weight of gelatin to geniposidic acid obtained by extraction with a solvent and the solvent extract of Eucommia leaf comprising 6~100mg / g on a dry weight in terms of Eucommia leaf Capsule film. The capsule film according to claim 1, wherein the solvent extract of Tochu Nakaba is an extract of Tochu Nakaba water and / or ethanol .   The capsule film according to claim 1 or 2, wherein the solvent extract of Tochu Nakaba is a dry powder of the solvent extract of Tochu Nakaba. The capsule film according to any one of claims 1 to 3 , wherein the capsule is a soft capsule. The capsule obtained using the capsule membrane | film | coat of any one of Claims 1-4 . The contents were, gelatin, and 1 to 40 parts by weight containing based on 100 parts by weight of gelatin geniposidic acid obtained by extraction with a solvent and the solvent extract of Eucommia leaf comprising 6~100mg / g on a dry weight in terms of Eucommia leaf A method for producing a capsule, comprising filling a capsule formed with a capsule film, or encapsulating with a capsule film.