HK1247570A1 - Composition for soft capsule shell - Google Patents

Description

Composition for soft capsule coating

Technical Field

The present invention relates to a composition for a soft capsule coating, a soft capsule coating formed from the composition for a soft capsule coating, and a soft capsule in which the soft capsule coating is filled with a capsule content. The soft capsule of the present invention is excellent in plasticity and softness, and has gloss and transparency.

Background

When the content enclosed in the soft capsule is a liquid (solution or suspension), the volume thereof changes greatly with a change in the temperature of the environment, and therefore the soft capsule film needs plasticity and flexibility. When the soft capsule film lacks plasticity and flexibility, the soft capsule film may be cracked due to a change in volume of the contents, and the contents may leak out. Therefore, a plasticizer is added to the soft capsule film to improve plasticity and flexibility.

As the plasticizer, glycerin is often used. Glycerin has a hygroscopic property and a moisturizing effect, but a soft capsule coating containing glycerin softens under high temperature and high humidity conditions and tends to make the surface sticky, and therefore a soft capsule having this soft capsule coating has the following problems: during the preservation process, the adhesion occurs between the soft capsules or between the soft capsules and the preservation container.

In addition, in the soft capsule film, sorbitol may be used as a plasticizer together with glycerin, but it is known that sorbitol crystals precipitate in the soft capsule film containing sorbitol due to the influence of drying conditions. Soft capsules have high market value in terms of transparent appearance, and therefore, the appearance thereof is seriously impaired by crystallization.

A soft capsule coating of a soft capsule in which glycerin is not used in order to solve the above problems is reported (patent document 1). However, since glycerin is safe and readily available, there is a need for a soft capsule that is not sticky even when glycerin is used as a plasticizer and has an excellent appearance.

On the other hand, in a soft capsule for enclosing Ibuprofen (Ibuprofen), a soft capsule coating film to be used utilizes a base containing gelatin as a main component and a plasticizer containing special sorbitol (a mixture of sorbitol and sorbitan) and maltitol as main components (patent document 2). Further, for the purpose of obtaining a soft capsule from a non-gelatin substance, a soft capsule coating film using a base agent composed of kappa-carrageenan (kappa-carrageenan), iota-carrageenan (iota-carrageenan) and sodium starch octenyl succinate, and a plasticizer composed of a special sorbitol (a mixture of sorbitol and sorbitan), a maltitol syrup and glycerin has been disclosed (patent document 3).

The sorbitan has the effect of preventing sorbitol from crystallizing and keeping a soft capsule film transparent. However, since sorbitan is an additive which is not included in the list of specified additives approved by japan's ministry of health and labor and the list of conventional additives, it is desired that the transparency of the soft capsule film can be obtained without using sorbitan.

Further, it is described that a soft capsule film of a soft capsule which is easily chewed after a long period of time and can maintain solubility contains gelatin, glycerin, maltitol and sorbitol (patent document 4). However, it is not known that a soft capsule using a soft capsule coating film (obtained by blending each component in a base composed of gelatin, or carrageenan and starch, and a plasticizer composed of glycerin, maltitol, and sorbitol at a specific ratio) is excellent in gloss and transparency.

Documents of the prior art

Patent document

Patent document 1: japanese patent laid-open publication No. 2013-203671

Patent document 2: japanese patent application laid-open No. 2003-508432

Patent document 3: japanese Kohyo publication No. 2007-524527

Patent document 4: chinese patent No. 101711875 gazette

Disclosure of Invention

Problems to be solved by the invention

The present invention addresses the problem of providing a soft capsule which, despite the use of glycerin as a plasticizer, is less likely to cause softening of the soft capsule coating and surface stickiness, and which has excellent gloss and transparency.

Means for solving the problems

A composition for soft capsule coating is prepared by mixing a base mainly composed of gelatin or a mixture of starch and carrageenan and a plasticizer mainly composed of sorbitol, maltitol and glycerin at a specific ratio, and a capsule coating formed from the composition for soft capsule coating is excellent in plasticity and flexibility, and can form a soft capsule which is free from adhesion between capsules and a container and is excellent in gloss and transparency. The soft capsule of the present invention can maintain flexibility even when it contains a composition having a property of easily becoming hard with time under severe conditions as a capsule content.

That is, the present invention relates to the following.

(1) A composition for a soft capsule coating film, comprising: a base agent comprising gelatin or a mixture of starch and carrageenan as a main component; and a plasticizer comprising sorbitol, maltitol and glycerin as main components, wherein when the base is a base comprising gelatin as a main component, sorbitol, maltitol and glycerin are contained in the plasticizer in an amount of 1 to 15 parts by mass, 1 to 30 parts by mass and 40 to 60 parts by mass, respectively, based on 100 parts by mass of the gelatin;

when the base is a base mainly composed of a mixture of starches and carrageenan, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 30 to 60 parts by mass of glycerin, based on 100 parts by mass of the mixture of starches and carrageenan.

(2) The composition for a soft capsule film according to (1), wherein the starch is one or more starches selected from the group consisting of oxidized starch, starch dispersion, moist heat-treated starch and acid-treated starch.

(3) The composition for a soft capsule film according to (1) or (2), wherein the carrageenan is kappa-carrageenan and/or iota-carrageenan.

(4) A soft capsule coating film comprising the composition for a soft capsule coating film according to any one of (1) to (3).

(5) A soft capsule, wherein the capsule content is filled in the soft capsule envelope in (4).

(6) A method for producing a soft capsule, characterized by forming a film of a composition for a soft capsule envelope into a soft capsule envelope and filling the capsule content, wherein the composition for a soft capsule envelope comprises: a base agent comprising gelatin or a mixture of starch and carrageenan as a main component; and a plasticizer containing sorbitol, maltitol and glycerin as main components,

in the production method, when the base is a base mainly composed of gelatin, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 40 to 60 parts by mass of glycerin, based on 100 parts by mass of gelatin;

when the base is a base mainly composed of a mixture of starches and carrageenan, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 30 to 60 parts by mass of glycerin, based on 100 parts by mass of the mixture of starches and carrageenan.

(7) The process for producing a soft capsule according to (6), wherein the starch is one or more starches selected from the group consisting of oxidized starch, starch dispersion, moist heat-treated starch and acid-treated starch.

(8) The process for producing a soft capsule according to (6) or (7), wherein the carrageenan is kappa-carrageenan and/or iota-carrageenan.

Effects of the invention

The soft capsule coating of the present invention obtained by using the composition for a soft capsule coating of the present invention is excellent in plasticity and flexibility. The soft capsule of the present invention formed of the soft capsule coating film is transparent, and therefore, the content liquid can be visually observed, and the soft capsule also has gloss, so that the soft capsule has excellent appearance and high commercial value. In addition, the soft capsule of the present invention is excellent in surface moisture retention and does not have the problem of cracking.

Detailed Description

(composition for Soft Capsule coating)

The composition for a soft capsule coating film of the present invention contains: a base agent comprising gelatin or a mixture of starch and carrageenan as a main component; and a plasticizer comprising sorbitol, maltitol and glycerin as main components, wherein when the base is a base comprising gelatin as a main component, the plasticizer comprises 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol and 40 to 60 parts by mass of glycerin per 100 parts by mass of gelatin; when the base is a base mainly composed of a mixture of starches and carrageenan, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 30 to 60 parts by mass of glycerin, based on 100 parts by mass of the mixture of starches and carrageenan, and is not particularly limited as long as the above composition is used. The method for producing a soft capsule of the present invention is a method for forming a film of a composition for a soft capsule film comprising a base mainly composed of gelatin and a plasticizer mainly composed of 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol and 40 to 60 parts by mass of glycerin with respect to 100 parts by mass of gelatin, molding the film into a soft capsule film, and filling the capsule with the capsule content; alternatively, the composition for soft capsule coating is not particularly limited as long as it is a composition for soft capsule coating comprising a base mainly composed of a mixture of starches and carrageenans and a plasticizer mainly composed of 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol and 30 to 60 parts by mass of glycerin with respect to 100 parts by mass of the mixture of starches and carrageenans, and the main component is a component having a content of 60% by mass or more, preferably 70% by mass or more, more preferably 80% by mass or more, 90% by mass or more or 95 to 100% by mass. The composition for a soft capsule film of the present invention may contain water and optional additives in addition to the base and plasticizer, and the form thereof is not particularly limited, and may be a solution, a suspension, an emulsion or a paste, or may be a powder, a granule or a solid, and it may be dissolved or dispersed in water or other liquid materials. Examples of the additives include: natural pigment, synthetic pigment, various sweeteners, preservatives, water activity reducing agent, pH regulator, etc.

Examples of the gelatin include: gelatin is produced by heating and extracting crude collagen obtained by treating, for example, skins, bones, tendons, and the like of cattle, pigs, chickens, and fish as a raw material with an acid or an alkali. As the gelatin, a hydrolysate or hydrolysate of gelatin, a modified gelatin such as succinylated gelatin or phthaloylated gelatin, or the like may be used. Any kind of gelatin may be preferably used.

The gelatin preferably has a gel strength of 100 to 300g, more preferably 130 to 250 g. The gel strength can be measured in accordance with JIS K-6503 (2001).

Examples of the starch include: potato starch, corn starch, tapioca starch, wheat starch, rice starch, and processed starches obtained by subjecting these starches to various processes such as physical processing and chemical processing, either alone or in combination.

examples of the processed starch to which physical processing is applied include an alphatized starch, a moist heat-treated starch, a starch dispersion obtained by subjecting a starch paste to ultrasonic treatment, and examples of the processed starch to which chemical processing is applied include an etherified starch (hydroxypropyl starch, carboxymethyl starch, etc.), an esterified starch (acetic starch, octenyl succinic acid starch, phosphorylated starch, acetylated starch, etc.), a crosslinked starch (phosphoric acid crosslinked starch, adipic acid crosslinked starch, etc.), an oxidized starch, an acid-treated starch, and the like.

The oxidized starch is obtained by oxidizing starch with an oxidizing agent. For convenience, low-viscosity, self-modified starch obtained by thermochemically treating starch with an oxidizing agent is also included in the oxidized starch. The oxidizing agent is not particularly limited, and examples thereof include: alkali metal hypochlorite such as sodium hypochlorite; alkaline earth metal salts of hypochlorous acid such as calcium hypochlorite; alkali metal chlorite salts such as sodium chlorite and potassium chlorite; alkaline earth metal chlorite salts such as barium chlorite and the like.

The carboxyl group content of the oxidized starch is preferably 1.1% by mass or less, and particularly preferably 0.8% by mass or less. Quantification of carboxyl groups in starch was carried out according to the method described in Juanshi labour Notification No. 485 (No. 216, page 28 to 35, outside the 10.1.10.2008 (in 20. years).) (see electronic government web pages: http:// search. e-gov. go. jp/servlet/PcmFileDownload.

The acid-treated starch is a starch obtained by treating a starch with an acid. Examples of the acid include: inorganic acids or organic acids such as sulfuric acid, hydrochloric acid, phosphoric acid, and acetic acid.

The starch dispersion is not particularly limited as long as it is a starch dispersion obtained by subjecting a starch paste to ultrasonic treatment, and examples thereof include commercially available Fsmash (manufactured by Dimura chemical Co., Ltd.). The heat-moisture treated starch is not particularly limited as long as it is a commercially available starch as the "heat-moisture treated starch", and may be obtained by heat-moisture treatment in the presence of a salt.

In the present invention, one or more kinds of starches selected from oxidized starches, starch dispersions, wet heat-treated starches, and acid-treated starches are preferably used.

The carrageenan used in the composition for a soft capsule film of the present invention is one of galactans having a sulfate group, and is known to be present in red algae. The carrageenan is mainly classified into 3 types of iota carrageenan (iota carrageenan), kappa carrageenan (kappa carrageenan) and lambda carrageenan (lambda carrageenan) according to the gel characteristics or structure. In the specification of food additives in japan, 3 types of "refined carrageenan", "processed eucheuma algae" and "eucheuma algae powder" are specified (see "catalogue note of existing additive varieties" (note of existing additive name book リスト note ) (1999) issued by the food additives society of japan), and these 3 types differ only in the degree of refinement, and essentially all include the carrageenan used in the composition for soft capsule film of the present invention.

From the viewpoint of gelling properties, iota-carrageenan and kappa-carrageenan are preferred in the present invention. The carrageenan may be a pure product or a product containing a standardized substance. Among them, the standardizing substance may be one or two or more selected from the group consisting of sugars such as sucrose, glucose, maltose, and lactose, and dextrin. Preferably sucrose or dextrin. The dextrin is preferably acid decomposition dextrin and enzymolysis dextrin. The dextrin used herein is a substance different from cyclodextrin (maltodextrin is decomposed further than dextrin) (volume 8 of the chemical dictionary, page 897, co-pending press), and is different from cyclodextrin.

Alternatively, a mixed raw material obtained by previously mixing iota-carrageenan and kappa-carrageenan may be used.

From the viewpoint of the strength of the soft capsule coating and the fluidity of the soft capsule coating solution, the iota-carrageenan content is preferably 10 to 60 parts by mass, more preferably 20 to 50 parts by mass, and particularly preferably 25 to 45 parts by mass, when the total of all the components of the base is 100 parts by mass.

In addition, the content of the kappa-carrageenan may be appropriately adjusted within a range of 0 to 5.0 parts by mass when the total amount of all the components of the base is 100 parts by mass in consideration of the use of the soft capsule and the like.

In the composition for a soft capsule coating of the present invention, when the base is a base mainly composed of gelatin as described above, the base is 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 40 to 60 parts by mass of glycerin, based on 100 parts by mass of gelatin, preferably 3 to 15 parts by mass of sorbitol, 3 to 25 parts by mass of maltitol, and 40 to 55 parts by mass of glycerin, more preferably 5 to 10 parts by mass of sorbitol, 5 to 15 parts by mass of maltitol, and 40 to 50 parts by mass of glycerin.

In addition, as described above, when the base is a base mainly composed of a mixture of starches and carrageenan, 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 30 to 60 parts by mass of glycerin are preferably used, 3 to 15 parts by mass of sorbitol, 3 to 25 parts by mass of maltitol, and 35 to 55 parts by mass of glycerin are more preferably used, and 5 to 10 parts by mass of sorbitol, 5 to 15 parts by mass of maltitol, and 40 to 50 parts by mass of glycerin are more preferably used, based on 100 parts by mass of the mixture of starches and carrageenan.

The sorbitol used as a plasticizer in the composition for a soft capsule film of the present invention may be a crystalline powder or a sorbitol syrup. In addition, the sorbitol and sorbitol syrup does not contain sorbitan. In the composition for a soft capsule coating of the present invention, maltitol used as a plasticizer may be crystalline powder or maltitol syrup. Further, as the mixture of sorbitol and maltitol, a liquid mixture material, a powder mixture material, and a co-crystal material of sorbitol and maltitol, which are commercially available in the form of "reducing syrup", can be used.

(Soft capsule envelope)

The soft capsule coating of the present invention is a soft capsule coating formed from the composition for soft capsule coating of the present invention, and can be produced by a conventional method. For example, it can be prepared by the following method: a base mainly composed of gelatin or a mixture of starch and carrageenan and a plasticizer mainly composed of sorbitol, maltitol and glycerin are stirred and dispersed in water, respectively, and stirred and dissolved at 60 to 98 ℃, and vacuum defoamed, and spread to a uniform thickness on a stainless steel plate using an applicator, to prepare a soft capsule coating. In the case of a punching method using a roll-die type soft capsule filling machine or the like described later, the following method can be used: a base mainly composed of gelatin or a mixture of starch and carrageenan and a plasticizer mainly composed of sorbitol, maltitol and glycerin are stirred and dispersed in water, respectively, and then stirred and dissolved at 60 to 98 ℃ to be vacuum defoamed, and then spread on a rotating drum at 5 to 60 ℃ by a casting device to prepare a soft capsule film (also referred to as a film-receiving sheet).

(Soft capsule)

The soft capsule of the present invention is a preparation in which the capsule content is filled in the capsule film of the present invention. The soft capsule can be produced by a dipping method in which the capsule content is filled into the molded body after molding into a predetermined capsule shape, and preferably, molding into a predetermined capsule shape and filling of the capsule content are performed simultaneously, and for example, the soft capsule can be produced by a punching method using a roll-model soft capsule filling machine or the like, a flat plate method, or the like. Among them, from the viewpoint of industrial productivity, it is preferable to manufacture soft capsules by using a roll-mode soft capsule filling machine.

The method for preparing the soft capsule by using the rolling mode soft capsule filling machine comprises the following steps: the soft capsule coating composition is molded into a coating film by stretching it on a rotating drum, 2 pieces of the coating film are pressed into a capsule shape by a pair of rotating molds (mold rolls), and molding of the soft capsule and filling of the capsule contents are simultaneously performed by this method.

The soft capsule of the present invention can also be obtained as a seamless capsule, and can be produced by a method called a dripping method or a solidification method in a liquid by using surface tension. Specifically, the capsule content is sprayed or dropped into a gas or a hydrophobic liquid from an inner nozzle of a two-fluid nozzle (double-sleeve nozzle), and the composition for a soft capsule film of the present invention is sprayed or dropped into a gas or a hydrophobic liquid from an outer nozzle, and the composition for a film is gelled and fixed by cooling or the like, thereby producing a seamless capsule.

The shape of the soft capsule is not particularly limited, and for example, in addition to an oval (football) shape, a long (oblong) shape, a round (spherical) shape, a tubular shape, and the like, a special shape such as a so-called self-cutting type (also referred to as a twist-off type) exemplified in each of japanese design registration nos. 1492794, 1482869, 1365845, and 1365844 may be manufactured by forming a mold.

The soft capsule of the present invention can be used in various applications such as medicines, quasi-drugs (quasi drugs), cosmetics, foods, and the like, and the composition of the capsule content can be appropriately determined according to the application. The form of the content may be any of a solution, a suspension, a paste, a powder, a granule, and the like, and is preferably a solution, a suspension, or a paste.

Hereinafter, capsule contents which can be filled in the soft capsule of the present invention are exemplified, but not limited to these capsule contents.

The fat or oil may contain: avocado oil, almond oil, linseed oil, fennel oil, perilla seed oil, olive squalane (olive squalane), orange oil, deep sea fish oil (orange roughy oil), sesame oil, garlic oil, cocoa butter, pumpkin seed oil, chamomile oil, carrot oil, cucumber oil, tallow fatty acid, shiitake seed oil (kukuui nut oil), cranberry seed oil, brown rice germ oil, rice bran oil, wheat germ oil, safflower oil, shea butter (shea butter), liquid shea butter, perilla oil, soybean oil, evening primrose oil, camellia oil, corn oil, rapeseed oil, saw palm extract oil, coix seed oil, peach kernel oil (persicoil), parsley seed oil, castor oil, sunflower oil, grape seed oil, borage oil, macadamia nut oil, meadowfoam seed oil, cottonseed oil, sea weed oil, mink oil, egg yolk oil, fish oil, palm oil, coconut oil, beeswax, coconut oil, sea cucumber wax, sea cucumber oil, safflower oil, macadamia nut oil, mango seed oil, cottonseed oil, peanut oil, sea cucumber oil, and the like, Long chain/medium chain/short chain fatty acid triglyceride, diacylglyceride, beef tallow, lard, squalene, squalane, pristane, and hydrides of these oils and fats.

Natural waxes and chemical waxes (wax) may include: shellac wax (shellac wax), beeswax, carnauba wax, spermaceti, lanolin, liquid lanolin, reduced lanolin, hard lanolin, cyclic lanolin, lanolin wax, candelilla wax, wood wax, montan wax, shellac wax, rice bran wax, and the like. As the hydrogenated oil, there may be contained: hydrogenated vegetable oil, hydrogenated beef tallow, hydrogenated lard, etc., which are obtained by hydrogenating vegetable fats and oils.

The lecithin may contain, for example: egg yolk lecithin, soybean lecithin, zymolytic lecithin (lysolecithin), phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, sphingomyelin, dicetyl phosphate, stearylamine, phosphatidylglycerol, phosphatidic acid, phosphatidylinositol amine, cardiolipin, ceramide phosphorylethanolamine, ceramide phosphorylglycerol, and the like.

The lecithin is enzymatically hydrolyzed, for example, by phospholipase A₂Acting on egg yolk lecithin and soybean lecithin.

As the mineral oil, there may be contained: liquid paraffin, vaseline, paraffin, ceresin, microcrystalline wax, etc.

The fatty acids may include: natural fatty acids such as lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid, oleic acid, linoleic acid, conjugated linoleic acid, linolenic acid, docosahexaenoic acid, eicosapentaenoic acid, 12-hydroxystearic acid, undecylenic acid, tall oil, lanolin fatty acid, and the like; synthetic fatty acids such as isononanoic acid, caproic acid, 2-ethylbutyric acid, isovaleric acid, 2-methylvaleric acid, 2-ethylhexanoic acid, isovaleric acid, etc.; and fats and oils containing these fatty acids as the fatty acid component.

The vitamins may include: vitamin a group: retinol, retinal (vitamin a1), dehydroretinal (vitamin a2), carotene, lycopene (provitamin a); vitamin B group: furanthiamine, thiamine hydrochloride, thiamine sulfate (vitamin B1), riboflavin (vitamin B2), pyridoxine (vitamin B6), cyanocobalamin, methylcobalamin (vitamin B12), folic acids, nicotinic acids, pantothenic acids, biotin, choline, inositol; vitamin C group: ascorbic acid or a derivative thereof; vitamin D group: ergocalciferol (vitamin D2), cholecalciferol (vitamin D3), dihydrotachysterol; vitamin E group: vitamin E or derivatives thereof, ubiquinones; vitamin K group: plant menadione (vitamin K1), menadione (vitamin K2), menatetrenone, menadione (vitamin K3), menadione (vitamin K4); and others: essential fatty acid (vitamin F), carnitine, ferulic acid, gamma-oryzanol, orotic acid, vitamin P (rutin, eriocitrin, hesperidin), vitamin U, etc. In addition, others may also contain lutein.

As the irritant, may be contained: capsicum tincture, capsicum oil, pelargonyl oxamide, cantharides tincture, ginger oil, peppermint oil, L-menthol, camphor, benzyl nicotinate, etc.

The ultraviolet absorber and the blocking agent may contain: benzophenone derivatives (2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, sodium 2-hydroxy-4-methoxybenzophenone-5-sulfonate, dihydroxydimethoxybenzophenone, sodium dihydroxydimethoxybenzophenone-sulfonate, 2, 4-dihydroxybenzophenone, tetrahydroxybenzophenone, etc.), p-aminobenzoic acid derivatives (p-aminobenzoic acid, ethyl p-aminobenzoate, glycerol p-aminobenzoate, amyl p-dimethylaminobenzoate, octyl p-dimethylaminobenzoate, etc.), methoxycinnamic acid derivatives (ethyl p-methoxycinnamate, isopropyl p-methoxycinnamate, octyl p-methoxycinnamate, 2-ethoxyethyl p-methoxycinnamate, isopropyl p-methoxycinnamate, octyl p-methoxycinnamate, ethyl p-methoxycinnamate, etc.), Sodium p-methoxycinnamate, potassium p-methoxycinnamate, glycerol mono-2-ethylhexanoate di-p-methoxycinnamate, etc.), salicylic acid derivatives (octyl salicylate, phenyl salicylate, homomenthyl salicylate, dipropylene glycol salicylate, ethylene glycol salicylate, myristyl salicylate, methyl salicylate, etc.), anthranilic acid derivatives (methyl anthranilate, etc.), urocanic acid derivatives (urocanic acid, ethyl urocanic acid, etc.), coumarin derivatives, amino acid-based compounds, benzotriazole derivatives, tetrazole derivatives, imidazoline derivatives, pyrimidine derivatives, dioxane derivatives, camphor derivatives, furan derivatives, pyridone (pyrrone) derivatives, nucleic acid derivatives, allantoin derivatives, nicotinic acid derivatives, vitamin B6 derivatives, umbelliferone, esculin, heptaphyllin, etc.), salicylic acid derivatives (octyl salicylate, phenyl salicylate, salicylic acid, homomenthyl salicylate, ethylene glycol salicylate, benzotriazole derivatives, methyl salicylate, etc.), anthranilic acid derivatives, coumarin derivatives, amino acid, Benzyl cinnamate, cinoxate, oxybenzone (oxybenzone), dioxybenzophenone (dioxybenzone), octophenone (octabenzone), sulindac, 2, 4-dihydroxybenzophenone (benzoresorcinol), arbutin, guaiazulene, alkannin, baicalin, baicalein, berberine, Neo Heliopan, Escalol, zinc oxide, talc, kaolin, and the like.

The whitening agent may include: p-aminobenzoic acid derivatives, salicylic acid derivatives, anthranilic acid derivatives, coumarin derivatives, amino acid-based compounds, benzotriazole derivatives, tetrazole derivatives, imidazoline derivatives, pyrimidine derivatives, dioxane derivatives, camphor derivatives, furan derivatives, pyridone derivatives, nucleic acid derivatives, allantoin derivatives, nicotinic acid derivatives, vitamin C or its derivatives (magnesium ascorbyl phosphate, vitamin C glucoside, etc.), vitamin E or its derivatives, kojic acid or its derivatives, oxybenzone, benzophenone, arbutin, guaiazulene, alkannin, baicalin, baicalein, berberine, placenta extract, ellagic acid, 4-n-butylresorcinol (Rucinol), and the like.

As the tyrosinase activity inhibitor, there may be contained: vitamin C or its derivative (magnesium ascorbyl phosphate, ascorbyl glucoside, etc.), hydroquinone or its derivative (hydroquinone benzyl ether, etc.), kojic acid or its derivative, vitamin E or its derivative, N-acetyl tyrosine or its derivative, glutathione, hydrogen peroxide, zinc peroxide, placenta extract, ellagic acid, arbutin, 4-N-butylresorcinol, silk extract, plant extract (chamomile, mulberry, gardenia, angelica, sanguisorba, sophora flavescens, artemisia, honeysuckle, phellodendron, houttuynia, poria cocos, coix lacryma-jobi, sesameseed, hop, hawthorn, eucalyptus, yarrow, hollyhock, cinnamon, fructus viticis, witch hazel, white mulberry (white mulberry) or mulberry (Aino mulberry), fortune eupatorium, platycodon grandiflorum, dodder, euphorbia seed, ephedra, ligusticum wallichii, pubescent angelica root, bupleurum, ledebouriella root, ginseng, etc.), hydroquinone extract, vitamin E extract, Radix glehniae, scutellaria baicalensis, moutan bark, peony, geranium wilfordii, kudzu root, liquorice, gallnut, aloe, cimicifuga foetida, safflower, green tea, black catechu, blueberry, astragalus oblata) and the like.

The substance for reducing and decomposing melanin may contain: phenyl mercury hexachlorophene, mercury (II) oxide, mercurous chloride (I), aqueous hydrogen peroxide, zinc peroxide, hydroquinone or derivatives thereof, and the like.

The substance having the metabolism-promoting effect and the cell-activating effect may contain: hydroquinone, lactobacillus extract, placenta extract, Ganoderma extract, vitamin A, vitamin E, allantoin, spleen extract, thymus extract, yeast extract, fermented milk extract, plant extract (aloe, Scutellariae radix, herba Equiseti Arvinsis, radix Gentianae, Burdock, radix Arnebiae, radix Dauci Sativae, hamamelis, flos Lupuli, Coicis semen, herba Lamii Japonicae, herba Swertiae Bimaculatae, radix Angelicae sinensis, herba Sidae Rhombifoliae, hydrangea, fructus forsythiae, fructus Cucumidis Sativi, herba Thymi vulgaris, herba Rosmarini officinalis, and parsley), etc.

The astringent may contain: succinic acid, allantoin, zinc chloride, zinc sulfate, zinc oxide, calamine, zinc p-phenolsulfonate, aluminum potassium sulfate, resorcinol, ferric chloride, tannic acid (including catechin compounds), and the like.

As the active oxygen scavenger, may contain: SOD, catalase, glutathione peroxidase, etc.

As the antioxidant, there may be contained: vitamin C or its salt, stearate, vitamin E or its derivative, nordihydroguaiaretic acid, Butylated Hydroxytoluene (BHT), Butylated Hydroxyanisole (BHA), hydroxytyrosol, p-hydroxyanisole, propyl gallate, sesamol, sesamolin, gossypol, propolis, etc.

the lipid peroxide production inhibitor comprises β -carotene, plant extract (cultured cells of semen Sesami, hydrangea, Hypericum erectum, Hamamelis mollis, clove, Melissa officinalis, Isodon japonicus, Betula platyphylla, herba Solidaginis, herba Rosmarini officinalis, Nandinae Domesticae, fructus Rosae Multiflorae, semen Ginkgo, and green tea).

As the anti-inflammatory agent, may be contained: ichthammol, indometacin, kaolin, salicylic acid, sodium salicylate, methyl salicylate, acetylsalicylic acid, diphenhydramine hydrochloride, D-camphor, DL-camphor, hydrocortisone, guaiazulene, chamazulene, chlorphenamine maleate, glycyrrhizic acid or salt thereof, glycyrrhetinic acid or salt thereof, licorice extract, lithospermum extract, fructus Rosae Multiflorae extract, propolis, etc.

As antibacterial/bactericidal/disinfectant agents, may be contained: rivanol (acrinol), sulfur, calcium gluconate, chlorhexidine gluconate, sulfanilamide, merbromin, lactoferrin or a hydrolysate thereof, alkyldiaminoethylglycine hydrochloride solution, triclosan, sodium hypochlorite, chloramine T, bleaching powder, an iodine compound, iodoform, sorbic acid or a salt thereof, propionic acid or a salt thereof, salicylic acid, dehydroacetic acid, parabens, undecylenic acid, thiamine lauryl sulfate, thiamine lauryl nitrate, phenol, cresol, p-chlorophenol, p-chloroxylenol, p-chlorocresol, thymol, phenylethyl alcohol, o-phenylphenol, Irgasan CH3565, halocarban (halocarban), hexachlorophene, chlorhexidine, ethanol, methanol, isopropanol, benzyl alcohol, ethylene glycol, propylene glycol, 2-phenoxyethanol, 1, 2-pentanediol, zinc pyrithione (zinc pyrithione), chlorobutanol, isopropyl methylphenol, triclosan, sodium hypochlorite, chloramine T, iodine, nonionic surfactants (polyoxyethylene lauryl ether, polyoxyethylene nonylphenyl ether, polyoxyethylene octylphenyl ether, etc.), amphoteric surfactants, anionic surfactants (sodium lauryl sulfate, potassium lauroyl sarcosinate, etc.), cationic surfactants (cetyltrimethylammonium bromide, benzalkonium chloride, benzethonium chloride, methyl violet), formaldehyde, hexamine (hexamine), brilliant green, malachite green, crystal violet (crystalviolet), diazolidinyl urea (germanll), photoreceptor No. 101, photoreceptor No. 201, photoreceptor No. 401, N-long chain acyl basic amino acid derivatives and acid addition salts thereof, zinc oxide, hinokitiol, sophora flavescens, propolis, etc.

the moisturizer may contain glycerin, propylene glycol, 1, 3-butylene glycol, polyethylene glycol, tricaprylin, glycolic acid (α -hydroxy acid), hyaluronic acid or a salt thereof, chondroitin sulfate or a salt thereof, water-soluble chitin or a derivative thereof or a chitosan derivative, pyrrolidone carboxylic acid or a salt thereof, sodium lactate, urea, sorbitol, an amino acid or a derivative thereof (valine, leucine, isoleucine, threonine, methionine, phenylalanine, tryptophan, lysine, glycine, alanine, asparagine, glutamine, serine, cysteine, cystine, tyrosine, proline, hydroxyproline, aspartic acid, glutamic acid, hydroxylysine, arginine, ornithine, histidine, and sulfates, phosphates, nitrates, citrates, or pyrrolidone carboxylic acids of these amino acids), and the like.

As the various organic acids, there may be contained: glycolic acid, citric acid, malic acid, tartaric acid, lactic acid, ferulic acid, phytic acid, and the like.

The hair agent may contain: selenium disulfide, alkylisoquinolinium bromide solution, zinc pyrithione, pheniramine ester (biphenamine), dithiane (thiantol), beaver tincture, ginger tincture, capsicum tincture, quinine hydrochloride, concentrated ammonia, potassium bromate, sodium bromate, thioglycolic acid, and the like.

As the perfume, it may contain: moschus, civet, nutria, and ambergris; fennel (anise) essential oil, angelica essential oil, ylang essential oil, orris essential oil, fennel essential oil, sweet orange essential oil, cananga (cananga) essential oil, caraway (caraway) essential oil, cardamom essential oil, guaiacum essential oil, cumin (cumin) essential oil, sassafras essential oil, cinnamon essential oil, geranium essential oil, copaiba essential oil, coriander essential oil, perilla essential oil, cedar essential oil, citronella essential oil, jasmine essential oil, zingiber essential oil, cedar essential oil, spearmint (spearmint) essential oil, peppermint (peppermint) essential oil, anise essential oil, tuberose essential oil, clove essential oil, orange flower essential oil, gaultheria glauca (wiltergler) essential oil, tolerosa (tollulsba) essential oil, guano essential oil, rose essential oil (pasamor essential oil), juniper essential oil, Plant essences such as bergamot essential oil, peru balsam essential oil, rosewood (Bois de Rose) essential oil, cinnamomum camphora essential oil, mandarin essential oil, eucalyptus essential oil, lime essential oil, lavender essential oil, agilawood (linaloe) essential oil, lemongrass essential oil, lemon essential oil, rosemary (rosemary) essential oil, and japanese mint essential oil; other synthetic flavors such as coffee flavor and yogurt flavor are available.

In addition, it may contain nutritional auxiliary components and health food components. Specifically, there may be mentioned: fish oil, garlic, vitamin B1, so-called egg oil (a brown to black liquid obtained by heating egg yolk with a slow fire such as an iron pan while stirring the egg yolk, which is a healthy food material from ancient times), and the like.

The soft capsule of the present invention can be stored and circulated in a packaged form such as a bottle pack, PTP pack, pouch, or the like.

Examples

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited to these examples.

The following materials were used as starting materials.

Gelatin (acid-treated gelatin derived from pig skin, manufactured by Nippi.Inc.)

Kappa-carrageenan (Mitsubishi Shoji food Co., Ltd.)

Iota-carrageenan (40% by mass addition product of standardized substance (sucrose), MSC Corp.)

Oxidized starch (STABILOSE, manufactured by Songgu chemical industry Co., Ltd.)

Starch dispersion (Fsmash, product of Shu chemical Co., Ltd.)

Heat and moisture treatment of Starch (Soft Starch, manufactured by Starch industries Co., Ltd.)

Acid-treated starch (Eliane Gel, manufactured by Avebe Corp.)

Glycerol (manufactured by Nichira oil Co., Ltd.)

D-sorbitol 70% solution (Mitsubishi Shoji Foodtech Co., Ltd.)

Maltitol "LESYS" (manufactured by MC-Towa Co., Ltd.)

Reducing syrup (B Food Science Co., Ltd.)

Examples 1 to 11 and comparative examples 1 to 5 Soft Capsule preparation Using a Rolling-model Soft Capsule filling machine

1. Preparation of Water-soluble raw Material and the like

An appropriate amount of water (raw material water) was prepared, and glycerin, sorbitol, maltitol, and reducing syrup in the amounts (parts by mass) shown in table 1 were added thereto and dissolved with stirring.

2. Preparation of soft capsule

Gelatin, kappa-carrageenan, iota-carrageenan, oxidized starch, a starch dispersion and moisture-heat treated starch in the amounts (parts by mass) shown in table 1 were stirred and dispersed in the liquid obtained in the above 1, and then further dissolved with stirring at 60 to 98 ℃ to be vacuum defoamed, and then spread on a rotating drum at 5 to 45 ℃ by a casting device to prepare a sheet-like soft capsule film (also referred to as a film-receiving sheet).

3. Preparation of blueberry series capsule content

the preparation method comprises the steps of adding beewax and glycerin fatty acid ester into perilla oil, heating to about 70 ℃ for dissolution, stirring and cooling the heated and dissolved liquid to about 30 ℃ to prepare high-viscosity liquid, sequentially adding blueberry extract powder, lutein suspension oil, astragalus bulbophyllum dry extract, β -carotene suspension and mixed tocopherol solution into the high-viscosity liquid, stirring and mixing, carrying out vacuum defoaming, wet-type crushing by using a colloid mill device, and properly sieving to obtain the blueberry capsule content.

The viscosity of the content of the blueberry-series capsule was 10,000mPa · s at 25 ℃ (BII viscometer available from east china co., ltd.).

4. Preparation of soft capsules

The capsule contents selected from the group consisting of vegetable oil (MCT), soybean lecithin, and the blueberry-based capsule contents prepared in the above 3 were filled between 2 coated tablets while feeding the 2 coated tablets prepared in the above 2 between a pair of rotating cylindrical molds via a lubricating roller and a deflector roller, respectively, and encapsulated while adjusting the segment temperature appropriately according to the coating formulation to form Oval-5-shaped (olive-shaped) soft capsules, and the capsules were further stored in a dryer with the relative humidity adjusted to 20% or less for 24 hours to prepare soft capsules. For examples 1 to 11 and comparative examples 1,2, 4 and 5 in which encapsulation was achieved, the softness and appearance of the soft capsules were evaluated. The results are shown in Table 2.

[ evaluation of flexibility ]

The deformation of the soft capsule when pressed with a finger was observed by 5 professional panelists to evaluate whether the soft capsule was soft or hard.

[ evaluation of appearance ]

The appearance (whether the soft capsule coating was transparent, whether the soft capsule coating components were separated out) and whether the film was glossy were evaluated by visual observation by 5 professional panelists.

[ Table 1]

[ Table 2]

As shown in Table 2, the soft capsules of examples 1 to 11 were soft, glossy and beautiful. As is clear from comparison between example 1 and comparative example 1, and between example 2 and comparative example 2, softness, gloss, and appearance can be obtained by adding D-sorbitol and maltitol as plasticizers in addition to glycerin.

In addition, in the case of obtaining a soft capsule of soybean lecithin with carrageenan and starch as base agents, the problem so far was that the adhered portion could be adhered only by slight thinning, but the soft capsule envelope of the present invention was able to be filled with soybean lecithin (see example 3 and comparative example 3).

Further, it is understood from comparative examples 4 and 5 that although the plasticizer containing glycerin and maltitol and the plasticizer containing glycerin and D-sorbitol can impart flexibility, maltitol and D-sorbitol crystallize and cause the coating film to become cloudy.

In addition, the soft capsules after storage at 40 ℃ for 4 months and the soft capsules after cold storage were subjected to an impact resistance test. The impact resistance test is as follows: the 1 soft capsule was placed, a 50g weight was dropped from a height of 10cm, and the number of cracked pieces in the soft capsule was calculated as 20 pieces. If the coating of the soft capsule loses plasticity, the soft capsule becomes easily cracked. Therefore, when the number of soft capsules exhibiting impact resistance, i.e., cracking, is small, this means that the soft capsule film does not lose plasticity and is excellent in quality. The results of the impact resistance test after storage at 40 ℃ for 4 months are shown in Table 3. Further, the results of the impact resistance test after the storage under cooling are shown in Table 4.

[ Table 3]

Table 3: impact resistance test after storage at 40 ℃ for 4 months

	Example 1	Comparative example 1 modification*1	Example 2	Comparative example 2 modification*2
					At the time of manufacture	0	0	0	0
40 ℃/4 months	0	12	0	11

1 change the amount of glycerin of comparative example 1 from 45 parts by mass to 50 parts by mass

2 change the amount of glycerin of comparative example 2 from 45 parts by mass to 50 parts by mass

[ Table 4]

Table 4: impact resistance test after storage under cooling

2 change the amount of glycerin of comparative example 2 from 45 parts by mass to 50 parts by mass

It is known that soft capsules containing a blueberry-containing composition as a content tend to be hard and also tend to crack due to a change in conditions, and as shown in table 3, the soft capsules of examples 1 and 2 have impact resistance and maintain flexibility after being stored at 40 ℃ for 4 months. Also, according to Table 4, the soft capsule of example 2 still had impact resistance after storage under cooling and maintained flexibility. Therefore, it is found that the soft capsule of the present invention can maintain flexibility and impact resistance even when the capsule content is a composition having a property of easily becoming hard with time under severe conditions, and is very advantageous in terms of improvement of product quality.

Industrial applicability of the invention

The soft capsule film containing the composition for a soft capsule film of the present invention is excellent in plasticity and flexibility, and the soft capsule of the present invention formed from the composition is transparent and allows visual observation of the content liquid, and furthermore, has gloss, and therefore is excellent in appearance and high in commercial value. The soft capsule of the present invention is excellent in surface moisture retention, does not have a problem of cracking, and can maintain flexibility and impact resistance of the soft capsule even when the capsule content contained therein is a composition having a property of easily becoming hard with time under severe conditions. Pharmaceutical ingredients, nutritional supplement ingredients, health food ingredients, and the like can be encapsulated in the soft capsule of the present invention.

Claims (8)

1. A composition for a soft capsule coating film, comprising: a base agent comprising gelatin or a mixture of starch and carrageenan as a main component; and a plasticizer comprising sorbitol, maltitol and glycerin as main components, characterized in that,

when the base is a base mainly composed of gelatin, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol and 40 to 60 parts by mass of glycerin, based on 100 parts by mass of gelatin;

when the base is a base mainly composed of a mixture of starches and carrageenan, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 30 to 60 parts by mass of glycerin, based on 100 parts by mass of the mixture of starches and carrageenan.

2. The composition for a soft capsule coating of claim 1, wherein the starch is one or more starches selected from the group consisting of oxidized starch, starch dispersion, moist heat-treated starch and acid-treated starch.

3. The composition for a soft capsule coating according to claim 1 or 2, wherein the carrageenan is kappa-carrageenan and/or iota-carrageenan.

4. A soft capsule coating film comprising the composition for a soft capsule coating film according to any one of claims 1 to 3.

5. A soft capsule filled with capsule contents in the soft capsule film of claim 4.

6. A method for producing a soft capsule, characterized by forming a film of a composition for a soft capsule envelope into a soft capsule envelope and filling the capsule content, wherein the composition for a soft capsule envelope comprises: a base agent comprising gelatin or a mixture of starch and carrageenan as a main component; and a plasticizer containing sorbitol, maltitol and glycerin as main components,

in the production method, when the base is a base mainly composed of gelatin, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 40 to 60 parts by mass of glycerin, based on 100 parts by mass of gelatin;

when the base is a base mainly composed of a mixture of starches and carrageenan, the plasticizer contains 1 to 15 parts by mass of sorbitol, 1 to 30 parts by mass of maltitol, and 30 to 60 parts by mass of glycerin, based on 100 parts by mass of the mixture of starches and carrageenan.

7. The method for producing a soft capsule according to claim 6, wherein the starch is one or more starches selected from the group consisting of oxidized starch, starch dispersion, moist heat-treated starch and acid-treated starch.

8. The method for producing a soft capsule according to claim 6 or 7, wherein the carrageenan is kappa-carrageenan and/or iota-carrageenan.