WO2015008748A1 - 軟カプセル皮膜 - Google Patents
軟カプセル皮膜 Download PDFInfo
- Publication number
- WO2015008748A1 WO2015008748A1 PCT/JP2014/068787 JP2014068787W WO2015008748A1 WO 2015008748 A1 WO2015008748 A1 WO 2015008748A1 JP 2014068787 W JP2014068787 W JP 2014068787W WO 2015008748 A1 WO2015008748 A1 WO 2015008748A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- starch
- soft capsule
- acid
- mass
- oil
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
- A23L29/256—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from seaweeds, e.g. alginates, agar or carrageenan
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
- A61K8/732—Starch; Amylose; Amylopectin; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
- A61K2800/82—Preparation or application process involves sonication or ultrasonication
Definitions
- the present invention relates to a soft capsule film and a soft capsule using the same.
- Soft capsules are used in a wide range of fields such as pharmaceuticals, foods, and cosmetics.
- the most widely used soft capsule film base is gelatin, which is inexpensive and non-toxic, and exhibits excellent mechanical strength, film-forming ability, and the like.
- gelatin which is inexpensive and non-toxic, and exhibits excellent mechanical strength, film-forming ability, and the like.
- BSE bovine spongiform encephalopathy
- capsule coatings containing processed starch and iota carrageenan obtained by acid-treating glutinous corn starch Patent Document 1
- acid-decomposing wax Soft capsule film formed by blending corn starch, gelling agent and plasticizer containing film forming composition for soft capsule Patent Document 2
- starch, ⁇ carrageenan, metal salt, dextrin, plasticizer and water Patent Document 3
- Starch derivative mixture Starch degradation product, gum mix, reduced maltose, plasticizer and water, and soft capsule shell
- soft capsule coatings require appropriate fluidity, good film formability, appropriate coating sheet strength, elongation, adhesiveness, etc. during capsule production, and after encapsulation, Blocking resistance to prevent adhesion between capsules, elasticity, transparency, disintegration, etc. are required.
- film sheet thickness about 0.9 mm
- the film sheet strength and adhesive force are often insufficient.
- the coating sheet is made thin (about 0.6 mm) to ensure the coating sheet strength and adhesion necessary for encapsulation.
- the present invention has been made in view of the actual situation as described above, and has a vegetable soft capsule film and a soft capsule that exhibit good adhesiveness while having high film sheet strength and that provide excellent film performance. About providing.
- the inventors of the present invention have achieved high coating sheet strength by combining iota carrageenan and a specific starch dispersion that has been subjected to ultrasonic treatment with starch paste. It was found that a capsule film showing good adhesiveness can be obtained by suppressing the biting of the film base into the bonded portion. Furthermore, after encapsulating, the inventors have found that excellent film performance such as blocking resistance, elasticity, transparency, and rapid disintegration can be obtained, thereby completing the present invention.
- this invention provides the soft capsule membrane
- the soft capsule of the present invention is also excellent in film performance such as blocking resistance after drying, elasticity, transparency, and disintegration.
- the soft capsule film of the present invention contains (A) iota carrageenan and (B) a starch dispersion obtained by subjecting a starch paste solution to ultrasonic treatment.
- Carrageenan is a kind of galactan having a sulfate group and is known to exist in red algae.
- Each carrageenan may be a pure product or may contain a standardized substance.
- a standardization substance 1 type, or 2 or more types selected from the group which consists of saccharides, such as sucrose, glucose, maltose, and lactose, and dextrin is mentioned.
- the ratio of the standardizing substance is preferably 50% by mass or less, and more preferably 45% by mass or less.
- content of the carrageenan mentioned later shall contain a standardization substance.
- Carrageenans can be classified mainly into three types, iota carrageenan, kappa carrageenan, and lambda carrageenan, depending on the gelation characteristics and structure.
- iota carrageenan is used as component (A).
- the content of (A) iota carrageenan is preferably 20% by mass or more, more preferably 25% by mass or more, and more preferably 30% by mass or more in the total amount of solid components from the viewpoint of the strength of the coating sheet and the elasticity. Preferably, 35 mass% or more is more preferable.
- the content of (A) iota carrageenan is preferably 20 to 55% by mass, more preferably 25 to 55% by mass, more preferably 30 to 50% by mass, and 35 to 45% by mass in the total amount of solid components. Is more preferable.
- the solid component refers to a film composition excluding purified water and a plasticizer.
- the starch dispersion obtained by sonicating the starch paste solution (B) used in the present invention is a known substance, for example, produced from starch by a method described in Japanese Patent No. 4288381 or a method analogous thereto. Is done.
- the starch paste liquid is prepared by a conventional method, for example, by heating starch in water to gelatinize the starch.
- the starch content in the starch paste solution is not particularly limited, but is preferably 1% by mass or more, more preferably 5% by mass or more, and more preferably 10% by mass or more.
- starch examples include corn starch, waxy corn starch, tapioca starch, potato starch, sweet potato starch, and wheat starch. These can be used alone or in combination of two or more. Among these, waxy corn starch is preferable from the comprehensive viewpoint (the point of film strength and the point of gelation strength).
- the starch used for preparing the starch paste is preferably unmodified, that is, not subjected to modification such as acid treatment, pregelatinization, etherification or acetylation.
- the viscosity of the starch paste liquid when subjected to ultrasonic treatment (B-type viscometer, starch content 5 mass%, liquid temperature 95 ° C.) varies depending on the type of starch, but is 400 to 800 mPa ⁇ s. 400 to 600 mPa ⁇ s is preferable.
- the conditions for ultrasonic treatment can be set as appropriate.
- the viscosity (B-type viscometer, starch content 20 mass%, liquid temperature 80 ° C.) of the starch dispersion after ultrasonic treatment is preferably 350 mPa ⁇ s or less, although it varies depending on the type of starch, 10 to 350 mPa ⁇ s. s is more preferable.
- the form of the starch dispersion formed by subjecting the starch paste solution to ultrasonic treatment may be liquid, but the form of a dried product obtained by drying the starch dispersion is preferred. Examples of the drying method include spray drying, freeze drying, evaporation to dryness, and the like. In the present invention, a commercially available product may be used as the starch dispersion obtained by subjecting the starch paste solution to ultrasonic treatment (B).
- the content of the starch dispersion formed by sonication of the starch paste solution is preferably 10% by mass or more in the total amount of solid components from the viewpoint of adhesiveness. 20 mass% or more is more preferable, 28 mass% or more is still more preferable, 35 mass% or more is further more preferable, 45 mass% or more is further more preferable, 50 mass% or more is further more preferable, and 55 mass% or more is further more preferable. Further, from the viewpoint of the coating sheet strength, 75% by mass or less is preferable, 70% by mass or less is more preferable, and 65% by mass or less is more preferable in the total amount of solid components.
- the content of the starch dispersion obtained by subjecting the starch paste solution to ultrasonic treatment is preferably 10 to 75% by mass, more preferably 20 to 75% by mass, and more preferably 28 to 75% by mass in the total amount of solid components. It is more preferably 75% by mass, further preferably 45 to 75% by mass, further preferably 50 to 70% by mass, and further preferably 55 to 65% by mass.
- (A) iota carrageenan and (B) the content mass ratio [(A) :( B)] in the total amount of the solid components of the starch dispersion obtained by subjecting the starch paste solution to ultrasonication are: From the standpoint of film strength (film strength, gelation strength), 1: 0.3 to 1: 3 is preferable, 1: 0.6 to 1: 2.5 is more preferable, and 1: 1 to 1: 2.3 is more preferable.
- the soft capsule film of the present invention preferably further contains kappa carrageenan from the viewpoint of promoting gelation.
- the content of kappa carrageenan is preferably 0.1% by mass or more, more preferably 0.3% by mass or more, and further preferably 0.5% by mass or more in the total amount of solid components from the viewpoint of gelation strength. Moreover, 3.5 mass% or less is preferable from a viewpoint of film strength (fragility), and 2.5 mass% or less is more preferable.
- the content of kappa carrageenan is preferably 0.1 to 3.5 mass%, more preferably 0.3 to 3.5 mass%, and further preferably 0.5 to 2.5 mass% in the total amount of solid components. preferable.
- the soft capsule film of the present invention may contain a gelling agent other than iota or kappa carrageenan such as sodium alginate, pullulan, glucomannan, gum arabic, and farcellulan, if necessary.
- a gelling agent other than iota or kappa carrageenan such as sodium alginate, pullulan, glucomannan, gum arabic, and farcellulan, if necessary.
- the content of the gelling agent other than iota or kappa carrageenan is 1% by mass or less, more preferably 0.5% by mass or less, particularly in the total amount of solid components. It is preferable that it is 0.1 mass% or less.
- the soft capsule film of the present invention may contain, if necessary, starches other than the starch dispersion obtained by subjecting starch paste liquid such as unmodified starch, modified starch, and starch degradation product to ultrasonic treatment. Can do.
- the content of starches other than the starch dispersion formed by sonication of the starch paste is 50% by mass or less in the total amount of solid components from the viewpoint of the film sheet strength, adhesive strength and elasticity after drying. Is preferable, 47 mass% or less is more preferable, 45 mass% or less is further more preferable, and 10 mass% or less is still more preferable.
- the lower limit is 0% by mass.
- the soft capsule film of the present invention if necessary, various additives used for the soft capsule film, such as plasticizers, natural pigments, synthetic pigments, various sweeteners, preservatives, water activity lowering agents, A pH adjuster etc. can be contained.
- the plasticizer is not particularly limited, and examples thereof include glycerin, sorbitol, erythritol, propylene glycol, and polyethylene glycol. Of these, glycerin and sorbitol are preferable.
- the content of the plasticizer in the soft capsule film of the present invention is preferably 30 parts by mass or more and more preferably 35 parts by mass or more with respect to 100 parts by mass of the total amount of solid components from the viewpoint of flexibility. Moreover, from an adhesive point, 60 mass parts or less are preferable with respect to 100 mass parts of total amounts of a solid component, and 50 mass parts or less are more preferable.
- the content of the plasticizer is preferably 30 to 60 parts by mass and more preferably 35 to 50 parts by mass with respect to 100 parts by mass of the total amount of solid components.
- the soft capsule film of the present invention can be produced according to a conventional method.
- (A) Iota carrageenan and (B) starch dispersion obtained by ultrasonic treatment of starch paste, and various additives are stirred and dispersed in water as necessary, and stirred at 70 to 98 ° C. After dissolution, vacuum degassing may be performed.
- Water is preferably 160 parts by mass or more, and more preferably 200 parts by mass or more with respect to 100 parts by mass of the total amount of solid components.
- the amount of water in the coating liquid is large, the film thickness after drying becomes rather thin, and thus effects such as easy swallowing and rapid disintegration can be obtained.
- a soft capsule can be obtained by forming such a soft capsule film into a predetermined shape and drying it.
- the soft capsule can be produced, for example, by a conventionally used method for producing a soft capsule, for example, a punching method using a rotary die type soft capsule filling machine, or a flat plate method.
- a rotary die type soft capsule filling machine is a method of punching two coated sheets formed by spreading a soft capsule coating solution on a rotating drum into a capsule shape with a pair of rotating molds (die rolls). Molding and filling of the capsule contents are performed simultaneously.
- the shape of the soft capsule is not particularly limited, and examples thereof include special types such as an oval (football) type, an oblong (ellipse) type, a round (spherical) type, a tube type, and a self-cut type.
- the “self-cut type” is a drug that is encapsulated in a hollow body and a tab that is connected to the upper end of the body via a neck portion, and the tab is twisted from the body. Cosmetics, foods, chemicals, etc. are used after spilling out and are sometimes called “twist-off” or “thread-cut”.
- the soft capsule of the present invention can be used for various uses such as pharmaceuticals, quasi-drugs, cosmetics, and foods, 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.
- a capsule is illustrated. Each of these components can be contained in any part of the capsule.
- waxes and waxes shellac wax, beeswax, carnauba wax, whale wax, lanolin, liquid lanolin, reduced lanolin, hard lanolin, cyclic lanolin, lanolin wax, candelilla wax, mole, montan wax, shellac wax, rice wax, etc.
- the hardened oil it is possible to contain a hardened vegetable oil obtained by hydrogenating vegetable fats, hardened beef fat, hardened tallow oil, and the like.
- mineral oil liquid paraffin, petrolatum, paraffin, ozokelide, ceresin, microcrystalline wax and the like can be contained.
- fatty acids 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 , Natural fatty acids such as lanolin fatty acid, isononanoic acid, caproic acid, 2-ethylbutanoic acid, isopentanoic acid, 2-methylpentanoic acid, 2-ethylhexanoic acid, isopentanoic acid and the like, and fats and oils containing these fatty acids as fatty acid composition Etc. can be contained.
- vitamin A group retinol, retinal (vitamin A1), dehydroretinal (vitamin A2), carotene, lycopene (provitamin A), vitamin B group: fursultiamine, thiamine hydrochloride, thiamine sulfate (vitamin B1 ), Riboflavin (vitamin B2), pyridoxine (vitamin B6), cyanocobalamin, methylcobalamin (vitamin B12), folic acid, nicotinic acids, pantothenic acids, biotins, choline, inositols, vitamin C group: ascorbic acid or its derivatives, Vitamin D group: Ergocalciferol (vitamin D2), cholecalciferol (vitamin D3), dihydrotaxosterol, vitamin E group: vitamin E or its derivatives, ubiquinones, vitamin K group: phytonadione (bi Min K1), menaquinone (vitamin K2), menate
- pepper tincture red pepper oil, nonyl acid vanillamide, cantalis tincture, ginger tincture, ginger oil, mint oil, l-menthol, camphor, benzyl nicotinate, and the like can be contained.
- benzophenone derivatives (2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, 2-hydroxy-4-methoxybenzophenone-5-sulfonic acid sodium, dihydroxydimethoxy Benzophenone, dihydroxydimethoxybenzophenone-sodium sulfonate, 2,4-dihydroxybenzophenone, tetrahydroxybenzophenone, etc.
- paraaminobenzoic acid derivatives paraaminobenzoic acid, ethyl paraaminobenzoate, glyceryl paraaminobenzoate, amyl paradimethylaminobenzoate, para Octyl dimethylaminobenzoate
- methoxycinnamate derivatives ethyl paramethoxycinnamate, isopropyl paramethoxycinnamate, paramethoxycinnamon
- whitening agents paraaminobenzoic acid derivatives, salicylic acid derivatives, anthranilic acid derivatives, coumarin derivatives, amino acid compounds, benzotriazole derivatives, tetrazole derivatives, imidazoline derivatives, pyrimidine derivatives, dioxane derivatives, camphor derivatives, furan derivatives, pyrone derivatives, nucleic acids Derivatives, allantoin derivatives, nicotinic acid derivatives, vitamin C or derivatives thereof (vitamin C phosphate magnesium salt, vitamin C glucoside, etc.), vitamin E or derivatives thereof, kojic acid or derivatives thereof, oxybenzone, benzophenone, arbutin, guaiazulene, shikonin , Baicalin, baicalein, berberine, placenta extract, ellagic acid, lucinol and the like.
- vitamin C or a derivative thereof vitamin C phosphate magnesium salt, vitamin C glucoside, etc.
- hydroquinone or a derivative thereof hydroquinone benzyl ether, etc.
- kojic acid or a derivative thereof vitamin E or a derivative thereof, N -Acetyltyrosine or its derivatives, glutathione, hydrogen peroxide, zinc peroxide, placenta extract, ellagic acid, arbutin, lucinol, silk extract, plant extract (camomile, mulberry, gardenia, touki, garlic, clara, mugwort, honeysuckle, Kihada, Dokudami, Matsuhodo, pearl barley, nettle, hop, hawthorn, eucalyptus, yarrow,retea, keihi, mankei, hamamelis, carraguwa or yamagwa, life-prolonging grass, bell
- phenylmercury hexachlorophene As a melanin reduction or decomposition substance, phenylmercury hexachlorophene, mercuric oxide, mercuric chloride, hydrogen peroxide solution, zinc peroxide, hydroquinone or a derivative thereof can be contained.
- hydroquinone As a turnover promoting action and cell activator, hydroquinone, lactic acid bacteria extract, placenta extract, ganoderma extract, vitamin A, vitamin E, allantoin, spleen extract, thymus extract, yeast extract, fermented milk extract, plant extract (aloe, ougone) , Horsetail, gentian, burdock, shikon, carrot, hamamelis, hops, yokoinin, mandarin duck, sea bream, pearl millet, red snapper, achacha, hypericum, cucumber, red pepper, mannen wax, parsley) and the like.
- succinic acid As astringents, succinic acid, allantoin, zinc chloride, zinc sulfate, zinc oxide, calamine, zinc paraphenol sulfonate, potassium aluminum sulfate, resorcin, ferric chloride, tannic acid (including catechin compounds), etc. can be included is there.
- SOD active oxygen scavenger
- catalase catalase
- glutathione peroxidase glutathione peroxidase
- Anti-inflammatory agents include ictamol, indomethacin, kaolin, salicylic acid, sodium salicylate, methyl salicylate, acetylsalicylic acid, diphenhydramine hydrochloride, d-camphor, dl-camphor, hydrocortisone, guaiazulene, camazulene, chlorpheniramine maleate, glycyrrhizic acid or its salts , Glycyrrhetinic acid or a salt thereof, licorice extract, sicon extract, age extract, propolis and the like.
- Antibacterial / bactericidal / disinfectant agents include acrinol, sulfur, calcium gluconate, chlorhexidine gluconate, sulfamine, mercurochrome, lactoferrin or its hydrolyzate, alkyldiaminoethylglycine chloride solution, triclosan, sodium hypochlorite, chloramine T, salashi Powder, iodine compound, iodoform, sorbic acid or its salt, propionic acid or its salt, salicylic acid, dehydroacetic acid, parahydroxybenzoic acid esters, undecylenic acid, thiamine lauryl sulfate, thiamine lauryl nitrate, phenol, cresol, p- Chlorophenol, p-chloro-m-xylenol, p-chloro-m-cresol, thymol, phenethyl alcohol, O-phenylphenol, Irgasan CH3565,
- glycerin As humectants, glycerin, propylene glycol, 1,3-butylene glycol, polyethylene glycol, glycerin tricaprycapric acid, glycolic acid ( ⁇ -hydroxy acid), hyaluronic acid or its salt, chondroitin sulfate or its salt, water-soluble chitin or its Derivatives or chitosan derivatives, pyrrolidone carboxylic acid or salts thereof, sodium lactate, urea, sorbitol, amino acids or derivatives 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, hist
- glycolic acid citric acid, malic acid, tartaric acid, lactic acid, ferulic acid, phytic acid and the like can be contained.
- selenium disulfide for hair, selenium disulfide, alkylisoquinolinium bromide, zinc pyrithione, biphenamine, thianthol, castari tincture, pepper tincture, pepper tincture, quinine hydrochloride, strong ammonia water, potassium bromate, sodium bromate, thioglycol It can contain an acid or the like.
- natural animal fragrances such as musk, civet, castorium, ambergris, anise essential oil, angelica essential oil, ylang ylang essential oil, iris essential oil, fennel essential oil, orange essential oil, cananga essential oil, caraway essential oil, cardamom essential oil, guayakwood essential oil, cumin Essential oil, black letter essential oil, cinnamon essential oil, cinnamon essential oil, geranium essential oil, copaiba balsam essential oil, coriandel essential oil, perilla essential oil, cedarwood essential oil, citronella essential oil, jasmine essential oil, gingergrass essential oil, cedar essential oil, spearmint essential oil, western peppermint essential oil, large Perfume essential oil, tuberose essential oil, clove essential oil, orange flower essential oil, winter green essential oil, trout balsam essential oil, buttery essential oil, rose essential oil, palmarosa essential oil, persimmon essential oil, hiba essential oil, sandalwood essential oil, petit gren essential oil, bay essential oil
- soft capsules are packaged, stored and distributed in packaging forms such as bottling packaging, PTP packaging, and pouches.
- Iota carrageenan Standardized substance (sucrose) added by 40% by mass (manufactured by MSC). * Kappa Carrageenan: CT-1000 (Mitsubishi Corporation Foodtech) Starch dispersion obtained by ultrasonic treatment of starch paste: F Smash (derived from waxy corn starch) Oxidized starch: Stabilose (Matsutani Chemical Industry Co., Ltd.) Wet heat-treated starch: Soft starch SF-930 (manufactured by Sanwa Starch Co., Ltd.) Glycerin: Food additive grade (manufactured by Sakamoto Pharmaceutical Co., Ltd.) * Each prescription amount of “iota carrageenan” described in the prescription column of each test example describes an amount including a standardized substance.
- Test Examples 1 to 6 Production of soft capsules using a rotary die type soft capsule filling machine (1) Starch dispersion obtained by ultrasonic treatment of iota carrageenan, kappa carrageenan and starch paste solution in the amounts (parts by mass) shown in Table 1 The product (simply referred to as “starch dispersion”), oxidized starch and glycerin were each stirred and dispersed in water, then dissolved with stirring at 90 to 98 ° C., and vacuum degassed. Soft capsules were produced from this coating solution using a rotary die type soft capsule filling machine. First, the coating liquid was spread on a rotating drum by a casting apparatus to prepare a coating sheet. At this stage, the following [a. Evaluation of film sheet strength] and [b. Evaluation of Elongation of Film Sheet].
- Test Examples 1 to 4 using starch dispersions derived from iota carrageenan and waxy corn starch were excellent in film sheet strength and adhesiveness during capsule molding. Moreover, it was excellent in the film
- Test Example 4 containing kappa carrageenan had a fast gelation and a high yield.
- Test Example 5 using iota carrageenan and oxidized starch was inferior in adhesiveness and could not be encapsulated. In Test Example 6, it took time to disintegrate the soft capsule.
- Test Example 7 using a starch dispersion derived from iota carrageenan and waxy corn starch has excellent film sheet strength and adhesiveness at the time of capsule molding, and is also excellent in film performance after encapsulation. Met.
- Test Example 8 using iota carrageenan and oxidized starch showed poor adhesion and leakage of the contents.
- Test Examples 9 to 11 using starch dispersions derived from iota carrageenan and waxy corn starch are excellent in film sheet strength and adhesiveness at the time of capsule molding, and also excellent in film performance after encapsulation. It was a soft capsule.
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Abstract
Description
一方で、昨今の牛海綿状脳症(BSE)の問題や宗教上の理由から、動物由来のゼラチンの代替品が求められており、カプセルにおいても例外ではない。
しかしながら、前述の従来技術においてはこのような皮膜性能を総合的に備えているとは云い難いのが実状であった。とりわけ、従来の皮膜組成では、通常のゼラチン皮膜と同様の皮膜シートの厚さ(約0.9mm)にすると、皮膜シート強度及び接着力が十分ではない場合が多かった。そのため、皮膜シートを薄く(約0.6mm)してカプセル化に必要な皮膜シート強度及び接着力を確保していた。しかし、皮膜シートを薄くすると内容液の粒子が皮膜の接合部分に噛み込んだ場合には、接合部分にごく小さな穴が開き、カプセル内容物が漏れる不具合が生じる場合もあった。この不具合は、皮膜シートを薄くする程顕著であった。
また、本発明は、上記軟カプセル皮膜を用いて得られる軟カプセルを提供するものである。
カラギナンは、硫酸基をもつガラクタンの一種であり、紅藻類に存在していることが知られている。カラギナンは、日本の食品添加物の規定では、「精製カラギナン」、「加工ユーケマ藻類」、「ユーケマ藻末」の三種類が規定されている(日本食品添加物協会刊、「既存添加物名簿収載品目リスト注解書」(1999)参照)が、これらは精製度が異なるのみで、本質的には全て本発明におけるカラギナンに含まれる。
カラギナンは、それぞれ純粋品でもよいし、標準化物質を含んだものでもよい。ここで、標準化物質としては、ショ糖、ブドウ糖、マルトース、乳糖等の糖類及びデキストリンからなる群から選ばれた1種又は2種以上が挙げられる。カラギナンに標準化物質が含まれる場合、標準化物質の割合は50質量%以下、更に45質量%以下が好ましい。なお、カラギナンとして標準化物質を含んだものを利用する際、後述するカラギナンの含有量は、標準化物質を含むものとする。
(A)イオタカラギナンの含有量は、皮膜シート強度の点、弾力性の点から、固形成分の合計量中、20質量%以上が好ましく、25質量%以上がより好ましく、30質量%以上がより好ましく、35質量%以上が更に好ましい。また、皮膜液粘度の点から、固形成分の合計量中、55質量%以下が好ましく、50質量%以下がより好ましく、45質量%以下が更に好ましい。また、(A)イオタカラギナンの含有量は、固形成分の合計量中、20~55質量%が好ましく、25~55質量%がより好ましく、30~50質量%がより好ましく、35~45質量%が更に好ましい。なお、この発明において固形成分とは、皮膜組成の中から、精製水と可塑剤を除いたもののことである。
澱粉糊液は、常法、例えば、澱粉を水中等で加熱して澱粉質を糊化させて調製される。澱粉糊液における澱粉の含有量は、特に制限されないが、1質量%以上が好ましく、5質量%以上がより好ましく、10質量%以上がより好ましい。
なお、澱粉糊液の調製に用いられる澱粉は、未化工、すなわち、酸処理、アルファ化、エーテル化、アセチル化等の化工を行っていないものが好ましい。
超音波処理により、澱粉糊液の粘度は低下し、澱粉分散物が得られる。超音波処理後の澱粉分散物の粘度(B型粘度計、澱粉の含有量20質量%、液温80℃)は、澱粉の種類によって相違するものの、350mPa・s以下が好ましく、10~350mPa・sがより好ましい。
本発明において、(B)澱粉糊液に超音波処理がされてなる澱粉分散物は市販品を使用することもできる。
カッパカラギナンの含有量は、ゲル化強度の点から、固形成分の合計量中、0.1質量%以上が好ましく、0.3質量%以上がより好ましく、0.5質量%以上が更に好ましい。また、皮膜強度(脆弱性)の観点から3.5質量%以下が好ましく、2.5質量%以下がより好ましい。カッパカラギナンの含有量は、固形成分の合計量中、0.1~3.5質量%が好ましく、0.3~3.5質量%がより好ましく、0.5~2.5質量%が更に好ましい。
ただし、皮膜の物性、軟カプセルの品質を考慮して、イオタ又はカッパカラギナン以外のゲル化剤の含有量は、固形成分の合計量中、1質量%以下、更に0.5質量%以下、特に0.1質量%以下であることが好ましい。
澱粉糊液に超音波処理がされてなる澱粉分散物以外の澱粉類の含有量は、皮膜シート強度、接着力及び乾燥後の弾力性の点から、固形成分の合計量中、50質量%以下が好ましく、47質量%以下がより好ましく、45質量%以下が更に好ましく、10質量%以下が更に好ましい。下限値は0質量%である。
本発明の軟カプセル皮膜における可塑剤の含有量は、柔軟性の点から、固形成分の合計量100質量部に対して、30質量部以上が好ましく、35質量部以上がより好ましい。また、付着性の点から、固形成分の合計量100質量部に対して、60質量部以下が好ましく、50質量部以下がより好ましい。可塑剤の含有量は、固形成分の合計量100質量部に対して、30~60質量部が好ましく、35~50質量部がより好ましい。
以下に、カプセルに含有し得るものを例示する。これら各成分は、カプセル剤中のいかなる部分にも含有しうる。
イオタカラギナン:標準化物質(ショ糖)40質量%添加品(MSC社製)。*
カッパカラギナン:CT-1000(三菱商事フードテック社製)
澱粉糊液に超音波処理がされてなる澱粉分散物:エフスマッシュ(ワキシーコーン澱粉に由来)
酸化澱粉:スタビローズ(松谷化学工業社製)
湿熱処理澱粉:ソフトスターチSF-930(三和澱粉社製)
グリセリン:食品添加物グレード(阪本薬品工業社製)
*各試験例の処方欄に記載の「イオタカラギナン」の各処方量は、標準化物質を含む量を記載した。
(1)表1に示した量(質量部)のイオタカラギナン、カッパカラギナン、澱粉糊液に超音波処理がされてなる澱粉分散物(単に「澱粉分散物」と記した)、酸化澱粉、グリセリンをそれぞれ水に攪拌・分散させた後、90~98℃で攪拌しながら溶解させ、真空脱泡した。この皮膜液から、ロータリーダイ式軟カプセル充填機を用いて軟カプセルを製造した。
先ず、皮膜液をキャスティング装置により、回転ドラム上に展延して皮膜シートを調製した。この段階で、下記〔a.皮膜シート強度の評価〕及び〔b.皮膜シートの伸びの評価〕を行った。
また、カプセル化ができた試験例1~4と試験例6については、下記〔g.乾燥後のカプセルの崩壊性の評価〕を行った。結果を表1に示した。
専門パネル5名の感覚により、以下に示す評価基準に従って、皮膜シートの強さを評価した。
5:とても強い
4:強い
3:やや弱い
2:弱い
1:とても弱い。
専門パネル5名の感覚により、皮膜シートの強度の評価時に同時に、以下に示す評価基準に従って、皮膜シートの伸びを評価した。
5:とても伸びて、弾力性がある
4:伸びて、弾力性がある
3:伸びはあるが、弾力性がやや弱い
2:ほとんど伸びがなく、弾力性が弱い
1:伸びがなく、弾力性がない
専門パネル5名で乾燥前のカプセルを指で押しつぶして、以下に示す評価基準に従って、カプセル成形直後の皮膜シートの接着性を評価した。
5:強く押しても内容液が全く漏れ出さないし、24時間静置してもすべてのカプセルに浸出が発生しない
4:強く押しても内容液は漏れ出さないが、24時間静置すると一部のカプセルに浸出が発生する
3:強く押すとごく少量の内容液が漏れてしまう
2:弱く押しても少量の内容液が漏れてしまう
1:弱く押しても内容液が漏れてしまう
専門パネル5名でカプセルを指で押した際の変形を観察し、以下に示す評価基準に従って、カプセルの弾力性を評価した。
5:変形しないか、少し変形してもすぐに元の形に戻る
4:押すと少し変形するが、しばらく置けば元の形に戻る
3:押すと変形し、元の形に戻るのに時間がかかる
2:押すと変形し、殆ど元に戻らない
1:押したら変形したまま元に戻らない
専門パネル5名でカプセルをガラス瓶に入れ、逆さにして落下するかどうか観察し、以下に示す評価基準に従って、カプセルの付着性を評価した。
5:ガラス瓶を逆さにするだけで、カプセルがパラパラと落ちる
4:ガラス瓶を逆さにして軽く振ると、カプセルが落ちる
3:ガラス瓶を逆さにして軽くたたくと、カプセルが落ちる
2:ガラス瓶を逆さにしてたたきつけると、ようやくカプセルが落ちる
1:ガラス瓶にカプセルが強固にはりついている
専門パネル5名で目視にて、以下に示す評価基準に従って、カプセルの透明性を評価した。
5:ゼラチン皮膜と同等
4:ゼラチン皮膜と殆ど同等
3:ゼラチン皮膜よりやや劣る
2:刷りガラスに近い
1:刷りガラスと同等
日局準拠の崩壊試験(補助盤あり)により、軟カプセルから内容物である油滴が流出する時間(分)を測定した。n=6で測定し、その平均値を記録した。
カッパカラギナンを配合した試験例4は、ゲル化も早く、収率が高かった。
一方、イオタカラギナンと酸化澱粉を用いた試験例5は、接着性に劣りカプセル化できなかった。また、試験例6では、軟カプセルの崩壊に時間がかかった。
表2に示した量(質量部)のイオタカラギナン、カッパカラギナン、澱粉糊液に超音波処理がされてなる澱粉分散物(単に「澱粉分散物」と記した)、酸化澱粉、グリセリンをそれぞれ水に攪拌・分散させ、上記試験例と同様に皮膜液を調製した後、ロータリーダイ式軟カプセル充填機を用いてセルフカット型の軟カプセルを製造した。
また上記試験例と同様に、〔a.皮膜シート強度の評価〕、〔b.皮膜シートの伸びの評価〕、〔c.カプセル成形直後の皮膜シートの接着性の評価〕、〔d.乾燥後のカプセルの弾力性の評価〕、〔e.乾燥後のカプセルの付着性の評価〕及び〔f.乾燥後のカプセルの透明性の評価〕を行った。結果を表2に示した。
一方、イオタカラギナンと酸化澱粉を用いた試験例8は、接着性に劣り内容物の漏出が認められた。
表3に示した量(質量部)のイオタカラギナン、カッパカラギナン、澱粉糊液に超音波処理がされてなる澱粉分散物(単に「澱粉分散物」と記した)、塩の存在下で湿熱処理がされてなる澱粉(単に「湿熱処理澱粉」と記した)、グリセリンをそれぞれ水に攪拌・分散させ、上記試験例と同様に皮膜液を調製した後、ロータリーダイ式軟カプセル充填機を用いて軟カプセルを製造した。
また上記試験例と同様に、〔a.皮膜シート強度の評価〕、〔b.皮膜シートの伸びの評価〕、〔c.カプセル成形直後の皮膜シートの接着性の評価〕、〔d.乾燥後のカプセルの弾力性の評価〕、〔e.乾燥後のカプセルの付着性の評価〕、〔f.乾燥後のカプセルの透明性の評価〕及び〔g.乾燥後のカプセルの崩壊性の評価〕を行った。結果を表3に示した。
Claims (10)
-
(A)イオタカラギナンと(B)澱粉糊液に超音波処理がされてなる澱粉分散物とを含有することを特徴とする軟カプセル皮膜。 - 更に、可塑剤を含有する請求項1記載の軟カプセル皮膜。
- (A)イオタカラギナンの含有量が固形成分の合計量中20~55質量%である請求項1又は2記載の軟カプセル皮膜。
- (B)澱粉糊液に超音波処理がされてなる澱粉分散物の含有量が固形成分の合計量中10~75質量%である請求項1~3のいずれか1項記載の軟カプセル皮膜。
- (A)イオタカラギナンと(B)澱粉糊液に超音波処理がされてなる澱粉分散物の固形成分の合計量中の含有質量比[(A):(B)]が1:0.3~1:3である請求項1~4のいずれか1項記載の軟カプセル皮膜。
- (B)澱粉糊液に超音波処理がされてなる澱粉分散物が、ワキシーコーン澱粉に由来する澱粉分散物である請求項1~5のいずれか1項記載の軟カプセル皮膜。
- ワキシーコーン澱粉が未化工の澱粉である請求項6記載の軟カプセル皮膜。
- 更にカッパカラギナンを含有する請求項1~7のいずれか1項記載の軟カプセル皮膜。
- カッパカラギナンの含有量が固形成分の合計量中0.1~3.5質量%である請求項8記載の軟カプセル皮膜。
- 請求項1~9のいずれか1項記載の軟カプセル皮膜を用いて得られる軟カプセル。
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EP3023096A1 (en) | 2016-05-25 |
US20160175258A1 (en) | 2016-06-23 |
JPWO2015008748A1 (ja) | 2017-03-02 |
WO2015008399A1 (ja) | 2015-01-22 |
JP5688193B1 (ja) | 2015-03-25 |
EP3023096A4 (en) | 2017-03-22 |
US9901547B2 (en) | 2018-02-27 |
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