WO2016052573A1 - Capsule - Google Patents

Capsule Download PDF

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Publication number
WO2016052573A1
WO2016052573A1 PCT/JP2015/077630 JP2015077630W WO2016052573A1 WO 2016052573 A1 WO2016052573 A1 WO 2016052573A1 JP 2015077630 W JP2015077630 W JP 2015077630W WO 2016052573 A1 WO2016052573 A1 WO 2016052573A1
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WIPO (PCT)
Prior art keywords
capsule
component
present
gelatin
content
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PCT/JP2015/077630
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English (en)
Japanese (ja)
Inventor
慎治 谷口
Original Assignee
小林製薬株式会社
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Publication of WO2016052573A1 publication Critical patent/WO2016052573A1/fr

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein

Definitions

  • the present invention relates to a capsule. More specifically, the present invention relates to a capsule in which a content containing anthocyanins, anthocyanidins, proanthocyanidins, and / or catechins is filled in a capsule made of a capsule film containing gelatin. The present invention relates to a capsule capable of suppressing curing.
  • Polyphenols such as anthocyanins, proanthocyanidins, and procyanidins have excellent antioxidant action and are used in various fields such as foods and pharmaceuticals.
  • anthocyanins have an effect of relieving eye strain and are widely used as functional food materials and pharmaceutical materials.
  • catechin which is a type of polyphenol, is also known to have beneficial effects such as anti-oxidation, bactericidal activity, blood glucose level suppression, LDL cholesterol lowering, anti-cancer and the like in various fields such as food and pharmaceuticals. Widely used.
  • capsules have the advantages of being easy to take, masking the odor and taste of the contents, and having a high content release rate, and are widely used as supplements and pharmaceuticals.
  • capsules using a capsule film containing gelatin are excellent in safety, quick solubility in vivo, and feeling of eating (food texture), and are widely used.
  • a capsule film containing gelatin may be hardened by cross-linking or the like due to interaction with components in the contents to be filled in the capsule or a decomposition product thereof.
  • Such a hardening of the capsule film leads to a decrease in solubility in the living body, which in turn reduces the bioavailability of the contents and the feeling of administration. Therefore, the formulation of a capsule using a capsule film containing gelatin is It is necessary to design the contents so that the capsule film can be prevented from curing.
  • Patent Document 1 the technology disclosed in Patent Document 1 is a formulation that improves the capsule film characteristics from the composition of the content itself to be filled by reducing the solubility of the capsule film over time by the formulation design of the capsule film itself. It's not technology.
  • the content containing these polyphenols is filled into a capsule made of a capsule film containing gelatin.
  • the capsule film hardens over time.
  • Such hardening of the capsule film not only lowers the feeling of eating (food texture) but also decreases the disintegration property in the digestive tract. Therefore, in order to put into practical use a capsule in which the content containing the polyphenol is filled in a capsule made of a capsule film containing gelatin, it is necessary to develop a formulation technique for suppressing the hardening of the capsule film over time.
  • the present invention can suppress the hardening of the capsule film over time in a capsule in which a content containing anthocyanin, proanthocyanidin, procyanidin, and / or catechin is filled in a capsule made of a capsule film containing gelatin. It is an object to provide formulation technology.
  • the present inventor has intensively studied to solve the above problems, and as a content to be filled in a capsule comprising a capsule film containing gelatin, (A) together with anthocyanin, proanthocyanidin, procyanidin, and / or catechin, B) It has been found that the hardening of the capsule film over time can be suppressed by containing soy isoflavones and / or metabolites thereof. Furthermore, it has also been found that by using equol as the component (B), the effect of inhibiting the capsule film over time is significantly improved. The present invention has been completed by further studies based on this finding.
  • Item 1 A capsule in which a content containing at least one polyphenol selected from the group consisting of anthocyanins, proanthocyanidins, procyanidins and catechins, and (B) soy isoflavone and / or a metabolite thereof is a capsule film containing gelatin. Capsules characterized by being filled in.
  • Item 2. Item 2. The capsule according to Item 1, wherein the total amount of the component (B) is 2.5 to 250 parts by weight per 100 parts by weight of the total amount of the component (A).
  • Item 3. Item 3.
  • Item 4. Item 4. The capsule according to any one of Items 1 to 3, wherein the component (A) is derived from fruit and / or tea leaves. Item 5.
  • Item 5. The capsule according to any one of Items 1 to 4, wherein the component (B) is equol.
  • Item 6. Item 6. The capsule according to any one of Items 1 to 5, which is a soft capsule.
  • a content filled in a capsule comprising a capsule film containing gelatin, (A) at least one polyphenol selected from the group consisting of anthocyanins, proanthocyanidins, procyanidins and catechins and (B) soy isoflavones and / or their metabolism
  • the capsule film can be prevented from hardening with time even if the capsule film made of a capsule film containing gelatin is filled with the content containing anthocyanin, proanthocyanidin, procyanidin, and / or catechin. . Therefore, since the capsule of the present invention can suppress a decrease in solubility in the living body, it can further prevent the capsule from cracking without impairing the bioavailability and texture (texture) of the contents, It becomes possible to keep the capsule stable over time.
  • the capsule of the present invention comprises at least one polyphenol ((A) component) selected from the group consisting of anthocyanins, proanthocyanidins, procyanidins and catechins, and soy isoflavone and / or its metabolite ((B) component).
  • the content to be contained is filled in a capsule made of a capsule film containing gelatin.
  • the capsule of the present invention will be described in detail.
  • the content filled in the capsule of the present invention contains at least one polyphenol selected from the group consisting of anthocyanins, proanthocyanidins, procyanidins, and catechins. These specific polyphenols have the effect of hardening the capsule film containing gelatin over time, but in the present invention, the combination of the component (B) described later suppresses the hardening of the capsule film over time. It becomes possible.
  • Anthocyanins are glycosides in which anthocyanidins are linked to sugars as aglycones.
  • chemically synthesized anthocyanins may be used, but those derived from plants are preferably used.
  • Anthocyanins include, for example, blueberries, apples, elderberries, grapes, strawberries, red currants, cowberries, gooseberries, cranberries, salmonberries, bilberries, cassis, cherries, hakuruberries, blackberries, plums, white berries, boysenberries, It is known to be contained in plants such as mulberry, raspberry, red currant, logan berry, purple sweet potato, purple corn, red rice, black rice, black beans, black sesame, red cabbage, red radish and perilla.
  • Anthocyanins used in the present invention are purified products purified from plant parts such as fruits, seeds, pulp, pericarp, seed coat, leaves, etc., extracts extracted from these plant parts, and pulverization of these plant parts.
  • any of a finely-sliced thing, juice, etc. may be sufficient.
  • purifying or extracting a polyphenol from a plant is well-known,
  • purified substance or extract of anthocyanin obtained according to the well-known method can be used.
  • purified substance or extract of anthocyanin is also commercially available, you may use the refined
  • Proanthocyanidins are compounds that are condensed or polymerized at positions 4-6 or 4-8 with flavan-3-ol as a structural unit, and are polyphenols also called condensed tannins.
  • proanthocyanidins may be chemically synthesized, but it is preferable to use plant-derived ones.
  • Proanthocyanidins are, for example, apples, blueberries, elderberries, grapes, strawberries, red currants, cowberries, gooseberries, cranberries, salmonberries, bilberries, cassis, cherries, hakulberries, blackberries, plums, white berries, boysenberries , Mulberry, raspberry, red currant, logan berry, persimmon, pine, persimmon, wild peach, wheat, wheat, soybean, black soybean, cacao, red bean, tochi, peanut, ginkgo leaf, green tea It has been known.
  • Proanthocyanidins used in the present invention are purified products purified from plant parts such as fruits, seeds, pulp, pericarp, seed coat, leaves, etc., extracts extracted from these plant parts, Any of grinding
  • purifying or extracting polyphenol from a plant is well-known,
  • the purified product or extract of proanthocyanidin obtained according to the well-known method can be used.
  • a purified product or extract of proanthocyanidins can be obtained commercially, a commercially available purified product or extract of proanthocyanidins may be used in the present invention.
  • Procyanidins are polyphenols having a structure in which catechins are polymerized.
  • procyanidins may be chemically synthesized, but are preferably plant-derived.
  • Procyanidins are, for example, apples, loquats, grapes, blueberries, raspberries, cranberries, strawberries, avocados, false acacia, bilberries, pine, strawberries, wild peaches, pine, strawberries, wheat, wheat, soybeans, black soybeans, cacao, red beans, tochi, It is known to be contained in plants such as peanuts, ginkgo leaves and green tea. In particular, it is known that proanthocyanidins are the main component of apple polyphenol contained in apples.
  • the procyanidins used in the present invention are purified products purified from plant parts such as fruits, seeds, pulp, pericarp, seed coat, bark, leaves and shells of these plants, extracts extracted from these plant parts, these It may be any of pulverized plant parts, shredded products and juices.
  • purifying or extracting polyphenol from a plant is well-known,
  • the purified product or extract of procyanidin obtained according to the well-known method can be used.
  • a purified product or extract of procyanidin is also commercially available, a commercially available purified product or extract of procyanidin may be used in the present invention.
  • Catechin is a polyphenol also known as a bitter component of tea.
  • chemically synthesized catechins may be used, but those derived from tea are preferably used.
  • the catechin used in the present invention may be any of a purified product purified from tea leaves, an extract extracted from tea leaves, a ground or chopped tea leaf.
  • purifying or extracting catechin from tea leaves is well-known, In this invention, the purified product or extract of catechin obtained according to the well-known method can be used.
  • a purified product or extract of catechin is also commercially available, a purified product or extract of catechin that is commercially available may be used in the present invention.
  • component (A) one type may be used alone from among anthocyanins, proanthocyanidins, procyanidins and catechins, or two or more types may be used in combination.
  • anthocyanins anthocyanins, procyanidins and catechins are preferable.
  • a purified product or extract of polyphenol obtained from fruit is rich in anthocyanins and / or procyanidins and can be suitably used as the component (A).
  • a purified product or extract of polyphenol obtained from blueberry fruit is rich in anthocyanins and is suitable as the component (A).
  • the purified product or extract of polyphenol obtained from tea leaves contains abundant catechins and can be suitably used as the component (A).
  • the content of component (A) is not particularly limited, but is, for example, 4.5 to 50 % By weight, preferably 4.5 to 45% by weight, more preferably 4.5 to 36% by weight.
  • the content filled in the capsule of the present invention contains soy isoflavone and / or a metabolite thereof together with the specific polyphenol.
  • soybean isoflavone and / or its metabolite it becomes possible to suppress the time-dependent hardening of the capsule film caused by the specific polyphenol.
  • soybean isoflavone contained in soybean, and specifically, daidzein, daidzin, acetyl daidzin, malonyl daidzin, genistein, genistin, acetylgenistin, malonylgenistin, glycitein, glycitin, acetylglycitin, malonyl glycine Chin etc. are mentioned.
  • soybean isoflavones may be used alone or in combination of two or more.
  • the soybean isoflavone may be any one purified from soybeans, extracted from soybeans, pulverized or chopped soybeans, or the like.
  • the soy isoflavone metabolite is a compound produced by soy isoflavone being metabolized by intestinal bacteria, and specific examples include equol and dihydrogenenistein. These metabolites of soybean isoflavone may be used alone or in combination of two or more.
  • a metabolite of soy isoflavone can be produced by converting soy isoflavone by an enzymatic reaction or a chemical reaction.
  • a refined product may be used as the metabolite of soy isoflavone, and a fermented product obtained by fermenting soy isoflavone or a raw material containing it (soybean, soy germ, etc.) or its extraction. You may use things.
  • component (B) either soybean isoflavone or a metabolite thereof may be used alone, or these may be used in combination.
  • a soybean metabolite is preferable, and equol is more preferable.
  • fermented products obtained by fermenting soy isoflavones or raw materials containing them (soybeans, soy germs, etc.) or extracts thereof contain abundant soy isoflavones and equol, and especially as component (B) It can be suitably used.
  • the content of the component (B) (content of soy isoflavone and / or its metabolite itself) is not particularly limited, but for example 0.12 to 20% by weight Is mentioned.
  • the content of the component (B) in the content used in the present invention is preferably 0.18 to 20% by weight from the viewpoint of more effectively suppressing the time-lapse hardening of the capsule film containing gelatin. %, More preferably 0.25 to 14% by weight.
  • the ratio of the component (B) to the component (A) is not particularly limited, for example, (B) per 100 parts by weight of the total amount of the component (A)
  • the total amount of the components is 2.5 to 250 parts by weight.
  • the total amount of component (B) is preferably 4 to 250 parts by weight per 100 parts by weight of component (A). More preferred is 5.5 to 250 parts by weight.
  • the contents filled in the capsule of the present invention may contain an oily base (component (C)) as necessary.
  • an oily base By containing such an oily base, it becomes possible to more effectively suppress changes in properties such as hardening over time of the capsule film containing gelatin.
  • the oily base is not particularly limited as long as it can be used for foods or pharmaceuticals, and examples thereof include vegetable oils, animal oils, higher fatty acids, waxes and the like.
  • Specific vegetable oils include safflower oil, olive oil, wheat germ oil, rice oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, jojoba oil, avocado oil, fennel oil, Examples include clove oil, mint oil, eucalyptus oil, and lemon oil. These vegetable oils may be used individually by 1 type, and may be used in combination of 2 or more type.
  • animal oils include lard, fish oil, squalane and beef tallow. These animal oils may be used alone or in combination of two or more.
  • higher fatty acids include fatty acids having 8 to 22 carbon atoms, and specific examples include docosahexaenoic acid, eicosapentaenoic acid, stearic acid, lauric acid, myristic acid, palmitic acid, sebacic acid, and oleic acid. It is done. These higher fatty acids may be used alone or in combination of two or more.
  • wax examples include carnauba wax, candelilla wax, rice bran wax, beeswax, wood wax, sugar cane wax, and palm wax. These waxes may be used alone or in combination of two or more.
  • oily bases may be used alone or in combination of two or more.
  • vegetable oils and waxes are preferable.
  • the content of the component (C) is not particularly limited, but for example, 40 to 91% by weight, preferably 45 to 91% by weight, more preferably 50 to 91% by weight. %.
  • the contents filled in the capsule of the present invention may contain a surfactant (component (D)) as necessary.
  • a surfactant is included in order to improve the dispersibility of the components (A) and (B).
  • the surfactant is not particularly limited as long as it can be used for foods or pharmaceuticals.
  • Nonionic surfactant coconut oil fatty acid amidopropyl betaine, lauryldimethylaminoacetic acid betaine, lauryldimethylamine oxide, 2-alkyl-N-carboxymethyl-N-hydroxyethylimidazolium betaine, N-lauryldiaminoethylglycine, N -Amphoteric surfactants such as myristyldiaminoethylglycine, N-alkyl-1-hydroxyethylimidazoline betaine sodium; lauryltrimethylammonium chloride, Stearyl trimethyl ammonium, benzethonium chloride, benzalkonium chloride, cationic surfactants such as chloride stearyl dimethyl benzyl ammonium.
  • nonionic surfactants are preferable, and glycerin fatty acid esters, sucrose fatty acid esters, and lecithin are more preferable.
  • surfactants may be used individually by 1 type, and may be used in combination of 2 or more type.
  • the content of the component (D) is not particularly limited, but for example, 1 to 10% by weight, preferably 2 to 9% by weight, more preferably 2 to 8% by weight. %.
  • the contents filled in the capsule of the present invention may contain other nutritional components and pharmacological components as necessary.
  • Such nutritional components and pharmacological components are not particularly limited as long as they can be used in foods and pharmaceuticals.
  • vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin A, vitamin D Vitamins such as vitamin E, vitamin K, niacin, pantothenic acid, folic acid, biotin and lycopene; stomachic agents such as betaine hydrochloride and betanecol chloride; acrinol, berberine chloride, creosote, tannic acid, scopolamine hydrobromide, methyl bromide
  • Antitrophic agents such as atropine, papaverine hydrochloride, ethyl aminobenzoate; antihistamines such as isothibenzyl hydrochloride, diphenylpyraline hydrochloride, diphenhydramine hydrochloride, chlorpheniramine maleate, alimemazine tartrate; dextromethorphan hydrobromide, tipipedi Antiseptics such as dihydrocodeine phosphate; minerals such as calcium, sulfur, magnesium, zinc, selenium, iron; proteins such as
  • the contents filled in the capsule of the present invention may contain other bases and additives as required.
  • bases and additives are not particularly limited as long as they can be used in foods and pharmaceuticals.
  • water-soluble polymers, emulsifiers, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters , Buffers, antioxidants, preservatives, acidulants, bitters, fragrances, powders, thickeners, dyes, chelating agents and the like may be used alone or in combination of two or more.
  • content of these bases and additives it sets suitably according to the kind etc. of the additive component to be used.
  • Form of contents The form of the contents filled in the capsule of the present invention is not particularly limited, and may be any of liquid, solid, semi-solid (gel, cream, paste), etc. Is semi-solid, more preferably cream.
  • the contents are filled using a capsule made of a capsule film containing gelatin.
  • the capsule used in the present invention may be either a soft capsule or a hard capsule.
  • the soft capsule is cured with a relatively soft capsule film. Since suppression is highly required, it can be said to be suitable as a capsule used in the present invention.
  • gelatin used as the raw material for the capsule film is not particularly limited, and gelatin used for general capsule film production may be used. Specific examples include acid-treated gelatin, alkali-treated gelatin, amphoteric-treated gelatin, and chemically modified gelatin. These gelatins may be used alone or in combination of two or more.
  • the gelatin content in the capsule film is not particularly limited, and examples thereof include 40 to 80% by weight, preferably 45 to 80% by weight, and more preferably 50 to 75% by weight.
  • the capsule film may contain a plasticizer as needed in order to promote plasticization of gelatin.
  • the kind of the plasticizer is not particularly limited as long as it can be used for foods and pharmaceuticals, and examples thereof include glycerin, sorbitol, propylene glycol and the like. These plasticizers may be used individually by 1 type, and may be used in combination of 2 or more type.
  • the content of the plasticizer in the capsule film is not particularly limited, and examples thereof include 15 to 55% by weight, preferably 15 to 50% by weight, and more preferably 20 to 45% by weight.
  • the capsule film may contain a colorant as necessary.
  • a colorant may be either a synthetic colorant or a natural colorant as long as it can be used in foods and pharmaceuticals. For example, Blue No. 1, Red No. 106, Yellow No. 4, Green No. 3 etc. are mentioned. These colorants may be used alone or in combination of two or more.
  • capsule film water, water-soluble polymers, emulsifiers, lower alcohols, pH adjusters, buffering agents, oxidation agents, etc. are used for the purpose of improving the capsule film stability, seasoning, and solubility adjustment, as necessary.
  • Additives such as inhibitors, preservatives, acidulants, bitters, fragrances, powders, thickeners, chelating agents may be included. These additives may be used individually by 1 type, and may be used in combination of 2 or more type.
  • the capsule of the present invention has beneficial effects such as antioxidant, eye strain recovery, sterilization, blood sugar level suppression, LDL cholesterol lowering, anti-cancer, blood flow improvement, anti-arteriosclerosis and the like. Can demonstrate. Further, the present invention is based on the above component (B), in addition to the prevention or treatment of diseases and symptoms such as menopause, osteoporosis, arteriosclerosis, myocardial infarction, breast cancer, prostate cancer, arteriosclerosis and the like. , Can improve the balance of female hormones. Therefore, the present invention can be provided as foods such as supplements, functional foods, health and health foods, and sick foods in addition to pharmaceuticals.
  • the capsule of the present invention is prepared by mixing the components (A) and (B), and if necessary, the component (C), the component (D), and other additive components to obtain a desired form.
  • the content can be produced by filling capsules made of a capsule film containing gelatin.
  • the filling of the contents into the capsule can be performed according to a known capsule manufacturing method.
  • a capsule film composition in which raw materials for capsule film are mixed may be processed into a thin film shape, and the contents in a desired form may be encapsulated using this.
  • a capsule composed of a pair of a body and a cap may be molded in advance and filled with the desired content.
  • the component (B) has an action of suppressing the time-dependent hardening of the capsule that occurs when the capsule containing a capsule film containing gelatin is filled with the content containing the component (A). Therefore, the present invention further includes (A) at least one polyphenol selected from the group consisting of anthocyanins, proanthocyanidins, procyanidins and catechins in a content filled in a capsule comprising a capsule film containing gelatin and (B (2) Provided is a method for inhibiting capsule hardening, characterized by coexisting soybean isoflavones and / or metabolites thereof.
  • the types and amounts of the components (A) and (B) used, other components added to the contents, the composition of the capsules, etc. As described in the column.
  • Blueberry licorice extract powdered extract obtained by extracting polyphenol from blueberry; containing 35% by weight of anthocyanin; manufactured by Indena Japan Co., Ltd.
  • Fruit polyphenol a mixture of powdered extracts obtained by extracting polyphenols from fruits such as apples and grapes; a total amount of anthocyanins and apple polyphenols of 100% by weight; manufactured by Nexira Japan)
  • Green tea extract Powdered extract obtained by extracting catechin from tea leaves of green tea; containing 40% by weight of catechin; manufactured by Maruzen Pharmaceutical Co., Ltd.
  • Soybean extract Powdered extract obtained by extracting isoflavone from soybean; containing 40% by weight of soybean isoflavone; manufactured by Nippon Shinyaku Co., Ltd.)
  • Fermented soy germ Fermented fermented soy germ ; containing 5% by weight of equol and excluding soy isoflavone
  • Test Example 1 Cream-like contents having the compositions shown in Tables 1 and 2 were prepared and tested for effects on capsule films containing gelatin. Specifically, 20 g of water and 4 g of glycerin were mixed and heated to 80 ° C., after which 10 g of gelatin was added and gently stirred until the gelatin was dissolved to prepare a gelatin solution. This gelatin solution was dropped into a petri dish so as to have a thickness of 5 mm and dried at room temperature for 24 hours to prepare a gelatin sheet (disc shape having a diameter of 10 cm).
  • safflower oil, glycerin fatty acid ester, and beeswax shown in Tables 1 and 2 are stirred while heating, and after these are dissolved, cooling is performed while stirring, and the oily base and the surfactant are mixed. A mixture was obtained. To this mixture, other additive components were added and stirred to prepare a creamy content.
  • a gelatin sheet cut into a 2 cm square was immersed in 20 g of the obtained contents and allowed to stand at 25 ° C. for 4 weeks. Thereafter, the hardness of the gelatin sheet after 4 weeks of immersion was measured using a rheometer (“CR500DX”, manufactured by Sun Scientific Co., Ltd.). For the measurement of hardness with a rheometer, an intrusion degree measuring adapter was used, and the maximum load at the time of piercing was used as a measured value. From the measured value of hardness with a rheometer, the rate of increase in hardening (%) of the gelatin sheet was calculated by the following calculation method.
  • Soft capsules were prepared by encapsulating the contents shown in Tables 3 to 6 (300 mg per capsule) with a capsule film containing gelatin. Specifically, a predetermined amount of safflower oil, glycerin fatty acid ester, and beeswax shown in Tables 3 to 6 are stirred while heating, and after these are dissolved, they are cooled while stirring to obtain an oily base and a surfactant. A mixture of was obtained. To this mixture, other additive components were added and stirred to prepare a creamy content. According to the general manufacturing method of a soft capsule, 300 mg of the obtained contents were encapsulated with a capsule film (containing 100 mg of gelatin and 50 mg of glycerin per capsule) to produce a soft capsule. Each of the obtained soft capsules was suppressed in the capsule film over time, and had excellent storage stability.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
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Abstract

[Problème] L'objectif de la présente invention est de proposer une technique de formulation avec laquelle le durcissement d'un enrobage de capsule avec le temps peut être supprimé dans une capsule qui est formée par introduction de contenu, comprenant une anthocyanine, une proanthocyanidine, une procyanidine et/ou une catéchine, dans une capsule comprenant un revêtement de capsule qui comprend de la gélatine. [Solution] La présente invention concerne le durcissement du revêtement d'une capsule avec le temps qui peut être supprimé par intégration (A) d'une anthocyanine, d'une proanthocyanidine, d'une procyanidine et/ou de catéchine ainsi que (B) d'un isoflavone de soja et/ou d'un métabolite de celui-ci.
PCT/JP2015/077630 2014-09-30 2015-09-29 Capsule WO2016052573A1 (fr)

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Cited By (1)

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JP2021155374A (ja) * 2020-03-27 2021-10-07 フジッコ株式会社 腸内エクオール産生菌増加剤、エクオール産生促進剤、及び血中エクオール濃度上昇剤

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JP2019131536A (ja) 2018-01-30 2019-08-08 学校法人北里研究所 麻黄エキス、又はエフェドリンアルカロイド除去麻黄エキスより得られた高分子縮合型タンニンを含有する抽出分画物とその製法及び用途
EP3946402A1 (fr) * 2019-03-29 2022-02-09 Evonik Operations GmbH Préparations contenant des extraits de baies destinées à être utilisées dans la prophylaxie et/ou le traitement d'infections virales provoquées par le virus de l'herpès
WO2022204757A1 (fr) * 2021-03-30 2022-10-06 Noxopharm Limited Formulation d'isoflavone améliorée

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WO2006076240A2 (fr) * 2005-01-10 2006-07-20 The Procter & Gamble Company Compositions, produits et methodes destines a combattre la surcharge ponderale chez un mammifere
CN101120951A (zh) * 2006-08-10 2008-02-13 孙欣 润巢软胶囊及其制作方法
CN101513473A (zh) * 2008-02-18 2009-08-26 武汉枫叶红生物科技有限公司 一种能双向调节骨密度、修复骨关节的组方及制备方法
JP2011079786A (ja) * 2009-10-08 2011-04-21 Sankyo:Kk 崩壊遅延を防止または抑制したポリフェノール類、レシチン、ビタミンｅ含有ソフトカプセル
JP2011105763A (ja) * 2000-06-21 2011-06-02 Kao Corp Ｐｐａｒ依存的遺伝子転写活性化剤

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JP2011105763A (ja) * 2000-06-21 2011-06-02 Kao Corp Ｐｐａｒ依存的遺伝子転写活性化剤
WO2006076240A2 (fr) * 2005-01-10 2006-07-20 The Procter & Gamble Company Compositions, produits et methodes destines a combattre la surcharge ponderale chez un mammifere
CN101120951A (zh) * 2006-08-10 2008-02-13 孙欣 润巢软胶囊及其制作方法
CN101513473A (zh) * 2008-02-18 2009-08-26 武汉枫叶红生物科技有限公司 一种能双向调节骨密度、修复骨关节的组方及制备方法
JP2011079786A (ja) * 2009-10-08 2011-04-21 Sankyo:Kk 崩壊遅延を防止または抑制したポリフェノール類、レシチン、ビタミンｅ含有ソフトカプセル

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021155374A (ja) * 2020-03-27 2021-10-07 フジッコ株式会社 腸内エクオール産生菌増加剤、エクオール産生促進剤、及び血中エクオール濃度上昇剤
JP7438816B2 (ja) 2020-03-27 2024-02-27 フジッコ株式会社 腸内エクオール産生菌増加剤、エクオール産生促進剤、及び血中エクオール濃度上昇剤

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