WO2020004202A1 - COMPOSITION INCLUDING D-chiro-INOSITOL - Google Patents

COMPOSITION INCLUDING D-chiro-INOSITOL Download PDF

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Publication number
WO2020004202A1
WO2020004202A1 PCT/JP2019/024383 JP2019024383W WO2020004202A1 WO 2020004202 A1 WO2020004202 A1 WO 2020004202A1 JP 2019024383 W JP2019024383 W JP 2019024383W WO 2020004202 A1 WO2020004202 A1 WO 2020004202A1
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Prior art keywords
composition
acid
inositol
chiro
salt
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PCT/JP2019/024383
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French (fr)
Japanese (ja)
Inventor
信哉 宅見
公輔 田中
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小林製薬株式会社
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Publication of WO2020004202A1 publication Critical patent/WO2020004202A1/en

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    • 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
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00—Preparations for affecting hair growth

Definitions

  • the present invention relates to a composition comprising D-chiro-inositol.
  • the present invention also relates to an external preparation containing the composition.
  • Inositol (1,2,3,4,5,6-cyclohexanehexaol) has a structure in which one hydrogen atom on each carbon of cyclohexane is replaced by one hydroxy group, and is known as a vitamin-like active substance. I have. Inositol has nine types of stereoisomers depending on the combination of hydroxy group configurations.
  • Patent Document 1 discloses a hair restorer containing inositol as an active ingredient.
  • “inositol” used in the prior art refers to myo-inositol (cis-1,2,3,5-trans-4) as an additive for pharmaceuticals, quasi-drugs, cosmetics, and the like. , 6-cyclohexanehexaol) (see, for example, Non-Patent Documents 1 to 3).
  • the present inventors have found that among stereoisomers of inositol, chiro-inositol is a compound useful as a hair restorer (see Patent Document 2).
  • D-chiro-inositol is a water-soluble compound among the isomers of inositol.
  • D-chiro-inositol was found to be an inositol stereoisomer as well as in aqueous solution. It has been found that a precipitate tends to be formed.
  • D-chiro-inositol has a very low solubility in solvents other than water, and tends to form precipitates more easily when an aqueous solution having a water ratio of less than a predetermined value is placed in a low-temperature environment. It is in.
  • an object of the present invention is to provide a composition capable of suppressing the precipitation of D-chiro-inositol.
  • the present inventors have conducted intensive studies in order to solve the above-mentioned problems.
  • the composition containing D-chiro-inositol has a D-chiro-inositol content of D-chiro-inositol equal to or higher than a predetermined value.
  • the present inventors have found that the composition is capable of suppressing the deposition of chiro-inositol, and have completed the present invention.
  • the present invention provides the following inventions.
  • [6] including a salt of an organic acid
  • the surfactant comprises a nonionic surfactant.
  • the nonionic surfactant comprises polyoxyethylene hydrogenated castor oil or polyoxyethylene polyoxypropylene alkyl ether.
  • An external preparation containing the composition according to any one of [1] to [10].
  • An external preparation for scalp comprising the composition according to any one of [1] to [10].
  • composition capable of suppressing the precipitation of D-chiro-inositol even in a low-temperature environment.
  • composition of the present invention is a composition containing D-chiro-inositol and water.
  • D-chiro-inositol examples include, but are not particularly limited to, those extracted from naturally occurring buckwheat, beans, citrus, etc., those extracted and purified from legumes by fermentation, those chemically synthesized, and Commercial products can be mentioned.
  • the extraction method is not particularly limited, and a known extraction method can be used.
  • the content of D-chiro-inositol in the composition of the present invention is not particularly limited, but is preferably 0.001 to 20% by mass, more preferably 0.01 to 20% by mass, and still more preferably 0 to 20% by mass. 0.05 to 15% by mass, more preferably 1 to 10% by mass, still more preferably 3 to 7% by mass.
  • % by mass means the mass percentage of the components contained in the composition with respect to the mass of the entire composition.
  • X to Y means that it is X or more and Y or less.
  • the composition of the present invention can be used as an external preparation.
  • external preparations include, for example, agents for cracks and irrigations, agents for rashes and sores, agents for sea urchin and octopus, agents for dryness and irritations, agents for wrinkles and spots, humectants, hair dyes, hair restorers, shampoos, Rinse, conditioner, lotion, cream, milky lotion, hand cream, medicated soap, pack and the like can be mentioned.
  • the composition of the present invention contains D-chiro-inositol, a composition having a vitamin-like effect and a hair-growth activity can be obtained, and may be used as a hair-growth agent.
  • the hair growth activity is, specifically, an activity relating to hair shaft growth promotion, hair growth, prevention of hair loss, and the like, and preferably an activity relating to hair shaft growth promotion and hair growth.
  • the composition of the present invention may further include an organic acid or a salt thereof.
  • the composition of the present invention preferably contains an organic acid and a salt of the organic acid.
  • the feeling of use in a preparation containing the composition of the present invention can be improved. It tends to be. It is presumed that such an effect is attributable to the fact that the organic acid or a salt thereof exerts a chelating effect and functions to reduce the stimulus contributed by a solvent other than water, for example, a monoalcohol having 1 to 3 carbon atoms. (However, the factor is not limited to this.)
  • the organic acid means an organic compound which is acidic alone in water.
  • the organic acid is not particularly limited as long as it is an organic compound exhibiting acidity, and examples thereof include monocarboxylic acids and polycarboxylic acids, and organic sulfonic acids.
  • monocarboxylic acids and organic sulfonic acids are preferable, and organic sulfonic acids are more preferable, from the viewpoint of suppressing the precipitation of D-chiro-inositol.
  • the monocarboxylic acid means an organic compound having one carboxylic acid in the molecule
  • the polyvalent carboxylic acid means an organic compound having two or more carboxylic acids in the molecule
  • the organic sulfonic acid means an organic compound having at least one sulfonic acid in a molecule.
  • a monocarboxylic acid For example, Formic acid, acetic acid, propionic acid, and valeric acid are mentioned.
  • polyvalent carboxylic acid examples include, but are not particularly limited to, dicarboxylic acid, tricarboxylic acid, and tetracarboxylic acid, and include, for example, citric acid, edetic acid, phthalic acid, isophthalic acid, terephthalic acid, succinic acid, fumaric acid, and maleic acid. Acids, malic acid, and tartaric acid. Among these, citric acid and edetic acid are preferred.
  • Organic sulfonic acids include, but are not limited to, methanesulfonic acid, benzenesulfonic acid, and taurine.
  • the salt in the organic acid salt is not particularly limited, and includes, for example, a sodium salt, a potassium salt, a calcium salt, and a magnesium salt. Of these, sodium salts are preferred.
  • the organic acids or salts thereof may be used alone or in combination of two or more. When two or more kinds are used in combination, a combination of two or more kinds of organic acids or a combination of two or more kinds of salts of organic acids may be used. These may be used in combination. When an organic acid and a salt of the organic acid are used, the organic acid and the organic acid of the salt of the organic acid may be the same or different, but the organic acid and the salt of the organic acid are used in combination. Is preferred.
  • the content of the organic acid or a salt thereof in the composition of the present invention is not particularly limited, but is usually 0.001 to 5% by mass, preferably 0.01 to 3% by mass, more preferably 0.03% by mass. To 1% by mass, more preferably 0.05 to 1% by mass.
  • the composition of the present invention may further include a surfactant.
  • a surfactant By containing a surfactant, it tends to be possible to suppress the precipitation of D-chiro-inositol in an aqueous solution containing D-chiro-inositol.
  • a surfactant in the composition of the present invention, it tends to be possible to improve the feeling of use in a preparation containing the composition of the present invention. It is presumed that the factor that exerts such effects is due to the fact that the surfactant improves the solubility of D-chiro-inositol in an aqueous solution (however, the factor is not limited to this).
  • the surfactant examples include, but are not particularly limited to, a nonionic surfactant, a cationic surfactant, an anionic surfactant, and an amphoteric surfactant.
  • nonionic surfactants are preferable from the viewpoint that a good feeling in use is obtained, particularly, from the viewpoint of excellent permeability into pores.
  • One type of surfactant may be used alone, or two or more types may be used in combination.
  • the HLB value of the surfactant is not particularly limited, but is preferably 2 to 17, more preferably 6 to 17, and even more preferably 12 to 17.
  • HLB is an abbreviation for hydrophile-lipophile balance, and is one of the indices indicating the effect of a surfactant.
  • the HLB value when two or more surfactants are contained is a weighted average of the HLB values of each surfactant.
  • the nonionic surfactant means a surfactant that does not exhibit ionicity in an aqueous solution.
  • Nonionic surfactants include, but are not particularly limited to, for example, polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene sorbitan oleate, monoesters of oleic acid and glycerin, and oleic acid. Esters of diglycerin.
  • polyoxyethylene-hardened castor oil and polyoxyethylene poly-polyethylene are preferred from the viewpoint of suppressing the precipitation of D-chiro-inositol and obtaining a good feeling in use, particularly from the viewpoint of excellent permeability into pores.
  • Oxypropylene alkyl ethers are preferred.
  • the cationic surfactant and the anionic surfactant mean a surfactant that becomes a cation and an anion when dissociated in an aqueous solution, respectively, and the amphoteric surfactant has a pH of the aqueous solution in the aqueous solution.
  • Means a surfactant that becomes one of a cation, an anion, and a zwitterion depending on the Examples of the cationic surfactant include, but are not particularly limited to, alkyldimethylamine, alkyltrimethylammonium salt, and dialkyldimethylammonium salt.
  • the anionic surfactant include, but are not particularly limited to, fatty acid salts and alkyl sulfates.
  • Examples of the amphoteric surfactant include, but are not particularly limited to, alkylamino fatty acid salts, alkyl betaines, and alkylamine oxides.
  • the content of the surfactant in the composition of the present invention is not particularly limited, but is usually 0.1 to 10% by mass, preferably 0.5 to 7% by mass, and more preferably 1 to 5% by mass. It is.
  • the content of water in the composition of the present invention is not particularly limited as long as it contains water within a range of 40% by mass or more, but is preferably 70% by mass or less, more preferably 50% by mass or less.
  • the proportion of water is within the above range, it becomes possible to suppress the precipitation of D-chiro-inositol even in a low-temperature environment, particularly when the composition of the present invention contains an organic acid or a salt thereof.
  • This also makes it possible to suppress the precipitation of D-chiro-inositol.
  • a factor that exerts such an effect is that D-chiro-inositol is precipitated in a low-temperature environment because the water content is 40% by mass or more because D-chiro-inositol is water-soluble.
  • the organic acid or its salt functions to reduce the promotion of D-chiro-inositol precipitation by exerting a chelating action (however, the factor is not limited to this).
  • the factor is not limited to this.
  • water examples include pure water such as ion-exchanged water, ultrafiltration water, reverse osmosis water, and distilled water, and water from which ionic impurities such as ultrapure water have been removed as much as possible.
  • the composition of the present invention may further contain a mono- and / or polyhydric alcohol having 1 to 3 carbon atoms.
  • a polyhydric alcohol By containing a polyhydric alcohol, it tends to be possible to suppress the precipitation of D-chiro-inositol in an aqueous solution containing D-chiro-inositol.
  • a monoalcohol having 1 to 3 carbon atoms and / or a polyhydric alcohol By containing a monoalcohol having 1 to 3 carbon atoms and / or a polyhydric alcohol, a composition having antibacterial properties and moisture retention tends to be obtained.
  • the monoalcohol having 1 to 3 carbon atoms is methanol, ethanol, n-propanol and isopropanol, preferably ethanol and isopropanol, and more preferably ethanol.
  • the polyhydric alcohol means an alcohol having two or more hydroxyl groups in a molecule.
  • glycerin ethylene glycol, diethylene glycol, triethylene glycol, propylene glycol (1,2-propanediol), dipropylene glycol, trimethylolpropane, 1,3-propylene glycol ( 1,3-propanediol), isobutylene glycol (2-methyl-1,2-propanediol), 1,2-butanediol, 1,3-butyleneglycol (1,3-butanediol), 1,4-butane Diol, 2-butene-1,4-diol, 1,2-pentanediol, 1,5-pentanediol, 2-methyl-2,4-pentanediol, 1,2-hexanediol, 1,6-hexanediol , 2-ethyl-1,3-hexanediol, 1, - heptanediol
  • the content of the mono-alcohol having 1 to 3 carbon atoms in the composition of the present invention is not particularly limited, but the content of the mono-alcohol having 1 to 3 carbon atoms can be set high.
  • the content of the monoalcohol having 1 to 3 carbon atoms in the composition of the present invention is usually 80% by mass or less, may be 60% by mass or less, may be 30 to 60% by mass, and may be 30 to 50% by mass. Or 30 to 40% by mass.
  • the content of the polyhydric alcohol in the composition of the present invention is not particularly limited, but is usually 0.1% by mass or more, preferably 0.5% by mass or more, more preferably 0.5 to 30% by mass. And more preferably 0.5 to 20% by mass, and still more preferably 0.5 to 15% by mass.
  • the composition of the present invention may further include a monoterpene.
  • a monoterpene By containing a monoterpene, there is a tendency that a refreshing feeling can be imparted and a composition excellent in suppressing the precipitation of D-chiro-inositol can be obtained.
  • monoterpene examples include, but are not particularly limited to, monoterpene hydrocarbons such as limonene, pinene, and camphor; monoterpene alcohols such as citronellol, geraniol, linalool, menthol, terpineol, and borneol; monoterpenes such as citronellal, citral, and safranal Aldehydes; monoterpene ketones such as menthone, carbomentone, and yonone; Preferably, it is a monoterpene alcohol, and more preferably, menthol. These monoterpenes may be d-, l-, or dl-form.
  • menthol for example, l-menthol and d-menthol are preferred, and l-menthol is more preferred. It may be used as a mixture of 1-menthol and d-menthol. Monoterpenes may be used alone or in combination of two or more.
  • the content of the monoterpene in the composition of the present invention is not particularly limited, but in addition to imparting a refreshing feeling, suppressing precipitation of D-chiro-inositol, suppressing dripping and irritating feeling (crisp feeling) of the obtained composition. And 0.01 to 10% by mass, more preferably 0.05 to 2% by mass, and still more preferably 0.1 to 1.0% by mass because of excellent suppression of separation of the monoterpene itself. %, And still more preferably 0.7 to 1.0% by mass.
  • composition of the present invention may further contain additives that are generally acceptable in pharmaceuticals, quasi-drugs, cosmetics, and the like.
  • additives include, but are not limited to, excipients, stabilizers, odor correctors, bases, dispersants, diluents, emulsifiers, transdermal absorption enhancers, preservatives, coloring agents, oils (oils, fats, minerals, Oil, etc.), thickeners, polymers, film-forming agents, ultraviolet absorbers, cell activators, antioxidants, preservatives, fresheners, deodorants, pigments, dyes, fragrances, sugars, amino acids, vitamins, Organic acids, organic amines, plant extracts and the like can be mentioned.
  • the composition of the present invention is not particularly limited, and can be produced by mixing components contained in the present invention.
  • the order of mixing the components is not particularly limited.
  • the conditions for mixing are not particularly limited, and the composition of the present invention can be obtained according to a conventionally known method.
  • the composition of the present invention when used as an external preparation, it can be used as a drug, a quasi-drug, a cosmetic or the like.
  • it can be used as an external preparation for skin, an external preparation for hair, and an external preparation for scalp, and more specifically, a dermatological drug, a hair drug and a scalp drug, a quasi-drug for skin, and a hair
  • It can be used for quasi-drugs and quasi-drugs, as well as skin cosmetics, hair cosmetics and scalp cosmetics. More specifically, it can be in the form of an ointment, cataplasm, liniment, lotion, topical solution, dusting agent, cream, gel, emulsion, hair tonic, hair spray.
  • the “external preparation for hair” and the “external preparation for scalp” may be the same or different in the form and usage as the external preparation. Or scalp.
  • “external preparation for skin” is a concept including “external preparation for scalp” and means an external preparation that acts directly on the skin without being limited to the scalp.
  • the method of the invention comprises the step of administering a composition of the invention to a subject.
  • the dose of D-chiro-inositol per administration to a subject is not particularly limited, but is preferably 0.005 to 200 mg, more preferably 0.05 to 100 mg, and still more preferably 0.5 to 100 mg. 10 mg.
  • the frequency of administration of the composition of the present invention to a subject is not particularly limited, but is preferably 1 to 6 times per day, more preferably 1 to 3 times per day, and still more preferably 1 to 3 times per day. ⁇ 2 times.
  • composition of the present invention is administered is not particularly limited, and includes, for example, humans, animals such as domestic animals and pets.
  • D-chiro-inositol D-chiro-inositol (manufactured by Wako Pure Chemical Industries, Ltd .; hereinafter abbreviated as "DCI”) [Organic acid or salt thereof] Citric acid (Showa Kako) Sodium citrate (Showa Kako Co., Ltd .; hereinafter abbreviated as "Na citrate”) Sodium edetate (manufactured by Junsei Chemical Co., Ltd .; hereinafter, abbreviated as “Na edetate”) [Surfactant] HCO-10 (polyoxyethylene (10) hydrogenated castor oil, HLB value: 6.5, manufactured by Nikko Chemicals) HCO-20 (polyoxyethylene (20) hydrogenated castor oil, HLB value: 10.5, manufactured by Nikko Chemicals) HCO-40 (polyoxyethylene (40) hydrogenated castor oil, HLB value: 12.5, manufactured by Nikko Chemicals) H
  • Example 1 A solution obtained by dissolving DCI and an organic acid and / or a salt thereof in purified water and adding a solution obtained by mixing EtOH and a surfactant so that each component has the composition shown in Table 1 below is added. Each composition was diluted and mixed to prepare a formulation.
  • Formulation stability test The obtained preparation was evaluated for the precipitation of DCI in each composition by the following method. Formulations of each composition were prepared in 3 lots, and DCI precipitation was induced by a low-temperature cycle (12 hours 5 ° C incubation, 12 hours -20 ° C repeated for 14 days), and visually evaluated based on the following indices did. The evaluation results are shown in Table 1 (the number of N is 3). In all lots, no precipitation of crystals was observed " ⁇ " Even with 1Lot, slight precipitation of crystalline material was observed " ⁇ " Even with 1 Lot, a small number of crystals were precipitated. Even with 1 Lot, many crystals precipitated

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Abstract

[Problem] To provide a composition that makes it possible to suppress deposition of D-chiro-inositol. [Solution] This composition includes D-chiro-inositol and water, wherein the content of water is equal to or more than 40 mass%.

Description

Ｄ－ｃｈｉｒｏ－イノシトールを含む組成物Composition comprising D-chiro-inositol



　本発明は、Ｄ－ｃｈｉｒｏ－イノシトールを含む組成物に関する。また、本発明は、該組成物を含む外用剤に関する。


The present invention relates to a composition comprising D-chiro-inositol. The present invention also relates to an external preparation containing the composition.





　イノシトール（１，２，３，４，５，６－シクロヘキサンヘキサオール）は、シクロヘキサンの各炭素上の水素原子が１つずつヒドロキシ基に置換した構造を有し、ビタミン様作用物質として知られている。イノシトールは、ヒドロキシ基の立体配置の組み合わせにより、９種類の立体異性体が存在する。


Inositol (1,2,3,4,5,6-cyclohexanehexaol) has a structure in which one hydrogen atom on each carbon of cyclohexane is replaced by one hydroxy group, and is known as a vitamin-like active substance. I have. Inositol has nine types of stereoisomers depending on the combination of hydroxy group configurations.





　特許文献１には、イノシトールを有効成分として含有する育毛剤が開示されている。特許文献１におけるように、先行文献において使用される「イノシトール」とは、医薬品、医薬部外品又は化粧品等の添加物として、ｍｙｏ－イノシトール（シス－１，２，３，５－トランス－４，６－シクロヘキサンヘキサオール）の立体異性体を通常意味する（例えば非特許文献１～３参照）。



　また、本発明者らは、イノシトールの立体異性体の内、ｃｈｉｒｏ－イノシトールが、育毛剤として有用な化合物であることを見出した（特許文献２参照）。


Patent Document 1 discloses a hair restorer containing inositol as an active ingredient. As in Patent Document 1, “inositol” used in the prior art refers to myo-inositol (cis-1,2,3,5-trans-4) as an additive for pharmaceuticals, quasi-drugs, cosmetics, and the like. , 6-cyclohexanehexaol) (see, for example, Non-Patent Documents 1 to 3).



In addition, the present inventors have found that among stereoisomers of inositol, chiro-inositol is a compound useful as a hair restorer (see Patent Document 2).





特開２００６－２８０２６号公報JP 2006-28026 A 国際公開第２０１７／１８８３９３号WO 2017/188393






　ここで、本発明者らは、イノシトールの立体異性体の内、Ｄ－ｃｈｉｒｏ－イノシトールは、イノシトールの異性体の中でも水溶性を有する化合物であることを見出した。



　しかしながら、これらのＤ－ｃｈｉｒｏ－イノシトールの特性を生かすべく、Ｄ－ｃｈｉｒｏ－イノシトールを含む組成物についての研究を続ける中で、Ｄ－ｃｈｉｒｏ－イノシトールは、イノシトールの立体異性体の内でも水溶液中で析出物を生成し易い傾向にあることを発見した。特に、Ｄ－ｃｈｉｒｏ－イノシトールは、水以外への溶媒への溶解性が非常に低く、水の割合が所定値未満である水溶液が低温環境下に置かれた場合により析出物を生成しやすい傾向にある。


Here, the present inventors have found that, among the stereoisomers of inositol, D-chiro-inositol is a water-soluble compound among the isomers of inositol.



However, while continuing to study compositions containing D-chiro-inositol in order to take advantage of these properties of D-chiro-inositol, D-chiro-inositol was found to be an inositol stereoisomer as well as in aqueous solution. It has been found that a precipitate tends to be formed. In particular, D-chiro-inositol has a very low solubility in solvents other than water, and tends to form precipitates more easily when an aqueous solution having a water ratio of less than a predetermined value is placed in a low-temperature environment. It is in.





　そこで、本発明は、Ｄ－ｃｈｉｒｏ－イノシトールの析出を抑制することの可能な組成物を提供することを目的とする。


Accordingly, an object of the present invention is to provide a composition capable of suppressing the precipitation of D-chiro-inositol.





　本発明者らは、上記課題を解決するために鋭意研究を重ねた結果、Ｄ－ｃｈｉｒｏ－イノシトールを含む組成物が、水の割合を所定値以上とすることにより、低温環境下においてもＤ－ｃｈｉｒｏ－イノシトールの析出を抑制することの可能な組成物であることを見出し、本発明を完成するに至った。


The present inventors have conducted intensive studies in order to solve the above-mentioned problems. As a result, the composition containing D-chiro-inositol has a D-chiro-inositol content of D-chiro-inositol equal to or higher than a predetermined value. The present inventors have found that the composition is capable of suppressing the deposition of chiro-inositol, and have completed the present invention.





　すなわち、本発明は、以下の発明を提供する。



［１］　Ｄ－ｃｈｉｒｏ－イノシトールと水とを含み、



　水の含有量が４０質量％以上である、組成物。



［２］　Ｄ－ｃｈｉｒｏ－イノシトールの含有量が０．００１～２０質量％である、［１］に記載の組成物。



［３］　有機酸及び／又はその塩をさらに含む、［１］又は［２］に記載の組成物。



［４］　有機酸を含み、



　有機酸がモノカルボン酸又は多価カルボン酸である、［３］に記載の組成物。



［５］　多価カルボン酸を含み、



　多価カルボン酸がクエン酸又はエデト酸である、［４］に記載の組成物。



［６］　有機酸の塩を含み、



　塩が、ナトリウム塩、カリウム塩、カルシウム塩、及びマグネシウム塩からなる群より選択される１種又は２種以上である、［２］～［５］のいずれかに記載の組成物。



［７］　有機酸と有機酸の塩とを含む、［２］～［６］のいずれかに記載の組成物。



［８］　界面活性剤をさらに含む、［１］～［７］のいずれかに記載の組成物。



［９］　界面活性剤がノニオン性界面活性剤を含む、［８］に記載の組成物。



［１０］　ノニオン性界面活性剤がポリオキシエチレン硬化ヒマシ油又はポリオキシエチレンポリオキシプロピレンアルキルエーテルを含む、［９］に記載の組成物。



［１１］　［１］～［１０］のいずれかに記載の組成物を含む外用剤。



［１２］　［１］～［１０］のいずれかに記載の組成物を含む頭皮用外用剤。


That is, the present invention provides the following inventions.



[1] containing D-chiro-inositol and water,



A composition having a water content of 40% by mass or more.



[2] The composition according to [1], wherein the content of D-chiro-inositol is 0.001 to 20% by mass.



[3] The composition according to [1] or [2], further comprising an organic acid and / or a salt thereof.



[4] containing an organic acid,



The composition according to [3], wherein the organic acid is a monocarboxylic acid or a polycarboxylic acid.



[5] containing a polycarboxylic acid,



The composition according to [4], wherein the polycarboxylic acid is citric acid or edetic acid.



[6] including a salt of an organic acid,



The composition according to any one of [2] to [5], wherein the salt is one or more selected from the group consisting of a sodium salt, a potassium salt, a calcium salt, and a magnesium salt.



[7] The composition according to any one of [2] to [6], comprising an organic acid and a salt of the organic acid.



[8] The composition according to any one of [1] to [7], further comprising a surfactant.



[9] The composition according to [8], wherein the surfactant comprises a nonionic surfactant.



[10] The composition according to [9], wherein the nonionic surfactant comprises polyoxyethylene hydrogenated castor oil or polyoxyethylene polyoxypropylene alkyl ether.



[11] An external preparation containing the composition according to any one of [1] to [10].



[12] An external preparation for scalp, comprising the composition according to any one of [1] to [10].





　本発明によれば、低温環境下においてもＤ－ｃｈｉｒｏ－イノシトールの析出を抑制することの可能な組成物が提供される。


According to the present invention, there is provided a composition capable of suppressing the precipitation of D-chiro-inositol even in a low-temperature environment.





　以下、本発明の組成物及びその具体的な実施形態を説明することにより、本発明を明らかにする。しかし、本発明は、以下で説明する具体的な実施形態に限定されるものではない。


Hereinafter, the present invention will be clarified by describing the composition of the present invention and specific embodiments thereof. However, the present invention is not limited to the specific embodiments described below.





　本発明の組成物は、Ｄ－ｃｈｉｒｏ－イノシトールと水とを含む組成物である。


The composition of the present invention is a composition containing D-chiro-inositol and water.





　Ｄ－ｃｈｉｒｏ－イノシトールとしては、特に限定されないが、例えば、天然に存在する蕎麦、豆類、柑橘類等から抽出したもの、発酵法によりマメ科植物から精製して抽出したもの、化学合成したもの、及び市販品が挙げられる。ここで、抽出する方法としては、特に限定されず、公知の抽出法を用いることができる。


Examples of D-chiro-inositol include, but are not particularly limited to, those extracted from naturally occurring buckwheat, beans, citrus, etc., those extracted and purified from legumes by fermentation, those chemically synthesized, and Commercial products can be mentioned. Here, the extraction method is not particularly limited, and a known extraction method can be used.





　本発明の組成物におけるＤ－ｃｈｉｒｏ－イノシトールの含有量は、特に限定されないが、好ましくは０．００１～２０質量％であり、より好ましくは０．０１～２０質量％であり、さらに好ましくは０．０５～１５質量％であり、よりさらに好ましくは１～１０質量％であり、さらにより好ましくは３～７質量％である。


The content of D-chiro-inositol in the composition of the present invention is not particularly limited, but is preferably 0.001 to 20% by mass, more preferably 0.01 to 20% by mass, and still more preferably 0 to 20% by mass. 0.05 to 15% by mass, more preferably 1 to 10% by mass, still more preferably 3 to 7% by mass.





　本明細書において、「質量％」とは、組成物全体の質量に対する組成物に含有される成分の質量百分率を意味する。



　また、本明細書において「Ｘ～Ｙ」と表記する場合は、Ｘ以上Ｙ以下であることを意味する。


In the present specification, “% by mass” means the mass percentage of the components contained in the composition with respect to the mass of the entire composition.



Further, in the present specification, the expression “X to Y” means that it is X or more and Y or less.





　本発明の組成物は、外用剤として使用し得る。外用剤としては、例えば、ひび・あかぎれ用剤、あせも・ただれ用剤、うおのめ・たこ用剤、かさつき・あれ用剤、しわ・しみ用剤、保湿剤、染毛剤、育毛剤、シャンプー、リンス、コンディショナー、化粧水、クリーム、乳液、ハンドクリーム、薬用石鹸、及びパック等が挙げられる。



　本発明の組成物は、Ｄ－ｃｈｉｒｏ－イノシトールを含むことにより、ビタミン様作用や育毛活性を付与した組成物を得ることができ、育毛剤として使用してもよい。



　育毛活性は、具体的には、毛幹成長促進、発毛、脱毛防止等に関する活性であり、好ましくは毛幹成長促進及び発毛に関する活性である。


The composition of the present invention can be used as an external preparation. Examples of external preparations include, for example, agents for cracks and irrigations, agents for rashes and sores, agents for sea urchin and octopus, agents for dryness and irritations, agents for wrinkles and spots, humectants, hair dyes, hair restorers, shampoos, Rinse, conditioner, lotion, cream, milky lotion, hand cream, medicated soap, pack and the like can be mentioned.



Since the composition of the present invention contains D-chiro-inositol, a composition having a vitamin-like effect and a hair-growth activity can be obtained, and may be used as a hair-growth agent.



The hair growth activity is, specifically, an activity relating to hair shaft growth promotion, hair growth, prevention of hair loss, and the like, and preferably an activity relating to hair shaft growth promotion and hair growth.





　本発明の組成物は、有機酸又はその塩をさらに含んでもよい。また、特に限定されないが、本発明の組成物は、有機酸と有機酸の塩とを含むことが好ましい。



　有機酸又はその塩を含むことにより、水以外の溶媒、例えば炭素数１～３のモノアルコールをさらに含む場合であっても、本発明の組成物を含む製剤における使用感を向上させることが可能となる傾向にある。このような効果を奏する要因は、有機酸又はその塩がキレート作用を発揮し、水以外の溶媒、例えば炭素数１～３のモノアルコールが寄与する刺激を緩和するよう機能することによるものと推察される（ただし、要因はこれに限定されない。）。


The composition of the present invention may further include an organic acid or a salt thereof. Although not particularly limited, the composition of the present invention preferably contains an organic acid and a salt of the organic acid.



By containing an organic acid or a salt thereof, even when the composition further contains a solvent other than water, for example, a monoalcohol having 1 to 3 carbon atoms, the feeling of use in a preparation containing the composition of the present invention can be improved. It tends to be. It is presumed that such an effect is attributable to the fact that the organic acid or a salt thereof exerts a chelating effect and functions to reduce the stimulus contributed by a solvent other than water, for example, a monoalcohol having 1 to 3 carbon atoms. (However, the factor is not limited to this.)





　有機酸とは、水中において単体で酸性を示す有機化合物を意味する。



　有機酸としては、酸性を示す有機化合物であれば特に限定されないが、モノカルボン酸及び多価カルボン酸、並びに有機スルホン酸が挙げられる。これらの中では、良好な使用感が得られるという観点から、多価カルボン酸が好ましい。一方、本発明において、これらの中では、Ｄ－ｃｈｉｒｏ－イノシトールの析出の抑制の観点から、モノカルボン酸及び有機スルホン酸が好ましく、有機スルホン酸がより好ましい。


The organic acid means an organic compound which is acidic alone in water.



The organic acid is not particularly limited as long as it is an organic compound exhibiting acidity, and examples thereof include monocarboxylic acids and polycarboxylic acids, and organic sulfonic acids. Among these, polyvalent carboxylic acids are preferable from the viewpoint that a good feeling in use can be obtained. On the other hand, in the present invention, among these, monocarboxylic acids and organic sulfonic acids are preferable, and organic sulfonic acids are more preferable, from the viewpoint of suppressing the precipitation of D-chiro-inositol.





　モノカルボン酸とは、分子内にカルボン酸を１個もつ有機化合物を意味し、多価カルボン酸とは、分子内にカルボン酸を２個以上もつ有機化合物を意味する。



　有機スルホン酸とは、分子内にスルホン酸を少なくとも１個もつ有機化合物を意味する。



　モノカルボン酸としては、特に限定されないが、例えば、ギ酸、酢酸、プロピオン酸、及び吉草酸が挙げられる。



　多価カルボン酸としては、特に限定されないが、ジカルボン酸、トリカルボン酸、テトラカルボン酸等が挙げられ、例えば、クエン酸、エデト酸、フタル酸、イソフタル酸、テレフタル酸、コハク酸、フマル酸、マレイン酸、リンゴ酸、及び酒石酸が挙げられる。これらの中では、クエン酸及びエデト酸が好ましい。



　有機スルホン酸としては、特に限定されないが、メタンスルホン酸、ベンゼンスルホン酸、及びタウリンが挙げられる。



　有機酸の塩における塩としては、特に限定されないが、例えば、ナトリウム塩、カリウム塩、カルシウム塩、及びマグネシウム塩が挙げられる。これらの中では、ナトリウム塩が好ましい。


The monocarboxylic acid means an organic compound having one carboxylic acid in the molecule, and the polyvalent carboxylic acid means an organic compound having two or more carboxylic acids in the molecule.



The organic sulfonic acid means an organic compound having at least one sulfonic acid in a molecule.



Although it does not specifically limit as a monocarboxylic acid, For example, Formic acid, acetic acid, propionic acid, and valeric acid are mentioned.



Examples of the polyvalent carboxylic acid include, but are not particularly limited to, dicarboxylic acid, tricarboxylic acid, and tetracarboxylic acid, and include, for example, citric acid, edetic acid, phthalic acid, isophthalic acid, terephthalic acid, succinic acid, fumaric acid, and maleic acid. Acids, malic acid, and tartaric acid. Among these, citric acid and edetic acid are preferred.



Organic sulfonic acids include, but are not limited to, methanesulfonic acid, benzenesulfonic acid, and taurine.



The salt in the organic acid salt is not particularly limited, and includes, for example, a sodium salt, a potassium salt, a calcium salt, and a magnesium salt. Of these, sodium salts are preferred.





　有機酸又はその塩は、１種を単独で使用してもよく、２種以上を組み合わせて使用してもよい。２種以上を組み合わせて使用する場合、２種以上の有機酸の組み合わせであってもよく、２種以上の有機酸の塩の組み合わせであってもよく、有機酸と有機酸の塩を2種以上組み合わせて用いてもよい。



　有機酸と有機酸の塩とを用いる場合において、有機酸と、有機酸の塩の有機酸とは、同一でも異なっていてもよいが、有機酸と、当該有機酸の塩とを組み合わせて用いることが好ましい。


The organic acids or salts thereof may be used alone or in combination of two or more. When two or more kinds are used in combination, a combination of two or more kinds of organic acids or a combination of two or more kinds of salts of organic acids may be used. These may be used in combination.



When an organic acid and a salt of the organic acid are used, the organic acid and the organic acid of the salt of the organic acid may be the same or different, but the organic acid and the salt of the organic acid are used in combination. Is preferred.





　本発明の組成物における有機酸又はその塩の含有量は、特に限定されないが、通常０．００１～５質量％であり、好ましくは０．０１～３質量％であり、より好ましくは０．０３～１質量％であり、さらに好ましくは０．０５～１質量％である。


The content of the organic acid or a salt thereof in the composition of the present invention is not particularly limited, but is usually 0.001 to 5% by mass, preferably 0.01 to 3% by mass, more preferably 0.03% by mass. To 1% by mass, more preferably 0.05 to 1% by mass.





　本発明の組成物は、界面活性剤をさらに含んでもよい。



　界面活性剤を含むことにより、Ｄ－ｃｈｉｒｏ－イノシトールを含む水溶液において、Ｄ－ｃｈｉｒｏ－イノシトールの析出を抑制することが可能となる傾向にある。また、本発明の組成物において、界面活性剤を含むことにより、本発明の組成物を含む製剤における使用感を向上させることが可能となる傾向にある。このような効果を奏する要因は、界面活性剤がＤ－ｃｈｉｒｏ－イノシトールの水溶液に対する溶解性を向上させることによるものと推察される（ただし、要因はこれに限定されない。）。


The composition of the present invention may further include a surfactant.



By containing a surfactant, it tends to be possible to suppress the precipitation of D-chiro-inositol in an aqueous solution containing D-chiro-inositol. In addition, by including a surfactant in the composition of the present invention, it tends to be possible to improve the feeling of use in a preparation containing the composition of the present invention. It is presumed that the factor that exerts such effects is due to the fact that the surfactant improves the solubility of D-chiro-inositol in an aqueous solution (however, the factor is not limited to this).





　界面活性剤としては、特に限定されないが、ノニオン性界面活性剤、カチオン性界面活性剤、アニオン性界面活性剤、及び両性界面活性剤が挙げられる。これらの中では、良好な使用感が得られるという観点、特に毛穴への浸透性に優れるという観点から、ノニオン性界面活性剤が好ましい。



　界面活性剤は、１種を単独で使用してもよく、２種以上を組み合わせて使用してもよい。


Examples of the surfactant include, but are not particularly limited to, a nonionic surfactant, a cationic surfactant, an anionic surfactant, and an amphoteric surfactant. Among these, nonionic surfactants are preferable from the viewpoint that a good feeling in use is obtained, particularly, from the viewpoint of excellent permeability into pores.



One type of surfactant may be used alone, or two or more types may be used in combination.





　界面活性剤のＨＬＢ値は、特に限定されないが、２～１７であることが好ましく、６～１７であることがより好ましく、１２～１７であることがさらに好ましい。ＨＬＢ値がこのような範囲にある界面活性剤を用いることにより、Ｄ－ｃｈｉｒｏ－イノシトールの析出が軽減される傾向にある。なお、ＨＬＢは、親水親油バランス（hydrophile-lipophile balance）の略称であり、界面活性剤が果たす効果を表す指標の一つであり、ＨＬＢ値が大きいほど親水性が高いことを示す。本発明におけるＨＬＢ値とは、Daviesの式であるＨＬＢ＝７＋Σ（親水基の基数）－Σ（親油基の基数）によって算出した値をいう（以下、単に「ＨＬＢ値」という場合に同じ。）。また、２種以上の界面活性剤を含有する場合のＨＬＢ値は、各界面活性剤のＨＬＢ値の加重平均値である。


The HLB value of the surfactant is not particularly limited, but is preferably 2 to 17, more preferably 6 to 17, and even more preferably 12 to 17. By using a surfactant having an HLB value in such a range, the precipitation of D-chiro-inositol tends to be reduced. HLB is an abbreviation for hydrophile-lipophile balance, and is one of the indices indicating the effect of a surfactant. The larger the HLB value, the higher the hydrophilicity. The HLB value in the present invention refers to a value calculated by HLB = 7 + Σ (the number of hydrophilic groups) −Σ (the number of lipophilic groups) which is a formula of Davies (hereinafter, simply referred to as “HLB value”). ). The HLB value when two or more surfactants are contained is a weighted average of the HLB values of each surfactant.





　ノニオン性界面活性剤とは、水溶液中でイオン性を示さない界面活性剤を意味する。



　ノニオン性界面活性剤としては、特に限定されないが、例えば、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンポリオキシプロピレンアルキルエーテル、オレイン酸ポリオキシエチレンソルビタン、オレイン酸とグリセリンのモノエステル、及びオレイン酸とジグリセリンのエステルが挙げられる。これらの中では、Ｄ－ｃｈｉｒｏ－イノシトールの析出の抑制の観点及び良好な使用感が得られるという観点、特に毛穴への浸透性に優れるという観点から、ポリオキシエチレン硬化ヒマシ油及びポリオキシエチレンポリオキシプロピレンアルキルエーテルが好ましい。


The nonionic surfactant means a surfactant that does not exhibit ionicity in an aqueous solution.



Nonionic surfactants include, but are not particularly limited to, for example, polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene sorbitan oleate, monoesters of oleic acid and glycerin, and oleic acid. Esters of diglycerin. Among these, polyoxyethylene-hardened castor oil and polyoxyethylene poly-polyethylene are preferred from the viewpoint of suppressing the precipitation of D-chiro-inositol and obtaining a good feeling in use, particularly from the viewpoint of excellent permeability into pores. Oxypropylene alkyl ethers are preferred.





　カチオン性界面活性剤及びアニオン性界面活性剤とは、それぞれ、水溶液中で解離したときに陽イオン及び陰イオンとなる界面活性剤を意味し、両性界面活性剤は、水溶液中で該水溶液のｐＨに応じて陽イオン、陰イオン、及び両性イオンのいずれかとなる界面活性剤を意味する。



　カチオン性界面活性剤としては、特に限定されないが、例えば、アルキルジメチルアミン、アルキルトリメチルアンモニウム塩、及びジアルキルジメチルアンモニウム塩が挙げられる。



　アニオン性界面活性剤としては、特に限定されないが、例えば、脂肪酸塩、及びアルキル硫酸塩が挙げられる。



　両性界面活性剤としては、特に限定されないが、例えば、アルキルアミノ脂肪酸塩、アルキルベタイン、及びアルキルアミンオキシドが挙げられる。


The cationic surfactant and the anionic surfactant mean a surfactant that becomes a cation and an anion when dissociated in an aqueous solution, respectively, and the amphoteric surfactant has a pH of the aqueous solution in the aqueous solution. Means a surfactant that becomes one of a cation, an anion, and a zwitterion depending on the



Examples of the cationic surfactant include, but are not particularly limited to, alkyldimethylamine, alkyltrimethylammonium salt, and dialkyldimethylammonium salt.



Examples of the anionic surfactant include, but are not particularly limited to, fatty acid salts and alkyl sulfates.



Examples of the amphoteric surfactant include, but are not particularly limited to, alkylamino fatty acid salts, alkyl betaines, and alkylamine oxides.





　本発明の組成物における界面活性剤の含有量は、特に限定されないが、通常０．１～１０質量％であり、好ましくは０．５～７質量％であり、より好ましくは１～５質量％である。


The content of the surfactant in the composition of the present invention is not particularly limited, but is usually 0.1 to 10% by mass, preferably 0.5 to 7% by mass, and more preferably 1 to 5% by mass. It is.





　本発明の組成物における水の含有量は、４０質量％以上の範囲内で水を含んでいれば特に限定されないが、好ましくは７０質量％以下であり、より好ましくは５０質量％以下である。



　水の割合が上記範囲内にあることにより、低温環境下においてもＤ－ｃｈｉｒｏ－イノシトールの析出を抑制することが可能となり、特に本発明の組成物が有機酸又はその塩を含む場合であってもＤ－ｃｈｉｒｏ－イノシトールの析出を抑制することが可能となる。特に、このような効果を奏する要因は、Ｄ－ｃｈｉｒｏ－イノシトールが水溶性であるため、水の含有量が４０質量％以上であることにより、Ｄ－ｃｈｉｒｏ－イノシトールが低温環境下で析出すること、特に有機酸又はその塩がキレート作用を発揮してＤ－ｃｈｉｒｏ－イノシトールの析出を促進することを緩和するよう機能することによるものと推察される（ただし、要因はこれに限定されない。）。また、本発明の組成物を含む製剤における使用感を向上させること、また、優れた毛穴への浸透性も発揮させることが可能となる。


The content of water in the composition of the present invention is not particularly limited as long as it contains water within a range of 40% by mass or more, but is preferably 70% by mass or less, more preferably 50% by mass or less.



When the proportion of water is within the above range, it becomes possible to suppress the precipitation of D-chiro-inositol even in a low-temperature environment, particularly when the composition of the present invention contains an organic acid or a salt thereof. This also makes it possible to suppress the precipitation of D-chiro-inositol. In particular, a factor that exerts such an effect is that D-chiro-inositol is precipitated in a low-temperature environment because the water content is 40% by mass or more because D-chiro-inositol is water-soluble. In particular, it is presumed that the organic acid or its salt functions to reduce the promotion of D-chiro-inositol precipitation by exerting a chelating action (however, the factor is not limited to this). In addition, it is possible to improve the feeling of use in a preparation containing the composition of the present invention, and to exhibit excellent permeability to pores.





　水としては、例えば、イオン交換水、限外濾過水、逆浸透水、及び蒸留水等の純水、並びに超純水のような、イオン性不純物を極力除去したものが挙げられる。


Examples of the water include pure water such as ion-exchanged water, ultrafiltration water, reverse osmosis water, and distilled water, and water from which ionic impurities such as ultrapure water have been removed as much as possible.





　本発明の組成物は、炭素数１～３のモノアルコール及び／又は多価アルコールをさらに含んでもよい。



　多価アルコールを含むことにより、Ｄ－ｃｈｉｒｏ－イノシトールを含む水溶液において、Ｄ－ｃｈｉｒｏ－イノシトールの析出を抑制することが可能となる傾向にある。



　炭素数１～３のモノアルコール及び／又は多価アルコールを含むことにより、抗菌性及び保湿性を付与した組成物を得ることができる傾向にある。


The composition of the present invention may further contain a mono- and / or polyhydric alcohol having 1 to 3 carbon atoms.



By containing a polyhydric alcohol, it tends to be possible to suppress the precipitation of D-chiro-inositol in an aqueous solution containing D-chiro-inositol.



By containing a monoalcohol having 1 to 3 carbon atoms and / or a polyhydric alcohol, a composition having antibacterial properties and moisture retention tends to be obtained.





　炭素数１～３のモノアルコールとしては、メタノール、エタノール、ｎ－プロパノール、及びイソプロパノールであり、エタノール、イソプロパノールが好ましく、エタノールがさらに好ましい。



　多価アルコールとは、分子内に水酸基を２個以上もつアルコールを意味する。



　多価アルコールとしては、特に限定されないが、例えば、グリセリン、エチレングリコール、ジエチレングリコール、トリエチレングリコール、プロピレングリコール（１，２－プロパンジオール）、ジプロピレングリコール、トリメチロールプロパン、１，３－プロピレングリコール（１，３－プロパンジオール）、イソブチレングリコール（２－メチル－１，２－プロパンジオール）、１，２－ブタンジオール、１，３－ブチレングリコール（１，３－ブタンジオール）、１，４－ブタンジオール、２－ブテン－１，４－ジオール、１，２－ペンタンジオール、１，５－ペンタンジオール、２－メチル－２，４－ペンタンジオール、１，２－ヘキサンジオール、１，６－ヘキサンジオール、２－エチル－１，３－ヘキサンジオール、１，７－ヘプタンジオール、及び１，８－オクタンジオール等が挙げられる。これらの中では、グリセリン、プロピレングリコール及び１，３－ブチレングリコールが好ましい。



　炭素数１～３のモノアルコール及び多価アルコールは、それぞれ独立に、１種を単独で使用してもよく、２種以上を組み合わせて使用してもよい。


The monoalcohol having 1 to 3 carbon atoms is methanol, ethanol, n-propanol and isopropanol, preferably ethanol and isopropanol, and more preferably ethanol.



The polyhydric alcohol means an alcohol having two or more hydroxyl groups in a molecule.



Although it does not specifically limit as a polyhydric alcohol, For example, glycerin, ethylene glycol, diethylene glycol, triethylene glycol, propylene glycol (1,2-propanediol), dipropylene glycol, trimethylolpropane, 1,3-propylene glycol ( 1,3-propanediol), isobutylene glycol (2-methyl-1,2-propanediol), 1,2-butanediol, 1,3-butyleneglycol (1,3-butanediol), 1,4-butane Diol, 2-butene-1,4-diol, 1,2-pentanediol, 1,5-pentanediol, 2-methyl-2,4-pentanediol, 1,2-hexanediol, 1,6-hexanediol , 2-ethyl-1,3-hexanediol, 1, - heptanediol, and 1,8-octanediol, and the like. Of these, glycerin, propylene glycol and 1,3-butylene glycol are preferred.



Mono- and polyhydric alcohols having 1 to 3 carbon atoms may be used alone or in combination of two or more.





　本発明の組成物における炭素数１～３のモノアルコールの含有量は、特に限定されないが、炭素数１～３のモノアルコールの含有量を高く設定することも可能である。



　本発明の組成物における炭素数１～３のモノアルコールの含有量は、通常８０質量％以下であり、６０質量％以下としてもよく、３０～６０質量％としてもよく、３０～５０質量％としてもよく、３０～４０質量％としてもよい。


The content of the mono-alcohol having 1 to 3 carbon atoms in the composition of the present invention is not particularly limited, but the content of the mono-alcohol having 1 to 3 carbon atoms can be set high.



The content of the monoalcohol having 1 to 3 carbon atoms in the composition of the present invention is usually 80% by mass or less, may be 60% by mass or less, may be 30 to 60% by mass, and may be 30 to 50% by mass. Or 30 to 40% by mass.





　本発明の組成物における多価アルコールの含有量は、特に限定されないが、通常０．１質量％以上であり、好ましくは０．５質量％以上であり、より好ましくは０．５～３０質量％であり、さらに好ましくは０．５～２０質量％であり、よりさらに好ましくは０．５～１５質量％である。


The content of the polyhydric alcohol in the composition of the present invention is not particularly limited, but is usually 0.1% by mass or more, preferably 0.5% by mass or more, more preferably 0.5 to 30% by mass. And more preferably 0.5 to 20% by mass, and still more preferably 0.5 to 15% by mass.





　本発明の組成物は、モノテルペンをさらに含んでもよい。



　モノテルペンを含むことにより、清涼感を付与するとともに、Ｄ－ｃｈｉｒｏ－イノシトールの析出抑制により優れた組成物を得ることができる傾向にある。


The composition of the present invention may further include a monoterpene.



By containing a monoterpene, there is a tendency that a refreshing feeling can be imparted and a composition excellent in suppressing the precipitation of D-chiro-inositol can be obtained.





　モノテルペンとしては、特に制限されないが、リモネン、ピネン、カンフル等のモノテルペン系炭化水素；シトロネロール、ゲラニオール、リナロール、メントール、テルピネオール、ボルネオール等のモノテルペン系アルコール；シトロネラール、シトラール、サフラナール等のモノテルペン系アルデヒド；メントン、カルボメントン、ヨノン等のモノテルペン系ケトン等が挙げられる。好ましくはモノテルペン系アルコールであり、より好ましくはメントールである。これらのモノテルペンは、ｄ－，ｌ－，ｄｌ－体のいずれでもよい。特にメントールとしては、例えば、ｌ－メントール及びｄ－メントールが好ましく、ｌ－メントールがより好ましい。ｌ－メントール及びｄ－メントールの混合物として使用してもよい。



　モノテルペンは、１種を単独で使用してもよく、２種以上を組み合わせて使用してもよい。


Examples of the monoterpene include, but are not particularly limited to, monoterpene hydrocarbons such as limonene, pinene, and camphor; monoterpene alcohols such as citronellol, geraniol, linalool, menthol, terpineol, and borneol; monoterpenes such as citronellal, citral, and safranal Aldehydes; monoterpene ketones such as menthone, carbomentone, and yonone; Preferably, it is a monoterpene alcohol, and more preferably, menthol. These monoterpenes may be d-, l-, or dl-form. Particularly as menthol, for example, l-menthol and d-menthol are preferred, and l-menthol is more preferred. It may be used as a mixture of 1-menthol and d-menthol.



Monoterpenes may be used alone or in combination of two or more.





　本発明の組成物におけるモノテルペンの含有量は、特に限定されないが、清涼感の付与に加え、Ｄ－ｃｈｉｒｏ－イノシトールの析出抑制、得られる組成物の液だれ及び刺激感（ぴりぴり感）の抑制、ならびにモノテルペン自体の分離の抑制に優れることから、好ましくは０．０１～１０質量％であり、より好ましくは０．０５～２質量％であり、さらに好ましくは０．１～１．０質量％であり、よりさらに好ましくは０．７～１．０質量％である。


The content of the monoterpene in the composition of the present invention is not particularly limited, but in addition to imparting a refreshing feeling, suppressing precipitation of D-chiro-inositol, suppressing dripping and irritating feeling (crisp feeling) of the obtained composition. And 0.01 to 10% by mass, more preferably 0.05 to 2% by mass, and still more preferably 0.1 to 1.0% by mass because of excellent suppression of separation of the monoterpene itself. %, And still more preferably 0.7 to 1.0% by mass.





　本発明の組成物は、医薬品、医薬部外品又は化粧品等で通常許容される添加物をさらに含んでもよい。



　添加物としては、特に限定されないが、例えば、賦形剤、安定剤、矯臭剤、基剤、分散剤、希釈剤、乳化剤、経皮吸収促進剤、保存剤、着色剤、油分（油脂、鉱物油等）、増粘剤、ポリマー、皮膜形成剤、紫外線吸収剤、細胞賦活剤、酸化防止剤、防腐剤、清涼剤、消臭剤、顔料、染料、香料、糖類、アミノ酸類、ビタミン類、有機酸、有機アミン、植物抽出物等が挙げられる。


The composition of the present invention may further contain additives that are generally acceptable in pharmaceuticals, quasi-drugs, cosmetics, and the like.



Examples of the additive include, but are not limited to, excipients, stabilizers, odor correctors, bases, dispersants, diluents, emulsifiers, transdermal absorption enhancers, preservatives, coloring agents, oils (oils, fats, minerals, Oil, etc.), thickeners, polymers, film-forming agents, ultraviolet absorbers, cell activators, antioxidants, preservatives, fresheners, deodorants, pigments, dyes, fragrances, sugars, amino acids, vitamins, Organic acids, organic amines, plant extracts and the like can be mentioned.





　本発明の組成物は、特に限定されず、本発明に含まれる成分を混合することにより製造することができる。各成分を混合する順番は特に限定されない。



　また、混合する場合の条件も、特に限定されず、従来公知の方法に従って、本発明の組成物とすることができる。


The composition of the present invention is not particularly limited, and can be produced by mixing components contained in the present invention. The order of mixing the components is not particularly limited.



The conditions for mixing are not particularly limited, and the composition of the present invention can be obtained according to a conventionally known method.





　本発明の組成物を外用剤として用いる場合、医薬品、医薬部外品又は化粧品等として使用することが可能である。例えば皮膚用外用剤、頭髪用外用剤及び頭皮用外用剤に使用することが可能であり、より具体的には皮膚用医薬品、頭髪用医薬品及び頭皮用医薬品、皮膚用医薬部外品、頭髪用医薬部外品及び頭皮用医薬部外品、並びに皮膚用化粧品、頭髪用化粧品及び頭皮用化粧品に使用することが可能である。より具体的には、軟膏、パップ、リニメント、ローション、外用液剤、散布剤、クリーム、ジェル、乳液、ヘアトニック、ヘアスプレーの形態とすることが可能である。



　本明細書において、「頭髪用外用剤」及び「頭皮用外用剤」は、外用剤として使用する形態や用法が同一であっても異なっていてもよいが、主として直接的に作用する箇所が頭髪であるのか頭皮であるのかの点で異なる。また、「皮膚用外用剤」は、「頭皮用外用剤」を含む概念であり、頭皮に限定されず皮膚に直接的に作用するための外用剤を意味する。


When the composition of the present invention is used as an external preparation, it can be used as a drug, a quasi-drug, a cosmetic or the like. For example, it can be used as an external preparation for skin, an external preparation for hair, and an external preparation for scalp, and more specifically, a dermatological drug, a hair drug and a scalp drug, a quasi-drug for skin, and a hair It can be used for quasi-drugs and quasi-drugs, as well as skin cosmetics, hair cosmetics and scalp cosmetics. More specifically, it can be in the form of an ointment, cataplasm, liniment, lotion, topical solution, dusting agent, cream, gel, emulsion, hair tonic, hair spray.



In the present specification, the “external preparation for hair” and the “external preparation for scalp” may be the same or different in the form and usage as the external preparation. Or scalp. Further, “external preparation for skin” is a concept including “external preparation for scalp” and means an external preparation that acts directly on the skin without being limited to the scalp.





　本発明の方法は、本発明の組成物を対象に投与する工程を含む。対象への１投与あたりのＤ－ｃｈｉｒｏ－イノシトールの投与量は、特に限定されないが、好ましくは０．００５～２００ｍｇであり、より好ましくは０．０５～１００ｍｇであり、さらに好ましくは０．５～１０ｍｇである。


The method of the invention comprises the step of administering a composition of the invention to a subject. The dose of D-chiro-inositol per administration to a subject is not particularly limited, but is preferably 0.005 to 200 mg, more preferably 0.05 to 100 mg, and still more preferably 0.5 to 100 mg. 10 mg.





　対象への本発明の組成物の投与回数は、特に限定されないが、好ましくは１日あたり１～６回であり、より好ましくは１日あたり１～３回であり、さらに好ましくは１日あたり１～２回である。


The frequency of administration of the composition of the present invention to a subject is not particularly limited, but is preferably 1 to 6 times per day, more preferably 1 to 3 times per day, and still more preferably 1 to 3 times per day. ~ 2 times.





　本発明の組成物を投与する対象は、特に限定されないが、例えば、ヒト、家畜・愛玩動物等の動物が挙げられる。


The subject to which the composition of the present invention is administered is not particularly limited, and includes, for example, humans, animals such as domestic animals and pets.





　以下、実施例によって本発明を更に詳細に説明するが、本発明はこれらの実施例に限定されるものではない。


Hereinafter, the present invention will be described in more detail with reference to Examples, but the present invention is not limited to these Examples.





　本実施例において用いる成分は、以下のとおりである。



［Ｄ－ｃｈｉｒｏ－イノシトール］



　Ｄ－ｃｈｉｒｏ－イノシトール（和光純薬工業社製、以下「DCI」と略する。）



［有機酸又はその塩］



　クエン酸（昭和化工社製）



　クエン酸ナトリウム（昭和化工社製、以下「クエン酸Na」と略する。）



　エデト酸ナトリウム（純正化学社製、以下「エデト酸Na」と略する。）



［界面活性剤］



　ＨＣＯ－１０（ポリオキシエチレン（１０）硬化ヒマシ油、ＨＬＢ値：６．５、日光ケミカルズ社製）



　ＨＣＯ－２０（ポリオキシエチレン（２０）硬化ヒマシ油、ＨＬＢ値：１０．５、日光ケミカルズ社製）



　ＨＣＯ－４０（ポリオキシエチレン（４０）硬化ヒマシ油、ＨＬＢ値：１２．５、日光ケミカルズ社製）



　ＨＣＯ－５０（ポリオキシエチレン（５０）硬化ヒマシ油、ＨＬＢ値：１３．５、日光ケミカルズ社製）



　ＨＣＯ－６０（ポリオキシエチレン（６０）硬化ヒマシ油、ＨＬＢ値：１４、日光ケミカルズ社製）



　ＰＰＧ－８セテス－２０（セタノールに酸化エチレン及び酸化プロピレンを付加重合したもの、ＨＬＢ値：１２．５、日光ケミカルズ社製、以下「PBC44」と略する。）



　ＰＰＧ－４セテス－２０（ポリオキシエチレンポリオキシプロピレンセチルエーテル、ＨＬＢ値：１６．５、日光ケミカルズ社製、以下「PBC34」と略する。）



　ポリソルベート８０（オレイン酸ポリオキシエチレンソルビタン、ＨＬＢ値：１５、日光ケミカルズ社製）



　オレイン酸グリセリル（オレイン酸とグリセリンのモノエステル、ＨＬＢ値：２．５、日光ケミカルズ社製）



　オレイン酸ポリグリセリル－２（オレイン酸とジグリセリンのエステル、ＨＬＢ値：５．５、日光ケミカルズ社製）



［炭素数１～３のモノアルコール］



　エタノール（和光純薬工業社製、以下「EtOH」と略する。）



［多価アルコール］



　プロピレングリコール（和光純薬工業社製）



　１，３－ブチレングリコール（和光純薬工業社製）



　グリセリン（和光純薬工業社製）



［モノテルペン］



　ｌ－メントール（和光純薬工業社製、以下「l-mentol」と略する。）



［水］



　精製水


The components used in this example are as follows.



[D-chiro-inositol]



D-chiro-inositol (manufactured by Wako Pure Chemical Industries, Ltd .; hereinafter abbreviated as "DCI")



[Organic acid or salt thereof]



Citric acid (Showa Kako)



Sodium citrate (Showa Kako Co., Ltd .; hereinafter abbreviated as "Na citrate")



Sodium edetate (manufactured by Junsei Chemical Co., Ltd .; hereinafter, abbreviated as “Na edetate”)



[Surfactant]



HCO-10 (polyoxyethylene (10) hydrogenated castor oil, HLB value: 6.5, manufactured by Nikko Chemicals)



HCO-20 (polyoxyethylene (20) hydrogenated castor oil, HLB value: 10.5, manufactured by Nikko Chemicals)



HCO-40 (polyoxyethylene (40) hydrogenated castor oil, HLB value: 12.5, manufactured by Nikko Chemicals)



HCO-50 (polyoxyethylene (50) hardened castor oil, HLB value: 13.5, manufactured by Nikko Chemicals)



HCO-60 (polyoxyethylene (60) hydrogenated castor oil, HLB value: 14, Nikko Chemicals Co., Ltd.)



PPG-8 ceteth-20 (addition polymerization of ethylene oxide and propylene oxide to cetanol, HLB value: 12.5, manufactured by Nikko Chemicals, hereinafter abbreviated as "PBC44")



PPG-4 Ceteth-20 (polyoxyethylene polyoxypropylene cetyl ether, HLB value: 16.5, manufactured by Nikko Chemicals Co., Ltd .; hereinafter abbreviated as “PBC34”)



Polysorbate 80 (polyoxyethylene sorbitan oleate, HLB value: 15, manufactured by Nikko Chemicals)



Glyceryl oleate (monoester of oleic acid and glycerin, HLB value: 2.5, manufactured by Nikko Chemicals)



Polyglyceryl-2 oleate (ester of oleic acid and diglycerin, HLB value: 5.5, manufactured by Nikko Chemicals)



[Monoalcohol with 1 to 3 carbon atoms]



Ethanol (Wako Pure Chemical Industries, Ltd .; hereinafter abbreviated as "EtOH")



[Polyhydric alcohol]



Propylene glycol (Wako Pure Chemical Industries, Ltd.)



1,3-butylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.)



Glycerin (Wako Pure Chemical Industries, Ltd.)



[Monoterpene]



l-menthol (manufactured by Wako Pure Chemical Industries, Ltd .; hereinafter abbreviated as "l-mentol")



[water]



purified water





実施例１



　各成分を下記表１に示す組成になるように、精製水にDCIと有機酸及び／又はその塩とを溶解させ、EtOHと界面活性剤とを混合した溶液を添加し、残容量をEtOHで希釈、混合し、各組成物を製剤として調製した。


Example 1



A solution obtained by dissolving DCI and an organic acid and / or a salt thereof in purified water and adding a solution obtained by mixing EtOH and a surfactant so that each component has the composition shown in Table 1 below is added. Each composition was diluted and mixed to prepare a formulation.





Ａ．製剤安定性試験



　得られた製剤について、以下の方法で、各組成におけるDCIの析出について評価した。



　各組成における製剤を3Lotずつ作成し、低温サイクル（12時間5℃インキュベートの後、12時間-20℃を14日間繰り返す）によりDCIの析出を誘導して、目視により、以下の指標に基づいて評価した。評価結果を表１に示す（Ｎ数は３である）。



　全てのLotで、結晶物の析出はみられない「◎」



　1Lotでも、わずかな結晶物の析出がみられた「〇」



　1Lotでも、少数の結晶物の析出がみられた「△」



　1Lotでも、多数の結晶物の析出がみられた「×」


A. Formulation stability test



The obtained preparation was evaluated for the precipitation of DCI in each composition by the following method.



Formulations of each composition were prepared in 3 lots, and DCI precipitation was induced by a low-temperature cycle (12 hours 5 ° C incubation, 12 hours -20 ° C repeated for 14 days), and visually evaluated based on the following indices did. The evaluation results are shown in Table 1 (the number of N is 3).



In all lots, no precipitation of crystals was observed "◎"



Even with 1Lot, slight precipitation of crystalline material was observed "〇"



Even with 1 Lot, a small number of crystals were precipitated.



Even with 1 Lot, many crystals precipitated





Ｂ．使用感の試験



　得られた製剤について、以下の方法で、各組成における製剤による塗布時の使用感（毛穴への浸透性）を評価した。



　各組成における製剤を3Lotずつ作成し、それを0.25% Coomassie Brilliant Blue R-250（CBB R-250、東京化成工業社製）の呈色製剤に調製した。次に、C57BL/6マウスの背部体毛をバリカンで1mm長へ刈りそろえた上で、呈色製剤を塗布した。塗布後は速やかに呈色製剤をふき取り、塗布した部分の皮膚を採取し、生切片を作成した。作成した生切片を光学顕微鏡で観察し、毛包への色素到達深度について以下の指標に基づいて評価した。



＜使用感＞



・毛穴への浸透性



　毛根の3/4以上の深部へ色素が到達していることが認められた「◎」



　毛根の2/4～3/4の深部へ色素が到達していることが認められた「○」



　毛根の1/4～2/4の深部へ色素が到達していることが認められた「△」



　毛根の1/4以上の深部へ色素が到達していることが認められない「×」


B. Test of usability



With respect to the obtained preparations, the feeling of use (penetration into pores) at the time of application by the preparations of each composition was evaluated by the following method.



A preparation of each composition was prepared in 3 lots, and it was prepared as a color preparation of 0.25% Coomassie Brilliant Blue R-250 (CBB R-250, manufactured by Tokyo Chemical Industry Co., Ltd.). Next, the back hair of the C57BL / 6 mouse was trimmed to a length of 1 mm with a hair clipper, and a coloring preparation was applied. Immediately after the application, the coloring preparation was wiped off, and the skin at the applied portion was collected to prepare a raw section. The prepared raw sections were observed with an optical microscope, and the depth of the dye reaching the hair follicles was evaluated based on the following indices.



<Usability>



・ Penetration into pores



It was recognized that the pigment reached deeper than 3/4 of the hair root.



"○" that pigment was found to reach the deep part of 2/4 to 3/4 of hair root



It was recognized that the pigment reached the deep part of 1/4 to 2/4 of the hair root "△"



"X" that pigment does not reach deeper than 1/4 of hair root





Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001




　表１の結果より、DCI含有製剤における水の割合が４０質量％以上であることにより、DCIの析出を効果的に抑制できると判断できる。


From the results in Table 1, it can be determined that the precipitation of DCI can be effectively suppressed when the proportion of water in the DCI-containing preparation is 40% by mass or more.

Claims (12)




  1. 　Ｄ－ｃｈｉｒｏ－イノシトールと水とを含み、水の含有量が４０質量％以上である、組成物。


    A composition comprising D-chiro-inositol and water, wherein the content of water is 40% by mass or more.





  2. 　Ｄ－ｃｈｉｒｏ－イノシトールの含有量が０．００１～２０質量％である、請求項１に記載の組成物。


    The composition according to claim 1, wherein the content of D-chiro-inositol is 0.001 to 20% by mass.





  3. 　有機酸及び／又はその塩をさらに含む、請求項１又は２に記載の組成物。


    The composition according to claim 1, further comprising an organic acid and / or a salt thereof.





  4. 　有機酸を含み、有機酸がモノカルボン酸又は多価カルボン酸である、請求項３に記載の組成物。


    The composition according to claim 3, comprising an organic acid, wherein the organic acid is a monocarboxylic acid or a polycarboxylic acid.





  5. 　多価カルボン酸を含み、多価カルボン酸がクエン酸又はエデト酸である、請求項４に記載の組成物。


    The composition according to claim 4, comprising a polycarboxylic acid, wherein the polycarboxylic acid is citric acid or edetic acid.





  6. 　有機酸の塩を含み、塩が、ナトリウム塩、カリウム塩、カルシウム塩、及びマグネシウム塩からなる群より選択される１種又は２種以上である、請求項２～５のいずれか一項に記載の組成物。


    The method according to any one of claims 2 to 5, comprising a salt of an organic acid, wherein the salt is one or more selected from the group consisting of a sodium salt, a potassium salt, a calcium salt, and a magnesium salt. Composition.





  7. 　有機酸と有機酸の塩とを含む、請求項２～６のいずれか一項に記載の組成物。


    The composition according to any one of claims 2 to 6, comprising an organic acid and a salt of the organic acid.





  8. 　界面活性剤をさらに含む、請求項１～７のいずれか一項に記載の組成物。


    The composition according to any one of claims 1 to 7, further comprising a surfactant.





  9. 　界面活性剤がノニオン性界面活性剤を含む、請求項８に記載の組成物。


    9. The composition according to claim 8, wherein the surfactant comprises a nonionic surfactant.





  10. 　ノニオン性界面活性剤がポリオキシエチレン硬化ヒマシ油又はポリオキシエチレンポリオキシプロピレンアルキルエーテルを含む、請求項９に記載の組成物。


    The composition of claim 9, wherein the nonionic surfactant comprises a polyoxyethylene hydrogenated castor oil or a polyoxyethylene polyoxypropylene alkyl ether.





  11. 　請求項１～１０のいずれか一項に記載の組成物を含む外用剤。


    An external preparation comprising the composition according to any one of claims 1 to 10.





  12. 　請求項１～１０のいずれか一項に記載の組成物を含む頭皮用外用剤。


    An external preparation for scalp, comprising the composition according to any one of claims 1 to 10.
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WO2023228911A1 (en) * 2022-05-26 2023-11-30 一丸ファルコス株式会社 Novel agent for improving resilience and/or body of hair

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JP2006028026A (en) * 2004-07-12 2006-02-02 Doctor Program Kk Hair-growing agent
JP2008169185A (en) * 2007-01-15 2008-07-24 Hoyu Co Ltd Hair-treating agent composition and hair-treating method
JP2009108023A (en) * 2007-10-11 2009-05-21 Rohto Pharmaceut Co Ltd Hair grower
WO2017188393A1 (en) * 2016-04-27 2017-11-02 小林製薬株式会社 Hair-growth agent
JP2019085339A (en) * 2017-11-01 2019-06-06 小林製薬株式会社 Composition containing d-chiro-inositol
JP2019085342A (en) * 2017-11-01 2019-06-06 小林製薬株式会社 Composition containing d-chiro-inositol

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006028026A (en) * 2004-07-12 2006-02-02 Doctor Program Kk Hair-growing agent
JP2008169185A (en) * 2007-01-15 2008-07-24 Hoyu Co Ltd Hair-treating agent composition and hair-treating method
JP2009108023A (en) * 2007-10-11 2009-05-21 Rohto Pharmaceut Co Ltd Hair grower
WO2017188393A1 (en) * 2016-04-27 2017-11-02 小林製薬株式会社 Hair-growth agent
JP2019085339A (en) * 2017-11-01 2019-06-06 小林製薬株式会社 Composition containing d-chiro-inositol
JP2019085342A (en) * 2017-11-01 2019-06-06 小林製薬株式会社 Composition containing d-chiro-inositol

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