Hair growth or hair care agent composition

Abstract

To provide a hair growth or hair care agent composition containing hinokitiol, salicylic acid, edetic acid salt, and ethanol, which does not produce precipitates over time.SOLUTION: The above problems are solved by a hair growth or hair care agent composition containing at least hinokitiol, salicylic acid, edetic acid salt, and ethanol, a content of the edetic acid salt being 0.02 mass / volume% or more relative to the total volume of the composition, and a content of the ethanol being 30 to 70 vol.%, and pH is 3.7 or more and less than 6.0.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a hair growth agent or hair restoration composition. [Background technology]

[0002] Various formulations of hair growth or hair restoration compositions have been known, and hinokitiol and salicylic acid have been known as active ingredients of hair growth or hair restoration agents. For example, Patent Document 1 describes hinokitiol and salicylic acid as active ingredients for hair care and restoration. On the other hand, hair growth agents and hair care compositions need to be applied uniformly and widely to the scalp, and therefore, it is well known that they are filled into aerosol containers or spray containers made of metal for use. Aerosol containers use metal in the container body, and spray containers use metal in the spring or ball valve, and the formulation is in contact with the metal. However, there is a problem that formulations containing hinokitiol discolor over time when placed in containers containing metals such as stainless steel. To address this issue, it has been reported that discoloration can be prevented by adding a chelating agent (edetate) (Patent Document 2). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] WO2007 / 074602 [Patent Document 2] Patent Publication No. 2010-150155 Summary of the Invention [Problem to be solved by the invention]

[0004] The present inventors were developing a hair growth agent containing hinokitiol, salicylic acid, and ethanol, and found that the agent discolored over time when it came into contact with a metal such as stainless steel contained in a container. Therefore, they attempted to suppress the discoloration by adding edetate. However, they found a new problem in that a precipitate formed over time in the agent containing edetate. Therefore, an object of the present invention is to provide a hair growth or hair restoration composition containing hinokitiol, salicylic acid, edetate, and ethanol, which does not produce precipitates over time.A further object of the present invention is to provide a hair growth or hair restoration composition containing hinokitiol, salicylic acid, edetate, and ethanol, which inhibits discoloration caused by hinokitiol and does not produce precipitates over time. [Means for solving the problem]

[0005] The present inventors further investigated the problem of precipitates in formulations containing edetate and found that the pH of the formulation is lowered by salicylic acid, causing edetate to convert to edetic acid, resulting in the formation of precipitates. They also found that the formation of such precipitates can be significantly suppressed by adjusting the ethanol concentration and pH to fall within a predetermined range. That is, the present invention provides the following aspects. [1] A hair growth or hair care composition containing at least hinokitiol, salicylic acid, edetate, and ethanol, With respect to the total volume of the composition, The content of edetate is 0.02 mass / vol% or more, The ethanol content is 30 to 70% by volume, A hair growth or hair care composition having a pH of 3.7 or higher but less than 6.0. [2] The hair growth or hair care composition according to [1], which is filled in a container at least part of whose interior is made of metal. [3] The hair growth or hair care composition according to [1] or [2], wherein the content of salicylic acid is 0.02% by mass / volume or more. [4] The hair growth or hair care composition according to any one of [1] to [3], wherein the content of hinokitiol is 0.005 to 0.5% by mass / volume. [5] The hair growth or hair care composition according to any one of [1] to [4], wherein the ethanol content is 30 to 55% by volume. [6] The hair growth or hair care composition according to any one of [1] to [5], which has a pH of 4.0 or more and 5.5 or less. [7] The hair growth or hair care composition according to any one of [1] to [6], further comprising a hair growth promoting component, an anti-inflammatory component, an antihistamine component, and / or a vitamin component. [8] A hair growth or hair care composition according to [7], which contains carpronium or a salt thereof or a hydrate thereof as a hair growth promoting ingredient, diphenhydramine or a salt thereof or a hydrate thereof as an antihistamine ingredient, and at least one selected from the group consisting of pantothenyl ethyl ether, pyridoxine or a salt thereof or a hydrate thereof, and tocopherols as a vitamin ingredient. [9] A hair growth or hair care composition according to [7], which contains carpronium or a salt thereof or a hydrate thereof as a hair growth promoting ingredient, glycyrrhetinic acid or a salt thereof as an anti-inflammatory ingredient, and at least one selected from the group consisting of pantothenyl ethyl ether, and pyridoxine or a salt thereof or a hydrate thereof as a vitamin ingredient.

[10] The hair growth or hair care composition according to any one of [1] to [9], further comprising a surfactant, an alcohol other than ethanol, and / or a refreshing component.

[11] The surfactant comprises at least one selected from the group consisting of polyoxyethylene hydrogenated castor oil and polyoxyethylene sorbitan fatty acid ester; Alcohols other than ethanol include 1,3-butylene glycol, Contains l-menthol as a cooling ingredient.

[10] The hair growth or hair care composition according to

[10] .

[12] The surfactant comprises at least one selected from the group consisting of polyoxyethylene hydrogenated castor oil and polyethylene glycol monooleate; Alcohols other than ethanol include 1,3-butylene glycol,

[10] The hair growth or hair care composition according to

[10] .

[13] Based on the total volume of the composition, 0.02 to 2.0% by weight / volume of salicylic acid; 0.005 to 0.5 mass / volume % hinokitiol, 0.02 to 0.2% by weight / volume of edetate hydrate; 30 to 70% by volume of ethanol, 0.1 to 10.0% by mass / volume of carpronium chloride hydrate, 0.1 to 10.0% by mass / volume of pantothenyl ethyl ether; 0.005 to 0.5% by weight / volume of pyridoxine hydrochloride, 0.01 to 1.0% by mass / volume of diphenhydramine hydrochloride; 0.001 to 0.1% by weight / volume of tocopherol acetate; 0.5 to 9.0% by weight / volume of 1,3-butylene glycol; 0.02 to 2.0% by mass / volume of polyoxyethylene hydrogenated castor oil, and 0.04 to 4.0 mass / volume % polyoxyethylene sorbitan fatty acid ester; The hair growth or hair care composition according to [1],

[14] Based on the total volume of the composition, 0.02 to 2.0% by weight / volume of salicylic acid; 0.005 to 0.5 mass / volume % hinokitiol, 0.02 to 0.2% by weight / volume of edetate hydrate; 30 to 70% by volume of ethanol, 0.1 to 10.0% by mass / volume of carpronium chloride hydrate, 0.1 to 10.0% by mass / volume of pantothenyl ethyl ether; 0.005 to 0.5% by weight / volume of pyridoxine hydrochloride, Glycyrrhetinic acid in an amount of more than 0.01% by mass and not more than 0.55% by mass, 0.5 to 9.0% by weight / volume of 1,3-butylene glycol; 0.02 to 2.0% by mass / volume of polyoxyethylene hydrogenated castor oil, and 0.04 to 4.0% by mass / volume of polyethylene glycol monooleate; The hair growth or hair care composition according to [1], [Effects of the Invention]

[0006] According to the present invention, a hair growth or hair restoration composition containing hinokitiol, salicylic acid, edetate, and ethanol can be provided that does not produce precipitates over time due to edetate.Furthermore, the hair growth or hair restoration composition of the present invention can also suppress discoloration due to hinokitiol when a metal container is used. DETAILED DESCRIPTION OF THE INVENTION

[0007] A first aspect of the present invention is a hair growth or hair care composition containing at least hinokitiol, salicylic acid, edetate, and ethanol, With respect to the total volume of the composition, The content of edetate is 0.02 mass / vol% or more, The ethanol content is 30 to 70% by volume, a hair growth or hair care composition having a pH of 3.7 or more and less than 6.0; is.

[0008] As used herein, "hair growth agent composition" or "hair restoration agent composition" refers to a composition containing at least hinokitiol and salicylic acid as active ingredients of a hair growth agent or hair restoration agent. Hinokitiol is a natural component discovered in the essential oil of Taiwanese cypress, and is a compound that also has antibacterial properties. It is known as an active ingredient in hair growth agents or hair restoration agents. Salicylic acid is a plant hormone, a type of beta-hydroxy acid, and is known to have antibacterial and anti-inflammatory and analgesic properties, and is used as an active ingredient in hair growth agents or hair restoration agents. The "hair growth agent composition" or "hair restorer composition" of the present invention may contain any active ingredient that is usually incorporated into hair growth agents or hair restorers, other than hinokitiol and salicylic acid.

[0009] The hair growth or hair care composition of the present invention may further contain, in addition to hinokitiol and salicylic acid, one or more of a hair growth promoting component, an antihistamine component, and a vitamin component, or all of these, and may further contain one or more of a surfactant, an alcohol other than ethanol, and a cooling component, or all of these.

[0010] In the hair growth agent or hair care composition of the present invention, the content of salicylic acid relative to the total volume of the composition is preferably 0.02 mass / volume% or more, more preferably 0.02 to 2.0 mass / volume%, even more preferably 0.1 to 1.5 mass / volume%, and even more preferably 0.2 to 1.0 mass / volume%. In the hair growth agent or hair care composition of the present invention, the content of hinokitiol relative to the total volume of the composition is preferably 0.005 to 0.5 mass / volume%, more preferably 0.01 to 0.3 mass / volume%, even more preferably 0.02 to 0.2 mass / volume%, and even more preferably 0.04 to 0.1 mass / volume%.

[0011] The hair growth agent or hair care composition of the present invention contains edetate. In this specification, "edetate" also includes its hydrate form. Examples of edetate include sodium edetate hydrate (more precisely, disodium dihydrogen ethylenediaminetetraacetate dihydrate; also referred to as sodium edetate hydrate), disodium edetate, tetrasodium edetate, calcium edetate, and calcium disodium edetate, including their hydrates. Edetate is added to suppress discoloration of the composition due to reaction of hinokitiol with metal components contained in the container, pharmaceutical manufacturing equipment, or impurities in the drug substance. The content of edetate is 0.02% by mass / vol or more based on the total volume of the composition. The edetate content is preferably 0.02 to 0.2% by mass / vol, more preferably 0.02 to 0.15% by mass / vol, and even more preferably 0.03 to 0.1% by mass / vol. The content of sodium edetate hydrate is preferably 0.02 mass / volume % or more, more preferably 0.02 to 0.2 mass / volume %, more preferably 0.02 to 0.15 mass / volume %, and even more preferably 0.03 to 0.1 mass / volume %, relative to the total volume of the composition.

[0012] The pH of the hair growth or hair restoration composition of the present invention is 3.7 or higher but lower than 6.0. It has been found that the edetate salt added to inhibit discoloration due to the interaction between hinokitiol and metals can cause precipitation in the hair growth or hair restoration composition of the present invention containing salicylic acid. At a pH of 6.0 or higher, the edetate salt's effect of inhibiting discoloration due to the interaction between hinokitiol and metals is insufficient, so the pH is lower than 6.0. The pH is preferably 4.0 or higher but lower than 6.0. For reasons unknown, when the ethanol content is 60 to 70% by volume, a pH lower than 4.0 tends to cause precipitation. Therefore, a pH of 4.0 or higher is particularly preferred when the ethanol content is 60 to 70% by volume. The pH is more preferably 4.0 to 5.5, and even more preferably 4.2 to 5.2.

[0013] Preferred active ingredients of hair growth or hair restoration agents other than hinokitiol and salicylic acid that can be used in the hair growth or hair restoration composition of the present invention include hair growth ingredients, hair restoration ingredients, hair growth promoting ingredients, antihistamine ingredients, herbal ingredients, bactericidal ingredients, keratin softening ingredients, vitamin ingredients, anti-inflammatory ingredients, etc. The hair growth or hair restoration composition of the present invention preferably contains a hair growth promoting ingredient, antihistamine ingredient and / or vitamin ingredient as preferred active ingredients of hair growth or hair restoration agents other than hinokitiol and salicylic acid.

[0014] Examples of hair growth promoting ingredients include carpronium chloride or its hydrate, minoxidil, etc. Examples of antihistamine ingredients include diphenhydramine or its salt or its hydrate, chlorpheniramine or its salt or its hydrate, etc. Examples of vitamin ingredients include pantothenyl ethyl ether, pyridoxine or its salt or its hydrate, tocopherols, calcium pantothenate, etc. Examples of anti-inflammatory ingredients include glycyrrhetinic acid or its salt, glycyrrhizic acid or its salt, dipotassium glycyrrhizinate, etc. Examples of herbal ingredients include Kashu tincture, Jiaxing ginseng tincture, etc. Examples of tocopherols include tocopherol, tocotrienol, and derivatives thereof (e.g., esterified derivatives such as acetate ester, succinate ester, nicotinate ester, etc.), and salts thereof (e.g., alkaline earth metal salts such as calcium salt, magnesium salt, etc.). Other active ingredients of hair growth or hair restoration agents include 6-benzylaminopurine, pentadecanoic acid glyceride, resorcinol, estradiol benzoate, and the like.

[0015] More preferably, the hair growth or hair restoration composition of the present invention contains, as an active ingredient of the hair growth or hair restoration agent, at least one selected from the group consisting of carpronium chloride hydrate, pantothenyl ethyl ether, pyridoxine hydrochloride, diphenhydramine hydrochloride, and tocopherol acetate, and even more preferably contains all of carpronium chloride hydrate, pantothenyl ethyl ether, pyridoxine hydrochloride, diphenhydramine hydrochloride, and tocopherol acetate. Preferably, the hair growth or hair restoration composition of the present invention contains, as an active ingredient of the hair growth or hair restoration agent, at least one selected from the group consisting of carpronium chloride hydrate, pantothenyl ethyl ether, pyridoxine hydrochloride, and glycyrrhetinic acid, and more preferably contains all of carpronium chloride hydrate, pantothenyl ethyl ether, pyridoxine hydrochloride, and glycyrrhetinic acid.

[0016] When the hair growth agent or hair care composition of the present invention contains carpronium or a salt thereof, or a hydrate of these as a hair growth-promoting ingredient, the content thereof is, for example, preferably 0.1 to 10.0 mass / volume%, more preferably 0.5 to 5.0 mass / volume%, even more preferably 0.7 to 3.0 mass / volume%, and even more preferably 0.8 to 2.2 mass / volume%, relative to the total volume of the composition.

[0017] When the hair growth agent or hair care composition of the present invention contains pantothenyl ethyl ether as a vitamin component, the content thereof is, for example, preferably 0.1 to 10.0 mass / volume%, more preferably 0.5 to 5.0 mass / volume%, even more preferably 0.7 to 2.0 mass / volume%, and even more preferably 0.8 to 1.5 mass / volume%, relative to the total volume of the composition.

[0018] When the hair growth agent or hair care composition of the present invention contains pyridoxine or a salt thereof, or a hydrate thereof as a vitamin component, the content thereof is, for example, preferably 0.005 to 0.5 mass / volume %, more preferably 0.01 to 0.2 mass / volume %, and even more preferably 0.03 to 0.1 mass / volume %, relative to the total volume of the composition.

[0019] When the hair growth agent or hair care composition of the present invention contains diphenhydramine or a salt thereof, or a hydrate of these as the antihistamine component, the content thereof is, for example, preferably 0.01 to 1.0 mass / volume %, more preferably 0.05 to 0.5 mass / volume %, and even more preferably 0.08 to 0.2 mass / volume %, relative to the total volume of the composition.

[0020] When the hair growth agent or hair care composition of the present invention contains tocopherols, particularly tocopherol, tocotrienol, or derivatives thereof, as a vitamin component, the content thereof is, for example, preferably 0.001 to 0.1 mass / volume %, more preferably 0.005 to 0.05 mass / volume %, and even more preferably 0.008 to 0.02 mass / volume %, relative to the total volume of the composition.

[0021] When the hair growth agent or hair care composition of the present invention contains glycyrrhetinic acid or a salt thereof, or glycyrrhizinic acid or a salt thereof as an anti-inflammatory ingredient, from the viewpoint of activity, the amount, calculated as glycyrrhetinic acid or glycyrrhizinic acid, is preferably more than 0.01% by mass and not more than 0.55% by mass, more preferably 0.03 to 0.45% by mass, even more preferably 0.05 to 0.35% by mass, still more preferably 0.08 to 0.20% by mass, and even more preferably 0.10% by mass or more but less than 0.12% by mass.

[0022] The hair growth agent or hair care composition of the present invention is a solution containing ethanol. The ethanol content is 30 to 70% by volume relative to the total volume of the composition. More preferably, it is 30 to 60% by volume, even more preferably 30 to 55% by volume, and even more preferably 30 to 50% by volume. Edetic acid precipitates when the pH of the formulation is reduced. However, because edetic acid is practically insoluble in ethanol and slightly soluble in water, edetic acid precipitates when ethanol is contained at 60% by volume or more at a pH range below 4.0. Therefore, when ethanol is 60 to 70% by volume, the pH is preferably 4.0 or more and less than 6.0.

[0023] Examples of surfactants for use in the hair growth or hair restoration composition of the present invention include nonionic surfactants, cationic surfactants, and amphoteric surfactants.

[0024] Examples of nonionic surfactants include propylene glycol fatty acid esters, glycerin fatty acid esters, polyglycerin fatty acid esters, polyoxyethylene glycerin fatty acid esters, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbit beeswax, polyoxyethylene alkyl ethers, polyoxyethylene polyoxypropylene alkyl ethers, polyoxyalkylene hydrogenated castor oil, polyoxyalkylene sterols, polyethylene glycol fatty acid esters, etc. Specifically, one or more surfactants selected from polyoxyethylene hydrogenated castor oil 100, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene hydrogenated castor oil 50, polyoxyethylene hydrogenated castor oil 40, polysorbate 85, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 20, polyethylene glycol monooleate, etc. are preferred. More preferred examples include polyoxyethylene hydrogenated castor oil 60, polysorbate 80, and polyethylene glycol monooleate.

[0025] When the hair growth agent or hair care composition of the present invention contains a surfactant, the content thereof is preferably 0.06 to 6.0 mass / volume %, more preferably 0.1 to 3.0 mass / volume %, and even more preferably 0.3 to 1.3 mass / volume %, relative to the total volume of the composition. When the hair growth agent or hair care composition of the present invention contains polyoxyalkylene hydrogenated castor oil, preferably polyoxyethylene hydrogenated castor oil 60, the content thereof is preferably 0.02 to 2.0 mass / volume %, more preferably 0.05 to 1.0 mass / vol %, and even more preferably 0.1 to 0.5 mass / vol %, relative to the total volume of the composition. When the hair growth agent or hair care composition of the present invention contains polyethylene glycol monooleate, polyoxyethylene sorbitan fatty acid ester, preferably polysorbate 80, the content thereof is preferably 0.04 to 4.0 mass / volume %, more preferably 0.1 to 2.0 mass / volume %, and even more preferably 0.2 to 0.8 mass / volume %, relative to the total volume of the composition.

[0026] The hair growth or hair care composition of the present invention may further contain an alcohol other than ethanol, such as lower or higher alcohols, natural alcohols, and polyhydric alcohols (glycols, glycerins, sorbitols, etc.). Specifically, examples of alcohols other than ethanol include one selected from the group consisting of isopropanol, lauryl alcohol, myristyl alcohol, cetanol, oleyl alcohol, arachyl alcohol, behenyl alcohol, cetostearyl alcohol, propylene glycol, 1,3-butylene glycol, 3-methyl-1,3-butanediol, diethylene glycol monoethyl ether, glycerin (concentrated glycerin, etc.), and sorbitol. Preferable examples include propylene glycol, 1,3-butylene glycol, 3-methyl-1,3-butanediol, and diethylene glycol monoethyl ether, and more preferable examples include 1,3-butylene glycol.

[0027] When the hair growth agent or hair care composition of the present invention contains an alcohol other than ethanol, the content thereof is preferably 0.5 to 9.0 mass / volume %, more preferably 1.0 to 7.0 mass / volume %, and even more preferably 3.0 to 6.0 mass / volume %, relative to the total volume of the composition.

[0028] More preferably, the hair growth agent or hair restorer composition of the present invention contains carpronium chloride hydrate as a hair growth-promoting ingredient, or diphenhydramine hydrochloride as an antihistamine ingredient, or at least one vitamin ingredient selected from the group consisting of pantothenyl ethyl ether, pyridoxine hydrochloride, and tocopherol acetate, or at least one surfactant selected from the group consisting of polyoxyethylene hydrogenated castor oil 60 and polysorbate 80, and 1,3-butylene glycol as an alcohol other than ethanol. Also preferably, the refreshing ingredient is l-menthol. In addition, the hair growth agent or hair care composition contains, relative to the total volume of the composition, 0.02 to 2.0% by weight / volume of salicylic acid; 0.005 to 0.5 mass / volume % hinokitiol, 0.02 to 0.2% by weight / volume of edetate hydrate; 30 to 70% by volume of ethanol, 0.1 to 10.0% by mass / volume of carpronium chloride hydrate, 0.1 to 10.0% by mass / volume of pantothenyl ethyl ether; 0.005 to 0.5% by weight / volume of pyridoxine hydrochloride, 0.01 to 1.0% by mass / volume of diphenhydramine hydrochloride; 0.001 to 0.1% by weight / volume of tocopherol acetate; 0.5 to 9.0% by weight / volume of 1,3-butylene glycol; 0.02 to 2.0% by mass / volume of polyoxyethylene hydrogenated castor oil, and 0.04 to 4.0 mass / volume % polyoxyethylene sorbitan fatty acid ester; It is preferred that the compound contains:

[0029] Also preferably, the hair growth agent or hair care composition of the present invention contains carpronium or a salt thereof, or a hydrate of these, as a hair growth-promoting ingredient, glycyrrhetinic acid or a salt thereof, as an anti-inflammatory ingredient, at least one selected from the group consisting of pantothenyl ethyl ether and pyridoxine or a salt thereof, or a hydrate of these, as a vitamin ingredient, or at least one selected from the group consisting of polyoxyethylene hydrogenated castor oil and polyethylene glycol monooleate, as a surfactant, and 1,3-butylene glycol as an alcohol other than ethanol. In addition, the hair growth agent or hair care composition contains, relative to the total volume of the composition, 0.02 to 2.0% by weight / volume of salicylic acid; 0.005 to 0.5 mass / volume % hinokitiol, 0.02 to 0.2% by weight / volume of edetate hydrate; 30 to 70% by volume of ethanol, 0.1 to 10.0% by mass / volume of carpronium chloride hydrate, 0.1 to 10.0% by mass / volume of pantothenyl ethyl ether; 0.005 to 0.5% by weight / volume of pyridoxine hydrochloride, Glycyrrhetinic acid in an amount of more than 0.01% by mass and not more than 0.55% by mass, 0.5 to 9.0% by weight / volume of 1,3-butylene glycol; 0.02 to 2.0% by mass / volume of polyoxyethylene hydrogenated castor oil, and 0.04 to 4.0% by mass / volume of polyethylene glycol monooleate; It is preferred that the compound contains:

[0030] The hair growth or hair care composition of the present invention may be in any form such as a liquid, spray, gel, cream, aerosol, or foam. The preparation may be filled in any type of container, but is preferably filled in a container at least partly made of metal, particularly stainless steel, since this will not cause discoloration.

[0031] The hair growth agent or hair care composition of the present invention can be produced by appropriately mixing the ingredients using a conventionally known method. [Example]

[0032] Reference Example 1: Identifying the cause of discoloration in metal containers The inventors' experience has shown that when a formulation containing at least hinokitiol, salicylic acid, and ethanol comes into contact with a metal contained in a container, the formulation discolors over time, and that discoloration occurs only in the presence of metal. Since hinokitiol was suspected to be the component in the formulation that causes the discoloration, the following test was carried out. Solutions of the following Formulation Examples 1-1 to 1-3 (adjusted to pH 4.2 with sodium hydroxide) were prepared, stainless steel pieces (SUS304) were added, and the solution was stored at 50°C for 18 hours, and the presence or absence of discoloration was visually inspected. The formulation containing hinokitiol but not containing sodium edetate hydrate (Formulation Example 1-1) discolored, whereas the formulation without hinokitiol (Formulation Example 1-2) did not discolor, and therefore hinokitiol was identified as the cause of discoloration. Since no discoloration occurred in formulation example 1-3, which contained both hinokitiol and sodium edetate hydrate, it is believed that the inclusion of sodium edetate hydrate was able to suppress discoloration caused by some kind of reaction between hinokitiol and stainless steel pieces (Table 1).

[0033] TIFF2025156229000001.tif49164

[0034] Reference Example 2: Identification of conditions for precipitate formation by adding sodium edetate hydrate As shown in Reference Example 1, discoloration caused by hinokitiol could be suppressed by adding edetate sodium hydrate, so formulations using edetate sodium hydrate were further investigated. When salicylic acid, one of the active ingredients of hair growth agents, was added to an ethanol preparation containing hinokitiol and edetate sodium hydrate, precipitates were observed. When the pH was checked, it was found that the pH was lowered by the addition of salicylic acid, and it was thought that edetate sodium hydrate had converted to edetate, which has low solubility in ethanol, and precipitated. To confirm these points, the ethanol concentration and pH of an ethanol preparation containing edetate sodium hydrate and salicylic acid were adjusted using sodium hydroxide to determine the range within which precipitates would not form. Specifically, an ethanol solution formulation containing salicylic acid and edetate sodium hydrate was prepared in the amounts shown in Formulation Example 2 below, and formulations with ethanol (EtOH) amounts of 20 vol%, 30 vol%, 40 vol%, 50 vol%, 60 vol%, and 70 vol% were prepared. Each formulation was divided into a group with no pH adjustment and a group with the pH adjusted to 4.2 with sodium hydroxide, and stored at 5°C to observe the presence or absence of precipitates. At 30-70% EtOH by volume, precipitates were observed in the unadjusted pH group, but precipitation was suppressed at pH 4.2. Precipitates were also observed in the unadjusted pH group at EtOH concentrations of 20% or less by volume, but because these precipitates contained components other than edetic acid, the experimental results are not shown.

[0035] TIFF2025156229000002.tif44128

[0036] TIFF2025156229000003.tif76132

[0037] Reference Example 3: Identification of conditions for precipitate formation based on edetate sodium hydrate concentration As shown in Reference Example 1, discoloration caused by hinokitiol could be suppressed by adding edetate sodium hydrate, so the effect of edetate sodium hydrate concentration was examined for formulations using edetate sodium hydrate. Specifically, a preparation of an ethanol solution containing salicylic acid and edetate sodium hydrate was prepared in the amounts shown in Formulation Example 3 below, and the preparations shown in Tables 3-2 and 3-3 were prepared by changing the amount of edetate sodium hydrate from 0.04 to 0.10 mass / volume %. Each preparation was divided into a group with no pH adjustment and a group with the pH adjusted to 4.2 with sodium hydroxide, and stored at 5°C to observe the presence or absence of precipitates. At 0.04 to 0.10 mass / volume % sodium edetate hydrate, precipitates were observed in the unadjusted pH group, but in all cases, precipitation was suppressed in the pH 4.2 group.

[0038] TIFF2025156229000004.tif43132

[0039] TIFF2025156229000005.tif67157

[0040] TIFF2025156229000006.tif49157

[0041] Example 1: Production Example In the preparation formulations containing 30 to 50% by volume of ethanol and adjusted to a pH of 4.2 to 5.2 with sodium hydroxide, no precipitates were observed when stored at 5°C, regardless of the ethanol concentration or pH range (Examples 1A to 1I).

[0042] TIFF2025156229000007.tif125170

[0043] TIFF2025156229000008.tif126170

[0044] TIFF2025156229000009.tif127170

[0045] Example 2: Production Example The pH decrease caused by salicylic acid converts sodium edetate to edetic acid, and the conditions under which edetate precipitates due to the decreased solubility were investigated. The presence or absence of precipitation was evaluated in the low pH range (unadjusted pH 2.9 to pH 4.0) with 30 to 50% ethanol by volume. In the formulation containing 50% EtOH by volume and pH 3.2-4.0, edetic acid precipitation was observed at pH 3.6 or below. In the formulation containing 40% EtOH by volume and pH 3.0-4.0, edetic acid precipitation was observed at pH 3.6 or below. In the formulation containing 30% EtOH by volume and pH 2.9-4.0, edetic acid precipitation was observed only at pH 2.9.

[0046] TIFF2025156229000010.tif111143

[0047] TIFF2025156229000011.tif72126

[0048] TIFF2025156229000012.tif72126

[0049] TIFF2025156229000013.tif72123

[0050] Example 3: Production Example The conditions under which sodium edetate is converted to edetic acid due to a decrease in pH caused by salicylic acid, resulting in a decrease in solubility and the formation of a precipitate, were investigated. The presence or absence of precipitation in the low pH range (pH 3.6 to pH 3.8) when ethanol was used at 60 to 70% by volume in the formulation shown in Table 6-1 was evaluated (Experiments 50 to 55). The evaluation results for the same pH range in Example 2 with ethanol at 40 to 50% by volume (Experiments 35 to 37 and 45 to 47) are also listed in Table 6-1 for comparison. When EtOH was 40-50% by volume, no precipitation of edetic acid was observed in the formulation at pH 3.7-3.8, but when the ethanol was changed to 60-70% by volume, precipitation of edetic acid was observed.

[0051] TIFF2025156229000014.tif92131

[0052] Example 4: Production Example A piece of stainless steel (SUS304) was placed in the formulation of Table 7-1, which can suppress the precipitation of edetic acid due to a decrease in pH caused by salicylic acid, and stored at 50°C for 18 hours.The absorbance of the solution was measured using the following method to confirm whether discoloration caused by hinokitiol was suppressed. <Absorbance measurement method> The pH of the formulations in Table 7-1 (both formulations with and without added sodium edetate) was adjusted with sodium hydroxide as shown in Table 7-2. Approximately 12 mL of each formulation was dispensed into glass vials, sealed with an approximately 1 cm x 3 cm stainless steel piece (SUS304), and stored at 50°C for 18 hours in an aluminum zipper bag, shielded from light. The stainless steel piece was removed immediately after storage, and the formulations were cooled to room temperature and their absorbance at a wavelength of 530 nm was measured using a Shimadzu UV-Visible Spectrophotometer (UV-2700). The absorbance with added sodium edetate was designated Abs1, and the absorbance without added sodium edetate was designated Abs0. The absorbance inhibition rate was calculated using the following formula: Absorbance suppression rate (%) = (Abs0-Abs1) / Abs0×100 At pH 4.0 to 5.0, the absorbance suppression rate was relatively high and a significant discoloration suppression effect was observed.At pH 5.5 to 6.0, the absorbance suppression rate was low and no significant discoloration suppression effect was observed.

[0053] TIFF2025156229000015.tif52142

[0054] TIFF2025156229000016.tif46170

[0055] Example 5: Production Example Stainless steel pieces (SUS304) were placed in the formulations of Table 8-1, which can suppress the precipitation of edetic acid due to a decrease in pH caused by salicylic acid, and stored at 50°C for 18 hours. The absorbance was measured to confirm whether discoloration caused by hinokitiol was suppressed. The absorbance was measured in the same manner as in Example 4. At pH levels between 4.0 and 5.5, the absorbance suppression rate was high, and a significant discoloration suppression effect was observed. In particular, at pH levels between 4.0 and 5.0, the absorbance suppression rate was 50% or more, and the discoloration suppression effect was high. On the other hand, at pH levels above 6.0, the absorbance suppression rate was low, and no significant discoloration suppression effect was observed.

[0056] TIFF2025156229000017.tif103143

[0057] TIFF2025156229000018.tif56170

[0058] Example 6: Preparation example For the formulations in Table 9, the presence or absence of edetic acid precipitation due to a pH decrease caused by salicylic acid was confirmed for up to 4 weeks at 5° C. No precipitation was observed for any of the formulations up to 4 weeks.

[0059] TIFF2025156229000019.tif122167

Claims

1. A hair growth or hair care composition comprising at least hinokitiol, salicylic acid, edetate, and ethanol, With respect to the total volume of the composition, The content of edetate is 0.02% by mass / volume or more, The ethanol content is 30 to 70% by volume, A hair growth or hair care composition having a pH of 3.7 or more and less than 6.

0.

2. The hair growth or hair care composition according to claim 1, which is filled in a container at least part of whose interior is made of metal.

3. 2. The hair growth or hair care composition according to claim 1, wherein the content of salicylic acid is 0.02 mass / vol % or more based on the total volume of the composition.

4. 2. The hair growth or hair care composition according to claim 1, wherein the content of hinokitiol is 0.005 to 0.5% by mass / volume based on the total volume of the composition.

5. 2. The hair growth or hair care composition according to claim 1, wherein the ethanol content is 30 to 55% by volume based on the total volume of the composition.

6. The hair growth or hair care composition according to claim 1, having a pH of 4.0 or more and 5.5 or less.

7. The hair growth or hair care composition according to any one of claims 1 to 6, further comprising a hair growth promoting component, an anti-inflammatory component, an antihistamine component and / or a vitamin component.

8. 8. The hair growth or hair care composition according to claim 7, comprising carpronium or a salt thereof or a hydrate thereof as a hair growth promoting ingredient, diphenhydramine or a salt thereof or a hydrate thereof as an antihistamine ingredient, and at least one selected from the group consisting of pantothenyl ethyl ether, pyridoxine or a salt thereof or a hydrate thereof, and tocopherols as a vitamin ingredient.

9. 8. The hair growth or hair care composition according to claim 7, comprising carpronium or a salt thereof or a hydrate thereof as a hair growth promoting ingredient, glycyrrhetinic acid or a salt thereof or a hydrate thereof as an anti-inflammatory ingredient, and at least one selected from the group consisting of pantothenyl ethyl ether, and pyridoxine or a salt thereof or a hydrate thereof as a vitamin ingredient.

10. The hair growth or hair care composition according to any one of claims 1 to 6, further comprising a surfactant, an alcohol other than ethanol, and / or a refreshing component.

11. The surfactant contains at least one selected from the group consisting of polyoxyethylene hydrogenated castor oil and polyoxyethylene sorbitan fatty acid ester, The alcohol other than ethanol includes 1,3-butylene glycol, Contains l-menthol as a cooling ingredient. The hair growth or hair care composition according to claim 10.

12. The surfactant contains at least one selected from the group consisting of polyoxyethylene hydrogenated castor oil and polyethylene glycol monooleate, Alcohols other than ethanol include 1,3-butylene glycol. The hair growth or hair care composition according to claim 10.

13. With respect to the total volume of the composition, 0.02 to 2.0% by weight / volume of salicylic acid; 0.005 to 0.5% by mass / volume of hinokitiol, 0.02 to 0.2% wt / vol edetate hydrate; 30 to 70% by volume of ethanol, 0.1 to 10.0% by weight / volume of carpronium chloride hydrate; 0.1 to 10.0% by weight / volume of pantothenyl ethyl ether; 0.005 to 0.5% weight / volume of pyridoxine hydrochloride; 0.01 to 1.0% wt / vol diphenhydramine hydrochloride; 0.001 to 0.1% weight / volume of tocopherol acetate, 0.5 to 9.0% by weight / volume of 1,3-butylene glycol; 0.02 to 2.0% by mass / volume of polyoxyethylene hydrogenated castor oil, and 0.04 to 4.0% by mass / volume of polyoxyethylene sorbitan fatty acid ester; The hair growth or hair care composition according to claim 1, comprising:

Images