Composition for external preparation for skin

Abstract

The present invention addresses the problem of providing a composition for an external preparation for the skin, which contains an ester-based steroid and gamma-oryzanol and in which both components are completely dissolved, maintains the stability of the preparation and the stability of the components even if stored for a long period of time, suppresses skin irritation, and has an excellent feeling of use. The present invention relates to a composition for an external preparation for the skin, which contains the following components (A)-(C): (A) an ester-based steroid, (B) gamma-oryzanol, and (C) a medium-chain fatty acid triglyceride.

Description

Technical Field

[0001] The present invention relates to a composition for external use on skin containing an ester steroid. Background Art

[0002] Ester steroids represented by prednisolone valerate acetate have excellent anti-inflammatory effects and are widely used as therapeutic drugs for skin diseases such as eczema, dermatitis, prurigo, insect bites, psoriasis, palmoplantar pustulosis, etc. by external application to the skin.

[0003] It is known that the ester steroid is easily hydrolyzed, and in order to stably formulate, it is necessary to find a way to suppress the decomposition of the preparation. In addition, there is a problem that it is not soluble in vaseline, etc., which is known as an ointment base. From this point of view, a technology for preparing an ointment by formulating lactic acid ester in addition to steroids and medium-chain fatty acid triglycerides (Patent Document 1); a technology for preparing a liquid by formulating a large amount of ethanol in addition to steroids and medium-chain fatty acid triglycerides (Patent Document 2); a technology for preparing an external preparation by formulating polypropylene glycol in addition to steroids and polar oils (Patent Document 3).

[0004] On the other hand, γ-oryzanol is a component contained in rice bran, and is known to have sebum secretion promoting effects, skin temperature raising effects, and blood flow increasing effects. It is also used in cosmetics as a whitening agent.

[0005] However, γ-oryzanol has low solubility in oils, and it is difficult to stably mix it in a high concentration in an external preparation containing an oil. As an attempt to improve the solubility of γ-oryzanol, a technology of mixing γ-oryzanol with N-lauroyl-L-glutamic acid-2-octyldodecyl diester to prepare an external preparation (Patent Document 4) and a technology of mixing γ-oryzanol with hydrogenated phospholipids and a diester of a fatty acid having 8 to 18 carbon atoms and a diol to prepare an external preparation (Patent Document 5) have been reported.

[0006] Prior art literature

[0007] Patent Literature

[0008] Patent Document 1: Japanese Patent Application Laid-Open No. 4-308530

[0009] Patent Document 2: Japanese Patent Application Laid-Open No. 5-178748

[0010] Patent Document 3: Japanese Patent Application Publication No. 2016-188187

[0011] Patent Document 4: Japanese Patent Application Laid-Open No. 57-42621

[0012] Patent Document 5: Japanese Patent Application Publication No. 2008-231087 Summary of the invention

[0013] However, since the above-mentioned skin external preparations containing ester steroids or γ-oryzanol use special surfactants or solvents such as ethanol, there is a concern that the intercellular lipids in the stratum corneum of the epidermis may be softened and the skin barrier may be damaged, and the original purpose of the preparation, namely skin care, may not be fully achieved. When a solvent with insufficient solubility is used, there is a concern that these poorly soluble components may precipitate due to long-term storage, resulting in a rough feeling when applied to the skin, thereby reducing the feel of use and making the preparation uneven.

[0014] In addition, as described above, both ester steroids and γ-oryzanol have low solubility in oily agents, and external skin preparations containing both have not been commercialized.

[0015] Therefore, an object of the present invention is to provide a composition for external use on the skin which contains an ester steroid and γ-oryzanol and completely dissolves both components, maintains formulation stability and component stability even when stored for a long period of time, suppresses skin irritation, and provides excellent feeling during use.

[0016] Therefore, the present inventors have conducted various studies to solve the above-mentioned problems. First, in order to dissolve an ester steroid, a large amount of medium-chain fatty acid triglyceride needs to be used for the steroid. However, by adding γ-oryzanol for the purpose of imparting a sebum secretion promoting effect to an external preparation, it was found that the solubility of the ester steroid is improved and the amount of medium-chain fatty acid triglyceride can be reduced. As a result, it was found that the above-mentioned two components are completely dissolved, the formulation stability and component stability are maintained even after long-term storage, and a skin external preparation composition with excellent feeling of use is obtained, which suppresses skin irritation. In addition, it was found that if a higher alcohol is added thereto, the formulation stability and feeling of use after long-term storage are further improved.

[0017] That is, the present invention provides the following inventions [1] to

[11] .

[0018] [1] A composition for external use on skin comprising the following components (A) to (C):

[0019] (A) Ester steroids

[0020] (B) γ-oryzanol

[0021] (C) Medium chain fatty acid triglycerides.

[0022] [2] The composition for external use on skin according to [1], wherein the mass ratio (B / A) of the component (B) to the component (A) is 2 to 100.

[0023] [3] The composition for external use on skin according to [1] or [2], wherein the mass ratio (C / B) of the component (C) to the component (B) is 6 to 30.

[0024] [4] The skin external application composition according to any one of [1] to [3], wherein the content of component (A) is 0.01% to 0.5% by mass, the content of component (B) is 0.1% to 3% by mass, and the content of component (C) is 3% to 30% by mass.

[0025] [5] The composition for external use on skin according to any one of [1] to [4], further comprising a higher alcohol as a component (D).

[0026] [6] The composition for external use on skin according to [5], wherein the content of component (D) is 2% by mass to 15% by mass.

[0027] [7] The skin topical composition according to any one of [1] to [6], wherein component (A) is one or more selected from the group consisting of dexamethasone acetate, prednisolone acetate, prednisolone valerate acetate, hydrocortisone butyrate, hydrocortisone acetate, cortisone acetate and betamethasone valerate.

[0028] [8] The composition for external use on skin according to any one of [1] to [6], wherein component (A) is prednisolone valerate acetate.

[0029] [9] The composition for external use on skin according to any one of [5] to [8], wherein component (D) is a linear aliphatic monohydric alcohol having 12 to 22 carbon atoms.

[0030]

[10] The composition for external use on skin according to any one of [1] to [9], further comprising one or more selected from the group consisting of tocopherols, bactericides, local anesthetics, allantoin and antihistamines.

[0031]

[11] The skin external application composition according to any one of [1] to

[10] , further comprising one or more selected from the group consisting of an oil other than component (C) and component (D), an emulsifier, a buffer, a chelating agent, a polyol, and water.

[0032] The skin external preparation composition of the present invention dissolves both the ester steroid and γ-oryzanol to maintain stability for a long period of time, and also provides a good feeling during use. DETAILED DESCRIPTION

[0033] The present invention is a composition for external use on skin containing an ester steroid and γ-oryzanol. One embodiment of the composition is a composition for external use on skin containing the following components (A) to (C).

[0034] (A) Ester steroids

[0035] (B) γ-oryzanol

[0036] (C) Medium chain fatty acid triglycerides

[0037] Component (A) is an ester steroid. An ester steroid is a compound in which at least one hydroxyl group present in a synthetic or natural steroid skeleton is esterified with a fatty acid or the like, and has an excellent anti-inflammatory effect. Since the skin external preparation composition of the present invention contains the ester steroid, it can be used as a therapeutic drug for skin diseases such as eczema, dermatitis, prurigo, insect bites, psoriasis, palmoplantar pustulosis, etc.

[0038] As the ester steroid, any ester steroid that can be used as an external preparation for skin may be used, and examples thereof include clobetasol propionate, diflorasone acetate, mometasone furoate, betamethasone butyrate propionate, fluocinolone acetate, difluprednate, amcinonide, diflucortolone valerate, hydrocortisone butyrate propionate, deproton propionate, dexamethasone acetate, betamethasone valerate, beclomethasone propionate, prednisolone acetate, prednisolone valerate acetate, alclomethasone propionate, clobetasol butyrate, hydrocortisone butyrate, hydrocortisone acetate, cortisone acetate, etc. As component (A), one or more selected from these ester steroids may be used.

[0039] Among them, dexamethasone acetate, prednisolone acetate, prednisolone valerate acetate, hydrocortisone butyrate, hydrocortisone acetate, cortisone acetate, and betamethasone valerate are preferred; prednisolone valerate acetate, hydrocortisone butyrate, and betamethasone valerate are more preferred; and prednisolone valerate acetate is further preferred.

[0040] From the viewpoint of the effectiveness of component (A), the content of component (A) in the skin external preparation composition of the present invention is preferably 0.01% by mass or more, more preferably 0.05% by mass or more, and further preferably 0.1% by mass or more. In addition, from the viewpoint of the solubility of component (A) in the composition, it is preferably 0.5% by mass or less, more preferably 0.4% by mass or less, and further preferably 0.3% by mass or less. For example, it is preferably 0.01% by mass to 0.5% by mass, more preferably 0.05% by mass to 0.4% by mass, and further preferably 0.1% by mass to 0.3% by mass.

[0041] Component (B) is γ-oryzanol. γ-oryzanol is a general term for esters formed by condensation of ferulic acid and sterols contained in the lipids of rice bran. As main components, it contains oryzanol A (cycloartenol ferulate), oryzanol C (24-methylenecycloartanol ferulate), campesterol ferulate, etc. Since the skin topical composition of the present invention contains γ-oryzanol, the above-mentioned pharmacological effects of component (A) are improved and strengthened through its sebum secretion promoting effect. In addition, γ-oryzanol unexpectedly helps to improve the solubility of component (A) together with component (C).

[0042] γ-oryzanol is contained in rice germ oil, corn oil, and various grain oils in addition to rice bran, and therefore γ-oryzanol extracted from these oils can be used. Alternatively, commercially available products can be used.

[0043] From the viewpoint of the effectiveness of component (B), the content of component (B) in the skin external preparation composition of the present invention is preferably 0.1% by mass or more, more preferably 0.4% by mass or more, and further preferably 0.5% by mass or more. In addition, from the viewpoint of the solubility of component (B) in the composition, it is preferably 3% by mass or less, more preferably 2% by mass or less, and further preferably 1.5% by mass or less. For example, it is preferably 0.1% by mass to 3% by mass, more preferably 0.4% by mass to 2% by mass, and further preferably 0.5% by mass to 1.5% by mass.

[0044] Ingredient (C) is a medium chain fatty acid triglyceride. In the present invention, ingredient (C) mainly contributes to improving the solubility of ingredient (A) and ingredient (B), and also contributes to improving the storage stability of ingredient (A) and ingredient (B), the storage stability of the preparation, and the feel of the composition.

[0045] Medium chain fatty acid triglycerides generally refer to fatty acid triglycerides having 6 to 12 carbon atoms. However, since natural triglycerides have a distribution in the structural fatty acids, medium chain fatty acid triglycerides suitable for medium chain fatty acid triglycerides of pharmaceutical additive standards containing fatty acid triglycerides having 6 to 12 carbon atoms as the main component or tri(caprylic acid / capric acid)glyceride of quasi-drug raw material standards are preferred.

[0046] From the viewpoint of the solubility of components (A) and (B) in the composition, the storage stability of components (A) and (B), and the storage stability of the preparation, the content of component (C) in the skin external preparation composition of the present invention is preferably 3% by mass or more, more preferably 6% by mass or more, and further preferably 8% by mass or more. In addition, from the viewpoint of the feeling of use of the composition, it is preferably 30% by mass or less, more preferably 20% by mass or less, and further preferably 15% by mass or less. For example, it is preferably 3% to 30% by mass, more preferably 6% to 20% by mass, and further preferably 8% to 15% by mass.

[0047] In the present invention, as described above, component (B) contributes to improving the solubility of component (A) in the composition. From this viewpoint, the mass ratio (B / A) of component (B) to component (A) is preferably 2 to 100, preferably 3 to 50, and more preferably 4 to 15.

[0048] In addition, components (B) and (C) also contribute to improving the solubility of component (A) in the composition. From this viewpoint, the mass ratio (C / B) of component (C) to component (B) is preferably 6 to 30, more preferably 8 to 20, and even more preferably 10 to 15.

[0049] From the viewpoint of improving the long-term storage stability of components (A) and (B) in the composition, improving the solubility of components (A) and (B) and the long-term storage stability of the preparation, and improving the feel of the composition during use, it is preferred that the skin external preparation composition of the present invention further contains a higher alcohol as component (D).

[0050] Higher alcohols generally refer to long-chain alcohols having 6 or more carbon atoms. In the present invention, it is preferred to use a chain aliphatic monohydric alcohol having 8 to 24 carbon atoms, and more preferably a chain aliphatic monohydric alcohol having 12 to 22 carbon atoms. Specifically, lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, arachidyl alcohol, behenyl alcohol, oleyl alcohol, and the like can be cited.

[0051] From the viewpoint of improving the long-term storage stability of components (A) and (B) in the composition, improving the solubility of components (A) and (B) and the long-term storage stability of the preparation, the content of component (D) in the skin external preparation composition of the present invention is preferably 2% by mass or more, more preferably 4% by mass or more, and further preferably 6% by mass or more. In addition, from the viewpoint of improving the feeling of use of the composition, it is preferably 15% by mass or less, more preferably 12% by mass or less, and further preferably 10% by mass or less. For example, it is preferably 2% to 15% by mass, more preferably 4% to 12% by mass, and further preferably 6% to 10% by mass.

[0052] The skin topical composition of the present invention may contain, in addition to the above-mentioned ingredients, other active ingredients such as local anesthetics, bactericides, tocopherols, allantoin, antihistamines, etc.; oils other than the above-mentioned ingredients (C) and (D), emulsifiers, buffers, chelating agents, polyols, amino acids, water, etc.

[0053] As local anesthetics, lidocaine, dibucaine, tetracaine, hydroxydibucaine, bupivacaine, mepivacaine, prilocaine, diethylaminoethyl p-butylaminobenzoate, etc. can be mentioned, among which lidocaine and dibucaine are preferred, and lidocaine is more preferred. These lidocaine, dibucaine, and caine can also be used in the form of hydrochloride.

[0054] From the viewpoint of the solubility, stability and local anesthetic effect of components (A) and (B), the content of the local anesthetic in the skin external preparation composition of the present invention is preferably 0.1% by mass to 4% by mass, more preferably 0.2% by mass to 3% by mass, and even more preferably 0.5% by mass to 3% by mass.

[0055] As the bactericide, isopropylmethylphenol, methylparaben, ethylparaben, propylparaben, butylparaben, sodium dehydroacetate, p-cresol, etc. can be cited. Among these bactericides, isopropylmethylphenol is preferably used as a bactericide. Other parabens, etc. are preferably used as preservatives. These bactericides are preferably contained in the skin external preparation composition of the present invention in an amount of 0.02% to 1.0% by mass, and more preferably 0.05% to 0.5% by mass.

[0056] Examples of the tocopherols include tocopherol, tocopherol acetate, and tocopherol nicotinate. The content of the tocopherols in the skin external preparation composition of the present invention is preferably 0.1% by mass to 2% by mass, and more preferably 0.1% by mass to 1% by mass.

[0057] Allantoin is chemically called 5-ureidohydantoin, and is used as a skin care agent because of its tissue restorative effect, etc. From the perspective of the effect of allantoin, the content of allantoin in the skin external preparation composition of the present invention is preferably 0.1% to 1% by mass, more preferably 0.1% to 0.8% by mass, and further preferably 0.1% to 0.5% by mass.

[0058] Examples of the antihistamine include diphenhydramine, diphenhydramine hydrochloride, chlorpheniramine, chlorpheniramine maleate, benzimidazole, etc. The content of the antihistamine in the skin external preparation composition of the present invention is preferably 0.05% to 5% by mass, more preferably 0.1% to 3% by mass, and even more preferably 0.2% to 2% by mass.

[0059] Examples of the oil agent other than the above-mentioned component (C) and component (D) include vaseline, squalane, plastibase, paraffin, liquid paraffin, white beeswax, silicone oil and the like.

[0060] These oils are preferably contained in the skin external preparation composition of the present invention in an amount of 1% by mass or more and 80% by mass or less, more preferably 3% by mass to 80% by mass, and even more preferably 5% by mass to 80% by mass.

[0061] As emulsifiers, there can be mentioned nonionic surfactants such as polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid esters, glycerol fatty acid esters, polyoxyethylene fatty acid esters, polyoxyethylene alkyl ethers, sorbitan fatty acid esters, polyoxyethylene polyoxypropylene glycol, and ionic surfactants such as sodium lauryl sulfate and sodium cetyl sulfate, among which nonionic surfactants are preferably used. The content of the emulsifier in the skin external preparation composition of the present invention is preferably 0.5% to 10% by mass, and more preferably 0.5% to 8% by mass.

[0062] As the buffer, a combination of an aliphatic hydroxy acid such as lactic acid, citric acid, malic acid, tartaric acid, and an alkali metal salt thereof is preferred.

[0063] From the viewpoint of pH adjustment effect, the content of the buffer in the skin external preparation composition of the present invention is preferably 0.1 to 3% by mass, more preferably 0.2 to 2% by mass, and even more preferably 0.3 to 1.5% by mass.

[0064] The chelating agent is preferably ethylenediaminetetraacetic acid or sodium ethylenediaminetetraacetate. The content of the chelating agent in the skin external preparation of the present invention is preferably 0.1 to 2% by mass, more preferably 0.2 to 1% by mass, and even more preferably 0.2 to 0.8% by mass.

[0065] Examples of the polyol include glycerin, 1,3-butylene glycol, propylene glycol, dipropylene glycol, polyethylene glycol, etc. These polyols are preferably contained in the skin external preparation composition of the present invention in an amount of 2 to 20% by mass, more preferably 4 to 10% by mass.

[0066] The content of water in the skin external preparation composition of the present invention is preferably 0% to 70% by mass, and more preferably 0% to 60% by mass. It should be noted that it is preferred that the skin external preparation composition of the present invention contains substantially no water when it is in the form of an oily ointment, and contains water when it is a cream (including both water-in-oil emulsions and oil-in-water emulsions).

[0067] Furthermore, a thickener such as polyvinyl pyrrolidone, carboxymethyl cellulose, colloidal hydrated aluminum silicate, xanthan gum, locust bean gum, tragacanth gum, guar gum, gelatin, gum arabic, alginic acid, albumin, etc. may be blended into the skin external preparation composition of the present invention.

[0068] As described above, the skin preparation composition of the present invention can be an oily ointment or a cream. In the case of a cream, the pH is preferably 4 to 6, more preferably 4.5 to 5.6, and even more preferably 4.8 to 5.4 from the perspective of skin irritation and component stability. The pH is adjusted using the above-mentioned buffer.

[0069] The skin topical preparation composition of the present invention can be manufactured by uniformly mixing the above-mentioned components according to a conventional method. In addition, the skin topical preparation composition of the present invention as a cream is preferably manufactured by dissolving the lipophilic component and the hydrophilic component to which an emulsifier is added in a lipophilic base or water under heating, adding the latter to the former and stirring and emulsifying it with a homogenizer, and then cooling it to room temperature.

[0070] Since the skin external preparation composition of the present invention contains the ester steroid as the component (A), it is mainly used as a therapeutic agent for skin diseases such as eczema, dermatitis, prurigo, insect bites, psoriasis, palmoplantar pustulosis, etc. It can be used by applying an appropriate amount to the site where these skin diseases occur.

[0071] As described above, the composition for external use on skin of the present invention is stably dissolved in the composition by components (A) and (B), the composition is stable for a long time, and the feeling of use when applied to the skin is also good. Here, the stability of components (A) and (B) can be determined by determining whether the components (A) and (B) in the composition after long-term storage are decomposed by high performance liquid chromatography (HPLC). In addition, regarding the storage stability of long-term preparations, the emulsified state and the presence or absence of precipitates can be determined by visual observation and microscopic observation of the composition after long-term storage. In addition, regarding the feeling of use, the composition after long-term storage can be applied to the skin, and the presence or absence of roughness, ease of extension, and ease of application can be determined by sensory evaluation.

[0072] Example

[0073] Next, the present invention will be described in further detail with reference to Examples, but the present invention is not limited to these Examples.

[0074] Examples 1 to 15 and Comparative Examples 1 to 5

[0075] Oily ointments and creams were prepared according to conventional methods using the formulations described in Tables 1 to 3. The obtained preparations were evaluated for (1) component stability, (2) preparation stability, and (3) feeling in use by the following methods. In addition, (4) comprehensive evaluation of these evaluations was also performed. The results are shown in Tables 1 to 3.

[0076] (1) Regarding the stability of ingredients, in order to predict chemical changes during long-term storage, the preparation was stored under harsh conditions (50°C, 1 month), and the decomposition of ingredients (A) and (B) in the preparation was measured by high performance liquid chromatography (HPLC), and the evaluation was performed according to the following criteria. In addition, (2) Regarding the stability of the preparation, a so-called temperature cycle test was performed in which the low temperature was 5°C, the high temperature was 40°C, and the storage temperature was rapidly changed every 12 hours. The emulsification state and the presence of precipitates were evaluated by visual and microscopic observation of the composition after storage for 1 month according to the following criteria. In addition, (3) Regarding the feeling of use, the composition after storage for 1 month in the temperature cycle test under the same conditions as shown above was applied to the skin, and the presence of roughness, ease of spreading, and ease of application were evaluated by sensory testing according to the following criteria. It should be noted that (4) the comprehensive evaluation was evaluated according to the following criteria, based on the three items of (1) ingredient stability, (2) preparation stability, and (3) feeling of use, and divided into 5 levels.

[0077] (1) Evaluation of ingredient stability (after storage at 50°C for one month)

[0078] ◎: The residual rate of components (A) and (B) is 97% or more

[0079] ○: The residual rate of components (A) and (B) is 95% or more

[0080] △: The residual rate of components (A) and (B) is 90% or more

[0081] ×: The residual rate of either component (A) or (B) is less than 90%

[0082] (2) Evaluation of formulation stability (temperature cycle test, after 1 month storage)

[0083] ◎: Phase separation was not confirmed visually, and precipitates were not confirmed under microscopic observation.

[0084] In addition, regarding the cream, no change was observed in the emulsified state.

[0085] ○: Phase separation was hardly observed visually, and precipitates were hardly observed under microscope observation.

[0086] In addition, regarding the cream, almost no change was observed in the emulsified state.

[0087] △: Phase separation was slightly observed visually, or precipitates were slightly observed under a microscope.

[0088] ×: Phase separation was clearly observed visually, or precipitates were clearly observed under a microscope.

[0089] (3) Evaluation of the feeling of use (temperature cycle test, after storage for 1 month)

[0090] ◎: No roughness, easy to stretch moderately

[0091] ○: Almost no roughness, easy to spread

[0092] △: Slightly rough, or slightly hard and difficult to stretch, or slightly soft and too stretchy

[0093] ×: It feels noticeably rough, or is very hard and difficult to spread, or is too liquid and too spreadable

[0094] (4) Comprehensive evaluation

[0095] A: All three items are ◎

[0096] B: 2 items are ◎, 1 item is ○

[0097] C: 2 items or 3 items are marked with ○, no × or △

[0098] D: × is 1

[0099] E: × means 2 or more

[0100] [Table 1]

[0101]

[0102] [Table 2]

[0103]

[0104] [Table 3]

[0105]

[0106] As shown in Tables 1 to 3, the skin external preparation composition of the present invention comprising (A) ester steroid, (B) γ-oryzanol and (C) medium-chain fatty acid triglyceride has good solubility of components (A) and (B), is stable for a long period of time, and has a good feeling during use.

Claims

1. A composition for external use on skin, comprising the following components A to C: A: Ester steroids B: γ-oryzanol C: Medium chain fatty acid triglycerides.

2. The composition for external use on skin according to claim 1, wherein The mass ratio of component B to component A, that is, B / A, is 2-100.

3. The composition for external use on skin according to claim 1 or 2, wherein The mass ratio of component C to component B, that is, C / B, is 6-30.

4. The composition for external use on skin according to any one of claims 1 to 3, wherein The content of component A is 0.01% by mass to 0.5% by mass, the content of component B is 0.1% by mass to 3% by mass, and the content of component C is 3% by mass to 30% by mass.

5. The composition for external use on skin according to any one of claims 1 to 4, wherein It further contains component D: a higher alcohol.

6. The composition for external use on skin according to claim 5, wherein The content of component D is 2% by mass to 15% by mass.

7. The composition for external use on skin according to any one of claims 1 to 6, wherein Component A is one or more selected from the group consisting of dexamethasone acetate, prednisolone acetate, prednisolone valerate acetate, hydrocortisone butyrate, hydrocortisone acetate, cortisone acetate, and betamethasone valerate.

8. The composition for external use on skin according to any one of claims 1 to 6, wherein Ingredient A is prednisolone valerate acetate.

9. The composition for external use on skin according to any one of claims 5 to 8, wherein Component D is a chain aliphatic monohydric alcohol having 12 to 22 carbon atoms.

10. The composition for external use on skin according to any one of claims 1 to 9, wherein The composition further contains at least one selected from the group consisting of tocopherols, bactericides, local anesthetics, allantoin and antihistamines.

11. The composition for external use on skin according to any one of claims 1 to 10, wherein The composition further contains at least one selected from the group consisting of an oil agent other than Component C and Component D, an emulsifier, a buffer, a chelating agent, a polyol, and water.

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