External components

Abstract

The object of this disclosure is to provide a topical composition containing ceramide 2 and glycyrrhizic acid derivatives that can suppress separation during storage. [Solution] An external composition containing (A) ceramide 2, (B) at least one glycyrrhizic acid derivative selected from the group consisting of glycyrrhizic acid, its derivatives, and salts thereof, and (C1) a heparin-like substance and / or (C2) petrolatum, is characterized by suppression of separation during storage.

Description

Technical Field

[0001] The present disclosure relates to an external composition containing ceramide 2 and glycyrrhizic acids and capable of suppressing separation by storage.

Background Art

[0002] The stratum corneum is mainly composed of corneocytes and intercellular lipids forming a lamellar structure, and the lamellar structure of the intercellular lipids in the stratum corneum plays an important role in the barrier function and the moisturizing function. Further, about 50% of the intercellular lipids in the stratum corneum are composed of ceramides, and it is known that when the ceramide content in the stratum corneum decreases, the barrier function and the moisturizing function decrease.

[0003] Therefore, conventionally, external compositions containing ceramides have been developed for the purpose of maintaining the function of the stratum corneum by supplementing ceramides in the stratum corneum. For example, Patent Document 1 reports that an emulsified composition containing ceramide, a specific monoalkyl glyceryl ether or monoalkenyl glyceryl ether, a higher fatty acid, and a polyhydric alcohol has high stability and excellent usability.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Ceramides are broadly classified into human-type ceramides, animal-derived ceramides, plant-derived ceramides, and pseudo-ceramides. Of these, human-type ceramides have the same structure as ceramides found in human skin and have excellent affinity with the skin. Among human-type ceramides, ceramide 2 is the most abundant in human skin and plays a role in supporting moisturizing function. On the other hand, glycyrrhizic acid derivatives such as glycyrrhizic acid, its derivatives, and their salts have anti-inflammatory effects and are incorporated into topical compositions for purposes such as improving rough skin. The inventors of this invention proceeded with research to develop a topical composition containing ceramide 2 and glycyrrhizic acid derivatives, but encountered the problem that separation occurs when the topical composition containing ceramide 2 and glycyrrhizic acid derivatives is stored.

[0006] Therefore, the object of this disclosure is to provide a topical composition containing ceramide 2 and glycyrrhizic acid derivatives that can suppress separation during storage. [Means for solving the problem]

[0007] The inventors conducted diligent research to solve the aforementioned problems and found that by including a heparin-like substance and / or white petrolatum in an external composition containing ceramide 2 and glycyrrhizic acid derivatives, separation during storage can be suppressed, and excellent storage stability can be achieved. Furthermore, they found that an external composition containing ceramide 2, glycyrrhizic acid derivatives, a heparin-like substance and / or white petrolatum also has excellent usability, as it provides a good moisturizing feeling when applied to the skin. This disclosure was completed by further research based on these findings.

[0008] In other words, this disclosure provides external compositions in the following embodiments. Item 1. A topical composition comprising (A) ceramide 2, (B) at least one glycyrrhizic acid derivative selected from the group consisting of glycyrrhizic acid, its derivatives, and salts thereof, and (C1) a heparin-like substance and / or (C2) petrolatum. Item 2. The topical composition according to Item 1, wherein the content of component (A) is 0.001 to 10% by weight. Item 3. The external composition according to item 1 or 2, wherein the content of component (B) per 1 part by weight of component (A) is 0.01 to 100 parts by weight. Item 4. The external composition according to any one of items 1 to 3, wherein the content of component (C1) per 1 part by weight of component (A) is 0.001 to 50 parts by weight. Item 5. The external composition according to any one of items 1 to 4, wherein the content of component (C2) per 1 part by weight of component (A) is 0.01 to 100 parts by weight. Item 6. An emulsified composition, which is an external composition according to any one of items 1 to 5. Item 7. The topical composition described in Item 6, which is an oil-in-water type. [Effects of the Invention]

[0009] The topical compositions disclosed herein contain ceramide 2 and glycyrrhizic acid derivatives, yet are resistant to separation during storage. [Modes for carrying out the invention]

[0010] The topical compositions of this disclosure are characterized by containing (A) ceramide 2 (hereinafter also referred to as "component (A)"), (B) at least one glycyrrhizic acid derivative selected from the group consisting of glycyrrhizic acid, its derivatives, and salts thereof (hereinafter also referred to as "component (B)"), and (C1) heparinoid (hereinafter also referred to as "component (C1)") and / or (C2) petrolatum (hereinafter also referred to as "component (C2)"). The topical compositions of this disclosure have suppressed separation during storage. In preferred embodiments, the topical compositions of this disclosure have further improved moisturizing properties. The topical compositions of this disclosure will be described in detail below. In this disclosure, the numerical range "X~Y" refers to a range of X or more and Y or less.

[0011] [(A) Ceramide 2] The topical composition disclosed herein contains ceramide 2. Conventionally, when ceramide 2 is incorporated into topical compositions together with glycyrrhizic acid derivatives, separation occurs during storage. However, separation during storage is suppressed in the topical composition disclosed herein. Furthermore, conventionally, when ceramide 2 is incorporated into topical compositions together with glycyrrhizic acid derivatives, the moisturizing effect decreases. However, in preferred embodiments of the topical composition disclosed herein, the moisturizing effect is improved.

[0012] Ceramide 2 is N-stearoyldihydrosphingosine, a type of human-type ceramide.

[0013] The content of ceramide 2 in the topical composition of this disclosure is not particularly limited and can be set appropriately depending on the desired degree of separation inhibition and / or improvement of moisturizing effect, the formulation form, etc., but for example, 0.001 to 10% by weight is possible. From the viewpoint of enhancing the effect of separation inhibition and / or improvement of moisturizing effect, preferred content of component (A) is 0.01 to 10% by weight, more preferably 0.1 to 10% by weight, even more preferably 0.3 to 10% by weight, even more preferably 0.4 to 10% by weight, particularly preferably 0.45 to 10% by weight, 0.45 to 5% by weight, 0.45 to 3% by weight, or 0.45 to 2% by weight.

[0014] [(B) Glycyrrhizic acid derivatives] The topical composition of this disclosure contains, as component (B), at least one glycyrrhizic acid derivative selected from the group consisting of glycyrrhizic acid, its derivatives, and salts thereof. Conventionally, when glycyrrhizic acid derivatives are incorporated into topical compositions together with ceramide 2, separation occurs during storage, but separation during storage is suppressed in the topical composition of this disclosure. Furthermore, conventionally, when glycyrrhizic acid derivatives are incorporated into topical compositions together with ceramide 2, the moisturizing effect decreases, but in preferred embodiments of the topical composition of this disclosure, the moisturizing effect is improved.

[0015] Glycyrrhizic acid is a well-known drug that possesses anti-inflammatory and anti-allergic effects. While derivatives of glycyrrhizic acid are not particularly limited as long as they are pharmaceutically acceptable, specific examples include methyl glycyrrhizinate and stearyl glycyrrhizinate. Salts of glycyrrhizic acid and its derivatives are not particularly limited as long as they are pharmaceutically acceptable, but specific examples include alkali metal salts such as sodium salts and potassium salts; and ammonium salts.

[0016] In the topical compositions disclosed herein, one may be selected from glycyrrhizic acid, its derivatives, and salts thereof, or two or more may be used in combination.

[0017] Among these glycyrrhizic acid compounds, salts of glycyrrhizic acid are preferred, and dipotassium glycyrrhizinate is more preferred.

[0018] The total amount of component (B) in the topical composition of this disclosure is not particularly limited and can be set appropriately depending on the desired degree of separation inhibition and / or improvement of moisturizing effect, the use of the topical composition, the formulation form, etc., but for example, 0.01 to 10% by weight is possible. From the viewpoint of enhancing the effect of separation inhibition and / or improvement of moisturizing effect, a preferred content of component (B) is 0.01 to 2.5% by weight, more preferably 0.01 to 2% by weight, even more preferably 0.01 to 1.5% by weight, and even more preferably 0.01 to 1.2% by weight. Furthermore, since the topical composition of this disclosure is excellent in the effect of separation inhibition and improvement of moisturizing effect, even when the content of component (B) is relatively high, effective separation inhibition and / or improvement of moisturizing effect can be obtained. From this viewpoint, a preferred content of component (B) is 0.05 to 10% by weight, 0.1 to 10% by weight, 0.5 to 10% by weight, 0.8 to 10% by weight, or 1 to 10% by weight.

[0019] In the external composition of the present disclosure, the ratio of the component (A) to the component (B) is determined according to the content of each component described above. The content of the component (B) per 1 part by weight of the component (A) is preferably 0.01 to 100 parts by weight. From the viewpoint of enhancing the effect of suppressing separation and / or improving the moist feeling, the more preferable content of the component (B) per 1 part by weight of the component (A) is 0.01 to 50 parts by weight, more preferably 0.01 to 30 parts by weight, still more preferably 0.01 to 10 parts by weight, even more preferably 0.01 to 5 parts by weight, and particularly preferably 0.01 to 3 parts by weight. Further, since the external composition of the present disclosure is excellent in the effects of suppressing separation and improving the moist feeling, even when the ratio of the content of the component (B) to the component (A) is relatively high, the separation can be effectively suppressed and / or the moist feeling can be improved. From such a viewpoint, the suitable content of the component (B) per 1 part by weight of the component (A) includes 0.1 to 100 parts by weight, 0.5 to 100 parts by weight, 1 to 100 parts by weight, 1.5 to 100 parts by weight, and 1.8 to 100 parts by weight.

[0020] [(C1) heparin-like substance and / or (C2) petrolatum] The external composition of the present disclosure contains a heparin-like substance as the component (C1) and / or petrolatum as the component (C2). Conventionally, an external composition containing ceramide 2 and glycyrrhetinic acids causes separation during storage. However, in the external composition of the present disclosure, by using the (C1) heparin-like substance and / or the (C2) petrolatum in combination with ceramide 2 and glycyrrhetinic acids, the separation due to storage can be suppressed. Further, conventionally, the moist feeling of an external composition containing ceramide 2 and glycyrrhetinic acids decreases. However, in a preferred embodiment of the external composition of the present disclosure, by using the (C1) heparin-like substance and / or the (C2) petrolatum in combination with ceramide 2 and glycyrrhetinic acids, the moist feeling can be improved.

[0021] A heparin analogue is a polysulfated mucopolysaccharide such as chondroitin polysulfate, and is a known component that is known to have a moisturizing effect and a blood circulation promoting effect, etc. Regarding the origin of the heparin analogue used in the present disclosure, there is no particular limitation, but examples include those obtained by polysulfating mucopolysaccharides, those extracted from the tissues of edible animals (for example, lungs including bovine tracheal cartilage), etc. In the external composition of the present disclosure, a heparin analogue included in the Japanese Pharmacopoeia External Medicine Standards is preferably used as the heparin analogue.

[0022] As petrolatum, preferably white petrolatum is used. White petrolatum is a mixture of hydrocarbons obtained from petroleum, which has been decolorized and purified, and is an oily component.

[0023] The external composition of the present disclosure may contain either one of the (C1) component and the (C2) component, or may contain them in combination.

[0024] When the (C1) component is contained in the external composition of the present disclosure, the content of the (C1) component in the external composition of the present disclosure is not particularly limited, and can be appropriately set according to the degree of separation suppression and / or improvement of the moist feeling required, the use of the external composition, the dosage form, etc., but for example, 0.01 to 10% by weight can be mentioned. From the viewpoint of enhancing the effect of separation suppression and / or improvement of the moist feeling, the preferable content of the (C1) component is 0.01 to 1% by weight, more preferably 0.05 to 0.8% by weight, still more preferably 0.1 to 0.8% by weight, even more preferably 0.25 to 0.8% by weight or 0.3 to 0.6% by weight.

[0025] When the topical composition of the present disclosure contains component (C2), there are no particular limitations on the content of component (C2) in the topical composition of the present disclosure. It can be appropriately set according to the desired degree of separation inhibition and / or improvement of moisturizing effect, the use of the topical composition, the formulation form, etc., but for example, 0.01 to 20% by weight is possible. From the viewpoint of enhancing the effect of separation inhibition and / or improvement of moisturizing effect, a preferred content of component (C2) is preferably 0.5 to 15% by weight, more preferably 1 to 10% by weight, and even more preferably 2 to 7% by weight.

[0026] When the topical composition of this disclosure contains component (C1), the ratio of component (A) to component (C1) is determined according to the content of each of the above components. However, from the viewpoint of enhancing the effect of suppressing separation and / or improving moisturizing effect, the content of component (C1) per 1 part by weight of component (A) is preferably 0.001 to 50 parts by weight, preferably 0.005 to 30 parts by weight, more preferably 0.01 to 10 parts by weight, even more preferably 0.1 to 5 parts by weight, and even more preferably 0.3 to 4 parts by weight, 0.4 to 2 parts by weight, or 0.5 to 1 part by weight.

[0027] When the topical composition of this disclosure contains component (C2), the ratio of component (A) to component (C2) is determined according to the content of each of the above components. However, from the viewpoint of enhancing the effect of suppressing separation and / or improving moisturizing effect, the content of component (C2) per 1 part by weight of component (A) is preferably 0.01 to 100 parts by weight, more preferably 0.1 to 80 parts by weight, even more preferably 1 to 60 parts by weight, and even more preferably 2 to 40 parts by weight, 3 to 25 parts by weight, or 4 to 10 parts by weight.

[0028] [water] The topical compositions disclosed herein contain water for preparation into a desired formulation. The water content in the topical compositions disclosed herein may be set appropriately depending on the formulation, etc., but examples include 20 to 97% by weight, preferably 25 to 95% by weight, more preferably 30 to 90% by weight, and even more preferably 35 to 80% by weight.

[0029] [Polyhydric alcohols] The topical compositions disclosed herein may optionally contain polyhydric alcohols. The type of polyhydric alcohol is not particularly limited, as long as it is pharmaceutically acceptable, but examples include dihydric alcohols such as ethylene glycol, 1,3-butylene glycol, propylene glycol, isoprene glycol, diethylene glycol, dipropylene glycol, and polypropylene glycol; and trihydric alcohols such as glycerin. Among these polyhydric alcohols, 1,3-butylene glycol is preferred. These polyhydric alcohols may be used individually or in combination of two or more.

[0030] When a polyhydric alcohol is included in the topical composition of this disclosure, there are no particular limitations on its content, but for example, it may be 1 to 15% by weight, preferably 1 to 10% by weight, and more preferably 2 to 8% by weight.

[0031] [Surfactants] The topical compositions disclosed herein may contain surfactants for preparation into desired formulations. The surfactant may be a nonionic surfactant, anionic surfactant, cationic surfactant, or amphoteric surfactant, but a nonionic surfactant is preferred.

[0032] The types of nonionic surfactants are not particularly limited, as long as they are pharmaceutically acceptable, but examples include polyoxyethylene sorbitan fatty acid esters, polyoxyethylene hydrogenated castor oil, glycerin fatty acid esters, polyglycerin fatty acid esters, polyoxyethylene glycerin fatty acid esters, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene alkyl ethers, polyethylene glycol fatty acid esters, lecithin derivatives, etc.

[0033] Among these nonionic surfactants, preferred examples include polyoxyethylene sorbitan fatty acid esters and glycerin fatty acid esters, more preferably self-emulsifying glyceryl monostearate (glyceryl stearate (SE)) and polyoxyethylene sorbitan monostearate (polysorbate 60).

[0034] These nonionic surfactants may be used individually or in combination of two or more.

[0035] A preferred example of a surfactant used in the topical composition of this disclosure is a combination of polyoxyethylene sorbitan fatty acid ester and glycerin fatty acid ester. When using a combination of polyoxyethylene sorbitan fatty acid ester and glycerin fatty acid ester, the ratio is not particularly limited, but for example, per 100 parts by weight of polyoxyethylene sorbitan fatty acid ester, the amount of glycerin fatty acid ester can be 1 to 1000 parts by weight, preferably 10 to 600 parts by weight, more preferably 50 to 400 parts by weight, even more preferably 100 to 200 parts by weight, and particularly preferably 140 to 180 parts by weight.

[0036] When a surfactant is included in the topical composition of this disclosure, the amount can be appropriately set depending on the formulation form, the type of surfactant used, etc., but for example, the total amount of surfactant can be 0.1 to 20% by weight, preferably 0.5 to 15% by weight, more preferably 1 to 10% by weight, and even more preferably 2 to 7% by weight.

[0037] [Oily base] The topical compositions disclosed herein may contain oily bases (oils) other than component (C2) in order to prepare them into a desired formulation. The type of oily base is not particularly limited as long as it is pharmaceutically acceptable, but examples include mineral oil (other than component (C2)), higher monohydric alcohols, fatty acid alkyl esters, vegetable oils, animal oils, cholesterol, higher fatty acids having 12 to 34 carbon atoms, silicone oils, etc.

[0038] Among these oily bases, suitable examples include mineral oil (excluding the (C2) component) and higher monohydric alcohols. Specific examples of mineral oils include paraffin, hydrogenated polyisobutene, liquid paraffin, gelling hydrocarbons (such as Plastibase), ceresin, and microcrystalline wax. Higher monohydric alcohols are monohydric alcohols with 6 to 34 carbon atoms. Preferably, higher monohydric alcohols have 10 to 18 carbon atoms, and specific examples include octyl alcohol, decyl alcohol, lauryl alcohol, myristyl alcohol, cetanol, stearyl alcohol, oleyl alcohol, and eicosanol.

[0039] These oily bases may be used individually or in combination of two or more.

[0040] A suitable example of an oily base used in the external composition of this disclosure is a combination of mineral oil (other than component (C2)) and a higher monohydric alcohol. When using a combination of mineral oil (other than component (C2)) and a higher monohydric alcohol, the ratio is not particularly limited, but for example, per 100 parts by weight of mineral oil (other than component (C2)), the higher monohydric alcohol may be 0.1 to 1000 parts by weight, preferably 0.1 to 500 parts by weight, more preferably 1 to 200 parts by weight, even more preferably 5 to 100 parts by weight, and particularly preferably 20 to 50 parts by weight.

[0041] When an oily base (other than component (C2)) is included in the topical composition of the present disclosure, the amount thereof can be appropriately set depending on the formulation form, etc., but for example, the total amount of the oily base (other than component (C2)) can be 1 to 80% by weight, preferably 3 to 60% by weight, more preferably 5 to 40% by weight, even more preferably 10 to 20% by weight, and even more preferably 10 to 15% by weight.

[0042] [Other ingredients] In addition to the components described above, the topical compositions of this disclosure may contain other commonly used additives as needed. Examples of such additives include monohydric lower alcohols, pH adjusters, buffers, thickeners, solubilizers, antioxidants, stabilizers, fragrances, colorants, and the like. When these additives are included in the topical compositions of this disclosure, their content may be appropriately determined depending on the type of additive used.

[0043] Other specific examples of the additives mentioned above include carboxyvinyl polymers, xanthan gum, and metal oxide powders (such as Al, Mg, Sn, Zn, Co, Fe, Zr, Ti, Ce, etc.). However, preferred embodiments of this disclosure do not include one or more of these specific components.

[0044] Furthermore, the topical compositions disclosed herein may contain pharmacological components in addition to the components described above. Examples of such pharmacological components include antihistamines, local anesthetics, moisturizers, bactericides, antibacterial agents, antipruritics, skin protectants, blood circulation promoting components, vitamins, and the like. These pharmacological components may be used individually or in combination of two or more. When these pharmacological components are included in the topical compositions disclosed herein, their concentrations may be appropriately set according to the type of pharmacological component used, the desired effect, etc.

[0045] Specific examples of the above-mentioned pharmacological components include hyaluronic acid, its derivatives (acetylated hyaluronic acid with acetylated hydroxyl groups, sulfated hyaluronic acid with sulfated hydroxyl groups, cationized hyaluronic acid, hydrophobized hydrolyzed hyaluronic acid (hydrolyzed alkyl (C12-13) glyceryl hyaluronate, etc.), cross-linked hyaluronic acid, carboxymethyl hyaluronic acid, alkylene glycol hyaluronate, silanol hyaluronate, etc.), and salts thereof; however, tranexamic acid, its salts, and derivatives thereof (such as cetyl hydrochloride tranexamate) are also mentioned, but preferred embodiments of this disclosure do not include one or more of these specific components.

[0046] [Formulation form / dosage type] The topical compositions disclosed herein may be emulsified formulations such as oil-in-water emulsions and water-in-oil emulsions, or non-emulsified formulations such as solubilized formulations and aqueous ointments. In the prior art, when ceramide 2 and glycyrrhizic acid derivatives are included in emulsified formulations (particularly oil-in-water emulsions), separation due to storage tends to be significant. In contrast, the topical compositions disclosed herein can effectively suppress separation due to storage, even in emulsified formulations. In view of these effects, emulsified formulations, and more preferably oil-in-water emulsions, are preferred as topical compositions of the disclosure.

[0047] Furthermore, the topical compositions disclosed herein are used as topical skin pharmaceuticals (including quasi-drugs). Specific formulations of the topical compositions of the present invention include creams, lotions, gels, emulsions, liquids, poultices, patches, liniments, aerosols, aqueous ointments, and packs. Among these, creams and emulsions are preferred, and creams are more preferred.

[0048] [Manufacturing method] The topical compositions disclosed herein can be manufactured according to known formulation methods corresponding to their formulation form. For example, if the topical composition disclosed herein is an emulsified formulation, it can be prepared by separating the components to be contained into water-soluble components and oily components, preparing an aqueous phase containing the water-soluble components and an oil phase containing the oily components, and emulsifying these according to known methods. [Examples]

[0049] The present disclosure will be explained in more detail below with reference to examples, but the present disclosure is not limited to these examples.

[0050] Test example Topical emulsified compositions (oil-in-water emulsions, creams) shown in Tables 1-4 were prepared. Specifically, an oil phase composition consisting of oily components and an aqueous phase composition consisting of surfactants and aqueous components were dissolved at 75-86°C. The oil phase composition and the aqueous phase composition were mixed at 80°C, stirred, and cooled to room temperature to prepare the topical emulsified compositions.

[0051] <Evaluation of separation and control> The prepared topical emulsified compositions were filled into vials and stored at 50°C for 1 day. The degree of separation was evaluated based on the appearance after storage. Specifically, the degree of separation was evaluated on a 5-point scale, with "1" indicating no separation and "5" indicating significant separation. The results are shown in Tables 1 and 2.

[0052] <Evaluation of moisturizing effect> The degree of moisturizing effect of the topical compositions immediately after preparation was evaluated by expert panelists. Specifically, the degree of moisturizing effect of the topical composition in Reference Example 1 was used as a baseline, and the evaluation was performed in two stages: "○" if it was equal to or better than the reference example, and "×" if it was worse. The results are shown in Tables 3 and 4.

[0053] [Table 1]

[0054] [Table 2]

[0055] [Table 3]

[0056] [Table 4]

[0057] As shown in Table 1, no separation occurred during storage in topical compositions that did not contain components (A), (B), (C1), and (C2) (Reference Example 1), but significant separation was observed during storage in topical compositions containing components (A) and (B) (Comparative Example 1). In contrast, as shown in Tables 1 and 2, separation during storage was significantly suppressed in topical compositions containing components (A) and (B) and component (C1) or (C2) (Examples 1-9), resulting in a significant improvement in storage stability. In particular, separation during storage was significantly suppressed in topical compositions with the compositions of Examples 1, 2, 4-9, resulting in a significantly improved storage stability.

[0058] Furthermore, as shown in Table 3, the topical composition containing component (B) (Reference Example 2) provided comparable moisturizing effect to the topical composition without components (A), (B), (C1), and (C2) (Reference Example 1), but a decrease in moisturizing effect was observed in the topical composition containing components (A) and (B) (Comparative Example 1). In contrast, as shown in Tables 3 and 4, the topical compositions containing components (A) and (B) and component (C1) or (C2) (Examples 1-9) provided a moisturizing effect that was equal to or better than that of the topical composition in Reference Example 2.

Claims

1. A topical composition comprising (A) ceramide 2, (B) at least one glycyrrhizic acid derivative selected from the group consisting of glycyrrhizic acid, its derivatives, and salts thereof, and (C1) a heparin-like substance and / or (C2) petrolatum.

2. The topical composition according to claim 1, wherein the content of component (A) is 0.001 to 10% by weight.

3. The external composition according to claim 1 or 2, wherein the content of component (B) per 1 part by weight of component (A) is 0.01 to 100 parts by weight.

4. The external composition according to claim 1 or 2, wherein the content of component (C1) per 1 part by weight of component (A) is 0.001 to 50 parts by weight.

5. The external composition according to claim 1 or 2, wherein the content of component (C2) per 1 part by weight of component (A) is 0.01 to 100 parts by weight.

6. The external composition according to claim 1 or 2, which is an emulsified composition.

7. The topical composition according to claim 6, wherein it is an oil-in-water type.

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