External components

Abstract

The object of this disclosure is to provide a topical composition in which vitamin E is stabilized. [Solution] An external composition comprising (A) vitamin E, (B) at least one selected from the group consisting of salicylic acid, its derivatives, and salts thereof, (C) ethanol, and (D) a nonionic surfactant, housed in a container whose inner wall is made of polyethylene terephthalate, wherein the vitamin E is stabilized.

Description

【Technical Field】 【0001】 The present disclosure relates to an external composition containing vitamin E, which is contained in a container and in which vitamin E is stabilized. 【Background Art】 【0002】 Vitamin E has antioxidant, immunostimulatory, blood circulation promoting effects, etc., and is used as a compounding ingredient in external compositions. On the other hand, since vitamin E decreases over time due to adsorption to the inner wall of the container to be filled, there is a problem in stably compounding it in external compositions. 【0003】 As a technique for suppressing the adsorption of vitamin E to the container and enhancing the storage stability in a composition containing vitamin E, a technique of blending a specific polyoxyethylene alkyl ether and a specific polyoxyethylene hydrogenated castor oil in a specific ratio in a dentifrice composition containing vitamin E, an anionic surfactant, and an abrasive (Patent Document 1), a technique of blending a specific polyoxyethylene hydrogenated castor oil and an anionic surfactant in a dentifrice composition containing vitamin E (Patent Document 2), a technique of blending one or more selected from acyl amino acids, acyl taurine, and salts thereof, a specific polyoxyethylene hydrogenated castor oil, and one or more selected from sorbitol, glycerin, propylene glycol, and polyethylene glycol in a specific ratio in a liquid oral composition containing vitamin E, and storing it in a container whose innermost layer is made of polyethylene or polypropylene (Patent Document 3) is known. 【Prior Art Documents】 【Patent Documents】 【0004】 【Patent Document 1】 JP-A-2005-247786 【Patent Document 2】 JP-A-2004-250381 【Patent Document 3】 JP-A-2024-80341 【Summary of the Invention】 [Problems that the invention aims to solve] 【0005】 While the above-mentioned techniques, which are known to stabilize vitamin E, are specific to oral compositions, the stabilization of vitamin E in compositions suitable for topical use has not been sufficiently investigated. 【0006】 The object of this disclosure is to provide a topical composition in which vitamin E is stabilized. [Means for solving the problem] 【0007】 The inventors of the present invention conducted diligent research to solve the aforementioned problems and found that vitamin E can be stabilized in an external composition containing vitamin E by combining at least one selected from the group consisting of salicylic acid, its derivatives, and salts thereof, with ethanol and a nonionic surfactant, and by housing the composition in a container whose inner wall is made of polyethylene terephthalate. Stabilization of vitamin E means that the reduction in the amount of vitamin E dissolved or dispersed in the external composition is suppressed. This disclosure was completed by further research based on this finding. 【0008】 In other words, this disclosure provides external compositions in the following embodiments. Item 1. A topical composition comprising (A) vitamin E, (B) at least one selected from the group consisting of salicylic acid, its derivatives, and salts thereof, (C) ethanol, and (D) a nonionic surfactant, contained in a container whose inner wall is made of polyethylene terephthalate. Item 2. The topical composition according to Item 1, wherein the content of component (C) is 10% by weight or more. Item 3. The topical composition according to item 1 or 2, wherein the content of component (C) is less than 40% by weight. Item 4. The topical composition according to any one of items 1 to 3, wherein the (D) component is polyoxyethylene hydrogenated castor oil. Item 5. The topical composition according to any one of items 1 to 4, wherein the HLB value of component (D) is 11.0 to 15.0. Item 6. The topical composition according to any one of items 1 to 5, wherein the content of component (D) per 1 part by weight of component (A) is 0.5 to 8 parts by weight. Item 7. A topical composition according to any one of items 1 to 6, used for the improvement of acne or acne scars on the trunk. Item 8. A topical composition according to any one of items 1 to 7, which is a liquid, foam, ointment, cream, gel, or patch. [Effects of the Invention] 【0009】 According to this disclosure, a topical composition containing stabilized vitamin E is provided. [Modes for carrying out the invention] 【0010】 The topical composition disclosed herein comprises (A) vitamin E (hereinafter also referred to as "component (A)"), (B) at least one selected from the group consisting of salicylic acid, its derivatives, and salts thereof (hereinafter also referred to as "component (B)" or "salicylic acids"), (C) ethanol (hereinafter also referred to as "component (C)"), and (D) a nonionic surfactant (hereinafter also referred to as "component (D)"), and is characterized by being housed in a container whose inner wall is made of polyethylene terephthalate. The topical composition disclosed herein 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) Vitamin E The topical composition disclosed herein contains vitamin E as component (A). Although the amount of vitamin E decreases over time due to adsorption to the inner wall of the container in which it is filled, it is stabilized when contained together with salicylic acids, ethanol, and a nonionic surfactant in a container whose inner wall is made of polyethylene terephthalate. 【0012】 Vitamin E is tocopherol and / or its derivatives. The derivatives of tocopherol are not particularly limited to the extent that they are pharmaceutically acceptable, but examples include esters with carboxylic acids such as acetic acid, nicotinic acid, and succinic acid, and diesters with phosphoric acid. Furthermore, the derivative of tocopherol may be the d-isomer, l-isomer, or dl-isomer, but the dl-isomer is preferred. In addition, the derivative of tocopherol may be the α-isomer, β-isomer, γ-isomer, or δ-isomer, but the α-isomer is preferred. In the topical compositions of this disclosure, component (A) may be selected from tocopherol and its derivatives and used alone, or two or more may be used in combination. 【0013】 Among these components (A), tocopherol derivatives are preferred, and tocopherol acetate is preferred, from the viewpoint of stabilizing them more effectively. 【0014】 The content of component (A) in the topical composition of this disclosure is not particularly limited and may be set appropriately depending on the formulation form, etc., but the total amount of component (A) can be, for example, 0.05 to 10% by weight, preferably 0.1 to 10% by weight, more preferably 0.3 to 10% by weight, 0.3 to 5% by weight, 0.3 to 3% by weight, 0.3 to 1% by weight, or 0.3 to 0.8% by weight. 【0015】 (B) Salicylic acids The topical compositions of the present disclosure include, as component (B), at least one selected from the group consisting of salicylic acid, its derivatives, and salts thereof. The salicylic acids stabilize vitamin E when incorporated into a topical composition containing vitamin E, ethanol, and a nonionic surfactant, which is housed in a container whose inner wall is made of polyethylene terephthalate. 【0016】 The derivatives of salicylic acid are not particularly limited as long as they are pharmaceutically acceptable. For example, salicylic acid glycol, acetylsalicylic acid (aspirin), salicylamide (ethenzamide), sulfosalicylic acid, methyl salicylate, ethyl salicylate, ethylene glycol salicylate, dipropylene glycol salicylate, titanium salicylate, 2-ethylhexyl salicylate, homomentyl salicylate, phenyl salicylate and other salicylic acid esters can be mentioned. Examples of salts of salicylic acid and its derivatives include alkali metal salts such as sodium and potassium; alkaline earth metal salts such as magnesium. 【0017】 In the topical composition of the present disclosure, as the component (B), one kind selected from salicylic acid, its derivatives, and their salts may be used alone, or two or more kinds may be used in combination. 【0018】 Among the component (B), from the viewpoint of more effectively stabilizing vitamin E, salicylic acid and its derivatives are preferable, and salicylic acid is more preferable. 【0019】 Regarding the content of the component (B) in the topical composition of the present disclosure, it may be appropriately set according to the degree to which the stabilizing effect of vitamin E is required. For example, 0.08 to 10% by weight can be mentioned. From the viewpoint of more effectively stabilizing vitamin E, preferably 0.2 to 10% by weight, more preferably 0.3 to 10% by weight, still more preferably 0.4 to 10% by weight, even more preferably 0.45 to 10% by weight, 0.45 to 5% by weight, 0.45 to 3% by weight, or 0.45 to 1% by weight can be mentioned. 【0020】 In the external composition of the present disclosure, the ratio of the component (A) to the component (B) is not particularly limited and is determined according to the respective contents of the component (A) and the component (B) described above. However, from the viewpoint of more effectively stabilizing vitamin E, per 1 part by weight of the component (A), the component (B) is 0.01 to 100 parts by weight, preferably 0.1 to 100 parts by weight, more preferably 0.3 to 100 parts by weight, still more preferably 0.5 to 100 parts by weight, 0.5 to 10 parts by weight, 0.5 to 5 parts by weight, or 0.5 to 2 parts by weight. 【0021】 (C) Ethanol The external composition of the present disclosure contains ethanol as the component (C). Ethanol is incorporated into an external composition containing vitamin E, salicylic acids, and a nonionic surfactant, which is housed in a container whose inner wall is made of polyethylene terephthalate, to stabilize vitamin E. 【0022】 The content of the component (C) in the external composition of the present disclosure is not particularly limited and may be appropriately set according to the degree of the stabilizing effect of vitamin E required. For example, 10% by weight or more may be mentioned. From the viewpoint of more effectively stabilizing vitamin E, preferably 15% by weight or more, more preferably 20% by weight or more, still more preferably 22.84% by weight or more may be mentioned. Further, since the external composition of the present disclosure has an excellent stabilizing effect on vitamin E, the stabilizing effect of vitamin E can be effectively obtained without incorporating a large amount of ethanol. From such a viewpoint, preferable examples of the content of the component (C) in the external composition of the present disclosure include, for example, 25% by weight or less, preferably 24% by weight or less, more preferably 23.5% by weight or less. In the external composition of the present disclosure, the content of the component (C) being less than 25% by weight, preferably 24.5% by weight or less, more preferably 23% by weight or less is also preferable from the viewpoint of the durability of the container. 【0023】 In the topical composition disclosed herein, the ratio of component (A) to component (C) is not particularly limited and is determined according to the respective contents of component (A) and component (C) as described above. However, from the viewpoint of stabilizing vitamin E more effectively, the amount of component (C) per 1 part by weight of component (A) is preferably 5 parts by weight or more, or 10 parts by weight or more, more preferably 20 parts by weight or more, even more preferably 30 parts by weight or more, even more preferably 40 parts by weight or more, and particularly preferably 45 parts by weight or more. Furthermore, from the viewpoint of container durability, the amount of component (C) per 1 part by weight of component (A) is preferably 100 parts by weight or less, more preferably 60 parts by weight or less, and even more preferably 50 parts by weight or less. 【0024】 (D) Nonionic surfactant The topical compositions disclosed herein include a nonionic surfactant as component (D). The nonionic surfactant, when incorporated into a topical composition containing vitamin E, salicylic acids, and ethanol, maintains the solubility of vitamin E. 【0025】 The type of nonionic surfactant is not particularly limited, but examples include polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene alkyl ether, polyglycerin fatty acid ester, polyoxyethylene glycerin fatty acid ester, glycerin fatty acid ester, polyoxyethylene sorbitan fatty acid ester, sorbitan fatty acid ester, polyoxyethylene alkyl ether, polyethylene glycol fatty acid ester, and the like. Among these, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid ester, and polyoxyethylene polyoxypropylene alkyl ether are preferred, and polyoxyethylene hydrogenated castor oil is preferred. 【0026】 The HLB of the nonionic surfactant is not particularly limited, but examples include 11.0 to 15.0, and from the viewpoint of stabilizing vitamin E more effectively, it is preferably 12.0 to 15.0, more preferably 12.2 to 15.0, and even more preferably 12.5 to 15.0. 【0027】 The HLB (Hydrophile-Lypophile Balance) value is a value that indicates the affinity of a nonionic surfactant for water and oil. In this disclosure, the HLB value of the nonionic surfactant is a value obtained by a measurement method that conforms to the actual measurement of HLB values ​​by emulsification method described on pages 854-855 of "Handbook - Cosmetics and Pharmaceutical Raw Materials - Revised Edition," Nikko Chemicals Co., Ltd., revised edition published February 1, 1977. Specifically, the nonionic surfactant to be measured for HLB value is combined with polyoxyethylene sorbitan monostearate (NIKKOL TS-10, HLB 14.9) as a standard substance, and the total amount of these two emulsifiers is kept constant, while only the ratio is changed to emulsify liquid paraffin (HLB 10.1), which is the substance to be emulsified. After standing for 24 hours, the optimal ratio of surfactant at which stability is determined from the amount of creaming, turbidity, and water separation of the lower layer, and the HLB value x of the surfactant is calculated using the following formula (1). y=(x×Amount used (mass%)+z×Amount used (mass%)) / 100...Formula (1) In equation (1) above, x represents the HLB value of the nonionic surfactant (the substance being measured), y represents the HLB value of the liquid paraffin, and z represents the HLB value of polyoxyethylene sorbitan monostearate (the standard substance). The HLB value of the liquid paraffin can be determined in a similar manner by combining sorbitan monostearate (NIKKOL SS-10, HLB 4.7) and polyoxyethylene sorbitan monostearate (NIKKOL TS-10, HLB 14.9). 【0028】 Nonionic surfactants with an HLB value of 11.0 to 15.0 include, specifically, POE hydrogenated castor oils such as POE hydrogenated castor oil 30, POE hydrogenated castor oil 40, POE hydrogenated castor oil 50, and POE hydrogenated castor oil 60; POE sorbitan fatty acid esters such as POE(20) sorbitan tristearate, POE(20) sorbitan trioleate, POE(20) sorbitan monooleate, and POE(20) sorbitan monoisostearate; POE(20)POP(8) cetyl ether, POE(30)POP(6) decyltetradecyl ether, and POE(20)POP(6) decyl Examples include POE alkyl ethers such as tetradecyl ether; POE alkyl ethers such as POE(9) lauryl ether, POE(10) cetyl 3 ether, and POE(10) oleyl ether; polyglycerin fatty acid esters such as hexaglyceryl monolaurate and decaglyceryl monomyristate; POE glycerin fatty acid esters such as POE(15) glyceryl monooleate; and POE sorbitic acid fatty acid esters such as POE(60) sorbitic acid tetrastearate, POE(40) sorbitic acid tetraoleate, and POE(60) sorbitic acid tetraoleate. Here, "POE" is an abbreviation for polyoxyethylene and "POP" is an abbreviation for polyoxypropylene, and the number in parentheses after POE or POP is the average number of moles added. 【0029】 In the topical compositions of this disclosure, component (D) may be one of the above-mentioned nonionic surfactants selected and used alone, or two or more may be used in combination. 【0030】 (D) Among the components, from the viewpoint of stabilizing vitamin E more effectively, POE hydrogenated castor oil is preferred, more preferably POE hydrogenated castor oil 30, POE hydrogenated castor oil 40, POE hydrogenated castor oil 50, POE hydrogenated castor oil 60, and even more preferably POE hydrogenated castor oil 40 and POE hydrogenated castor oil 50. 【0031】 In the topical composition of this disclosure, the content of component (D) can be appropriately set depending on the formulation form, etc., but for example, it can be 0.1 to 10% by weight, and from the viewpoint of stabilizing vitamin E more effectively, it is preferably 0.5 to 10% by weight, more preferably 1 to 10% by weight, and even more preferably 1.5 to 10% by weight. Because the topical composition of this disclosure has an excellent vitamin E stabilizing effect, an effective vitamin E stabilizing effect can be obtained even without incorporating a large amount of nonionic surfactant. From this viewpoint, preferred examples of the content of component (D) in the topical composition of this disclosure include 0.1 to 8% by weight, more preferably 0.1 to 5% by weight, even more preferably 0.1 to 3% by weight, and even more preferably 0.1 to 2.5% by weight. 【0032】 In the topical composition disclosed herein, the ratio of component (A) to component (D) is not particularly limited and is determined according to the respective contents of component (A) and component (D) as described above. However, from the viewpoint of stabilizing vitamin E more effectively, the amount of component (D) per 1 part by weight of component (A) is preferably 0.5 to 20 parts by weight, more preferably 1 to 20 parts by weight, even more preferably 2 to 20 parts by weight, and even more preferably 3 to 20 parts by weight. Furthermore, since the topical composition disclosed herein has an excellent vitamin E stabilization effect, an effective vitamin E stabilization effect can be obtained even if the proportion of nonionic surfactant is not large. From this viewpoint, preferred examples of the content of component (D) per 1 part by weight of component (A) include 0.5 to 8 parts by weight, more preferably 0.5 to 6 parts by weight, and even more preferably 0.5 to 5 parts by weight. 【0033】 Other ingredients The topical compositions disclosed herein may, in addition to the components described above, contain, or may not contain, pharmaceutically acceptable bases and / or additives as needed. Examples of such bases and additives, whether present or absent, include water, surfactants, polyhydric alcohols, chelating agents, pH adjusters, buffering agents, preservatives, antioxidants, stabilizers, fragrances, colorants, and the like. When these additives are included in the topical compositions disclosed herein, their content may be appropriately determined depending on the type of base and / or additive used. 【0034】 If the topical composition of this disclosure contains a surfactant (i.e., a surfactant other than component (D)) among the other components, the total amount of the surfactant (other than component (D)) and component (D) may be, for example, 0.1 to 10% by weight, preferably 0.5 to 8% by weight, more preferably 1 to 5% by weight, and even more preferably 1.5 to 3% by weight or 1.5 to 2.5% by weight. Furthermore, the total amount of the surfactant (other than component (D)) and component (D) per 1 part by weight of component (A) may be, for example, 0.5 to 20 parts by weight, preferably 1 to 8 parts by weight, more preferably 2 to 6 parts by weight, and even more preferably 3 to 5 parts by weight. In a preferred embodiment of the topical composition of this disclosure, surfactants other than component (D) are not included. 【0035】 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, anti-inflammatory agents, 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. 【0036】 Preferably, the above anti-inflammatory agents include glycyrrhizic acids [specifically, glycyrrhizic acid, salts of glycyrrhizic acid, derivatives of glycyrrhizic acid (methyl glycyrrhizate, stearyl glycyrrhizate, etc.), salts of derivatives of glycyrrhizic acid, glycyrrhetinic acid, salts of glycyrrhetinic acid, derivatives of glycyrrhetinic acid (pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, monoglucuronide glycyrrhetinate, etc.), and / or salts of derivatives of glycyrrhetinic acid], and allantoins (allantoin chlorohydroxyaluminum, allantoin hydroxyaluminum, etc.). If the topical composition of the present disclosure contains glycyrrhizic acid compounds, the content of glycyrrhizic acid compounds is not particularly limited, but examples of total amounts include 0.05 to 10% by weight, preferably 0.1 to 10% by weight, more preferably 0.3 to 10% by weight, 0.3 to 5% by weight, 0.3 to 3% by weight, 0.3 to 1% by weight, or 0.3 to 0.8% by weight. If the topical composition of the present disclosure contains allantoins, the content of allantoins is not particularly limited, but examples of total amounts include 0.001 to 10% by weight, preferably 0.02 to 10% by weight, more preferably 0.05 to 10% by weight, even more preferably 0.1 to 10% by weight, 0.1 to 5% by weight, 0.1 to 3% by weight, 0.1 to 1% by weight, 0.1 to 0.8% by weight, or 0.1 to 0.4% by weight. 【0037】 Formulation form / dosage type The topical compositions disclosed herein may be either topical pharmaceuticals or cosmetics. Furthermore, the dosage form of the topical compositions disclosed herein is not particularly limited as long as it is applicable transdermally, and may be liquid, semi-solid, solid, etc., but preferably liquid or semi-solid, and more preferably liquid. 【0038】 The formulation form of the topical composition disclosed herein is not particularly limited, as long as it is applicable transdermally. Examples include liquid formulations (including lotions, sprays, aerosols, and emulsions), foam formulations, ointments, creams, gels, patches, etc. Among these, liquid formulations are preferred, and spray formulations are more preferred. 【0039】 container The container in which the topical composition of the present invention is contained has an inner wall made of polyethylene terephthalate (PET) that comes into contact with the topical composition. By being contained in this container, the vitamin E of the topical composition of the present invention is stabilized. 【0040】 In a container for containing the external composition of the present invention, the inner wall surface may be made of polyethylene terephthalate, and the container wall may be a single-layer structure or a multi-layer structure. In the case of a multi-layer structure, the resin constituting the innermost layer of the container may be polyethylene terephthalate. Examples of container forms include bottles [dispensing bottles (spray type, pump type), wide-mouth bottles, narrow-mouth bottles, etc.], tubes, etc. 【0041】 Manufacturing method The topical compositions disclosed herein can be manufactured by formulating them according to known formulation methods corresponding to their formulation form and filling them into the aforementioned containers. 【0042】 Purpose The topical compositions disclosed herein can be used for applications that utilize the effects of vitamin E and / or salicylic acids. Furthermore, the topical compositions disclosed herein are preferably used to improve acne on the trunk or acne scars on the trunk. Acne on the trunk includes those caused by Malassezia, i.e., Malassezia folliculitis. Specific sites where acne on the trunk occurs include the back, chest, and buttocks, with the back being preferred. Acne scars on the trunk include hyperpigmentation. [Examples] 【0043】 The present disclosure will be explained in more detail below with reference to examples, but the present disclosure is not limited to these examples. 【0044】 Test Example 1 External compositions (liquids) were prepared by mixing the ingredients shown in Table 1 in the indicated proportions. 15 mL of the prepared external composition was placed in 20 mL transparent containers (single-layer containers) of the materials shown in Table 1, and stored for one month under conditions of 50°C and 60% RH. The following [1] to [3] were evaluated. The results are shown in Table 1. 【0045】 [1] Stability of tocopherol acetate (inhibition of weight loss) The tocopherol acetate content in the topical composition before and after storage was measured by high-performance liquid chromatography. The tocopherol acetate content in the topical composition before storage was set to 100%, and the percentage of tocopherol acetate content in the topical composition after storage was calculated as the remaining percentage (%). A remaining percentage closer to 100% indicates a higher stabilization effect of tocopherol acetate. This evaluation was performed only if the evaluation in [3] below was ◎ or ○. 【0046】 [2] Container durability The external composition, still contained in its container, was dropped from a height of 1 meter onto a concrete floor, and the degree of container durability was evaluated according to the following criteria. ○: No damage or cracks were found in the container. ×: Damage or cracks are visible in the container. 【0047】 [3] Dissolution state of tocopherol acetate The appearance of the topical composition after storage was observed, and the degree of solubility of tocopherol acetate was evaluated according to the following criteria. ◎: Colorless and clear appearance ○: Translucent appearance due to a small amount of oil droplets ×: Cloudy appearance due to a large amount of oil droplets. 【0048】 [Table 1] 【0049】 As shown in Table 1, in topical compositions containing components (A) to (C), the dissolution state of component (A) after storage was poor when component (D) was not included (Comparative Example 1), while the dissolution state of component (A) after storage was improved when component (D) was included (Comparative Examples 2, 3 and Examples 1-3). Furthermore, in topical compositions containing components (A) to (D), component (A) was more stable when contained in PET containers (Examples 1-3) compared to when contained in PE containers (Comparative Examples 2, 3). Also, in topical compositions containing components (A) to (D), component (A) became unstable when the content of component (C) was higher when contained in PE containers (Comparative Example 2 compared to Comparative Example 3), whereas when contained in PET containers, component (A) was significantly more stable when the content of component (C) was higher (Example 1 compared to Example 2). In other words, it was found that the excellent stabilization effect of component (A) observed in Examples 1-3 is a unique effect of selecting PET as the container material. 【0050】 Furthermore, considering container durability, it is desirable that the content of component (C) be approximately 22.84% by weight or less (Examples 1 and 2 compared to Example 3), and when component (C) is approximately 22.84% by weight, a stabilization effect of component (A) comparable to that obtained when a larger amount of component (C) is present was obtained (Example 1 compared to Example 3). 【0051】 Furthermore, although not shown, the topical composition of Comparative Example 3 did not show improved stability of component (A) compared to the topical composition of Comparative Example 3 with component (B) removed, while the topical composition of Example 2 showed improved stability of component (A) compared to the topical composition of Example 2 with component (B) removed. In other words, it was found that the contribution of component (B) to the stabilization of component (A) is a unique effect of selecting PET as the container material. 【0052】 Test Example 2 An external composition (Example 4) was prepared by adding 0.2% by weight of allantoin and 0.5% by weight of dipotassium glycyrrhizinate to the composition of Example 1 of Test Example 1, and an external composition (Example 5) was prepared by adding 0.2% by weight of allantoin and 0.5% by weight of dipotassium glycyrrhizinate to the composition of Example 2, both as liquid formulations (spray formulations). The stability of component (A) in the external compositions of Examples 4 and 5 according to [1] of Test Example 1 was equivalent to that of Examples 1 and 2, respectively. 【0053】 The topical compositions of Examples 4 and 5 were applied for 4 weeks to 15 subjects with acne on their backs (including symptoms of Malassezia folliculitis) and acne scars on their backs (hyperpigmentation). The degree of improvement for each of the following conditions was evaluated on a 5-point scale, with a score of "5" indicating marked improvement and a score of "1" indicating no change. The percentage of subjects who answered with a score of 5 for improvement in back acne was 1.2 times higher in Example 4 than in Example 5. Similarly, the percentage of subjects who answered with a score of 5 for improvement in back acne scars was 1.1 times higher in Example 4 than in Example 5. 【0054】 Prescription examples Topical compositions (liquids (sprays)) with the formulations shown in Table 2 were prepared. All of the obtained topical compositions exhibited excellent solubility and stability of component (A), excellent container durability, and excellent efficacy against acne and acne scars on the back. 【0055】 [Table 2]

Claims

[Claim 1] A topical composition comprising (A) vitamin E, (B) at least one selected from the group consisting of salicylic acid, its derivatives, and salts thereof, (C) ethanol, and (D) a nonionic surfactant, housed in a container whose inner wall is made of polyethylene terephthalate. [Claim 2] The topical composition according to claim 1, wherein the content of component (C) is 10% by weight or more. [Claim 3] The topical composition according to claim 1 or 2, wherein the content of component (C) is 25% by weight or less. [Claim 4] The topical composition according to claim 1 or 2, wherein the (D) component is polyoxyethylene hydrogenated castor oil. [Claim 5] The topical composition according to claim 1 or 2, wherein the HLB value of component (D) is 11.0 to 15.

0. [Claim 6] The topical composition according to claim 1 or 2, wherein the content of component (D) relative to 1 part by weight of component (A) is 0.5 to 8 parts by weight. [Claim 7] The topical composition according to claim 1 or 2, used for improving acne on the trunk or acne scars on the trunk. [Claim 8] The external composition according to claim 1 or 2, which is a liquid, foam, ointment, cream, gel, or patch.

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