External composition

Abstract

To provide an external composition for improving inflammation caused by mask wearing, which has low irritation on skin while containing germicide, and excellent improvement effect of dermatitis caused by mask wearing.SOLUTION: When an external composition for improving inflammation caused by mask wearing is allowed to contain isopropylmethylphenol together with ufenamate, diphenhydramine and / or a salt thereof, tocopherol and / or a derivative thereof, irritation on skin becomes lower, and dermatitis caused by mask wearing can be effectively improved.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a composition for external use for improving inflammation caused by wearing a mask. [Background technology]

[0002] In recent years, the incidence of infectious diseases has increased, and awareness of infectious disease prevention has risen. Wearing a mask is considered to be effective in preventing infectious diseases, and the number of situations in which wearing a mask is mandatory to prevent the spread of infectious diseases is increasing. However, wearing a mask frequently can cause skin problems such as dermatitis, as the parts of the body covered by the mask are subject to friction caused by the mask.

[0003] Conventionally, there have been reports on techniques for suppressing skin troubles caused by wearing a mask. For example, Patent Document 1 reports that a semi-solid preparation or liquid containing a cocoon-derived component selected from hydrolyzed silk liquid, hydrolyzed silk ethyl liquid, and hydrolyzed silk powder in a paste base is applied to the mask body, thereby reducing inflammation of the skin after wearing a mask and promoting recovery. However, the technique of Patent Document 1 merely suppresses inflammation caused by pollen and viruses by applying a preparation of a specific composition to the mask, making it difficult for pollen and viruses to penetrate, and does not improve dermatitis caused by wearing a mask.

[0004] On the other hand, to improve dermatitis caused by wearing a mask, applying a topical composition containing an anti-inflammatory drug is effective, but to date, there has been little research into topical compositions used to improve inflammation caused by wearing a mask. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2011-4991 A DISCLOSURE OF THEINVENTION

Problems to be Solved by the Invention

[0006] When wearing a mask, it is easy to feel stuffy inside the mask due to sweat and breath. Therefore, for an external composition for improving inflammation caused by mask wearing, in order to maintain the hygiene of the facial area covered by the mask, it is desirable to contain a bactericide together with a component showing an anti-inflammatory effect. In addition, when wearing a mask frequently, the facial area covered by the mask tends to become hypersensitive to irritation. When a bactericide is contained in an external composition for improving inflammation caused by mask wearing, it is also important to reduce the irritation to the skin.

[0007] The present inventor conducted studies to develop an external composition for improving inflammation caused by mask wearing. As a result, when an external composition containing bufexamac, diphenhydramine and / or its salt, tocopherol and / or its derivative, and benzalkonium chloride was applied to the dermatitis site caused by mask wearing, it had irritation to the skin and the improvement effect of dermatitis was not satisfactory.

[0008] Therefore, an object of the present invention is to provide an external composition for improving inflammation caused by mask wearing, which contains a bactericide, has low irritation to the skin, and is excellent in the improvement effect of dermatitis caused by mask wearing.

Means for Solving the Problems

[0009] The present inventor conducted intensive studies to solve the above problems. As a result, it was found that in an external composition for improving inflammation caused by mask wearing, when bufexamac, diphenhydramine and / or its salt, tocopherol and / or its derivative, and isopropylmethylphenol are contained together, the irritation to the skin is low and the dermatitis caused by mask wearing can be effectively improved. The present invention was completed by further studies based on such findings.

[0010] That is, the present invention provides an invention in the following aspects. Item 1. An external composition for improving inflammation caused by wearing a mask, containing (A) bufexamac, (B) diphenhydramine and / or its salt, (C) tocopherol and / or its derivative, and (D) isopropylmethylphenol. Item 2. The external composition according to Item 1, further containing at least one glycyrrhetinic acid selected from the group consisting of (E) glycyrrhetinic acid, glycyrrhizic acid, their derivatives, and their salts. Item 3. The external composition according to Item 1 or 2, further containing (F) polyhydric alcohol.

Effect of the Invention

[0011] The external composition of the present invention has low irritation to the skin and can effectively improve inflammation caused by wearing a mask. Therefore, even if a mask is worn frequently or for a long time, it can suppress inflammation caused by friction with the mask, etc., and maintain or restore the facial area covered by the mask to a healthy skin state.

Modes for Carrying Out the Invention

[0012] The external composition of the present invention is used for improving inflammation caused by wearing a mask, and is characterized by containing (A) bufexamac, (B) diphenhydramine and / or its salt, (C) tocopherol and / or its derivative, and (D) isopropylmethylphenol. Hereinafter, the external composition of the present invention will be described.

[0013] [(A) Bufexamac] The external composition of the present invention contains bufexamac (sometimes referred to as component (A)). Bufexamac is also called butyl flufenamate and is a component known as a water-insoluble non-steroidal anti-inflammatory drug.

[0014] Regarding the content of component (A) in the external composition of the present invention, there is no particular limitation. For example, it may be 1 to 20% by weight, preferably 2 to 10% by weight. From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, the content of component (A) is preferably 3 to 10% by weight, more preferably 3 to 7% by weight.

[0015] [(B) Diphenhydramine and / or its salt] The external composition of the present invention contains diphenhydramine and / or its salt (which may also be referred to as component (B)). Diphenhydramine is a known component known to have an antihistamine effect.

[0016] The salt of diphenhydramine is not particularly limited as long as it is pharmaceutically acceptable. Specifically, acid addition salts such as hydrochloride, citrate, succinate, tartrate, fumarate, maleate, salicylate, diphenyldisulfonate, tannate, lauryl sulfate, and sulfate can be mentioned. These salts may be used alone or in combination of two or more.

[0017] In the external composition of the present invention, as component (B), one kind may be selected from diphenhydramine and its salts and used, or two or more kinds may be used in combination.

[0018] Among component (B), from the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, preferably diphenhydramine and diphenhydramine hydrochloride can be mentioned.

[0019] Regarding the content of component (B) in the external composition of the present invention, there is no particular limitation. For example, 0.01 to 5% by weight can be mentioned. From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, the content of component (B) is preferably 0.1 to 3% by weight, more preferably 0.1 to 2% by weight.

[0020] In the external composition of the present invention, the ratio of the component (B) to the component (A) is determined according to the respective contents of the component (A) and the component (B). For example, per 1 part by weight of the component (A), the component (B) is 0.01 to 1.2 parts by weight. From the viewpoint of further improving the effect of improving inflammation caused by wearing a mask and the effect of reducing irritation to the skin, per 1 part by weight of the component (A), the component (B) is preferably 0.05 to 0.8 parts by weight, more preferably 0.1 to 0.5 parts by weight.

[0021] [(C) Tocopherol and / or its derivative] The external composition of the present invention contains tocopherol and / or its derivative (which may also be referred to as the component (C)). Tocopherol is a known component known as vitamin E.

[0022] The derivative of tocopherol is not particularly limited as long as it is pharmaceutically acceptable. For example, ester forms with carboxylic acids such as acetic acid, nicotinic acid, and succinic acid, diester forms with phosphoric acid, etc. may be mentioned. Also, the derivative of tocopherol may be any of the d-form, l-form, and dl-form, but preferably the dl-form. Further, the derivative of tocopherol may be any of the α-form, β-form, γ-form, and δ-form, but preferably the α-form.

[0023] In the external composition of the present invention, as the component (C), one kind may be selected from tocopherol and its derivatives and used alone, or two or more kinds may be used in combination.

[0024] Among the components (C), from the viewpoint of further improving the effect of improving inflammation caused by wearing a mask and the effect of reducing irritation to the skin, preferably a derivative of tocopherol, more preferably an ester form of tocopherol with a carboxylic acid, still more preferably tocopherol acetate, particularly preferably d-α-tocopherol acetate, l-α-tocopherol acetate, dl-α-tocopherol acetate.

[0025] In the topical composition of the present invention, the content of component (C) is not particularly limited, and examples thereof include 0.05 to 2% by weight. From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, the content of component (C) is preferably 0.1 to 2% by weight, more preferably 0.1 to 1.3% by weight, and still more preferably 0.3 to 0.8% by weight.

[0026] In the topical composition of the present invention, the ratio of component (C) to component (A) is determined according to the respective contents of component (A) and component (C). For example, 0.01 to 1 part by weight of component (C) is included per 1 part by weight of component (A). From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, 0.03 to 0.5 part by weight, and more preferably 0.05 to 0.3 part by weight of component (C) is included per 1 part by weight of component (A).

[0027] [(D) Isopropylmethylphenol] The topical composition of the present invention contains isopropylmethylphenol (which may also be referred to as component (D)). Isopropylmethylphenol is a component known as a bactericide. In the topical composition of the present invention, isopropylmethylphenol is selected from bactericides and contained in combination with the above-mentioned components (A) to (C), whereby the irritation to the skin is low and the dermatitis caused by mask wearing can be effectively improved.

[0028] In the topical composition of the present invention, the content of component (D) is not particularly limited, and examples thereof include 0.001 to 5% by weight. From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin while exhibiting a bactericidal effect, the content of component (D) is preferably 0.005 to 1% by weight, and more preferably 0.05 to 0.5% by weight.

[0029] In the topical composition of the present invention, the ratio of the component (D) to the component (A) is determined according to the respective contents of the component (A) and the component (D). For example, per 1 part by weight of the component (A), the component (D) is 0.0001 to 0.1 part by weight. From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, per 1 part by weight of the component (A), the component (D) is preferably 0.005 to 0.5 part by weight, and more preferably 0.01 to 0.1 part by weight.

[0030] [(E) Glycyrrhetinic acids] In addition to the aforementioned components, the topical composition of the present invention may contain at least one glycyrrhetinic acid selected from the group consisting of glycyrrhetinic acid, glycyrrhizic acid, their derivatives, and their salts (which may also be referred to as the component (E)). By further containing glycyrrhetinic acids in the topical composition of the present invention, it becomes possible to further improve the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin.

[0031] Glycyrrhetinic acid is a known drug known to have anti-inflammatory and anti-allergic effects.

[0032] The derivatives of glycyrrhetinic acid are not particularly limited as long as they are pharmaceutically acceptable. For example, pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, monoglucuronide glycyrrhetinate, etc. may be mentioned. These derivatives of glycyrrhetinic acid may be used alone or in combination of two or more.

[0033] Glycyrrhizic acid is a known drug known to have anti-inflammatory and anti-allergic effects.

[0034] Derivatives of glycyrrhizic acid are not particularly limited as long as they are pharmaceutically acceptable. Examples thereof include methyl glycyrrhizinate, stearyl glycyrrhizinate, etc. These derivatives of glycyrrhizic acid may be used alone or in combination of two or more.

[0035] Salts of glycyrrhetinic acid, glycyrrhetic acid and / or their derivatives are not particularly limited as long as they are pharmaceutically acceptable. Examples thereof include alkali metal salts such as sodium salt, potassium salt; ammonium salts, etc. These salts may be used alone or in combination of two or more.

[0036] In the external composition of the present invention, as the component (E), one kind may be selected from glycyrrhetic acid, glycyrrhizic acid, their derivatives, and their salts and used alone, or two or more kinds may be used in combination.

[0037] Among the component (E), from the viewpoint of further improving the effect of improving inflammation caused by wearing a mask and the effect of reducing irritation to the skin, preferably glycyrrhetic acid, salts of glycyrrhizic acid, preferably glycyrrhetic acid, dipotassium glycyrrhizinate are mentioned.

[0038] When the external composition of the present invention contains the component (E), its content is not particularly limited. For example, 0.05 to 5% by weight may be mentioned. From the viewpoint of further improving the effect of improving inflammation caused by wearing a mask and the effect of reducing irritation to the skin, as the content of the component (E), preferably 0.1 to 1% by weight, more preferably 0.2 to 0.5% by weight may be mentioned.

[0039] When the (E) component is contained in the external composition of the present invention, the ratio of the (E) component to the (A) component is determined according to the respective contents of the (A) component and the (E) component. For example, per 1 part by weight of the (A) component, the (E) component is 0.01 to 0.9 parts by weight. From the viewpoint of further improving the effect of improving inflammation caused by mask wearing and the effect of reducing irritation to the skin, per 1 part by weight of the (A) component, the (E) component is preferably 0.03 to 0.5 parts by weight, more preferably 0.05 to 0.1 parts by weight.

[0040] [(F) Polyhydric alcohol] In addition to the aforementioned components, the external composition of the present invention may contain a polyhydric alcohol (sometimes referred to as the (F) component).

[0041] The polyhydric alcohol used in the present invention is not particularly limited as long as it is applicable to the skin. For example, ethylene glycol, 1,3 - butylene glycol, propylene glycol, isoprene glycol, diethylene glycol, dipropylene glycol, polypropylene glycol, glycerin, etc. can be mentioned.

[0042] In the external composition of the present invention, the (F) component may be used alone or in combination of two or more.

[0043] Among the (F) components, preferably 1,3 - butylene glycol and glycerin can be mentioned. Also, as a preferred example of the (F) component, a combination of 1,3 - butylene glycol and glycerin can be mentioned. When 1,3 - butylene glycol and glycerin are used in combination as the (F) component, the ratio thereof is not particularly limited. For example, per 1 part by weight of 1,3 - butylene glycol, glycerin is 0.01 to 100 parts by weight, preferably 0.1 to 10 parts by weight, more preferably 0.2 to 5 parts by weight.

[0044] When the component (F) is contained in the external composition of the present invention, its content is not particularly limited. For example, the total amount of the component (F) is 0.5 to 30% by weight, preferably 1 to 20% by weight, more preferably 5 to 15% by weight.

[0045] [Other components] In addition to the aforementioned components, the external composition of the present invention may contain other pharmacological components as needed. Examples of such pharmacological components include antihistamines, local anesthetics, anti-inflammatory agents, antipruritics, skin protectants, blood circulation promoting components, cooling agents, vitamins, mucopolysaccharides, and the like. These pharmacological components may be used alone or in combination of two or more. Also, when these pharmacological components are contained in the external composition of the present invention, their content may be appropriately set according to the type of pharmacological component used, the expected effect, and the like.

[0046] Furthermore, in order to prepare the external composition of the present invention into a desired dosage form, in addition to the aforementioned components, other bases and additives commonly used in skin external preparations and the like may be contained as needed. Such bases and additives are not particularly limited as long as they are pharmaceutically acceptable. For example, aqueous bases such as water and lower alcohols; oily bases such as oils, mineral oils, waxes and fats, ester oils, fatty acid alkyl esters, fatty acids, fatty acid esters, higher alcohols, cholesterol, etc.; additives such as surfactants, cooling agents, preservatives, flavoring agents, coloring agents, thickeners, pH adjusters, wetting agents, stabilizers, antioxidants, ultraviolet absorbers, chelating agents, adhesives, buffers, solubilizing aids, solubilizers, preservatives, etc. These bases and additives may be used alone or in combination of two or more. Also, when these bases and additives are contained in the external composition of the present invention, their content may be appropriately set according to the type of base and additive used, the dosage form, and the like.

[0047] [Dosage form and formulation form] Regarding the dosage form of the external composition of the present invention, there is no particular limitation as long as it can be transdermally applied to the facial area covered by the mask, and it may be in any form such as liquid, solid, semi-solid (cream, gel, ointment, paste, etc.). Further, the external composition of the present invention may be an emulsion preparation such as an oil-in-water emulsion preparation or a water-in-oil emulsion preparation, or may be a non-emulsion preparation such as a solubilized preparation or an aqueous ointment.

[0048] Regarding the formulation form of the external composition of the present invention, there is no particular limitation as long as it can be transdermally applied to the facial area covered by the mask. For example, cream preparations, ointment preparations, emulsion preparations, gel preparations, oil preparations, lotion preparations, liniment preparations, aerosol preparations, etc. can be mentioned. Among these, preferably, gel preparations, cream preparations, ointment preparations, emulsion preparations, and lotion preparations can be mentioned, and more preferably, gel preparations and cream preparations can be mentioned.

[0049] [Use · Method of Use] The external composition of the present invention is used for improving dermatitis caused by wearing a mask. In the present invention, the use for improving dermatitis caused by wearing a mask includes aspects used for the purpose of preventing, alleviating, or healing inflammation caused by wearing a mask. Further, the inflammation caused by wearing a mask is inflammation (contact dermatitis) that occurs when the facial area covered by the mask is subjected to friction or the like by the mask. The inflammation caused by wearing a mask includes symptoms such as swelling, itching, redness of the skin, rough skin, bumps, irritation, and acne. The external composition of the present invention is particularly preferably used for improving swelling, itching, redness of the skin, rough skin, bumps, or irritation caused by wearing a mask.

[0050] Further, the external composition of the present invention is used by appropriately applying or spraying an appropriate amount to the facial area covered by the mask before, during, or after wearing the mask. The appropriate application amount of the external composition of the present invention may be appropriately set according to the dosage form, formulation form, degree of dermatitis, etc.

Examples

[0051] Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited to these examples.

[0052] Test Example 1 An external composition (water-in-oil emulsion cream) having the composition shown in Table 1 was prepared. Twelve subjects with inflammation occurring in the facial area covered by the mask due to frequent wearing of the mask were applied with 0.2 g of the external composition of Comparative Example 1 on the left side of the face and 0.2 g of the external composition of Example 1 on the right side of the face twice a day (after washing the face in the morning and before going to bed) for one week. All the subjects complained of "rash", "itching", "redness", "rough and bumpy skin", and "dryness" caused by wearing the mask in the facial area covered by the mask. In addition, the subjects wore the mask for more than 9 hours a day during the one-week test period while applying each external composition. One week after the start of application of the external composition, for each item of "rash", "itching", "redness", "rough and bumpy skin", and "dryness" caused by wearing the mask, the subjects were evaluated for the degree of improvement on a five-point scale of satisfaction, somewhat satisfied, neither, somewhat dissatisfied, and dissatisfied, and the percentage of subjects evaluated as satisfied or somewhat satisfied was calculated, and the value rounded to the first decimal place was taken as the degree of improvement (%).

[0053] Also, 50 μL of each of the external compositions of Example 1 and Comparative Example 1 was set on a bandage for patch test and affixed to the inner side of the upper arm, and a 24-hour occlusion patch test was performed. The 24-hour occlusion patch test was conducted on 30 healthy subjects, the number of positive subjects (the number of subjects with erythema observed) was determined, and the irritation to the skin was evaluated according to the following criteria. · Judgment criteria for skin irritation ◎: The number of positive subjects is 0 to 1 〇: The number of positive subjects is 2 to 3 △: The number of positive subjects is 4 to 6 ×: The number of positive subjects is 7 to 30

[0054] The results are shown in Table 1. In the topical composition containing benzalkonium chloride together with bufexamac, diphenhydramine, and tocopheryl acetate (Comparative Example 1), the effect of improving inflammation caused by mask wearing was low, the number of positive cases in the 24-hour occlusive patch test was large, and skin irritation was recognized. On the other hand, in the topical composition containing isopropylmethylphenol together with bufexamac, diphenhydramine, and tocopheryl acetate (Example 1), the effect of improving inflammation caused by mask wearing was remarkably excellent, and skin irritation was sufficiently reduced.

[0055]

Table 1

[0056] Test Example 2 A topical composition (water-in-oil emulsion cream) having the composition shown in Table 2 was prepared. Twelve subjects with inflammation occurring in the facial area covered by the mask due to frequent mask wearing were targeted, and the degree of improvement of inflammation caused by mask wearing of each topical composition was evaluated under the same conditions as in Test Example 1. Furthermore, thirty healthy subjects were targeted, and the skin irritation of each topical composition was evaluated under the same conditions as in Test Example 1.

[0057] The results are shown in Table 2. Similar to the results of Test Example 1, in the topical composition containing bufexamac, diphenhydramine, and tocopheryl acetate, when benzalkonium chloride was blended (Comparative Example 2), the effect of improving inflammation caused by mask wearing was low, and skin irritation was also recognized. However, when isopropylmethylphenol was blended (Example 2), the effect of improving inflammation caused by mask wearing was remarkably high, and moreover, skin irritation was reduced.

[0058]

Table 2

[0059] Formulation Example An external composition (water-in-oil emulsion cream) having the composition shown in Table 3 was prepared. For comparison, a comparative external composition (water-in-oil emulsion cream) in which isopropylmethylphenol was replaced with the same amount of benzalkonium chloride was also prepared for the external composition having the composition shown in Table 3. Using these external compositions, the degree of improvement in inflammation caused by mask wearing and the irritation of each external composition to the skin were evaluated under the same conditions as in Test Example 1. As a result, each external composition shown in Table 3 had a significantly higher effect of improving inflammation caused by mask wearing and was also able to sufficiently reduce irritation to the skin, as compared with the corresponding comparative external composition.

[0060]

Table 3

Claims

1. (A) Ufenamate, (B) diphenhydramine and / or its salt, (C) at least one selected from the group consisting of tocopherol, an ester form of tocopherol and a carboxylic acid, and a diester form of tocopherol and phosphoric acid, (D) isopropylmethylphenol, and (E) at least one glycyrrhetinic acid selected from the group consisting of glycyrrhetinic acid, glycyrrhizic acid, pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, monoglucuronide glycyrrhetinate, methyl glycyrrhizinate, stearyl glycyrrhizinate, and their salts, an external composition for improving inflammation caused by wearing a mask (however, excluding the case of containing squalane).

2. The external composition according to claim 1, further containing (F) a polyhydric alcohol.

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