JP2021195325A - External composition - Google Patents

Abstract

To provide an external composition used for improving urinary rash.SOLUTION: The external composition comprises (A) ufenamate and (B) lidocaine. The external composition is effective in improving urinary rash.SELECTED DRAWING: None

Description

The present invention relates to an external composition used for improving urinary rash.

Urine leakage is a complaint that urine leaks involuntarily, and the number of complainants increases sharply from the 40s and tends to increase further with age. In response to this, an increasing number of people are using hygiene products such as urine leak pads and urine leak sheets for a comfortable daily life. However, there is a fact that the use of such hygiene products promotes urinary rash, and there is data that, for example, about 80% of people who use urinary pads have painful skin problems (non-). Patent Document 1).

The lower urinary tract is the most structurally different part between females and males, and urine leakage is particularly common in females due to the characteristics of the urinary incontinence mechanism due to anatomical differences (Non-Patent Document 2). In addition, since estrogen receptors are abundant in the urethra, bladder, and the anterior vaginal wall that supports them, atrophy of the urethra and vagina due to estrogen decline after menopause lowers urethral pressure and causes urinary incontinence. Become. Estrogen is low during menopause, and female urinary incontinence increases sharply after menopause (Non-Patent Document 3). In addition, the fact that the pelvic floor muscles are easier to loosen than men is also accelerating the rapid increase in urinary incontinence in women. For this reason, urinary rash in postmenopausal women is associated with peculiar intractability. Furthermore, there are many cases in which female-specific circumstances such as mixing of cages, pressure stimulation by underwear such as pantyhose, and frictional stimulation by the use of toilet paper further exacerbate the intractability peculiar to females with urinary rash.

"Degree of pain (people with skin problems due to urinary pad)", [online], May 2017, [Search on June 1, 2nd year of Reiwa], Internet <URL: https://www.kobayashi.co .jp / brand / kabunurse / trouble /> Norio Homma Key points of urinary incontinence treatment, urinary incontinence in girls, urology MOOK, Kanehara Publishing, 1992, 68-79 Masayasu Koyama, Urinary Incontinence and Its Management, Obstetrics and Gynecology, 2013, 80 (8), 1049-1055

An object of the present invention is to provide an external composition used for improving urinary rash.

As a result of diligent studies, the present inventors have found that an external composition containing ufenamate and lidocaines has an excellent effect on improving urinary rash. The present invention has been completed by further studies based on this finding.

That is, the present invention provides the inventions of the following aspects.
Item 1. An external composition containing (A) ufenamate and (B) lidocaine and / or a salt thereof, which is used for improving urinary rash.
Item 2. Item 2. The external composition according to Item 1, which is applied to women after the menopause.
Item 3. (C) The external composition according to Item 1 or 2, further containing an antihistamine.
Item 4. Item 3. The external composition according to Item 3, wherein the component (C) is chlorpheniramine and / or a salt thereof.

According to the present invention, there is provided an external composition used for improving urinary rash.

The composition for external use of the present invention comprises (A) ufenamate (hereinafter, also referred to as "(A) component") and (B) lidocaine and / or a salt thereof (hereinafter, "(B) component" or "lidocaine". It is characterized by containing (also described as) and used for improving urinary rash. In addition, the external composition of the present invention may further contain (C) an antihistamine (hereinafter, also referred to as "component (C)"). Further, the external composition of the present invention includes (D) tocopherol and / or a derivative thereof (hereinafter, also referred to as "(D) component" or "tocopherols"), (E) allantoin and a derivative thereof (hereinafter, in the following, "(E) Ingredient" or "Allantoins") and / or (F) Panthenol, its derivatives, and / or salts thereof (hereinafter, "(F) Ingredient" or "Panthenols" Also described) may be further contained. Hereinafter, the external composition of the present invention will be described in detail.

(A) Ufenamart The external composition of the present invention contains Ufenamart as a component (A). Ufenamate, also called butyl flufenamic acid, is a known drug as a fat-soluble non-steroidal anti-inflammatory drug. The component (A) alone does not have much effect of improving urinary rash, but the external composition of the present invention can exert an excellent effect of improving urinary rash.

In the external composition of the present invention, the content of the component (A) is appropriately set according to the medicinal effect to be exerted, and examples thereof include 1 to 20% by weight. From the viewpoint of further improving the effect of improving urinary rash, the content of the component (A) in the external composition of the present invention is preferably 3 to 6% by weight, more preferably 4.5 to 5.5% by weight. Can be mentioned.

(B) Lidocaines The external composition of the present invention contains lidocaine and / or a salt thereof as the component (B). Lidocaine, also referred to as xylocaine, is a known drug known to have a local anesthetic effect. The component (B) is a local anesthetic and does not improve urinary rash by itself, but when combined with the component (A), the effect of improving urinary rash is dramatically improved.

The salt of lidocaine is not particularly limited as long as it is pharmaceutically acceptable, and specific examples thereof include inorganic acid salts such as hydrochloride.

In the external composition of the present invention, one kind may be selected from lidocaine and a salt thereof and used alone, or two or more kinds may be used in combination. Among lidocaine and its salts, lidocaine is preferably mentioned from the viewpoint of further improving the effect of improving urinary rash.

The content of the component (B) in the external composition of the present invention may be appropriately set according to the medicinal effect to be imparted, and for example, the total amount of the component (B) is preferably 0.1 to 5% by weight. Is 0.2 to 2% by weight, more preferably 0.5 to 1.5% by weight.

In the external composition of the present invention, the ratio of the component (B) to the component (A) is determined according to the contents of the component (A) and the component (B), and is, for example, 1 part by weight of the component (A). The total amount of the component (B) is, for example, 0.01 to 1.5 parts by weight, preferably 0.05 to 1 part by weight, and more preferably 0.1 to 0.5 parts by weight.

(C) Antihistamine The external composition of the present invention can further contain an antihistamine as the component (C) from the viewpoint of further improving the effect of improving urinary rash.

The antihistamine is not particularly limited, and is, for example, an ethanolamine-based antihistamine such as diphenhydramine, bromodiphenhydramine, cremastine, chlorphenoxamine, diphenylpyraline, doxylamine, orphenadrin, phenyltroxamine; propyl such as chlorpheniramine, dimethinden, and tarastin. Amin-based antihistamines; ethylenediamine-based antihistamines such as mepyramine, metapyrrylene, and triperenamine; phenothiazine-based antihistamines such as alimemazine, hydroxyethylpromethazine, isotipendyl, mequitazine, oxomemazine, and promethazine; Piperazine antihistamines such as mecridin, oxatomid; ketotiphen, olopatazine, fexophenazine, loratazine, terphenazine, antazoline, azatazine, bamipin, cyproheptazine, deptropin, evastin, emedastin, epinastin, mebuhydroline Examples thereof include lysine, acrivastin, astemizole, azelastin, vilastin, desloratazine, and salts thereof. These antihistamines may be used alone or in combination of two or more.

The salt is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include inorganic acid salts and organic acid salts. Examples of the inorganic acid salt include hydrochloride, hydrobromide, nitrate, sulfate, phosphate and the like. Examples of the organic acid salt include monocarboxylates such as acetate, trifluoroacetate, butyrate, palmitate, and stearate; and polyvalents such as fumarate, maleate, succinate, and malonate. Carboxylate; oxycarboxylate such as lactate, tartrate, citrate, salicylate; organic sulfonic acid such as methanesulfonate, toluenesulfonate, tosylate, napadisilate, diphenyldisulfonate, etc. Examples thereof include salts and organic sulfates such as lauryl sulfate. These salts may be used alone or in combination of two or more.

Among these components (C), from the viewpoint of further improving the effect of improving urinary rash, an ethanolamine-based antihistamine and a propylamine-based antihistamine are preferable, and a propylamine-based antihistamine is more preferable, and further preferable. Examples include chlorpheniramine and salts thereof, and particularly preferably chlorpheniramine maleate.

When the external composition of the present invention contains the component (C), the content of the component (C) is not particularly limited and is appropriately set according to the type of the component (C), but the effect of improving urinary rash can be improved. From the viewpoint of further improvement, the total amount of the component (C) is, for example, 0.1 to 5% by weight, preferably 0.2 to 2% by weight, and more preferably 0.5 to 1.5% by weight.

Further, when the external composition of the present invention contains the component (C), the ratio of the component (C) to the component (A) is determined based on the range of the content of each component, but the improvement of urinary rash is improved. From the viewpoint of further improving the effect, the total amount of the component (C) per part by weight of the component (A) is, for example, 0.01 to 1.5 parts by weight, preferably 0.05 to 1 part by weight, more preferably. 0.1 to 0.5 parts by weight may be mentioned.

(D) Tocopherols The external composition of the present invention can further contain tocopherol and / or a derivative thereof as the component (D) from the viewpoint of further improving the effect of improving urinary rash.

Tocopherol is a known compound known as Vitamin E. The tocopherol may be any of d-form, l-form, and dl-form, but dl-form is preferable. Further, the tocopherol may be any of α-form, β-form, γ-form, and δ-form, but α-form is preferable.

The derivative of tocopherol is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include an ester form with a carboxylic acid such as acetic acid, nicotinic acid, and succinic acid, and a diester form with phosphoric acid. Among these tocopherol derivatives, an ester form with a carboxylic acid is preferable, and tocopherol acetate is more preferable, from the viewpoint of further improving the effect of improving urinary rash.

The derivative of tocopherol may be d-form, l-form, or dl-form, but dl-form is preferable. Further, the derivative of tocopherol may be any of α-form, β-form, γ-form, and δ-form, but α-form is preferable.

In the external composition of the present invention, as the component (D), one of tocopherol and its derivative may be selected and used alone, or two or more thereof may be used in combination. Among the components (D), from the viewpoint of further improving the effect of improving urinary rash, a derivative of tocopherol, more preferably an ester of tocopherol with a carboxylic acid, still more preferably tocopherol acetate, particularly preferably d-acetate. Examples thereof include α-tocopherol, l-α-tocopherol acetate, and dl-α-tocopherol acetate.

The content of the component (D) when the external composition of the present invention contains the component (D) is not particularly limited, but as the total amount of the component (D) from the viewpoint of further improving the effect of improving urinary rash. For example, 0.05 to 2% by weight, preferably 0.1 to 1.3% by weight, and more preferably 0.3 to 0.8% by weight.

Further, when the external composition of the present invention contains the component (D), the ratio of the component (D) to the component (A) is determined based on the range of the content of each component, but the improvement of urinary rash is improved. From the viewpoint of further improving the effect, the total amount of the component (D) is 0.01 to 1 part by weight, preferably 0.03 to 0.5 part by weight, and more preferably 0. 05 to 0.3 parts by weight can be mentioned.

(E) Allantoin The external composition of the present invention can further contain allantoin and its derivatives as the component (E) from the viewpoint of further improving the effect of improving urinary rash.

Allantoin is a compound also called 5-ureidohydantoin, and is a known drug known to have anti-inflammatory action, cell activation action, hemostatic action, bactericidal action, anti-ulcer action and the like.

The allantoin derivative is not particularly limited as long as it is pharmaceutically acceptable, and specific examples thereof include allantoin chlorohydroxyaluminum and allantoinhydroxyaluminum. These allantoin derivatives may be used alone or in combination of two or more.

In the external composition of the present invention, as the component (E), one kind may be selected and used from allantoin and its derivatives, or two or more kinds may be used in combination. Among these components (E), allantoin is preferably mentioned from the viewpoint of further improving the effect of improving urinary rash.

The content of the component (E) when the external composition of the present invention contains the component (E) is not particularly limited, but from the viewpoint of further improving the effect of improving urinary rash, the total amount of the component (E) is set as the total amount. For example, 0.05 to 1.0% by weight, preferably 0.1 to 0.5% by weight, and more preferably 0.1 to 0.3% by weight.

Further, when the external composition of the present invention contains the component (E), the ratio of the component (E) to the component (A) is determined based on the range of the content of each component, but the improvement of urinary rash is improved. From the viewpoint of further improving the effect, the total amount of the component (E) per part by weight of the component (A) is, for example, 0.01 to 0.2 parts by weight, preferably 0.02 to 0.1 parts by weight. The amount is preferably 0.02 to 0.06 parts by weight.

(F) Panthenol The external composition of the present invention further contains panthenol, a derivative thereof, and / or a salt thereof as the component (F) from the viewpoint of further improving the effect of improving urinary rash. Can be done.

Panthenol is a compound also called provitamin B5, and is a known drug as a cell activator, a moisturizer, and the like.

Specific examples of the panthenol derivative include pantothenyl ethyl ether and acetyl pantothenyl ethyl ether. These panthenol derivatives may be used alone or in combination of two or more.

The pantenol and / or a salt thereof is not particularly limited as long as it is pharmaceutically acceptable, but specifically, alkali metal salts such as potassium salt and sodium salt, and alkaline earth such as calcium salt. Examples include metal salts. These salts may be used alone or in combination of two or more.

When the external composition of the present invention contains the component (F), one of the components (F) is selected from panthenol, a salt of panthenol, a derivative of panthenol, and a salt of a derivative of panthenol. It may be used, or two or more kinds may be used in combination.

Among these panthenol types, panthenol is preferably mentioned from the viewpoint of further improving the effect of improving urinary rash.

The content of the component (F) when the external composition of the present invention contains the component (F) is not particularly limited, but from the viewpoint of further improving the effect of improving urinary rash, the total amount of the component (F) is set as the total amount. For example, 0.01 to 5.0% by weight, preferably 0.05 to 3.0% by weight, and more preferably 0.8 to 1.2% by weight.

Further, when the external composition of the present invention contains the component (F), the ratio of the component (F) to the component (A) is determined based on the range of the content of each component, but the improvement of urinary rash is improved. From the viewpoint of further improving the effect, the total amount of the component (F) per 1 part by weight of the component (A) is, for example, 0.002 to 1 part by weight, preferably 0.01 to 0.6 part by weight, more preferably. 0.15-0.25 parts by weight may be mentioned.

Other Ingredients The external composition of the present invention may contain other pharmacological components in addition to the above-mentioned components, if necessary. Examples of such pharmacological components include local anesthetics (dibucaine, procaine, tetracaine, bupivacaine, mepivacaine, chloroprocine, proparacaine, meprilcaine or salts thereof), benzoic acid alkyl esters (eg, ethyl aminobenzoate, parahydrochloride). (Diethylaminoethyl butylaminobenzoate), orthokine, oxesazein, oxypolyentoxydecane, funnel extract, percaminpase, tesitdecitin, etc.), anti-inflammatory agents (glycyrrhetinic acid, glycyrrhetinate, salicylic acid, glycol salicylate, methyl salicylate, indomethacin, fervinac, diclofenac Sodium, loxoprofen sodium, etc.), bactericides (zinc oxide, benzalkonium chloride, decalinium chloride, benzethonium chloride, cetylpyridinium chloride, isopropylmethylphenol, chlorhexidine hydrochloride, chlorhexidine gluconate, aqueous ammonia, sulfaziazine, lactic acid, phenol, etc.), Antipruritic agent (diphenhydramine, crotamitone, thiantoll, etc.), skin protectant (corodion, castor oil, etc.), blood circulation promoting component (nonyl acid vanillylamide, nicotinic acid benzyl ester, capsaicin, peppermint extract, etc.), refreshing agent (menthol, camphor, etc.) ), Vitamins (vitamins A, B, C, D, etc.), mucopolysaccharides (sodium chondroitin sulfate, hyaluronic acid, etc.) and the like.

In addition to the above-mentioned components, other bases and additives usually used for external skin preparations and the like may be contained, if necessary. Such base materials and additives are not particularly limited as long as they are pharmaceutically acceptable, but for example, water, lower alcohols (for example, isopropanol), polyhydric alcohols (glycerin, propylene glycol, dipropylene glycol). , 1,3-butylene glycol, etc.); oils (olive oil, saflower oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, lard, squalane, fish oil, etc.) , Mineral oil (liquid paraffin, paraffin, gelled hydrocarbon, vaseline, etc.), waxes / waxes (mitsurou, carnauba wax, candelilla wax, selecin, rice wax, microcrystallin wax, etc.), ester oil (isopropyl myristate, etc.) Isopropyl adipate, diethyl sebacate, isopropyl sebacate, isopropyl palmitate, cetyl palmitate, ethyl oleate, etc.), fatty acid alkyl esters, fatty acids (stearic acid, oleic acid, palmitic acid, behenic acid, linoleic acid, lanolin, etc.) , Fatty acid esters (cetyl palmitate, isopropyl palmitate, isopropyl myristate, ethyl linoleate, etc.), higher alcohols (stearyl alcohol, cetanol, behenyl alcohol, myristyl alcohol, oleyl alcohol, hexadecyl alcohol, lanolin alcohol, etc.), cholesterol, tri Oily bases such as glyceryl 2-ethylhexanate, cetyl 2-ethylhexanate, silicone oil (dimethylpolysiloxane, cyclic silicone, etc.); POE (10-50 mol) phytosterol ether, POE (10-50 mol) dihydrocholesterol Ether, POE (10-50 mol) 2-octyldodecyl ether, POE (10-50 mol) decyltetradecyl ether, POE (10-50 mol) oleyl ether, POE (2-50 mol) cetyl ether (set macrogol) 1000 etc.), POE (5-50 mol) behenyl ether, POE (5-30 mol) polyoxypropylene (5-30 mol) 2-decyltetradecyl ether, POE (10-50 mol) polyoxypropylene (2-) 30 mol) Polyoxyethylene alkyl ethers such as cetyl ethers, their phosphates and phosphates (POE cetyl ether sodium phosphate, etc.), POE (20-60 mol) sorbitan monoolates, POE (10-60 mol) ) Solbitan monoisostearate, POE (10-80 mol) glyceryl monoisostearate, POE (10-30 mol) glyceryl monostearate, POE (20-100 mol) / polyoxypropylene-modified silicone, POE / alkyl-modified Silicone, Monolaurate Polyethylene Glycol, Monopalmitate Polyethylene Glycol, Monostearate Polyethylene Glycol, Dilaurate Polyethylene Glycol, Dipalmitate Polyethylene Glycol, Distearate Polyethylene Glycol, Dioleate Polyethylene Glycol, Diricinoleate Polyethylene Glycol, Polyoxyethylene Cure Surfactants such as castor oil (5-100), polysorbate (20-85), glycerin fatty acid esters (glycerin monostearate, etc.), hydrogenated soybean phospholipids, hydrogenated lanolin alcohol; refreshing agents (menthol, camphor, etc.) Borneol, peppermint water, peppermint oil, etc.), preservatives (methylparaben, propylparaben, benzoic acid, sodium benzoate, sorbic acid, etc.), flavoring agents (citral, 1,8-sionel, citronellal, farnesol, etc.), colorants (Tar pigments (brown 201, blue 201, yellow 4, yellow 403, etc.), cocoa pigments, chlorophyll, aluminum oxide, etc.), viscous agents (carboxyvinyl polymer, hypromellose, polyvinylpyrrolidone, sodium alginate, ethyl cellulose, etc.) Hydroxyethyl cellulose, sodium carboxymethyl cellulose, xanthan gum, carrageenan, etc.), pH adjusters (phosphate, hydrochloric acid, citric acid, sodium citrate, succinic acid, tartrate acid, sodium hydroxide, potassium hydroxide, triethanolamine, triisopropanolamine, etc. ), Wetting agent (dl-pyrrolidone sodium carboxylate solution, D-sorbitol solution, macrogol, etc.), stabilizer (dibutylhydroxytoluene, butylhydroxyanisole, sodium edetate, sodium metaphosphate, L-arginine, L-asparagine) Acids, DL-alanine, glycine, sodium erythorbate, propyl gallate, sodium sulfite, sulfur dioxide, chlorogenic acid, catechin, rosemary extract, etc.), antioxidants, UV absorbers, chelating agents, adhesives, buffers , Additives such as solubilizers, solubilizers, preservatives and the like.

Properties, formulation form, etc. The properties of the external composition of the present invention are not particularly limited, and examples thereof include an aqueous liquid composition, an aqueous gel composition, an oil gel composition, and an emulsified composition. Among these, an emulsified composition is preferably mentioned from the viewpoint of further improving the effect of improving urinary rash. The emulsified state of the emulsified composition may be either an oil-in-water type or a water-in-oil type, but an oil-in-water type is preferable from the viewpoint of further improving the effect of improving urinary rash.

The pharmaceutical form of the external composition of the present invention is not particularly limited, and examples thereof include lotions, emulsions, ointments, and creams. Among these, emulsions and creams are preferable from the viewpoint of further improving the effect of improving urinary rash and the ease of application.

Specific examples of the external composition of the present invention include pharmaceuticals, quasi-drugs, cosmetics and the like. Among these pharmaceutical forms, pharmaceutical products are preferable.

Uses The external composition of the present invention is used for improving inflammation of urinary rash. The composition for external use of the present invention is not particularly limited as long as it is a person with urinary rash. Further, it does not matter whether or not hygienic products such as urine pads and urine leak sheets are used, but the external composition of the present invention is particularly capable of contact irritation due to constant contact with these hygienic products and /. Alternatively, it is preferably applied to urinary rash caused by the material of hygienic products not being suitable for the skin.

In addition, the external composition of the present invention is particularly preferably applied to post-menopausal females (that is, menopausal females and females who have passed the menopause). Urinary rash in women after menopause is caused by frequent urinary incontinence or frequent urinary incontinence, as well as contamination with cages, pressure irritation with underwear such as panty stockings, and / or frictional irritation due to the use of toilet paper. With peculiar circumstances, urinary rash presents peculiar intractability. Since the external composition of the present invention is excellent in the effect of improving inflammation of urinary rash, it is particularly effective for such intractable urinary rash peculiar to menopausal women.

The external composition of the present invention can be applied to the skin suffering from urinary rash by applying it 1 to 6 times a day. In addition, the external composition of the present invention is preferably applied, for example, for 5 days or more, preferably 1 week or more, in order to more effectively obtain the effect of improving urinary rash.

Hereinafter, the present invention will be specifically described with reference to Examples, but the present invention is not limited to these Examples.

Test Example 1
The external composition having the composition shown in Table 1 was prepared as an oil-in-water emulsified composition (cream preparation). The prepared external composition was applied to the affected area three times a day for one week for five postmenopausal women who complained of urinary rash. In addition to urinary incontinence, these subjects were affected by the use of hygienic products such as urine pads or urine leak sheets made of materials that are not suitable for the skin, contamination with cages, pressure stimulation with underwear such as panty stockings, and / or the use of toilet paper. I was aware of serious urinary incontinence due to frictional stimulation. In addition, none of the subjects had shaved the delicate zone. One week later, the degree of satisfaction with the improvement of the symptoms of urinary rash was scored and averaged on a 5-point VAS (0 is no improvement and the upper limit is 4), and the average score was calculated according to the following criteria. The "effect of improving urinary rash" was evaluated. The results are shown in Table 1.

<Evaluation criteria for improving urinary rash>
⊚: 3.0 or more 〇: 2.0 or more and less than 3.0 △: 1.0 or more and less than 2.0 ×: less than 1.0

As shown in Table 1, the effect of the external composition of Comparative Example 1 containing only ufenamate as an active ingredient was not so much, and almost no effect was observed in the case of Comparative Example 2 containing only lidocaine as an active ingredient. However, in the external composition of Example 1 containing ufenamate and lidocaine, a high effect of improving urinary rash was observed.

Test Example 2
The external composition having the composition shown in Table 2 was prepared as an oil-in-water emulsified composition (cream preparation). Seven postmenopausal women who complained of urinary rash were given the prepared external composition to the affected area three times a day for one week. In addition to urinary incontinence, these subjects were affected by the use of hygienic products such as urine pads or urine leak sheets made of materials that are not suitable for the skin, contamination with cages, pressure stimulation with underwear such as panty stockings, and / or the use of toilet paper. I was aware of serious urinary incontinence due to frictional stimulation. In addition, none of the subjects had shaved the delicate zone. One week later, the degree of satisfaction regarding the improvement of the symptoms of urinary rash was scored and averaged on a 10-point VAS (0 is no improvement and the upper limit is 9), and the average score is the "urinary rash improvement effect". Asked as. The results are shown in Table 2.

As shown in Table 2, the external composition of Comparative Example 3 containing chlorpheniramine maleate and tocopherol acetate did not show much effect, but the external composition of Example 2 further containing ufenamate and lidocaine had high urine. An effect of improving rash was observed, and the effect was recognized to be superior to that of the external composition of Example 1.

Formulation Examples External compositions having the compositions shown in Tables 3 and 4 were prepared. Both external composition had a high effect of improving urinary rash in postmenopausal women.

Claims (4)

An external composition containing (A) ufenamate and (B) lidocaine and / or a salt thereof, which is used for improving urinary rash. The external composition according to claim 1, which is applied to women after the menopause. (C) The external composition according to claim 1 or 2, further containing an antihistamine. The external composition according to claim 3, wherein the component (C) is chlorpheniramine and / or a salt thereof.