Water-soluble topical sheet preparation and method for improving the water-soluble properties of topical sheet preparations.

Abstract

To provide water-disintegrable sheet agents for external use with excellent water-disintegrable properties, which causes little frictional stimulation when used on diseased sites and the like in a state impregnated with a drug solution, and which is sufficiently dispersed in the water flow of the flush toilet and the like, after use, and prevents clogging of the sewer pipe and the like.SOLUTION: The present invention relates to a water-disintegrable sheet agent for external use, in a sheet agent for external use obtained by impregnating a sheet-like substrate with an aqueous composition, the sheet-like substrate having water disintegration, and the aqueous composition containing an antihistamine and / or a local anesthetic. The water-disintegrable sheet agent for external use of the present invention is for wiping the skin or mucous membranes, and further preferably comprises a packaging material.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a hydrolyzable topical sheet preparation and a method for improving the hydrolysis of a topical sheet preparation. [Background technology]

[0002] It is known that various symptoms can occur in areas that one does not want to touch directly, especially in the delicate areas. For example, women may experience itching, rashes, and inflammation due to menstrual blood, sweat, and urine during menstruation. Men may also experience itching due to sweat and urine. Due to its structure, the delicate area tends to become damp and humid, and the temperature rises easily, making the skin soft and susceptible to irritation, as well as allowing bacteria to multiply easily, which is thought to make itchy and other problems more likely to occur. Traditionally, creams or gels containing ingredients that stop itching, suppress bacterial growth, and reduce inflammation have been used to address these problems, but there have been issues with convenience of use and hygiene.

[0003] In recent years, drug-impregnated sheets that apply active ingredients while wiping away sweat and dirt have been developed (see Patent Documents 1 and 2). However, these drug-impregnated sheets use non-water-soluble nonwoven fabrics containing cotton, polyethylene, polypropylene, etc. as a base, so they must be disposed of as general waste after use, which can be unhygienic. In addition, there is a problem of friction irritation caused by the nonwoven fabric, especially when used in delicate areas. On the other hand, water-soluble fiber sheets for toilet cleaning that are impregnated with cleaning solution and can be flushed down the toilet after use have been known for some time (see Patent Document 3). However, it is known that impregnating water-soluble fiber sheets with an aqueous composition containing medicinal ingredients reduces their water-soluble properties, and a water-soluble drug-impregnated sheet has not yet been developed (see Non-Patent Document 1). [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] Japanese Patent Publication No. 2014-141470 [Patent Document 2] Japanese Patent Publication No. 2017-190314 [Patent Document 3] Japanese Patent Publication No. 2006-307389 [Non-patent literature]

[0005] [Non-Patent Document 1] Journal of Functional Paper Research, No. 31, pp. 42-49, 1992. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] The present invention was made based on the circumstances described above, and aims to provide an external sheet agent that, when used on diseased areas such as delicate areas while impregnated with a drug solution, causes little frictional irritation, and has excellent hydrolytic properties that allow the solution to dissipate sufficiently with the water flow of a flush toilet, etc., after use, without causing blockages in sewer pipes, etc. [Means for solving the problem]

[0007] The inventors of this invention diligently studied the treatment of various skin conditions in delicate areas and the functionality required for hydrolyzable sheets. As a result, they found that impregnating a hydrolyzable sheet substrate with an aqueous composition containing an antihistamine and / or a local anesthetic in a certain proportion significantly improves the hydrolysis of the sheet. Examples of antihistamines that can be used include diphenhydramine hydrochloride and chlorpheniramine maleate, and examples of local anesthetics that can be used include dibucaine hydrochloride and lidocaine hydrochloride. Furthermore, they found that a hydrolyzable sheet substrate impregnated with an aqueous composition containing an antihistamine and / or a local anesthetic in a certain proportion reduces frictional irritation during use, thus completing the present invention.

[0008] In other words, the gist of this invention is as follows:

[0009] [1] In an external sheet preparation in which a sheet-like substrate is impregnated with an aqueous composition, A hydrolyzable topical sheet preparation characterized in that the sheet-like substrate is hydrolyzable, and the aqueous composition contains an antihistamine and / or a local anesthetic. [2] A hydrolyzable external sheet preparation as described in [1], for wiping skin or mucous membranes. [3] A water-soluble external sheet preparation according to [1] or [2], further comprising a packaging material. [4] A hydrolyzable topical sheet according to any one of [1] to [3], wherein the antihistamine is at least one selected from the group consisting of diphenhydramine, chlorpheniramine and pharmacopositically acceptable salts thereof and derivatives thereof. [5] A hydrolyzable topical sheet preparation according to any one of [1] to [4], wherein the antihistamine is diphenhydramine and / or a salt thereof. [6] A hydrolyzable topical sheet preparation according to any one of [1] to [5], wherein the antihistamine content is 0.01 to 10% by weight relative to the total amount of the aqueous composition. [7] A hydrolyzable topical sheet according to any one of [1] to [6], wherein the local anesthetic is at least one selected from the group consisting of dibucaine, lidocaine and / or pharmacopositically acceptable salts thereof and derivatives thereof. [8] A hydrolyzable topical sheet according to any one of [1] to [7], wherein the local anesthetic is dibucaine and / or a salt thereof. [9] A hydrolyzable topical sheet according to any one of items [1] to [8], wherein the content of the local anesthetic is 0.005 to 10% by weight relative to the total amount of the aqueous composition.

[10] A hydrolyzable external sheet preparation described in any of [1] to [9], which is a pharmaceutical or quasi-drug.

[11] In an external sheet preparation comprising a water-soluble sheet-like substrate impregnated with an aqueous composition, A method for improving the hydrolysis of an external sheet preparation, characterized by incorporating an antihistamine and / or a local anesthetic into the above aqueous composition. [Effects of the Invention]

[0010] According to the present invention, when used on diseased sites such as delicate areas, etc., there is little frictional stimulation, and it has excellent hydrolyzability that it can be sufficiently dispersed by the water flow in a flush toilet or the like after use without causing blockage in a sewer pipe or the like, and a hydrolyzable external application sheet agent impregnated with a chemical solution can be provided. The hydrolyzable external application sheet agent of the present invention can apply an active ingredient while wiping off sweat and dirt at the target site, and is suitably used as a drug-impregnated sheet agent that can improve various symptoms in delicate areas such as itching, swelling, inflammation, fissured hemorrhoids, polypoid hemorrhoids, blisters, bleeding, prolapse, etc.

Brief Description of Drawings

[0011] [Figure 1] It is a figure showing the hydrolysis improvement rate (%) of the hydrolyzable external application sheet agent of the present invention.

Modes for Carrying Out the Invention

[0012] Hereinafter, the present invention will be described in detail. <Hydrolyzable External Application Sheet Agent> The hydrolyzable external application sheet agent of the present invention is an external application sheet agent in which a sheet-shaped base material is impregnated with an aqueous composition, wherein the sheet-shaped base material has hydrolyzability, and the aqueous composition contains an antihistamine and / or a local anesthetic. The hydrolyzable external application sheet agent of the present invention impregnates a hydrolyzable sheet base material with an aqueous composition containing an antihistamine such as diphenhydramine hydrochloride, chlorpheniramine maleate, etc., and / or a local anesthetic such as dibucaine hydrochloride, lidocaine hydrochloride, etc. at a certain ratio, whereby the hydrolyzability of the sheet is remarkably improved, and an unexpected and remarkable effect of reducing frictional stimulation during use is exhibited. Further, according to the hydrolyzable sheet agent of the present invention, by applying with a sheet impregnated with a chemical solution, the medicinal ingredient can be uniformly applied to the affected area, and since it is easy to discard, it can be used timely and hygienically even when away from home, and thus an effect leading to an improvement in QOL can be expected.

[0013] 1.Aqueous composition The aqueous composition in the hydrolyzable external sheet agent of the present invention contains an antihistamine and / or a local anesthetic. Here, the aqueous composition means a composition containing water, and usually contains 10% by weight or more of water in the composition, preferably 20% by weight or more, more preferably 30% by weight or more, and still more preferably 50% by weight or more. The water contained in the aqueous composition of the present invention may be pharmaceutically, pharmacologically or physiologically acceptable, and examples thereof include distilled water, tap water, purified water, sterilized purified water, etc. In addition, as long as the aqueous composition contains water as described above, it may be in a form emulsified by an emulsifier or the like.

[0014] [Antihistamine] The antihistamine is not particularly limited as long as it is a pharmacologically or physiologically acceptable antihistamine. Specific examples of the antihistamine include diphenhydramine, chlorpheniramine, isothipendyl and their salts, and derivatives thereof.

[0015] The above-mentioned "derivative" is a compound (drug) derived from a compound (drug) by a chemical reaction, and refers to their esters, ethers, alkylated products, glycosides, etc.

[0016] Examples of the above-mentioned "salt" include various salts such as organic acid salts, inorganic acid salts, and metal salts. Specifically, diphenhydramine hydrochloride, diphenhydramine salicylate, chlorpheniramine maleate, isothipendyl hydrochloride, etc. can be mentioned.

[0017] From the viewpoint of more effectively improving the hydrolysis of the hydrolyzable topical sheet preparation of the present invention, diphenhydramine, chlorpheniramine, and their salts, as well as their derivatives, are preferred as antihistamines; diphenhydramine, chlorpheniramine, and their salts are more preferred; diphenhydramine hydrochloride and chlorpheniramine maleate are even more preferred; and diphenhydramine hydrochloride is the most preferred. In the present invention, these antihistamines may be used individually or in any combination of two or more.

[0018] The amount of antihistamine in the aqueous composition described above is not particularly limited as long as the effect of the present invention is obtained, but is usually 0.001% to 20% by weight, preferably 0.01% to 10% by weight, more preferably 0.04% to 8.0% by weight, even more preferably 0.1% to 5.0% by weight, and particularly preferably 0.2% to 3.0% by weight, relative to the total amount of the aqueous composition.

[0019] [Local anesthetic] There are no particular restrictions on the use of local anesthetics as long as they are pharmacologically or physiologically acceptable. Specific examples of local anesthetics include dibucaine, lidocaine, procaine, meprilcaine and their salts, as well as their derivatives, ethyl aminobenzoate, and oxypolyethoxide decane.

[0020] The term "derivative" above refers to a compound (drug) derived from another compound (drug) through a chemical reaction, and includes esters, ethers, alkylates, glycosides, etc.

[0021] The "salts" mentioned above include various types of salts, such as organic salts, inorganic salts, and metal salts. Specifically, examples include dibucaine hydrochloride, lidocaine hydrochloride, procaine hydrochloride, and meprilcaine hydrochloride.

[0022] From the viewpoint of more effectively improving the hydrolysis of the hydrolyzable topical sheet preparation of the present invention, dibucaine, lidocaine, and salts thereof, as well as derivatives thereof, are preferred as local anesthetics, dibucaine, lidocaine and their salts are more preferred, dibucaine hydrochloride and lidocaine hydrochloride are even more preferred, and dibucaine hydrochloride is the most preferred. In the present invention, these local anesthetics may be used individually or in any combination of two or more.

[0023] The amount of local anesthetic in the aqueous composition described above is not particularly limited as long as the effect of the present invention is obtained, but is usually 0.001% to 20% by weight, preferably 0.005% to 10% by weight, more preferably 0.01% to 5.0% by weight, even more preferably 0.02% to 3.0% by weight, and particularly preferably 0.05% to 2% by weight, relative to the total amount of the aqueous composition.

[0024] [Other ingredients] The above aqueous composition may contain other components besides water and antihistamines and / or local anesthetics, depending on the purpose. Examples of other components include those that add medicinal effects to the hydrolyzable topical sheet preparation of the present invention, or those that improve the feel of the hydrolyzable topical sheet preparation of the present invention. Examples include polyhydric alcohols, anti-inflammatory agents, cooling agents, bactericides, vitamins, organic acids, moisturizing components, UV absorbing components, astringent components, peptides or their derivatives, amino acids or their derivatives, cleansing components, keratin softening components, cell activating components, anti-aging components, blood circulation promoting components, whitening components, antipruritics (excluding antihistamines), antiperspirants, etc. These other components may be used individually or in combination of two or more.

[0025] The polyhydric alcohols mentioned above are preferably those having 2 to 10 carbon atoms, and examples include glycerin, diglycerin, triglycerin, propylene glycol, dipropylene glycol, 1,3-butanediol, ethylene glycol, diethylene glycol, isoprene glycol, 1,3-butylene glycol, 1,2-pentanediol, sorbitol, xylitol, erythritol, mannitol, pentanediol, hexanediol, octanediol, decanediol, neopentyl glycol, and the like.

[0026] Examples of the above anti-inflammatory agents include allantoin and its derivatives, glycyrrhetinic acid and its derivatives, glycyrrhizic acid and its derivatives, salicylic acid derivatives, aminocaproic acid, azulene and its derivatives, zinc oxide, tocopherol acetate, hydrocortisone, prednisolone, and salts thereof.

[0027] Examples of the cooling agents mentioned above include terpenes such as menthol, camphor, borneol, geraniol, cineole, anethole, limonene, and eugenol (these may be d-isomers, l-isomers, or dl-isomers); and essential oils such as eucalyptus oil, bergamot oil, peppermint oil, cool mint oil, spearmint oil, fennel oil, peppermint oil, cinnamon oil, rose oil, and turpentine oil.

[0028] Examples of the above-mentioned disinfectants include isopropylmethylphenol, chlorhexidine, salicylic acid, benzalkonium chloride, acrinol, ethanol, benzethonium chloride, cresol, gluconic acid and its derivatives, povidone-iodine, potassium iodide, iodine, triclocarban, triclosan, photosensitizer 101, photosensitizer 201, parabens, phenoxyethanol, alkyldiaminoglycine hydrochloride, piroctoolamine, miconazole, and the like.

[0029] The above vitamins may be either water-soluble or fat-soluble vitamins, for example, vitamin B6 compounds such as pyridoxine, pyridoxal, pyridoxamine, 5'-pyridoxal phosphate, and their salts (e.g., pyridoxine hydrochloride, pyridoxine acetate, pyridoxal hydrochloride, pyridoxamine hydrochloride); pantothenic acids such as pantothenic acid, calcium pantothenate, pantothenyl alcohol (panthenol), D-panthesine, D-pantethine, coenzyme A, pantothenyl ethyl ether, and their salts; nicotinic acid, nicotine Nicotinic acids such as dl-α-tocopherol nicotinate, benzyl nicotinate, methyl nicotinate, β-butoxyethyl nicotinate, 1-(4-methylphenyl)ethyl nicotinate, nicotinamide, and salts thereof; γ-oryzanol, thiamine, dibenzoylthiamine, thiamine cetyl, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, and salts thereof (e.g., dibenzoylthiamine hydrochloride, thiamine hydrochloride, thiamine cetyl hydrochloride, thiamine thiocyanate, thiamine lauryl hydrochloride, thiamine Vitamin B1 compounds such as nitrates, thiamine monophosphates, thiamine lysine salts, thiamine triphosphates, thiamine monophosphate phosphates, thiamine diphosphate hydrochloride, thiamine triphosphate monophosphates; Vitamin B2 compounds such as riboflavin, flavin mononucleotide, flavin adenine dinucleotide, riboflavin butyrate, riboflavin tetrabutyrate, riboflavin 5'-phosphate sodium, riboflavin tetranicotinate, and their salts; and biotin, biocitin, and their salts. Vitamins such as otin; folic acid derivatives such as folic acid, pteroylglutamic acid, and their salts; vitamin B12 derivatives such as cyanocobalamin, hydroxocobalamin, deoxyadenosylcobalamin, and their salts; water-soluble vitamin C derivatives such as ascorbic acid, dehydroascorbic acid, ascorbic acid phosphate, ascorbic acid-2-glucoside, 3-O-ethylascorbic acid, and their salts (e.g., sodium ascorbate, sodium ascorbic acid phosphate, magnesium ascorbic acid phosphate);Examples include vitamin E derivatives such as dl-α-tocopherol, dl-α-tocopherol acetate, dl-α-tocopherol succinate, and dl-α-tocopherol calcium succinate; oil-soluble vitamin C derivatives such as ascorbigen-A, ascorbic acid stearate, ascorbic acid palmitate, L-ascorbyl dipalmitate, and tetra-2-hexyldecanoate ascorbyl; vitamin D derivatives such as ergocalciferol and cholecalciferol; vitamin K derivatives such as phylloquinone and phalnoquinone; and vitamin-like factors such as ferulic acid.

[0030] Examples of the above-mentioned organic acids include gluconic acid, aspartic acid, aminoethylsulfonic acid, citric acid, glutamic acid, succinic acid, oxalic acid, fumaric acid, propionic acid, malic acid, salicylic acid, glycolic acid, phytic acid, tartaric acid, acetic acid, lactic acid, and salts thereof. Examples of salts include salts of mineral acids such as sulfuric acid, hydrochloric acid, or phosphoric acid, salts of organic acids such as maleic acid or methanesulfonic acid, alkali metal salts such as sodium or potassium, alkaline earth metal salts, and ammonium salts.

[0031] Examples of the above-mentioned moisturizing ingredients include diglycerin trehalose; high molecular weight compounds such as sodium hyaluronate, heparinoid, sodium chondroitin sulfate, collagen, elastin, keratin, chitin, and chitosan; amino acids such as glycine, aspartic acid, and arginine; natural moisturizing factors such as sodium lactate, urea, and sodium pyrrolidone carboxylate; lipids such as ceramide, cholesterol, and phospholipids; and plant extracts such as chamomile extract, witch hazel extract, tea extract, and perilla extract.

[0032] Examples of the above-mentioned UV-absorbing components include octyl triazone, octyl dimethoxybenzylidene dioxoimidazolidine propionate, 2-ethylhexyl paramethoxycinnamate, and phenylbenzimidazole sulfonic acid.

[0033] Examples of the astringent components mentioned above include zinc sulfate, aluminum chloride, zinc sulfocarbonate, and tannic acid.

[0034] Examples of the peptides or their derivatives include keratin-degrading peptides, hydrolyzed keratin, collagen, fish-derived collagen, atelocollagen, gelatin, elastin, elastin-degrading peptides, collagen-degrading peptides, hydrolyzed collagen, hydroxypropylammonium chloride hydrolyzed collagen, elastin-degrading peptides, conchiolin-degrading peptides, hydrolyzed conchiolin, silk protein-degrading peptides, hydrolyzed silk, sodium lauroyl hydrolyzed silk, soy protein-degrading peptides, hydrolyzed soy protein, wheat protein, wheat protein-degrading peptides, hydrolyzed wheat protein, casein-degrading peptides, acylated peptides (palmitoyl oligopeptides, palmitoyl pentapeptides, palmitoyl tetrapeptides, etc.).

[0035] Examples of the above amino acids or their derivatives include betaine (trimethylglycine), proline, hydroxyproline, arginine, lysine, serine, glycine, alanine, phenylalanine, β-alanine, threonine, glutamic acid, glutamine, asparagine, aspartic acid, cysteine, cystine, methionine, leucine, isoleucine, valine, histidine, taurine, γ-aminobutyric acid, γ-amino-β-hydroxybutyric acid, carnitine, carnosine, creatine, and the like.

[0036] Examples of the above-mentioned cleansing ingredients include soaps selected from alkali metal salts such as potassium laurate, potassium myristate, potassium palmitate, or potassium stearate, alkanolamide salts, or amino acid salts; amino acid-based surfactants such as sodium cocoyl glutamate and sodium cocoyl methyl taurate; ether sulfate salts such as sodium laureth sulfate; ether carboxylate salts such as sodium lauryl ether acetate; sulfosuccinate salts such as sodium alkyl sulfosuccinate; fatty acid alkanolamides such as coconut oil fatty acid monoethanolamide and coconut oil fatty acid diethanolamide; monoalkyl phosphate salts such as sodium lauryl phosphate and sodium polyoxyethylene lauryl ether phosphate; betaine-type amphoteric surfactants such as coconut oil fatty acid amidopropyl dimethylaminoacetic acid betaine, lauryl dimethylaminoacetic acid betaine, 2-alkyl-N-carboxymethyl-N-hydroxyethylimidazolinium betaine, lauryl hydroxysulfobetaine, and lauroylamide ethyl hydroxyethyl carboxymethyl betaine hydroxypropyl sodium phosphate; and amino acid-type amphoteric surfactants such as sodium laurylaminopropionate.

[0037] Examples of the above-mentioned exfoliating ingredients include lactic acid, salicylic acid, gluconic acid, citric acid, malic acid, fruit acid, phytic acid, urea, and sulfur.

[0038] Examples of the cell-activating components mentioned above include amino acids such as γ-aminobutyric acid; vitamins such as retinol, thiamine, riboflavin, pyridoxine hydrochloride, and pantothenic acid; α-hydroxy acids such as glycolic acid and lactic acid; and tannins, flavonoids, saponins, and photosensitizer 301.

[0039] Examples of the anti-aging ingredients mentioned above include pangamic acid, kinetin, ursolic acid, turmeric extract, sphingosine derivatives, silicon, silicic acid, N-methyl-L-serine, and mevalonolactone.

[0040] The above-mentioned blood circulation-promoting components include those derived from plants (for example, Panax ginseng, Angelica keiskei, Arnica, Ginkgo biloba, Fennel, Ophiopogon japonicus, Watercress, Chamomile, Roman chamomile, Carrot, Gentian, Burdock, Rice, Hawthorn, Shiitake mushroom, Ginger, Hawthorn, Juniper, Cnidium officinale, Swertia japonica, Thyme, Clove, Citrus unshiu peel, Chili pepper, Angelica acutiloba, Prunus serrulata, Carrot, Garlic, Butcher's broom, Grape, Peony, Horse chestnut, Melissa, Yuzu, Coix seed, Mugwort, Rosemary, Rosehip, Citrus unshiu peel, Angelica acutiloba, Prunus serrulata, Peach, Apricot, Walnut, Corn, etc.); acetylcholine, ichthammol, Cantharis tincture, gamma-oryzanol, cepharanthine, trazoline, tocopherol nicotinate, glucosyl hesperidin, etc.

[0041] Examples of the above-mentioned whitening ingredients include tocopherol and tranexamic acid.

[0042] Examples of the above antipruritic agents (excluding antihistamines) include fluocinolone acetonide, fluocinonide, betamethasone valerate, betamethasone dipropionate, betamethasone propionate butyrate, hydrocortisone acetate, methylprednisolone acetate, dexamethasone, dexamethasone valerate, dexamethasone propionate, fludroxycortide, flumethasone pivalate, beclomethasone propionate, hydrocortisone butyrate, clobetasol propionate, diflucortone valerate, halcinide, and prednisolone acetate valerate. Adrenocortical steroids such as zolon, amsinides, hydrocortisone propionate butyrate, clobetazone butyrate, diflorazone acetate, diflupredner, alclomethasone propionate, budesonide, deprodone propionate, and mometasone furoate; nonsteroidal drugs such as ibuprofen piconol, suprofen, bufexamac, bendazac, and ufenamate; and crotamiton, coal tar, carbolic acid, naphthol, menthol, thymol, salicylic acid, chloral hydrate, aconitine, and tannins.

[0043] Examples of the antiperspirants mentioned above include aluminum chlorohydrate, aluminum chloride, zinc oxide, and zinc paraphenolsulfonate.

[0044] [Base material, carrier] The above aqueous composition can be prepared by mixing an antihistamine and / or local anesthetic, water, and the above-mentioned other components with a base or carrier commonly used in pharmaceuticals and quasi-drugs, and optionally with additives described later, in accordance with conventional methods, and then emulsifying or solubilizing as necessary to form various forms.

[0045] Examples of the above-mentioned bases or carriers include hydrocarbons such as squalane and petrolatum; silicone oils such as methylpolysiloxane, highly polymerized methylpolysiloxane, cyclic silicones, alkyl-modified silicones, amino-modified silicones, polyether-modified silicones, polyglycerin-modified silicones, silicone-alkyl chain-comodified polyether-modified silicones, silicone-alkyl chain-comodified polyglycerin-modified silicones, polyether-modified branched silicones, polyglycerin-modified branched silicones, acrylic silicones, phenyl-modified silicones, and silicone resins; fats and oils such as olive oil; waxes such as jojoba oil; sterols such as phytosterols and cholesterol; cellulose derivatives such as ethylcellulose, hydroxypropylcellulose, and hydroxypropylmethylcellulose; polysaccharides such as polyvinylpyrrolidone and carrageenan; vinyl polymers such as carboxyvinyl polymers and alkyl-modified carboxyvinyl polymers; lower alcohols such as ethanol and isopropanol; and if the above-mentioned aqueous composition contains polyhydric alcohols, the polyhydric alcohols may also serve as a base or carrier.

[0046] If the above aqueous composition contains a base or carrier other than a lower alcohol, the base or carrier is preferably, for example, a higher alcohol, hydrocarbon, oil or fat, esters, silicone oil, wax, or vinyl polymer, and more preferably a higher alcohol, ester oil, silicone oil, or vinyl polymer. Among these components, cetanol, cetostearyl alcohol, stearyl alcohol, behenyl alcohol, glyceryl tri-2-ethylhexanoate, dimethicone, cyclomethicone, polyether-modified silicone, polyglycerin-modified silicone, or carboxyvinyl polymer.

[0047] The bases or carriers described above may be used individually or in combination of two or more. Furthermore, the amounts used can be appropriately selected from a range known to those skilled in the art.

[0048] [Additives] The aqueous composition described above may contain known additives used in pharmaceuticals or quasi-drugs, such as surfactants, stabilizers, antioxidants, dispersants, chelating agents, pH adjusters, preservatives, thickeners, irritation reducers, fragrances, etc., to the extent that they do not impair the effects of the present invention. These additives may be used individually or in combination of two or more.

[0049] The above surfactants may be nonionic surfactants, cationic surfactants, anionic surfactants, amphoteric surfactants, etc., for example, sorbitan fatty acid esters such as sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan diglycerol penta-2-ethylhexyl sorbitan, sorbitan diglycerol tetra-2-ethylhexyl sorbitan; propylene glycol fatty acid esters such as propylene glycol monostearate; hydrogenated castor oil derivatives such as polyoxyethylene hydrogenated castor oil 40 (HCO-40), polyoxyethylene hydrogenated castor oil 50 (HCO-50), polyoxyethylene hydrogenated castor oil 60 (HCO-60), polyoxyethylene hydrogenated castor oil 80; polyoxyethylene monolauryl Examples include polyoxyethylene sorbitan fatty acid esters such as poly(20) sorbitan (polysorbate 20), polyoxyethylene(20) sorbitan monostearate (polysorbate 60), polyoxyethylene(20) sorbitan monooleate (polysorbate 80), and polyoxyethylene(20) sorbitan isostearate; polyoxyethylene monococonut oil fatty acid glyceryl; glycerin alkyl ethers; alkyl glucosides; polyoxyalkylene alkyl ethers such as polyoxyethylene cetyl ether; amines such as stearylamine and oleylamine; and silicone-based surfactants such as polyoxyethylene methylpolysiloxane copolymers, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, and PEG-9 polydimethylsiloxyethyl dimethicone.

[0050] Examples of the above-mentioned stabilizers include sodium polyacrylate, dibutylhydroxytoluene, and butylhydroxyanisole.

[0051] Examples of the above-mentioned antioxidants include dibutylhydroxytoluene, butylhydroxyanisole, sorbic acid, sodium sulfite, ascorbic acid, erythorbic acid, and L-cysteine ​​hydrochloride.

[0052] Examples of the above-mentioned dispersants include sodium pyrophosphate, sodium hexametaphosphate, polyvinyl alcohol, polyvinylpyrrolidone, methyl vinyl ether / maleic anhydride crosslinked copolymer, and organic acids.

[0053] Examples of the chelating agents mentioned above include EDTA-disodium salt and EDTA-calcium-disodium salt.

[0054] Examples of the pH adjusting agents mentioned above include inorganic acids (hydrochloric acid, sulfuric acid, etc.), organic acids (lactic acid, sodium lactate, citric acid, sodium citrate, succinic acid, sodium succinate, etc.), inorganic bases (potassium hydroxide, sodium hydroxide, etc.), and organic bases (triethanolamine, diisopropanolamine, triisopropanolamine, etc.).

[0055] Examples of the above-mentioned preservatives include benzoic acid, sodium benzoate, dehydroacetic acid, sodium dehydroacetate, isobutyl parahydroxybenzoate, isopropyl parahydroxybenzoate, butyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl parahydroxybenzoate, methyl parahydroxybenzoate, and phenoxyethanol.

[0056] Examples of the above-mentioned thickening agents include vinyl-based thickening agents such as polyvinyl alcohol, polyvinylpyrrolidone, and carboxyvinyl polymer; cellulose-based thickening agents such as methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, and carboxyethylcellulose; guar gum, pectin, pullulan, gelatin, locust bean gum, carrageenan, agar, xanthan gum, alkyl acrylate methacrylate copolymer, polyethylene glycol, bentonite, alginic acid, propylene glycol alginate, macrogol, sodium chondroitin sulfate, hyaluronic acid, sodium hyaluronate, (hydroxyethyl acrylate / sodium acryloyldimethyltaurate) copolymer, and (ammonium acryloyldimethyltaurate / vinylpyrrolidone) copolymer. Of these, vinyl-based thickeners and cellulose-based thickeners are preferred, and carboxyvinyl polymer, polyvinyl alcohol, polyvinylpyrrolidone, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, and carboxyethylcellulose are more preferred.

[0057] Examples of the irritation-reducing agents mentioned above include licorice extract, sodium alginate, gum arabic, and polyvinylpyrrolidone.

[0058] The above aqueous composition can be prepared by mixing water and an antihistamine, and optionally other components, bases or carriers, additives, etc., as described above, using conventional methods. If the aqueous composition is an emulsified composition, it can be prepared by adding an emulsifier and performing an emulsification treatment.

[0059] [pH] The pH of the above aqueous composition is not particularly limited and can be appropriately selected depending on the purpose, but is usually between 2.0 and 9.0, preferably between 3.0 and 8.0, more preferably between 4.0 and 7.0, even more preferably between 4.0 and 6.8, particularly preferably between 4.5 and 6.5, and even more preferably between 5.0 and 6.0. This pH can be adjusted, for example, by using the above pH adjusting agent.

[0060] 2. Sheet-like substrate The hydrolyzable external sheet preparation of the present invention is obtained by impregnating a hydrolyzable sheet-like substrate with the above-described aqueous composition.

[0061] As for the sheet-like substrate, there are no particular restrictions as long as it is hydrolytic, and depending on the purpose, a sheet manufactured to be hydrolytic using known raw materials and methods can be appropriately selected. Here, "hydrolytic" means the property of dispersing or dissolving and losing its original form when flushed down a toilet or the like. Therefore, if the sheet-like substrate used in the hydrolytic external sheet agent of the present invention is hydrolytic, the hydrolytic external sheet agent of the present invention can be disposed of by flushing it down a normal toilet or the like. Furthermore, the degree of hydrolyticity of the hydrolytic external sheet agent can be determined, for example, by the hydrolyticity test shown in the examples.

[0062] The material for the sheet-like substrate is not particularly limited as long as it can absorb the aqueous composition and hold a sufficient amount between its fibers or on its surface. It can be appropriately selected according to the purpose, and examples include pulp raw materials such as wood pulp, non-wood pulp, synthetic pulp, and recycled paper pulp; regenerated fibers such as rayon, cupro, Tencel, and lyocell; synthetic fibers such as olefins like polyethylene and polypropylene, polyesters, and polyamides; and nonwoven fabric raw materials made from natural fibers such as cotton and hemp. The sheet-like substrate can be manufactured by appropriately selecting one or more of these raw materials.

[0063] As a sheet-like substrate, a sheet mainly composed of cellulose fibers is preferred from the viewpoint of ease of forming a water-soluble sheet, processability, and cost, and paper and nonwoven fabrics are preferred. Furthermore, considering the viewpoint of good texture and superior usability, nonwoven fabrics containing pulp and rayon are more preferred.

[0064] The basis weight (basis weight) of the sheet-like substrate is set to 20-100 g / m², from the viewpoint of absorbing the above aqueous composition and easily retaining a sufficient amount between its fibers and on its surface. 2 It is 30-80g / m 2 Preferably, it is 40-60 g / m 2 It is preferable that it be so.

[0065] As a method for manufacturing sheet-like substrates, for example, as a method for manufacturing nonwoven fabrics, the following method can be used. That is, a method having two steps: a step of processing loose fibers into a sheet (web formation) and a step of bonding the fibers together to impart strength (web bonding). These steps can be appropriately combined depending on the raw materials, function, and application. Alternatively, it may be manufactured using only one of the steps. Typical web formation methods include dry methods such as carding, airlaid, spunbond, and meltblown methods, and wet methods such as papermaking. Web bonding methods include chemical bonding (adhesive method), thermal bonding (heat bonding method), needle punching, stitch bonding, and spunlace (water flow entanglement method).

[0066] Examples of commercially available sheet-like substrates include pulp / rayon = 80:20 (mass ratio) spunlace nonwoven fabric (basis weight: 50g / m²). 2 60g / m 2 (Manufactured by Daiwabo Polytech Co., Ltd.), 100% cotton spunlace nonwoven fabric (basis weight: 40g / m²) 2 (Manufactured by Nisshinbo Industries Ltd.), Rayon / PE / PP core-sheath fiber (NBFH) = 80 / 20 (mass ratio) spunlace nonwoven fabric (basis weight: 60g / m²) 2 (Manufactured by Daiwabo Co., Ltd.), PET / PP split fiber: Rayon = 60:40 (mass ratio) (Basis weight: 75g / m²) 2Examples include those manufactured by Daiwabo Co., Ltd. From the viewpoint of hydrolysis, pulp / rayon = 80:20 (by mass ratio) spunlace nonwoven fabric is more preferable.

[0067] The sheet-like substrate may or may not contain a water-soluble binder. Examples of water-soluble binders include carboxymethylcellulose, polyvinyl alcohol, starch or its derivatives, hydroxypropylcellulose, sodium alginate, tranto gum, guar gum, xanthan gum, acacia gum, carrageenan, galactomannan, gelatin, casein, albumin, purpuran, polyethylene oxide, viscose, polyvinyl ethyl ether, sodium polyacrylate, sodium polymethacrylate, polyacrylamide, hydroxylated derivatives of polyacrylic acid, and polyvinylpyrrolidone / vinylpyrrolidone vinyl acetate copolymer. However, from the viewpoint of achieving the effects of the present invention, it is preferable that the sheet-like substrate does not contain a water-soluble binder, i.e., is binder-free.

[0068] 3. Packaging material The hydrolyzable topical sheet of the present invention may further include packaging. That is, the hydrolyzable topical sheet of the present invention may be in a form in which a hydrolyzable sheet base material impregnated with an aqueous composition is packaged in packaging. Such packaging is not particularly limited as long as it can package the sheet base material impregnated with an aqueous composition, and can be appropriately selected according to the purpose, but from the viewpoint of preserving the hydrolyzable topical sheet, it is preferable that the packaging is made of a laminated film having at least an aluminum layer. The hydrolyzable topical sheet may be individually packaged, with one sheet packaged in one packaging, or it may be a multi-package type, with multiple sheets packaged in one packaging.

[0069] <Method for manufacturing a water-soluble topical sheet preparation> There are no particular limitations on the method for producing the hydrolyzable topical sheet preparation of the present invention, and a suitable method can be selected depending on the purpose. It can be produced in accordance with the lotions and topical liquids specified in the 17th edition of the Japanese Pharmacopoeia. For example, one method is to impregnate the sheet substrate with the prepared aqueous composition. There are no particular limitations on the impregnation method, and a suitable method can be selected depending on the purpose. For example, one method is to impregnate the sheet substrate by dropping or spraying the aqueous composition onto it, or by immersing the sheet substrate in the aqueous composition.

[0070] The amount of the aqueous composition impregnated into the sheet substrate (impregnation ratio) is such that, from the viewpoint of the transfer of the aqueous composition to the skin, the ratio of the weight of the aqueous composition to the weight of the sheet substrate (weight of the aqueous composition / weight of the sheet substrate) is usually 1 to 20, preferably 3 to 15, and more preferably 5 to 9.

[0071] <Uses of water-soluble topical sheet preparations> The hydrolyzable topical sheet of the present invention has excellent hydrolysis properties, which minimize frictional irritation when used on skin or mucous membranes, and disperse sufficiently with water flow such as that of a flush toilet after use, preventing blockages in sewer pipes, etc., making it suitable for a variety of applications. Furthermore, since the hydrolyzable topical sheet of the present invention allows for the application of active ingredients while wiping away sweat and dirt from the target area, the type of drug contained in the aqueous composition impregnated into the sheet base material can be appropriately selected according to the purpose, and it can be used to improve various symptoms and diseases, making it suitable for use as a pharmaceutical or quasi-drug.

[0072] The symptoms and diseases for which the hydrolyzable topical sheet preparation of the present invention can be used are not particularly limited, but examples include itching, rashes, inflammation, athlete's foot, insect bites, acne, pimples, psoriasis, sweating, atopic dermatitis, allergic dermatitis, anal fissures, hemorrhoids, swelling, bleeding, sores, etc. It can be used particularly for wiping the skin or mucous membranes, and is especially suitable for itching, rashes, inflammation, etc., in delicate areas.

[0073] <Method for Improving Hydrolyzability of External Application Sheet Agent> The present invention also includes a method for improving the hydrolyzability of an external application sheet agent, which is characterized in that an antihistamine agent and / or a local anesthetic agent is formulated in the aqueous composition in an external application sheet agent obtained by impregnating a sheet-like base material having hydrolyzability with the aqueous composition. Conventionally, it has been known that when an aqueous composition containing a pharmaceutical ingredient is impregnated into a hydrolyzable sheet, its hydrolyzability decreases, and a hydrolyzable drug-impregnated sheet has not been developed. However, it has been found that by impregnating a hydrolyzable sheet with an aqueous composition containing an antihistamine agent and / or a local anesthetic agent as a pharmaceutical ingredient, the hydrolyzability of the hydrolyzable sheet base material is remarkably improved. That is, according to the present invention, pharmaceuticals and quasi-drugs having hydrolyzability and being external application sheet agents impregnated with a drug solution have become possible. In addition, the explanations of terms such as "aqueous composition", "hydrolyzable sheet base material", "antihistamine agent", and "local anesthetic agent" in the method for improving hydrolyzability of the present invention can be applied to the respective explanations in the section of the hydrolyzable external application sheet agent.

Examples

[0074] Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to the following examples at all.

[0075] <Preparation of Hydrolyzable External Application Sheet Agent> As described below, a hydrolyzable external application sheet agent was prepared using a non-woven fabric as a hydrolyzable sheet base material.

[0076] As the non-woven fabric, a product manufactured by the spunlace method with pulp: rayon = 8:2, binder-free, and a basis weight of 50 g / m 2 was used. The weight of a 3 cm × 3 cm test piece of the above non-woven fabric was weighed, and each impregnating solution shown in Tables 1 to 3 below was impregnated into the non-woven fabric test piece in an amount of 200 μl to prepare hydrolyzable external application sheet agents of Examples and Comparative Examples.

[0077] <Hydrolyzability Test of Hydrolyzable External Application Sheet Agent> A hydrolysis test was performed on each of the hydrolyzable topical sheet preparations prepared as described above. The hydrolyzable topical sheet preparations of Examples 1 and 2 and Comparative Example 1 were each placed in a 50 ml centrifuge tube, 30 ml of purified water was added to the centrifuge tube, and the tube was vibrated for 45 seconds at a speed of 90 using a vibrator (IWAKI KM Shaker V-DX). After removing the large clumps of nonwoven fabric, the centrifuge tube containing the hydrolyzed nonwoven fabric was filtered through filter paper, the filter paper was dried, and the dry weight of the hydrolyzed nonwoven fabric was determined by weighing it before and after filtration. The improvement rate of hydrolysis in each example, with Comparative Example 1 as the baseline, was calculated using the following formula. The results are shown in Table 1 and Figure 1. <Hydrolysis Rate (%)> = (Dry weight of hydrated nonwoven fabric) / (Initial weight of nonwoven fabric) × 100 Here, the initial weight of the nonwoven fabric refers to the weight of the nonwoven fabric itself before it is impregnated with the liquid. <Improved Hydrolysis Rate (%)> = ((Hydrogenesis rate of hydrolyzable topical sheet agent in each example) / (Hydrogenesis rate of hydrolyzable topical sheet agent in Comparative Example 1) - 1) × 100

[0078] [Table 1]

[0079] As shown in Table 1 and Figure 1, in Examples 1 and 2, where diphenhydramine hydrochloride was added to the aqueous composition impregnated into the hydrolyzable sheet substrate, the hydrolysis of the hydrolyzable sheet was significantly improved. This improvement in hydrolysis increased in a manner dependent on the amount of diphenhydramine hydrochloride added to the aqueous composition impregnated into the hydrolyzable sheet substrate. This effect was completely unexpected.

[0080] <Friction sensation test of water-soluble topical sheet preparations> Test samples (external sheet agents) were prepared by impregnating a 2cm x 6cm test piece of a hydrolyzable sheet base with 0.6g of an aqueous composition having the same composition as used in Comparative Example 1, Example 1, or Example 2. Each test sample was attached to the moving table of a static friction measuring machine (TL201Ts: manufactured by Trinity Labs), and the coefficient of dynamic friction was measured under the conditions of a moving speed of 2mm / sec, a measurement distance of 30mm, and a load of 10g. The average coefficient of dynamic friction was calculated. The friction reduction rate for each test sample was calculated using the following formula. The results are shown in Table 2. <Friction Reduction Rate (%)> = (1 - (Average dynamic friction coefficient of the hydrolyzable topical sheet agent in each example) / (Average dynamic friction coefficient of the hydrolyzable topical sheet agent in Comparative Example 1)) × 100

[0081] [Table 2]

[0082] As shown in Table 2, in Examples 1 and 2, where diphenhydramine hydrochloride was incorporated into the aqueous composition impregnated into the hydrolyzable sheet substrate, it was found that frictional irritation in the drug-impregnated state was reduced. This frictional irritation reduction effect increased in a dependent manner with the amount of diphenhydramine hydrochloride. Such an effect was completely unexpected.

[0083] Next, the topical sheet preparations of Examples 3 to 6 were prepared by impregnating a hydrolyzable sheet base with an aqueous composition having the composition shown in Table 3 below (containing chlorpheniramine maleate as an antihistamine and dibucaine hydrochloride as a local anesthetic). Hydrolysis tests and friction tests were then performed according to the respective test methods described above. As a comparative example, the topical sheet preparation of Comparative Example 1, the same as that in Tables 1 and 2, was used. The results are also shown in Table 3.

[0084] [Table 3]

[0085] As shown in Table 3, in the example of topical sheet preparations in which chlorpheniramine maleate as an antihistamine or dibucaine hydrochloride as a local anesthetic was added to the aqueous composition impregnated into the hydrolyzable sheet substrate, the hydrolysis was significantly improved compared to the comparative example. Furthermore, it was found that frictional irritation in the drug solution-impregnated state was significantly reduced compared to the comparative example. Moreover, this hydrolysis improvement effect and frictional irritation reduction effect increased in a dependent manner depending on the amount of chlorpheniramine maleate or dibucaine hydrochloride.

[0086] From these results, it was found that by including an antihistamine and / or a local anesthetic in the aqueous composition impregnated into the hydrolyzable sheet substrate (nonwoven fabric), the hydrolysis of the hydrolyzable sheet substrate is improved, and frictional irritation in the drug-impregnated state is reduced, making it possible to provide a hydrolyzable topical sheet suitable for use in delicate areas.

[0087] The following are examples of formulations for the hydrolyzable topical sheet preparation of the present invention.

[0088] <Formula 1> Total volume: 100mL Diphenhydramine hydrochloride 1.0g 1,3-Butylene glycol 10g Concentrated glycerin 10g Sodium edetate hydrate 0.1g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0089] <Formulation 2> Total amount: 100mL Diphenhydramine hydrochloride 1.0g Allantoin 0.2g l-menthol 0.05g 1,3-Butylene glycol 15g Concentrated glycerin 5g Hydrogenated polyethylene castor oil 0.5g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0090] <Example Prescription 3> Total volume: 100 mL (pH 4.0) Chlorpheniramine maleate 0.2g Propylene glycol 5.0g Concentrated glycerin 5.0g pH adjuster (appropriate amount) Methyl parahydroxybenzoate 0.2g Purified water remainder

[0091] <Example Prescription 4> Total volume: 100 mL (pH 5.0) Chlorpheniramine maleate 1.0g 1,3-Butylene glycol 5.0g Concentrated glycerin 5.0g pH adjuster (appropriate amount) Methyl parahydroxybenzoate 0.2g Sodium edetate hydrate 0.05g Purified water remainder

[0092] <Example Prescription 5> Total volume: 100 mL (pH 4.5) Dibucaine hydrochloride 0.1g 1,3-Butylene glycol 5.0g Concentrated glycerin 5.0g pH adjuster (appropriate amount) Methyl parahydroxybenzoate 0.2g Sodium edetate hydrate 0.05g Purified water remainder

[0093] <Example Prescription 6> Total volume: 100 mL (pH 6.0) Dibucaine hydrochloride 0.5g 1,3-Butylene glycol 10g pH adjuster (appropriate amount) Methyl parahydroxybenzoate 0.2g D-Pantothenyl alcohol 1.0g Purified water remainder

[0094] <Example Prescription 7> Total volume: 100 mL (pH 5.5) Lidocaine hydrochloride 2.0g 1,3-Butylene glycol 10g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g D-Pantothenyl alcohol 1.0g Purified water remainder

[0095] <Example Prescription 8> Total volume: 100 mL (pH 4.3) Diphenhydramine hydrochloride 1.0g Polyoxyethylene hydrogenated castor oil 0.5g 1,3-Butylene glycol 15g Concentrated glycerin 5g Allantoin 0.2g l-menthol 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0096] <Example Prescription 9> Total volume: 100 mL (pH 4.0) Diphenhydramine hydrochloride 1.0g Dipotassium glycyrrhizinate 0.3g 1,3-Butylene glycol 5g Concentrated glycerin 5g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Purified water remainder

[0097] <Example Prescription 10> Total volume: 100 mL (pH 6.0) Diphenhydramine hydrochloride 2.0g Dipotassium glycyrrhizinate 0.3g 1,3-Butylene glycol 10g Concentrated glycerin 10g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0098] <Example Prescription 11> Total volume: 100 mL (pH 5.5) Ufenamat 5.0g Lidocaine hydrochloride 1.0g Polyoxyethylene hydrogenated castor oil 1.0g 1,3-Butylene glycol 10g Concentrated glycerin 10g pH adjuster (appropriate amount) Methyl parahydroxybenzoate 0.2g Purified water remainder

[0099] <Example Prescription 12> Total volume: 100 mL (pH 4.0) Diphenhydramine hydrochloride 1.0g Lidocaine hydrochloride 2.0g Dipotassium glycyrrhizinate 1.0g 1,3-Butylene glycol 10g Concentrated glycerin 10g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0100] <Example Prescription 13> Total volume: 100 mL (pH 5.0) Diphenhydramine hydrochloride 1.0g Benzethonium chloride 0.1g Ufenamat 5.0g 1,3-Butylene glycol 5.0g Concentrated glycerin 5.0g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0101] <Example Prescription 14> Total volume: 100 mL (pH 5.5) Diphenhydramine hydrochloride 1.0g Lidocaine hydrochloride 2.0g Dipotassium glycyrrhizinate 0.3g Allantoin 0.2g 1,3-Butylene glycol 5.0g Concentrated glycerin 10.0g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0102] <Example Prescription 15> Total volume: 100 mL (pH 5.0) Dibucaine hydrochloride 0.1g Benzalkonium chloride 0.05g Dipotassium glycyrrhizinate 0.3g D-Pantothenyl alcohol 1.0g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0103] <Example Prescription 16> Total volume: 100 mL (pH 5.0) Dibucaine hydrochloride 0.1g Benzalkonium chloride 0.05g Allantoin 0.2g D-Pantothenyl alcohol 1.0g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g Methyl parahydroxybenzoate 0.2g Purified water remainder

[0104] <Example Prescription 17> Total volume: 100 mL (pH 5.5) Lidocaine hydrochloride 3.0g 1,3-Butylene glycol 10g pH adjuster (appropriate amount) Sodium edetate hydrate 0.05g D-Pantothenyl alcohol 1.0g Purified water remainder [Industrial applicability]

[0105] The present invention provides a water-soluble topical sheet impregnated with a medicinal solution that minimizes frictional irritation when used on diseased areas such as delicate areas, and has excellent water-soluble properties that allow the solution to dissipate sufficiently with the water flow of a flush toilet after use, preventing blockages in sewer pipes, etc. The water-soluble topical sheet of the present invention can be used as a drug-impregnated sheet that can apply the active ingredient while wiping away sweat and dirt from the target area, and can improve various symptoms in delicate areas such as itching, rashes, inflammation, anal fissures, hemorrhoids, swelling, bleeding, and sores. Furthermore, the present invention allows for uniform application of the medicinal ingredients to the affected area by applying with a sheet impregnated with a medicinal solution, and because it is easy to dispose of, it can be used in a timely and hygienic manner even when out and about, which is expected to lead to an improvement in quality of life.

Claims

1. In an external sheet preparation in which a sheet-like substrate is impregnated with an aqueous composition, The above-mentioned sheet-like base material is a binder-free nonwoven fabric containing pulp and rayon as materials, having a basis weight of 30 to 80 g / m², being hydrolyzable, and the aqueous composition contains one or more selected from the group consisting of diphenhydramine hydrochloride, chlorpheniramine salt, and dibucaine salt, wherein in the case of diphenhydramine hydrochloride or chlorpheniramine salt, it contains 0.2% to 3.0% by weight of the entire aqueous composition, and in the case of dibucaine salt, it contains 0.05% to 2% by weight of the entire aqueous composition, characterized in that the above-mentioned sheet-like base material contains pulp and rayon as materials, is binder-free, has a basis weight of 30 to 80 g / m², is hydrolyzable, and the aqueous composition contains one or more selected from the group consisting of diphenhydramine hydrochloride, chlorpheniramine salt, and dibucaine salt, and in the case of dibucaine salt, it contains 0.05% to 2% by weight of the entire aqueous composition, characterized in that the above-mentioned sheet-like base material contains pulp and rayon as materials, is binder-free, is a nonwoven fabric having a basis weight of 30 to 80 g / m², is hydrolyzable, and the aqueous composition contains one or more selected from the group consisting of diphenhydramine hydrochloride, chlorpheniramine salt, and dibucaine salt

2. A water-soluble external sheet for delicate areas, as described in claim 1, for wiping skin or mucous membranes.

3. The aqueous composition is pH 3 to 6, according to claim 1 or 2, a hydrolyzable external sheet for delicate areas.

4. The aqueous composition further contains a chelating agent, as described in any one of claims 1 to 3, for use as a water-soluble external sheet for delicate areas.

5. The aqueous composition further contains an organic acid and / or a salt thereof, according to any one of claims 1 to 4, a hydrolyzable external sheet for delicate areas.

6. The water-soluble external sheet agent for delicate areas according to any one of claims 1 to 5, wherein the sheet-like base is a nonwoven fabric with a pulp:rayon ratio of 8:

2.

7. A hydrolyzable external sheet for delicate areas according to any one of claims 1 to 6, which is a pharmaceutical product or quasi-drug.

8. In an external sheet preparation comprising a water-soluble sheet-like substrate impregnated with an aqueous composition, A method for improving the hydrolysis of an external sheet preparation, characterized in that the above-mentioned sheet-like base material is a binder-free nonwoven fabric containing pulp and rayon as materials, with a basis weight of 30 to 80 g / m², and the above-mentioned aqueous composition is blended with one or more selected from the group consisting of diphenhydramine hydrochloride, chlorpheniramine salt, and dibucaine salt, in the case of diphenhydramine hydrochloride or chlorpheniramine salt, in an amount of 0.2% to 3.0% by weight of the entire aqueous composition, and in the case of dibucaine salt, in an amount of 0.05% to 2% by weight of the entire aqueous composition.

9. In an external sheet preparation comprising a water-soluble sheet-like substrate impregnated with an aqueous composition, A method for reducing friction in an external sheet, characterized in that the above-mentioned sheet-like base material is a binder-free nonwoven fabric containing pulp and rayon as materials, with a basis weight of 30 to 80 g / m², and the aqueous composition is blended with one or more selected from the group consisting of diphenhydramine hydrochloride, chlorpheniramine salt, and dibucaine salt, in the case of diphenhydramine hydrochloride or chlorpheniramine salt, in an amount of 0.2% to 3.0% by weight of the entire aqueous composition, and in the case of dibucaine salt, in an amount of 0.05% to 2% by weight of the entire aqueous composition.

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