KR20210065931A - functional patch - Google Patents

Abstract

[Problem] To provide a water-containing patch in which the adhesive force is maintained even after the moisture in the pressure-sensitive adhesive layer has evaporated.
[Solutions] An acrylic acid alkyl ester-based copolymer that is a copolymer of a mixture of monomers consisting of monomer A and monomer B, wherein the monomer A is a monomer having a glass transition temperature (Tg) of 270 K or more when homopolymerized with the monomer A and the monomer B is a monomer that becomes a polymer having a glass transition temperature (Tg) of 220 K or less when the monomer B is homopolymerized, and the ratio of the monomer A to the total mass of the monomer mixture is 30% by mass or more A water-containing patch formed by blending an acrylic acid alkylester-based copolymer in a proportion of 50% by mass or less in a pressure-sensitive adhesive layer.

Description

functional patch

The present invention relates to a water-based patch, and more particularly, to a water-based patch that maintains high adhesive force even after the moisture in the pressure-sensitive adhesive layer evaporates and has low skin irritation.

A patch using an adhesive base containing water (referred to as a water-based patch in the present specification), which is also generally referred to as a "pigment", is a solid layer (adhesive layer) containing an active ingredient, such as a drug, of a nonwoven fabric. It is a kind of patch provided on the support body of a back. Because the adhesive base containing water is used in the solid layer, the patch has low skin irritation, but the adhesive strength is weak. In particular, the adhesive strength decreases with the volatilization of moisture in the solid layer over time, so that it is peeled off the skin. Easy was the problem.

In order to solve this problem, an emulsion (also called emulsion) base in which an acrylic acid alkyl ester copolymer, known as a component constituting a non-aqueous (also called hydrophobic or lipophilic) pressure-sensitive adhesive, is dispersed is used as a solid of an aqueous patch. The technique of mix|blending with a layer (pressure-sensitive adhesive layer) is known.

For example, in Patent Document 1, 1% of a methyl acrylate / 2-ethylhexyl acrylate copolymer resin emulsion (trade name: Nikasol TS-620, Nippon Carbide Kogyo Co., Ltd.) is blended in a gel patch base (solid). A patch (comparative product) is disclosed.

Patent Document 2, for the purpose of providing a water-based patch that can achieve adhesion and re-adhesive force expression at the time of sticking for a long time, suppression of reduction in curing and softness accompanying loss of moisture, and suppression of breakage of the support during peeling. , Water-dispersible surfactant 0.01% by mass or more and 10.0% by mass or less, and methyl acrylate/2-ethylhexyl acrylate copolymer 5.0% by mass or more and 10% by mass or less of copper with respect to the entire composition for aqueous external patch. A patch for external use is disclosed.

In Patent Document 3, the problem is to provide a patch material having sufficient adhesion even when the water content of the gel patch decreases over time, and 2.5 to 10 times the mass of the neutralized product of polyacrylic acid and the neutralized product (5 to 10 times the mass (5 to 10 on a solid basis) 25% by mass) of methyl acrylate/2-ethylhexyl acrylate copolymer and polyacrylic acid are disclosed.

Patent Document 4 discloses a patch containing poly(methyl acrylate/2-ethylhexyl acrylate) and a surfactant such as polyethylene glycol fatty acid ester for the purpose of providing a patch material capable of peeling the release liner with less force. have.

The point obtained by using the adhesive composition containing 1.5 weight% of acrylic resin emulsion (brand name Nikazole TS-620) and 6.2 weight% of sodium polyacrylate in patent document 5 is disclosed.

Japanese Laid-Open Patent Publication No. 9-208462 Japanese Patent Publication No. 5650684 Specification Japanese Patent Publication No. 5921779 Specification International Publication No. 2016/104227 Japanese Laid-Open Patent Publication No. 2002-104957

As mentioned above, in order to improve the adhesive durability of a water-containing patch, it is known to mix|blend acrylic acid alkylester copolymers, such as a methyl acrylate / 2-ethylhexyl acrylate copolymer, with an adhesive layer. However, when the blending amount of the copolymer is small, for example, in the patch disclosed in Patent Document 1, the result is that both initial tack and continuous adhesiveness are lacking from a small amount of blending, and the desired effect of improving adhesive strength is not obtained. Moreover, even when the compounding quantity is increased, it cannot be said that the adhesive force in especially after volatilization of the water|moisture content in an adhesive layer is fully satisfactory compared with a tape agent.

The present inventors, as a result of earnest research in order to solve the above problems, have a glass transition temperature (Tg) of 270 K or more when homopolymerized as an acrylic acid alkyl ester copolymer in the pressure-sensitive adhesive layer of the water-containing patch. After the water in the pressure-sensitive adhesive layer evaporates by blending a copolymer containing 30 to 50% by mass of a monomer and a monomer having a Tg of 220K or less when homopolymerized so that the total amount of both monomers becomes 100% by mass, In addition, it discovered that adhesive force did not fall but improved rather, and skin irritation was also found low, and this invention was completed.

That is, the present invention provides an aqueous patch comprising a support, an adhesive layer provided on the support, and a release liner,

The said adhesive layer relates to the water-containing patch which contains the following 1) - 6) components as essential.

1) Acrylic hydrophilic adhesive

2) an acrylic acid alkyl ester-based copolymer, which is a copolymer of a mixture of monomers consisting of monomer A and monomer B,

The monomer A is a monomer that becomes a polymer having a glass transition temperature (Tg) of 270K or higher when the monomer A is homopolymerized,

The monomer B is a monomer that becomes a polymer having a glass transition temperature (Tg) of 220 K or less when the monomer B is homopolymerized,

With respect to the total mass of the said monomer mixture, the ratio of the said monomer A is a ratio of 30 mass % or more and 50 mass % or less, The acrylic acid alkylester copolymer

3) organic solvent

4) crosslinking agent

5) organic acids

6) water

And according to this invention, the following embodiment is provided further.

1. The above monomer A is (meth)acrylic acid alkyl esters such as methyl acrylate, methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, i-butyl methacrylate, t-butyl methacrylate, acetic acid At least one kind of monomer selected from the group consisting of vinyl, acrylonitrile, acrylamide and styrene,

The above-mentioned water-containing patch, wherein the monomer B is at least one type of monomer selected from the group consisting of butyl acrylate, 2-ethylhexyl acrylate, octyl acrylate and isononyl acrylate.

2. The monomer A is at least one kind of monomer selected from the group consisting of methyl acrylate, methyl methacrylate, ethyl methacrylate and n-butyl methacrylate,

The above-mentioned monomer B is at least one type of monomer selected from the group consisting of 2-ethylhexyl acrylate and butyl acrylate.

3. The water-based patch further comprising an active ingredient.

According to the present invention, it is a copolymer of a monomer mixture consisting of a monomer A, which becomes a polymer having a glass transition temperature (Tg) of 270 K or higher when homopolymerized, and a monomer B, which becomes a polymer having a Tg of 220 K or less when homopolymerized, By blending the acrylic acid alkyl ester copolymer in which the ratio of the monomer A is 30% by mass or more and 50% by mass or less with respect to the total mass of the monomer mixture in the pressure-sensitive adhesive layer of the water-containing patch, moisture in the pressure-sensitive adhesive layer is evaporated. It is possible to provide a water-based patch that can maintain adhesive strength even after application, has low skin irritation, and has no adhesion between solids and can be re-applied to the skin.

As described above, in order to increase the durability of the adhesive force of the aqueous patch, an acrylic acid alkyl ester copolymer such as methyl acrylate/2-ethylhexyl acrylate copolymer resin emulsion (trade name: Nikazole TS-620, Nippon Carbide Kogyo Co., Ltd.) A proposal to mix|blend this with an adhesive layer, and the proposal which increases this compounding quantity are made|formed. However, by the proposals so far, even when the compounding quantity of a copolymer is increased, it cannot be said that the adhesive force especially after volatilization of the water|moisture content in an adhesive layer (after water volatilization) is sufficient compared with a tape agent.

In the above subject, the present inventors, paying attention to the type of monomer constituting the acrylic acid alkylester-based copolymer, which has not been studied so far, and particularly the mixing ratio thereof, at the time of watering and after drying (after water volatilization) was evaluated for adhesion. Then, paying attention to the glass transition temperature (Tg) of the homopolymer composed of the monomer, a monomer having a Tg of 270K or higher when homopolymerized and a monomer having a Tg of 220K or lower when homopolymerized are combined. And by employing an acrylic acid alkylester copolymer in which the blending ratio of the monomers having a Tg of 270K or more of the homopolymer is 30% by mass or more and 50% by mass or less of all monomers, even when the blending amount of the copolymer is small, It was discovered that it became a patch which was excellent in the adhesive force at the time of drying as well as the time of hydrating, and became a patch with low skin irritation.

Hereinafter, the structure of the water-containing patch of this invention is demonstrated.

The water-containing patch of the present invention (hereinafter, also simply referred to as a "patch") consists of a support, an adhesive layer provided on the support, and a release liner.

The shape of the preparation portion comprising the patch, particularly the support, and the pressure-sensitive adhesive layer provided on the support is not particularly limited, and a quadrangle (square, rectangle, etc.), a quadrangle (trapezoid, rhombus, etc.), a polygon, a circle, an ellipse, a semicircle, Various shapes can be selected according to an affixing location, such as a triangular shape, a crescent shape, and the shape which combined these.

In addition, the area of a patch (particularly said preparation part) can be determined suitably, for example, it can consider the quantity of the active ingredient mix|blended with an adhesive layer, etc., and can set it as the range of 2-300 cm<2>, for example.

[Adhesive layer]

The water-containing adhesive of the present invention is characterized in that, in addition to the hydrophilic acrylic pressure-sensitive adhesive described later, an acrylic acid alkyl ester copolymer constituting the non-aqueous acrylic pressure-sensitive adhesive is also blended with the water-based pressure-sensitive adhesive layer. .

As an adhesive generally used for the adhesive layer (solid layer) of an aqueous adhesive, hydrophilic acrylic adhesives such as polyacrylic acid, partially neutralized polyacrylic acid, sodium polyacrylate, and N-vinylacetamide/sodium acrylate copolymer resin are widely used. is being used From the viewpoint of having high affinity with the hydrophilic acrylic pressure-sensitive adhesive described above and uniformly kneading it, as a non-aqueous pressure-sensitive adhesive to be blended with the water-based pressure-sensitive adhesive layer of the water-containing patch, acrylic and methacrylic emulsion type pressure-sensitive adhesives are preferably blended.

In addition, in this specification, "acrylic acid alkyl ester copolymer" is intended to include both alkyl esters of acrylic acid and methacrylic acid, and "acrylic pressure sensitive adhesive" also includes both acrylic pressure sensitive adhesive and methacrylic pressure sensitive adhesive. done with the intention of doing

<Acrylic acid alkyl ester copolymer>

The acrylic acid alkyl ester copolymer (non-aqueous adhesive base) constituting the non-aqueous acrylic pressure-sensitive adhesive is a component that exhibits adhesive strength, and the alkyl ester has 2 to 9 carbon atoms, and the glass transition temperature (Tg) when homopolymerized. A monomer that becomes a polymer of -55 ° C. (218 K) or lower, a monomer that becomes a polymer with a Tg of 8 to 165 ° C (281 to 438 K) when homopolymerized as a component for improving cohesion, and further, if necessary It is a copolymer composed of a monomer having a functional group such as a crosslinking point such as a carboxyl group or a hydroxyl group (an example of the monomer is given in Table 1)

The acrylic acid alkyl ester copolymer used in the present invention comprises a monomer A that becomes a polymer having a glass transition temperature (Tg) of 270K or higher when homopolymerized, and a polymer having a glass transition temperature (Tg) of 220K or lower when homopolymerized. It is a copolymer of the monomer mixture consisting of the monomer B to be used. The upper limit of the glass transition temperature Tg of the homopolymer of the monomer A is approximately 500K, and the lower limit of the glass transition temperature Tg of the homopolymer of the monomer B is approximately 200K.

In addition, a homopolymer obtained by polymerizing only a monomer exhibiting adhesive strength has high adhesive strength but is considered to have weak mechanical strength, and a copolymer having improved mechanical strength by copolymerization with a monomer that improves cohesive strength is generally used as an adhesive.

As mentioned in Table 1 above, as a monomer exhibiting adhesive force, in the present invention, butyl acrylate and 2-ethyl acrylate having a Tg of 220 K or less when the monomer is homopolymerized (homopolymer) as monomers with higher adhesive strength in the present invention. Hexyl, octyl acrylate, isononyl acrylate and the like are used. Among these, butyl acrylate and 2-ethylhexyl acrylate are preferable, and among them, 2-ethylhexyl acrylate having a history of use as a pharmaceutical additive and having high adhesive strength (low Tg of homopolymer) can be preferably used.

In addition, the monomers listed in Table 1 are mentioned as the monomer for improving cohesive strength (the Tg of the homopolymer is 270K or more), and among these, methyl acrylate, methyl methacrylate, ethyl methacrylate, and n-butyl methacrylate are preferable. , In the present invention, particularly preferred is methyl acrylate, which has high mechanical strength and does not significantly reduce adhesiveness (the Tg of the homopolymer is relatively low).

In addition, as mentioned in the prior art, as a commercially available alkyl acrylic acid ester copolymer used for a patch, Nippon Carbide Co., Ltd. Nikazole (registered trademark) TS-620 (methyl acrylate 2-ethyl acrylate) hexyl copolymer resin emulsion). The methyl acrylate/2-ethylhexyl acrylate copolymer resin emulsion is a product of the Pharmaceutical Additives Regulations.

The present inventors have found that, in Nikazole TS-620 (methyl acrylate 2-ethylhexyl acrylate copolymer resin emulsion), which has been used in water-containing adhesives so far, the desired adhesive force is not obtained, particularly from the pressure-sensitive adhesive layer. After water volatilizes, in view of the point that adhesive force falls, the change of the copolymerization ratio of the said copolymer was examined.

And in the above copolymer, as a result of various changes in the polymerization ratio of the monomer whose Tg of the homopolymer is 270K or more, that is, methyl acrylate, as shown in the results of Examples to be described later, the Tg of the homopolymer is 270K or more It was confirmed for the first time that the system using the copolymer used as the compounding quantity of the monomer (methyl acrylate etc.) used as 30 mass % or more can maintain adhesive force also at the time of the water volatilization of an adhesive layer. In addition, when the compounding quantity of the monomer (methyl acrylate etc.) which becomes Tg of a homopolymer of 270K or more exceeds 50 mass %, the emulsion aggregates and precipitates and it becomes difficult to redisperse, The upper limit was made into 50 mass % or less.

In the pressure-sensitive adhesive layer of the water-containing patch of the present invention, the blending amount of the alkyl acrylic acid ester-based copolymer (in the case of an emulsion, the amount converted to the solid content) is, for example, 0.1 based on the total mass of the pressure-sensitive adhesive layer of the water-containing patch. It can be set as mass % or more and 30 mass % or less, 1.0 mass % or more and 15 mass % or less, 5.0 mass % or more and 10 mass % or less.

In addition, the compounding ratio with the acrylic hydrophilic adhesive mentioned later is, for example, in mass ratio, acrylic acid alkylester type copolymer:acrylic-type hydrophilic adhesive =10:1-1:10, copper=5:1-1:5, copper =3:1 to 1:2, copper =2:1 to 1:1, etc.

<Active ingredient>

The active ingredient is optionally contained in the pressure-sensitive adhesive layer in the water-containing patch of the present invention. In the case where the active ingredient is not included, the water-based patch of the present invention can be used as a covering material for skin in a keloid state, a cushioning material for protecting cataracts, blisters, and the like.

When the pressure-sensitive adhesive layer contains an active ingredient, it contains a physiologically active substance. The physiologically active substance is not particularly limited as long as it has percutaneous absorption and exhibits pharmacological activity when administered to the body, and may be a water-soluble substance or a fat-soluble substance.

Examples of the physiologically active substance include nonsteroidal anti-inflammatory agents such as felbinac, flurbiprofen, diclofenac, diclofenac sodium, methyl salicylate, glycol salicylate (ethylene glycol salicylate), indomethacin, ketoprofen, ibuprofen, or Esters thereof; Antihistamines such as diphenhydramine and chlorpheniramine; Analgesics such as aspirin, acetaminophen, ibuprofen, and loxoprofen sodium; Local anesthetics such as lidocaine and dibucaine; Muscle relaxants such as master methonium chloride; Clotri Antifungal agents such as mazole; Antihypertensive agents such as clonidine; Vasodilators such as nitroglycerin and isosorbide nitrate; Vitamins such as vitamin A, vitamin E (tocopherol), tocopherol acetate, vitamin K, octothiacin and riboflavin butyrate, prostaglandins and scopolamine, fentanyl, red pepper extract, nonylic acid vanillylamide, capsaicin, l-menthol, and dl-camphor. A physiologically active substance may be used individually by 1 type, and may be used in combination of 2 or more type.

Although the compounding quantity of the said active ingredient can be suitably determined according to the kind, For example, 0.1 mass % or more and 30 mass % or less, or 0.5 mass % or more and 15 mass % based on the total mass of the adhesive layer of an aqueous adhesive patch. can be done below.

<Acrylic hydrophilic adhesive>

The pressure-sensitive adhesive layer of the water-containing patch of the present invention contains an acrylic hydrophilic pressure-sensitive adhesive.

As said acrylic hydrophilic adhesive, a water-soluble (meth)acrylic-type polymer is mentioned. A water-soluble (meth)acrylic polymer is a polymer obtained by superposing|polymerizing the (meth)acryloyl group containing monomer which has a functional group (hydrophilic group) which has water solubility, and exhibits adhesiveness by mix|blending with water in an adhesive layer. Examples of the water-soluble (meth)acrylic polymer include homopolymers such as polyacrylic acid and a neutralized product of polyacrylic acid; and copolymers such as N-vinylacetamide/sodium acrylate copolymer resin.

The polyacrylic acid neutralized product may be a completely neutralized polyacrylic acid product, a partially neutralized polyacrylic acid product, or a mixture thereof. The neutralized polyacrylic acid means a polyacrylic acid salt, and for example, sodium salt, potassium salt, calcium salt, ammonium salt or the like can be used.

The compounding quantity of the acrylic hydrophilic adhesive can be, for example, 0.1 mass % or more and 10 mass % or less, and 1 mass % or more and 8 mass % or less on the basis of the total mass of the adhesive layer of an aqueous adhesive patch.

<Organic solvent>

The organic solvent blended in the pressure-sensitive adhesive layer of the water-containing patch of the present invention may have a role of assisting the dissolution of active ingredients such as drugs and preventing the active ingredients from precipitating from the pressure-sensitive adhesive layer. Examples of such an organic solvent (dissolution aid) include crotamiton; N-methyl-2-pyrrolidone; Macrogol 400 (polyethylene glycol), polyalkylene glycol such as polybutylene glycol; diethyl adipate , fatty acid esters such as diisopropyl adipate, diethyl sebacate, diisopropyl sebacate, isopropyl myristate, isopropyl palmitate, and oleyl oleate; sorbitan esters such as polyoxyalkylene fatty acid esters and polyhydric alcohols such as 1,3-butanediol; dimethylformamide; and dimethyl sulfoxide. These can be used individually by 1 type or in combination of 2 or more types.

The compounding quantity of the organic solvent can be, for example, 0.1 mass % or more and 20 mass % or less on the basis of the total mass of the adhesive layer of an aqueous adhesive patch.

<crosslinking agent>

As a crosslinking agent mix|blended with the adhesive layer of the water-containing patch of this invention, a polyvalent metal salt is mentioned, Among them, the polyvalent metal compound containing aluminum is mentioned. Examples include hydroxides such as aluminum hydroxide and alumina magnesium hydroxide; aluminum chloride, aluminum sulfate, aluminum potassium sulfate, aluminum glycinate (dihydroxyaluminumaminoacetal), dihydroxyaluminum aminoacetate, synthetic aluminum silicate, dry aluminum hydroxide Regular salts or basic salts of inorganic or organic acids such as gel, kaolin, and aluminum stearate; double salts such as aluminum alum; aluminates such as sodium aluminate; inorganic aluminum complex salts and organic aluminum chelate compounds; synthetic hydrotalcite, silicic acid and polyvalent metal compounds such as magnesium aluminate and magnesium metasilicate aluminate, and these may be used alone or in combination of two or more thereof.

The blending amount of the crosslinking agent may be appropriately selected in consideration of the degree of crosslinking that may be a cause of residual adhesiveness to the skin or adhesiveness. Based on the total mass of the pressure-sensitive adhesive layer of the aqueous patch, for example, 0.01% by mass or more and 6.0% by mass or less, 0.01% by mass or more and 4.0% by mass or less, or 0.01% by mass or more and 2.0% by mass or less. can

<Organic Acid>

Examples of the organic acid to be blended in the pressure-sensitive adhesive layer of the aqueous patch of the present invention include citric acid, lactic acid, tartaric acid, gluconic acid, glycolic acid, malic acid, fumaric acid, metasulfonic acid, maleic acid, acetic acid, and the like. A combination of the above can be used.

The compounding quantity of an organic acid can be made into the range of 0.01 mass % or more and 5 mass % or less on the basis of the total mass of the adhesive layer of an aqueous adhesive patch, for example.

<water>

As described above, the aqueous patch of the present invention contains water (moisture) in the pressure-sensitive adhesive layer. In this specification, "water" contained in an adhesive layer includes water contained in the form of an emulsion, aqueous solution, etc. as well as being separately added as water at the time of forming an adhesive layer. Although the compounding quantity of water is not specifically limited, For example, 10 mass % or more and 90 mass % or less, 15 mass % or more and 70 mass % or less, 20 mass % or more 50 mass based on the total mass of the adhesive layer of an aqueous adhesive patch. % or less. In addition, this water compounding quantity is the value before sticking of a patch at the time of patch preparation, and it does not apply when water volatilizes from an adhesive layer with progress of sticking.

<Other optional ingredients>

In the adhesive layer of the water-containing patch of the present invention, as other optional components, a water-soluble high molecular compound, a surfactant, a wetting agent, a stabilizer, an antioxidant, an inorganic powder, a colorant, a fragrance, a preservative, etc. A component that can be generally blended into the pressure-sensitive adhesive layer of the patch) or the non-aqueous patch (tape) can be blended. These arbitrary components can be used individually or in combination of 2 or more types, respectively.

<Water-soluble high molecular compound>

Examples of the water-soluble high molecular compound include gelatin, agar, polyvinyl alcohol, polyvinyl pyrrolidone, propylene carbonate, carboxymethyl cellulose, carmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, Methylcellulose, sodium alginate, maleic anhydride copolymer, and carrageenan are mentioned. These can be used individually by 1 type or in combination of 2 or more types suitably.

The blending amount of the water-soluble high molecular compound is, for example, 1.0 mass% or more and 30 mass% or less, 3.0 mass% or more and 20 mass% or less, or 5.0 mass% or more on the basis of the total mass of the pressure-sensitive adhesive layer of the water-containing patch usually. It can be set as the range of 20 mass % or less.

<Surfactant>

Examples of the surfactant include polyoxyethylene such as polyoxyethylene monolaurate, polyoxyethylene monostearate, polyoxyethylene monooleate, polyethylene glycol distearate, polyethylene glycol diolate, and polypropylene glycol diolate. Fatty acid ester; Sorbitan monocaprylate, sorbitan monolaurate, sorbitan monomyristate, sorbitan monopalmitate, sorbitan monostearate, sorbitan distearate, sorbitan tristearate, sorbitan monool sorbitan fatty acid esters such as lactate, sorbitan trioleate, sorbitan monosesquioleate, and ethylene oxide adducts thereof; polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monopalmitate, polyoxy Polyoxyethylene sorbitans such as ethylene sorbitan monostearate, polyoxyethylene sorbitan tristearate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan trioleate, and polyoxyethylene sorbitan triisostearate Fatty acid ester; polyoxyethylene dodecyl ether (polyoxyethylene lauryl ether), polyoxyalkylene lauryl ether, polyoxyethylene tridecyl ether, polyoxyalkylene tridecyl ether, polyoxyethylene myristyl ether, polyoxyethylene polyoxyethylene alkyl ethers such as cetyl ether, polyoxyethylene oleyl ether, polyoxyethylene stearyl ether, polyoxyethylene behenyl ether, polyoxyethylene-2-ethylhexyl ether, and polyoxyethylene isodecyl ether; polyoxyethylene alkyl phenol ethers such as ethylene styrenated phenyl ether, polyoxyethylene nonyl phenyl ether, polyoxyethylene distyrene phenyl ether, and polyoxyethylene tribenzyl phenyl ether; glycerin fatty acid esters such as glycerin monostearate and glycerin monooleate ; Nonionic surfactants, such as polyethylene glycol, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, and lecithin, are mentioned. These can be used individually by 1 type or in combination of 2 or more types suitably.

The compounding quantity of these surfactant can be made into the range of 0.001 mass % or more and 10 mass % or less, 0.01 mass % or more and 5 mass % or less on the basis of the total mass of the adhesive layer of an aqueous adhesive patch.

<Wetting agent>

In the pressure-sensitive adhesive layer of the water-containing patch of the present invention, a wetting agent (also referred to as a moisturizing agent) can be blended in order to suppress evaporation of moisture over time. Examples of the wetting agent include polyhydric alcohols such as concentrated glycerin, D-sorbitol, ethylene glycol, propylene glycol, polyethylene glycol, polypropylene glycol, liquid paraffin, 1,3-propanediol, 1,4-butanediol, maltitol, and xylitol. can be heard These can be used individually by 1 type or in combination of 2 or more types suitably.

The blending amount of the wetting agent is, for example, 1.0% by mass or more and 70% by mass or less, 5.0% by mass or more and 60% by mass or less, or 10% by mass or more and 60% by mass based on the total mass of the pressure-sensitive adhesive layer of the water-containing patch usually. % or less.

<stabilizer>

In the pressure-sensitive adhesive layer of the water-containing patch of the present invention, a stabilizer may be blended in order to improve storage stability of the active ingredient or the like to light (especially ultraviolet), heat or oxygen.

Examples of the stabilizer include: sodium edetate (disodium salt of ethylenediamine tetraacetic acid); antioxidants such as dibutylhydroxytoluene (BHT); ultraviolet absorbers such as benzoylmethane derivatives; and the like.

The compounding quantity of a stabilizer can be normally made into the range of 0.01 mass % or more and 1 mass % or less on the basis of the total mass of the adhesive layer of an aqueous adhesive patch.

<Inorganic Powder>

As inorganic powder, calcium carbonate, magnesium carbonate, silicate, zinc oxide, titanium oxide, magnesium sulfate, calcium sulfate, etc. can be mix|blended.

[Support]

Examples of the support used for the water-containing patch of the present invention include a support having flexibility such as a film, a nonwoven fabric, a Japanese paper, a cotton fabric, a knitted fabric, a woven fabric, and a laminate composite of a nonwoven fabric and a film. These supports are preferably made of a flexible material capable of closely adhering to the skin and capable of following the movement of the skin, and a material capable of suppressing the occurrence of dermatitis or the like after sticking for a long time. As a material of these supports, for example, polyethylene, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, polystyrene, nylon, cotton, acetate rayon, rayon, rayon/polyethylene terephthalate composite, polyacrylic Ronitrile, polyvinyl alcohol, acrylic polyurethane, ester polyurethane, ether polyurethane, styrene-isoprene-styrene copolymer, styrene-butadiene-styrene copolymer, styrene-ethylene-propylene-styrene copolymer, styrene-butadiene rubber, an ethylene-vinyl acetate copolymer, cellophane, etc. as essential components are mentioned.

Moreover, the difference with skin color at the time of sticking can be decreased by coloring support bodies, such as cloth, with color tones, such as a skin color with a coloring agent. Moreover, the form of the plastic film excellent in transparency is employable from the point of being easy to look into the color tone of the skin under application.

The thickness of the support is usually about 5 µm to 1 mm. When the support is cloth, the thickness is preferably 50 µm to 1 mm, more preferably 100 to 800 µm, still more preferably 200 to 700 µm. When the support is a plastic film, the thickness is preferably 10 to 300 µm, more preferably 12 to 200 µm, still more preferably 15 to 150 µm. When the thickness of a support body is very thin about 5 micrometers - about 30 micrometers, since the handleability as a patch improves, when a peelable carrier film layer is provided on the surface opposite to the adhesive layer formed on the support body, it is preferable. However, when the thickness of the support body is smaller than 5 μm, the strength and handleability of the patch decrease, sticking to the skin becomes difficult, tearing by contact with other members, etc., or in a short time due to contact with water such as bathing. It may peel from the skin. In addition, when the thickness of the support is too large (more than 1 mm), the patch becomes difficult to follow the movement of the skin, and it becomes easy to form a peeling trigger in the periphery of the patch, so that it peels off from the skin in a short time, or There is a fear that a sense of incongruity increases.

Moreover, when a support body is a film, for the purpose of improving anchoring property of an adhesive and a support body, you may perform a process, such as a sandblasting process, a corona treatment, to one side or both surfaces of a support body.

Moreover, in order to make it easy to take out from a wrapping material, you may provide unevenness|corrugation on the single side|surface or both surfaces of a support body by methods other than sandblasting.

[Releasable Liner]

The release liner (also referred to as release layer and release paper) used in the water-containing patch of the present invention is preferably a material in which the drug in the pressure-sensitive adhesive layer is not easily absorbed and adsorbed, and is commonly used in the technical field of the patch. Can be used.

For example, polyester (polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, etc.), polypropylene (unstretched, stretched, etc.), polyethylene, polyurethane, polyvinyl chloride, polystyrene, etc. plastic film; Paper or synthetic paper such as , glassine paper, parchment paper, kraft paper; peeling processed paper coated with a release agent having release performance such as silicone resin or fluororesin on the plastic film, paper or synthetic paper, synthetic fiber, etc.; aluminum foil; these Colorless or colored sheets, such as laminated paper which laminated|stacked the film and sheet|seat in various ways, and the laminated release processed paper which coated the release agent on the said laminated paper are mentioned. Moreover, the release liner can also provide the unevenness|corrugation so that it may be easy to take out from a wrapping material.

Although the thickness of these release liners is not specifically limited, Usually, 10 micrometers - 1 mm, for example, 20 micrometers - 500 micrometers, Preferably it is the range of 40 micrometers - 200 micrometers.

The release liner can have a rectangular shape, a rectangular shape, a circular shape, or the like, and can have a shape with rounded corners as desired. The size may be the same shape as the size of the support in the adhesive preparation, or may be slightly enlarged. The release liner may be composed of one sheet or a plurality of divided sheets, and the perforated line may be composed of a straight line, a broken line, or a perforated line, or may be in a state where some of the release liners overlap.

[Method for producing hydrous patch]

The water-containing patch of the present invention can be produced using a conventionally known method. For example, as an example, it can be manufactured through the following steps i) or ii).

i) The process of coating an adhesive layer forming composition on a support body, and forming an adhesive layer, and the process of bonding together the adhesive layer formed on the support body, and a release liner.

ii) The process of coating the pressure-sensitive adhesive layer-forming composition on the release liner to form the pressure-sensitive adhesive layer, and the step of bonding the pressure-sensitive adhesive layer formed on the release liner and the support body together.

Moreover, the thickness of the said adhesive layer is although it does not specifically limit, Usually, 10 micrometers - 1000 micrometers, for example, it can be set as about 20 micrometers - 800 micrometers.

The pressure-sensitive adhesive layer-forming composition includes various components included in the pressure-sensitive adhesive layer described above: an active ingredient, an acrylic hydrophilic pressure-sensitive adhesive, an acrylic acid alkylester-based copolymer, an organic solvent, a crosslinking agent, an organic acid and water, and further, any other optional It is a semi-solid composition which may contain a component.

In addition, the water-based patch of the present invention is characterized in that the adhesive force is maintained when hydrated and dried (after water volatilization), and is also a patch with low skin irritation.

Here, skin irritation can be evaluated by, for example, the individual average value (average PII) of the primary skin irritation index (PII) by the Draize method, and the patch of the present invention can be, for example, 1.40 or less. .

The P.I.I. (Primary Irritation Index) by the Draize method is an evaluation method using a rabbit lesion. Specifically, the specimen (test substance) is affixed to the back of the rabbit, the specimen is removed after a predetermined time, and the reaction (the state of erythema and the size of the edema) of the application site after the lapse of a predetermined time is evaluated in 5 steps from 0 to 4 It is a value shown as a sum of two evaluation values (the average value when there are multiple judgment times), and it is evaluated by calculating the individual average value (average PII) in consideration of the evaluated individual differences.

In the present invention, after the specimen (water-based patch) is affixed for 24 hours, after removal of the specimen, the affixed location is observed after a predetermined time has elapsed, the irritant response is scored, and 30 minutes and 24 hours after removal Based on the scoring of the irritant response in the skin, the average PII is calculated and skin irritation is evaluated.

Example

Hereinafter, the present invention will be described in more detail by way of Examples, but the present invention is not limited to these Examples.

<Production of Patches>

In the following procedure, the patch of an Example and a comparative example was manufactured.

Example 1:

1.5 parts by mass of polyvinyl alcohol was dissolved in 20 parts by mass of purified water (aqueous phase).

Next, 1.25 parts by mass of ethylene glycol salicylate and 1 part by mass of L-menthol were dissolved by adding 1 part by mass of Macrogol (registered trademark) 400 (manufactured by Sanyo Kasei Industrial Co., Ltd.) (oil phase).

Further, 4 parts by mass of the partially neutralized polyacrylic acid, 4 parts by mass of carmellose sodium, and 0.25 parts by mass of dihydroxyaluminum aminoacetate were uniformly dispersed in 25 parts by mass of concentrated glycerin (glycerin phase).

In a stirrer, aqueous phase, methyl acrylate / 2-ethylhexyl acrylate copolymer emulsion (31.1 mass % of methyl acrylate in the copolymer, polyoxyethylene nonylphenyl ether (30EO) trace amount in the emulsion) 7 parts by mass, sodium edetate hydrate 0.20 mass part and 30 mass parts of D-sorbitol 70% aqueous solution were injected|thrown-in in this order, and it was made to disperse|distribute or melt|dissolve uniformly. Here, the oil phase and the glycerin phase were introduced in this order, and uniformly kneaded. Furthermore, 1 mass part of lactic acid was added, and after mass correction|amendment so that the total mass might be 100 mass parts with purified water, it kneaded|mixed uniformly under degassing conditions, and the adhesive layer formation composition of Example 1 was obtained.

The obtained pressure-sensitive adhesive layer-forming composition was rolled on the silicone side of a liner (one-sided silicone-treated PET (75 μm)) with a rolling mill adjusted to a slit width of 0.5 mm, and a knit support (polyester) was laminated, followed by 1 at 50°C. aged for a week. After aging, it was punched into an arbitrary shape to obtain the formulation of Example 1.

Example 2:

The formulation of Example 2 was prepared in the same manner as in Example 1 except that the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1% by mass) was changed to an emulsion having a blending amount of methyl acrylate of 40.8% by mass. got it

Example 3:

The formulation of Example 3 was prepared in the same manner as in Example 1, except that the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1% by mass) was changed to an emulsion having a blending amount of methyl acrylate of 46.7% by mass. got it

Example 4:

Methyl acrylate 2-ethylhexyl acrylate copolymer emulsion, methyl methacrylate 2-ethylhexyl acrylate copolymer emulsion (methyl methacrylate blending amount in the copolymer 30.0 mass %) 10 parts by mass (the solid content conversion value of the copolymer is 4.34 mass parts) except having changed to Example 1, it carried out similarly to Example 1, and obtained the formulation of Example 4.

Example 5:

Methyl acrylate 2-ethylhexyl acrylate copolymer emulsion, ethyl methacrylate 2-ethylhexyl acrylate copolymer emulsion (30.0 mass % of ethyl methacrylate compounding amount in the copolymer) 10 parts by mass (the solid content conversion value of the copolymer is 4.14 mass parts) except having changed to Example 1, it carried out similarly to Example 1, and obtained the formulation of Example 5.

Example 6:

The methyl acrylate 2-ethylhexyl acrylate copolymer emulsion was mixed with 10 parts by mass of n-butyl acrylate 2-ethylhexyl methacrylate copolymer emulsion (30.0 mass % of n-butyl methacrylate compounding amount in the copolymer) (copolymer of The formulation of Example 6 was obtained like Example 1 except having changed the solid content conversion value into 4.34 mass parts).

Example 7:

Methyl acrylate 2-ethylhexyl acrylate copolymer emulsion, methyl acrylate n-butyl acrylate copolymer emulsion (30.0 mass % methyl acrylate blending amount in the copolymer) 10 parts by mass (converted solid content of the copolymer is 4.54 parts by mass) Except having changed, it carried out similarly to Example 1, and obtained the formulation of Example 7.

Example 8:

Methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1 mass %) is replaced with an emulsion having a blending amount of methyl acrylate of 46.7 mass %, and the blending amount is 5 parts by mass (converted solid content of the copolymer is 2.95 parts by mass) ), except that the formulation of Example 8 was obtained in the same manner as in Example 1.

Example 9:

Methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1 mass %) is replaced with an emulsion having a blending amount of methyl acrylate of 46.7 mass %, and the blending amount is 10 parts by mass (converted solid content of the copolymer is 5.9 parts by mass) ), except that the formulation of Example 9 was obtained in the same manner as in Example 1.

Example 10:

The methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1 mass %) was replaced with an emulsion having a blending amount of methyl acrylate of 46.7 mass %, and the blending amount was 12 parts by mass (converted solid content of the copolymer was 7.08 parts by mass). ), except that the formulation of Example 10 was obtained in the same manner as in Example 1.

Example 11:

The methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1 mass %) was replaced with an emulsion containing 46.7 mass % of methyl acrylate, and the blending amount was 15 parts by mass (converted solid content of the copolymer was 8.85 parts by mass). ), except that the formulation of Example 11 was obtained in the same manner as in Example 1.

Example 12:

Methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (31.1 mass % of methyl acrylate compounding amount) is replaced with an emulsion containing 46.7 mass % of methyl acrylate, and the compounding amount is 20 parts by mass (converted solid content of the copolymer is 11.8 parts by mass) ), except that the formulation of Example 12 was obtained in the same manner as in Example 1.

Comparative Example 1:

The formulation of Comparative Example 1 was prepared in the same manner as in Example 1, except that the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1% by mass) was changed to an emulsion having a blending amount of methyl acrylate of 14.7% by mass. got it

Comparative Example 2:

The formulation of Comparative Example 2 was prepared in the same manner as in Example 1, except that the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (mixing amount of methyl acrylate 31.1 mass%) was changed to an emulsion having a blending amount of methyl acrylate of 27.0 mass%. got it

Comparative Example 3:

A formulation of Comparative Example 3 was obtained in the same manner as in Comparative Example 1, except that the blending amount of the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (methyl acrylate blending amount 14.7 mass%) was changed to 10 mass parts (10 mass%). .

Comparative Example 4:

A formulation of Comparative Example 4 was obtained in the same manner as in Comparative Example 1, except that the blending amount of the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (methyl acrylate blending amount 14.7 mass %) was changed to 15 mass parts (15 mass %). .

Comparative Example 5:

A formulation of Comparative Example 5 was obtained in the same manner as in Comparative Example 1 except that the blending amount of the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (methyl acrylate blending amount 14.7 mass%) was changed to 20 mass parts (20 mass%). .

Comparative Example 6:

A formulation of Comparative Example 6 was obtained in the same manner as in Comparative Example 1, except that the blending amount of the methyl acrylate 2-ethylhexyl acrylate copolymer emulsion (methyl acrylate blending amount 14.7 mass%) was changed to 25 mass parts (25 mass%). .

In addition, in the blending amount of the copolymer emulsion in Examples 1 to 3, Comparative Examples 1 and 2, the solid content conversion value of the copolymer is 4.13 based on the mass of all components constituting the pressure-sensitive adhesive layer. As for mass %, Example 4 and Example 6 are 4.34 mass % of copper, Example 5 and Example 7 are 4.14 mass % of copper, Example 8 is 2.95 mass % of copper, Example 9 is copper 5.90 mass %, Example 10 Silver copper 7.08 mass %, Example 11 8.85 mass % copper, Example 12 11.80 mass % copper, Comparative Example 3 5.90 mass % copper, Comparative Example 4 8.85 mass % copper, Comparative Example 5 11.80 mass % copper , Comparative Example 6 is 14.75 mass % copper.

Reference Example 1, Reference Example 2:

As the formulation of Reference Example 1, a commercially available tape agent (Feitas (registered trademark) 5.0, Hisamitsu Pharmaceutical Co., Ltd., lot number: SC08T) was used as the formulation of Reference Example 1, and as the formulation of Reference Example 2, a commercially available patchwork agent (Banterinco and It used for the various tests mentioned later using the new mini pad (VANTELIN KOWA NEW MINI-PAD), Kowa Co., Ltd., lot number: NA640).

Test Example 1 (Adhesive Force Test)

For each formulation of Examples 1 to 12, Comparative Examples 1 to 6, and Reference Example 1 and Reference Example 2, the initial (hereinafter referred to as "water time", the formulations of Examples and Comparative Examples immediately after production, The formulation of the Reference Example is immediately after opening the package of the product), and when dried overnight at 50° C. (hereinafter referred to as “drying”, in which all formulations have the liner peeled off (the pressure-sensitive adhesive layer is exposed) at 50° C. The adhesive strength of the inclined vortex of overnight holding) was performed according to the General Test Method of the Japanese Pharmacopoeia 6.12 Adhesion Test Method 3.2 Inclined Vortech Test Method.

The obtained results are shown in Tables 2 and 3.

Test Example 2 (Solid-to-solid peelability and re-adhesiveness test)

Examples 1 to 12, Comparative Examples 1 to 6, and each formulation of Reference Example 1 and Reference Example 2 were evaluated for inter-solid peelability and re-adhesion properties.

The obtained result is put together in Table 2 and Table 3, and is shown.

1) Peelability between solids

The liner of each formulation cut into the size of 5 cm x 5 cm was peeled off, each formulation was folded in two, adhesive layers were firmly bonded together, and it stopped for 30 second. Then, the bonded part was peeled and the following reference|standard evaluated (N=3).

(circle): peels easily

△: peels but deforms

x: does not peel

2) Reattachability

The liner of each formulation (10 cm x 7 cm) was peeled off, and it affixed on the inside of a human upper arm. After 30 seconds had elapsed, it peeled and affixed again to the other part of forearm, and the following reference|standard evaluated (N=3).

○: Re-adhesive

△: weak re-adhesiveness

×: No re-adhesiveness

<Test result>

As shown in Table 2, among the monomers constituting the acrylic acid alkylester-based copolymer, the compounding amount of the monomer A having a Tg of 270K or more of the homopolymer of the monomer, that is, acrylic acid in the methyl acrylate 2-ethylhexyl acrylate copolymer resin The compounding quantity of methyl, the compounding quantity of methyl methacrylate in the methyl methacrylate-acrylic acid 2-ethylhexyl copolymer resin, the compounding quantity of ethyl methacrylate in the ethyl methacrylate acrylate 2-ethylhexyl copolymer resin, methacryl The compounding amount of n-butyl methacrylate in the acid n-butyl acrylate 2-ethylhexyl copolymer resin and the compounding amount of methyl acrylate in the methyl acrylate n-butyl acrylate copolymer resin are 30% by mass or more, a resin emulsion using For the formulations of Examples 1 to 9, the vortex adhesive strength immediately after production (when hydrated) was slightly lower than that of a commercially available tape agent (Reference Example 1) and a commercially available patch agent (Reference Example 2) (see Table 3). However, the vortex adhesive force at the time of drying (drying at 50 degreeC overnight) showed the adhesive force substantially equivalent to the commercially available tape agent. In addition, as shown in the results of Example 3 and Examples 8 to 12, as the compounding amount of methyl acrylate/ethylhexyl acrylate copolymer resin (methyl acrylate compounding amount: 46.7 mass%) was increased, immediately after production (water Adhesive force increased in both of time) and drying, and in particular, in Examples 10 to 12, the adhesive force was equal to or higher than that of the commercially available products shown in Reference Example 1 and Reference Example 2, even when hydrated. In addition, in any of the Examples, even when the pressure-sensitive adhesive layers are adhered to each other, they can be easily peeled off, re-adhesiveness is also confirmed, and their performance is maintained even when the compounding amount of the acrylic acid alkyl ester-based copolymer is increased.

On the other hand, the formulations (Comparative Examples 1 and 2) in which the compounding amount of the monomer A, that is, the compounding amount of methyl acrylate in the methyl acrylate 2-ethylhexyl acrylate copolymer resin is less than 30% by mass (Comparative Examples 1 and 2), showed that the vortex adhesive strength at the time of drying was higher in Example 1 The result was lower than -12. Moreover, as mentioned above, when the compounding quantity of methyl acrylate exceeded 50 mass %, the emulsion aggregated and precipitated, redispersion became difficult, and the upper limit of the compounding quantity was 50 mass %.

Moreover, with respect to the methyl acrylate 2-ethylhexyl acrylate copolymer resin in which the compounding quantity of the methyl acrylate employ|adopted in Comparative Example 1 is 14.7 mass %, the compounding quantity of the said copolymer resin is 7 mass % - 25 mass % (as solid content, 4.13 mass %) The formulations (Comparative Example 1, Comparative Examples 3 to 6) increased in the range of -14.75 mass %) resulted in lower vortex adhesive strength than the formulations of Examples 1 to 3 both when hydrated and when dried.

In addition, the formulations of Comparative Examples 1 to 4 were evaluated for the same inter-solid releasability and re-adhesive properties as the formulations of Examples, but the formulations of Comparative Examples 5 and 6 had both inter-solid releasability and re-adhesive properties. The evaluation did not reach the formulations of Examples, and as the blending amount of the acrylic acid alkylester-based copolymer increased, the performance thereof tended to deteriorate rather.

And when the formulation of the reference example 1 which is a commercially available formulation adhered adhesive layers, it did not peel off, and it was evaluated that it does not have re-sticking property.

Moreover, in the formulation of the reference example 2, after making adhesive layers adhere, it peeled, but it brought the result which distortion generate|occur|produced, and although re-sticking, it became weak adhesiveness.

From the above results, among the monomers constituting the acrylic acid alkyl ester copolymer, the compounding amount of the monomer A (methyl acrylate, etc.) of the homopolymer of the monomer is 270 K or more is 30 to 50 mass %, the acrylic acid alkyl ester copolymer (acrylic acid By employing methyl/acrylic acid 2-ethylhexyl copolymer resin, etc.), it is confirmed that a formulation having excellent adhesion not only when hydrated but also when dry is obtained, and a formulation with easy inter-solid releasability and re-adhesion property is obtained. Confirmed.

Test Example 3 (Skin Primary Irritation Index Test)

The skin primary irritation index (P.I.I.) test based on the Draise method was performed by the following method. Further, the details of the Draize method, Draize J.H., Woodard, G. and Calvery, H.O. (1944): Methods for the study of irritation and Toxicity of substances applied topically to the skin and mocous membranes, J. Pharmacol Exp. Ther., 82:377-390).

The formulations of Examples 3 and Comparative Example 1 were punched with a diameter of 15 mmφ, the release liner was peeled off, and the white rabbit (17 weeks old, male, JW) (N=3) treated with bristle and body hair was affixed on the back of the affixed formulation. CATHEREEP (transparent adhesive film, Nichiban Co., Ltd.) which has moisture permeability was affixed from the top of the said formulation so that the whole might be covered.

After 24 hours of application, the cathelip and the preparation were peeled off, the application site of the preparation was wiped clean with purified water, the skin condition of the application site was observed 30 minutes after peeling and the lapse of 24 hours, and the draze shown in Table 4 Scoring of the stimulus response was performed on the basis of

In addition, based on the scoring values 30 minutes and 24 hours after peeling off the formulation, the average scoring value after 30 minutes or 24 hours, and the average skin primary irritation index (PII), which is the individual average value from each individual's primary skin irritation index (PII) ( average PII) was obtained.

In addition, as a positive control, DNBC (2,4-dinitrochloro-benzene), as a formulation of Reference Example 3, a commercially available patch (Nobinobi Salonsip (registered trademark) FH Ongam, Hisamitsu Pharmaceutical Co., Ltd.), As the formulation of Reference Example 4, a commercially available gel patch (HALIX (registered trademark) 55EX Ongam, Lion Co., Ltd.) was used and the skin primary irritation index test was similarly performed, 30 minutes or 24 hours later. The scoring average value, the skin primary irritation index (PII) and the skin primary irritation index (mean PII) of each individual were obtained.

The obtained results are shown in Table 5.

As shown in Table 5, the average primary irritation index (average P.I.I.) in the formulations of Example 3, Comparative Example 1, Reference Example 3 and Reference Example 4 was 0.7 to 1.0, indicating mild irritation.

On the other hand, the average primary stimulation index (average P.I.I.) in the positive control was 2.8, indicating moderate stimulation.

From the results of the above examples, according to the present invention, according to the present invention, among the monomers constituting the acrylic acid alkylester-based copolymer, the monomer A (methyl acrylate, etc.) content of the homopolymer of the monomer having a Tg of 270K or more is 30 to 50% by mass of alkyl acrylate By blending an ester-based copolymer (methyl acrylate, 2-ethylhexyl acrylate copolymer resin, etc.) in the pressure-sensitive adhesive layer of the water-containing patch, it is possible to provide a patch with low skin irritation while maintaining high adhesion when hydrated and dried. It has been confirmed that

Claims (4)

An aqueous patch comprising a support, an adhesive layer provided on the support, and a release liner,
An aqueous patch comprising the pressure-sensitive adhesive layer essentially containing the following 1) to 6) components.
1) Acrylic hydrophilic adhesive
2) It is an acrylic acid alkyl ester-based copolymer, which is a copolymer of a mixture of monomers consisting of monomer A and monomer B,
The monomer A is a monomer that becomes a polymer having a glass transition temperature (Tg) of 270 K or higher when the monomer A is homopolymerized,
The monomer B is a monomer that becomes a polymer having a glass transition temperature (Tg) of 220 K or less when the monomer B is homopolymerized,
With respect to the total mass of the said monomer mixture, the ratio of the said monomer A is a ratio of 30 mass % or more and 50 mass % or less, The acrylic acid alkylester type copolymer.
3) organic solvent
4) crosslinking agent
5) organic acids
6) water According to claim 1,
The monomer A is methyl acrylate, methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, i-butyl methacrylate, t-butyl methacrylate, vinyl acetate, acrylonitrile, acrylamide and styrene At least a kind of monomer selected from the group consisting of,
The aqueous patch wherein the monomer B is at least one kind of monomer selected from the group consisting of butyl acrylate, 2-ethylhexyl acrylate, octyl acrylate and isononyl acrylate. 3. The method of claim 2,
The monomer A is at least one kind of monomer selected from the group consisting of methyl acrylate, methyl methacrylate, ethyl methacrylate and n-butyl methacrylate,
The above-mentioned monomer B is at least one kind of monomer selected from the group consisting of 2-ethylhexyl acrylate and butyl acrylate. 4. The method according to any one of claims 1 to 3,
Further, an aqueous patch containing an active ingredient.