Patch

Abstract

Provided is a patch which has a preservative effect even without containing a preservative, and which has good adhesiveness. The present invention relates to an adhesive patch provided with a support and a paste layer laminated on the support, in which the paste layer contains flurbiprofen, a partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, a methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, and water, and the paste layer does not contain a preservative. Preferably, on the basis of the total mass of the paste layer, the content of the polyacrylic acid part neutralized substance is 5%-8% by mass, the content of the starch grafted acrylic acid 300 is 4%-6% by mass, the content of the sodium carboxymethyl cellulose is 0.1%-1% by mass, and the content of the methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion is 5%-10% by mass.

Description

Technical Field

[0001] This invention relates to a patch. More specifically, this invention relates to a patch containing flurbiprofen. Background Technology

[0002] In the context of adhesive patches, patches using an aqueous matrix are called poultices, while patches using a nearly water-free matrix are called adhesive tapes.

[0003] Because poultices contain water, there is a risk of microbial growth within the preparation, raising concerns about quality and hygiene. To prevent these problems, preservatives such as parabens can be used. However, depending on the dosage, preservatives can sometimes cause skin conditions, especially in individuals with sensitive skin; even small amounts can trigger skin irritation. Therefore, it is desirable to minimize or eliminate the use of preservatives.

[0004] Furthermore, poultices, due to their water content, have lower adhesiveness than adhesive tapes and are less irritating to the skin. Conversely, they are prone to peeling off the skin during application. Therefore, a poultice with improved skin adhesion has been developed. For example, a poultice comprising a support layer and an adhesive layer has been proposed, wherein the adhesive layer contains at least one selected from the group consisting of carboxymethyl cellulose and pharmacologically acceptable salts thereof, silicic anhydride, a drug, and a water-soluble polymer, and the silicic anhydride has a cumulative volume of 50% of its particle size D. 50 The size ranges from 0.2 to 9.0 μm (Patent Document 1).

[0005] Existing technical documents

[0006] Patent documents

[0007] Patent Document 1: Japanese Patent No. 7292560 Summary of the Invention

[0008] (a) Technical problems to be solved

[0009] The purpose of this invention is to solve the above-mentioned problems and disadvantages. Specifically, the purpose of this invention is to provide a patch that has a preservative effect even without preservatives and has good adhesion.

[0010] (II) Technical Solution

[0011] In order to solve the above-mentioned technical problems, the inventors of the present invention conducted in-depth research and found that by making the aqueous paste layer containing an adhesive component composed of a partially neutralized polyacrylic acid compound, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, and a methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion in a patch having a support and a paste layer laminated on the support, the patch has a preservative effect even without preservatives and has good adhesion, thus completing the present invention.

[0012] That is, the present invention relates to the patches described below [1] to [6]. [1]

[0014] A patch comprising a support and a cream layer laminated on the support, wherein,

[0015] The paste layer contains flurbiprofen, partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, and water.

[0016] This paste layer does not contain preservatives. [2]

[0018] According to the patch described in [1], wherein, based on the total mass of the ointment layer,

[0019] The content of the polyacrylic acid neutralizer is 5% to 8% by mass.

[0020] The content of starch-grafted acrylic acid 300 is 4% to 6% by mass.

[0021] The sodium carboxymethyl cellulose content is 0.1% to 1% by mass.

[0022] The content of the methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion is 5% to 10% by mass. [3]

[0024] According to the patch described in [1] or [2], the ointment layer comprises crotamiton, isopropyl myristate, peppermint oil, l-menthol, polysorbate 80, sorbitan sesquioleate, titanium dioxide, concentrated glycerin, tartaric acid, talc and dried aluminum hydroxide gel. [4]

[0026] According to the patch described in [3], the ointment layer contains the following components (1) to (17):

[0027] 0.1%~0.5% by mass of (1) flurbiprofen,

[0028] 0.1%~0.5% by mass of (2) Cromiton,

[0029] 1%~2% by mass of (3) isopropyl myristate,

[0030] 0.05%~0.5% by mass of (4) peppermint oil,

[0031] 0.2%~1% by mass of (5)-l-menthol,

[0032] 0.3%~0.7% by mass of (6) polysorbate 80,

[0033] 0.1%~0.3% by mass of (7) sorbitan sesquioleate,

[0034] 0.1%~0.3% by mass of (8) titanium dioxide,

[0035] 25%~35% by mass of (9) concentrated glycerol,

[0036] 5%~8% by mass of (10) polyacrylic acid partial neutralizer,

[0037] 4%~6% by mass of (11) starch grafted with acrylic acid 300,

[0038] 0.1%~1% by mass of (12) sodium carboxymethyl cellulose,

[0039] 5%~10% by mass of (13) methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion,

[0040] 0.5% to 1.0% by mass of (14) tartaric acid,

[0041] 3%~7% by mass of (15) talc,

[0042] 0.03%~0.08% by mass of (16) dried aluminum hydroxide gel,

[0043] 33%~55% (17%) of purified water,

[0044] The total mass of components (1) to (17) is 100. [5]

[0046] According to the patch described in [4], the patch is a patch having a padding layer on the ointment layer. [6]

[0048] According to the patch described in [5], the support is polyethylene terephthalate nonwoven fabric.

[0049] The liner layer is a polypropylene film.

[0050] (III) Beneficial Effects

[0051] According to the present invention, it is possible to provide a patch that has anti-corrosion effect even without preservatives and has good adhesion. Attached Figure Description

[0052] Figure 1 A schematic diagram of the apparatus used in the initial tack test of the inclined rolling ball in Test Example 2(1) is shown. Detailed Implementation

[0053] [Patch]

[0054] This invention relates to a patch having a support body and a cream layer laminated on the support body, wherein...

[0055] The paste layer contains flurbiprofen, partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, and water.

[0056] This paste layer does not contain preservatives.

[0057] <Ointment Layer>

[0058] The patch of the present invention comprises flurbiprofen, a partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, a methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, and water, and contains no preservatives.

[0059] Flurbiprofen is the ingredient that exerts its analgesic / anti-inflammatory effects.

[0060] The content of flurbiprofen is not particularly limited as long as it can exert analgesic / anti-inflammatory effects, but it is preferably 0.1% to 0.5% by mass, more preferably 0.2% to 0.4% by mass, based on the total mass of the ointment layer.

[0061] The adhesive component, composed of a partially neutralized polyacrylic acid compound, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, and a methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, is a component that can exert a preservative effect even without preservatives, and also a component that imparts adhesiveness to the paste layer.

[0062] "Preservative effect" refers to the function or property of preventing the growth of bacteria and fungi and thus preventing spoilage. Specifically, it refers to the judgment criteria of "Item IB" in the reference information "Test Method for Preservative Effect" of the Sixteenth Revised Japanese Pharmacopoeia.

[0063] In partially neutralized polyacrylic acid compounds, a portion of the acid groups of the polyacrylic acid is neutralized by alkali metals such as sodium and potassium, or by ammonium ions. Partially neutralized polyacrylic acid compounds can be used alone or in combination of two or more.

[0064] In this invention, as a partial neutralizer of polyacrylic acid, it is preferred that a portion of the acid groups of polyacrylic acid is neutralized by sodium.

[0065] Based on the total mass of the paste layer, the content of the polyacrylic acid partial neutralizer is preferably 5% to 8% by mass, more preferably 5% to 7% by mass.

[0066] Based on the total mass of the paste layer, the content of starch-grafted acrylic acid 300 is preferably 4% to 6% by mass.

[0067] Based on the total mass of the paste layer, the content of sodium carboxyl methyl cellulose is preferably 0.1% to 1% by mass, more preferably 0.3% to 0.7% by mass.

[0068] Based on the total mass of the paste layer, the content of the methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion is preferably 5% to 10% by mass, more preferably 5% to 7% by mass.

[0069] There are no particular restrictions on the water, but water that has undergone purification processes such as ion exchange, distillation, and filtration is preferred, and "purified water" as described in the Japanese Pharmacopoeia is even more preferred.

[0070] Based on the total mass of the paste layer, the water content is preferably 33% to 55% by mass, more preferably 40% to 50% by mass.

[0071] Preferably, the ointment layer of the patch of the present invention comprises:

[0072] Flurbiprofen and water, and

[0073] Based on the total mass of this paste layer

[0074] It is a 5% to 8% by mass of polyacrylic acid partial neutralizer.

[0075] 4% to 6% by mass of starch-grafted acrylic acid 300

[0076] Sodium carboxymethyl cellulose, at 0.1% to 1% by mass, and

[0077] It is a 5% to 10% by mass emulsion of methyl acrylate-2-ethylhexyl acrylate copolymer resin.

[0078] Furthermore, more preferably, the ointment layer of the patch of the present invention comprises:

[0079] Flurbiprofen and water, and

[0080] Based on the total mass of this paste layer

[0081] It is a 5% to 7% by mass neutralized polyacrylic acid fraction.

[0082] 4% to 6% by mass of starch-grafted acrylic acid 300

[0083] Sodium carboxymethyl cellulose at a concentration of 0.3% to 0.7% by mass, and

[0084] It is a 5% to 7% by mass emulsion of methyl acrylate-2-ethylhexyl acrylate copolymer resin.

[0085] Further preferably, the ointment layer of the patch of the present invention comprises:

[0086] Based on the total mass of this paste layer

[0087] Flurbiprofen at concentrations of 0.1% to 0.5% by mass.

[0088] It is a 5% to 8% by mass of polyacrylic acid partial neutralizer.

[0089] 4% to 6% by mass of starch-grafted acrylic acid 300

[0090] Sodium carboxymethyl cellulose, ranging from 0.1% to 1% by mass.

[0091] It is a 5%~10% by mass emulsion of methyl acrylate-2-ethylhexyl acrylate copolymer resin, and

[0092] It consists of 33% to 55% water by mass.

[0093] The ointment layer of the patch of the present invention is particularly preferred to include:

[0094] Based on the total mass of this paste layer

[0095] Flurbiprofen at concentrations of 0.2% to 0.4% by mass.

[0096] It is a 5% to 7% by mass neutralized polyacrylic acid fraction.

[0097] 4% to 6% by mass of starch-grafted acrylic acid 300

[0098] Sodium carboxymethyl cellulose, at a concentration of 0.3% to 0.7% by mass.

[0099] A 5%~7% by mass emulsion of methyl acrylate-2-ethylhexyl acrylate copolymer resin, and

[0100] It consists of 40% to 50% water by mass.

[0101] The ointment layer of the patch of the present invention may further include additives such as solubilizers, surfactants, colorants, wetting agents, pH adjusters, matrix and crosslinking agents, without impairing the effects of the present invention.

[0102] Examples of solubilizers include clomiphene, isopropyl myristate, peppermint oil, L-menthol, and diethylene glycol monoethyl ether. One solubilizer can be used alone, or two or more can be used in combination.

[0103] In this invention, the solubilizer is preferably selected from at least one of the group consisting of clomiphene, isopropyl myristate, peppermint oil and l-menthol, and more preferably a combination of clomiphene, isopropyl myristate, peppermint oil and l-menthol.

[0104] Based on the total mass of the paste layer, the content of the solubilizer (when two or more solubilizers are used, the total content) is preferably 1.35% to 4.0% by mass, more preferably 1.35% to 3.2% by mass.

[0105] When using a combination of clomiphene, isopropyl myristate, peppermint oil, and l-menthol, based on the total mass of the ointment layer, the preferred content is 0.1% to 0.5% by mass, the preferred content is 1% to 2% by mass, the preferred content is 0.05% to 0.5% by mass, and the preferred content is 0.2% to 1% by mass. More preferably, the preferred content is 0.1% to 0.3% by mass, the preferred content is 1% to 2% by mass, the preferred content is 0.05% to 0.3% by mass, and the preferred content is 0.2% to 0.6% by mass.

[0106] Examples of surfactants include, for example, polysorbate 80 [polyoxyethylene sorbitan monooleate (20E.O.)], polysorbate 60 [polyoxyethylene sorbitan monostearate], and polysorbate 20 [polyoxyethylene sorbitan monolaurate (20E.O.)]; sorbitan sesquioleate, sorbitan monooleate, and sorbitan sesquistearate. Surfactants can be used alone or in combination of two or more.

[0107] In this invention, the surfactant is preferably selected from at least one of the group consisting of polysorbate 80 and sorbitan sesquioleate, and more preferably a combination of polysorbate 80 and sorbitan sesquioleate.

[0108] Based on the total mass of the paste layer, the content of surfactant (when two or more surfactants are used, their total content) is preferably 0.4% to 1.0% by mass, more preferably 0.4% to 0.9% by mass.

[0109] When using a combination of polysorbate 80 and sorbitan sesquioleate, based on the total mass of the paste layer, it is preferable that the content of polysorbate 80 is 0.3% to 0.7% by mass and the content of sorbitan sesquioleate is 0.1% to 0.3% by mass, more preferably that the content of polysorbate 80 is 0.3% to 0.6% by mass and the content of sorbitan sesquioleate is 0.1% to 0.3% by mass.

[0110] Examples of colorants include titanium dioxide, iron oxide yellow, and ferric oxide. A single colorant can be used alone, or two or more can be used in combination.

[0111] In this invention, titanium dioxide is preferred as a colorant.

[0112] Based on the total mass of the paste layer, the content of the colorant (when using two or more colorants, the total content) is preferably 0.1% to 0.3% by mass.

[0113] Examples of wetting agents include concentrated glycerin, sorbitol solution, ethylene glycol, propylene glycol, polyethylene glycol, and polypropylene glycol. A single wetting agent can be used alone, or two or more can be used in combination.

[0114] In this invention, concentrated glycerin is preferred as a wetting agent.

[0115] Based on the total mass of the paste layer, the content of the wetting agent (when two or more wetting agents are used, their total content) is preferably 25% to 35% by mass, more preferably 25% to 32% by mass.

[0116] Examples of pH adjusters include tartaric acid, citric acid, oxalic acid, lactic acid, and acetic acid. A single pH adjuster can be used alone, or in combination of two or more.

[0117] In this invention, tartaric acid is preferred as a pH adjuster.

[0118] Based on the total mass of the paste layer, the content of the pH adjuster (when using two or more pH adjusters, the total content) is preferably 0.5% to 1.0% by mass, more preferably 0.5% to 0.7% by mass.

[0119] Examples of suitable matrices include talc, hydrated silica, and soft silica anhydrides. A single matrix can be used, or two or more matrices can be used in combination.

[0120] In this invention, talc is preferably used as the matrix.

[0121] Based on the total mass of the paste layer, the content of the matrix (when using two or more matrices, the total content) is preferably 3% to 7% by mass, more preferably 4% to 7% by mass.

[0122] Examples of crosslinking agents include dried aluminum hydroxide gel, aluminum dihydroxyaminoacetate, and magnesium aluminum hydroxide. One crosslinking agent can be used alone, or two or more can be used in combination.

[0123] In this invention, dried aluminum hydroxide gel is preferred as a crosslinking agent.

[0124] Based on the total mass of the paste layer, the content of the crosslinking agent (when two or more crosslinking agents are used, the total content) is preferably 0.03% to 0.08% by mass, more preferably 0.03% to 0.06% by mass.

[0125] From the perspective of demonstrating a significant antiseptic effect even without preservatives and good adhesion, the ointment layer of the patch of the present invention preferably contains, in addition to flurbiprofen, partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, methyl acrylate-2-ethylhexyl acrylate copolymer emulsion and water, clomiphene, isopropyl myristate, peppermint oil, l-menthol, polysorbate 80, sorbitan sesquioleate, titanium dioxide, concentrated glycerin, tartaric acid, talc and dried aluminum hydroxide gel.

[0126] Furthermore, more preferably, the ointment layer of the patch of the present invention contains the following components (1) to (17). Wherein, the total of components (1) to (17) is 100% by mass.

[0127] 0.1%~0.5% by mass of (1) flurbiprofen

[0128] 0.1%~0.5% of (2) Cromiton

[0129] 1%~2% by mass of (3) isopropyl myristate

[0130] 0.05%~0.5% by mass of (4) peppermint oil

[0131] 0.2%~1% by mass of (5)l-menthol

[0132] 0.3%~0.7% by mass of (6) polysorbate 80

[0133] 0.1%~0.3% by mass of (7) sorbitan sesquioleate

[0134] 0.1%~0.3% by mass of (8) titanium dioxide

[0135] 25%~35% by mass of (9) concentrated glycerol

[0136] 5%~8% by mass of (10) polyacrylic acid partial neutralizer

[0137] 4%~6% by mass of (11) starch-grafted acrylic acid 300

[0138] 0.1~1% by mass of (12) sodium carboxymethyl cellulose

[0139] 5%~10% by mass of (13) methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion

[0140] 0.5% to 1.0% by mass of (14) tartaric acid

[0141] 3%~7% by mass of (15) talc

[0142] 0.03%~0.08% by mass of (16) dried aluminum hydroxide gel

[0143] 33%~55% (17) of purified water

[0144] Furthermore, it is even more preferable that the ointment layer of the patch of the present invention contains the following components (1) to (17). Wherein, the total of components (1) to (17) is 100% by mass.

[0145] 0.2%~0.4% by mass of (1) flurbiprofen

[0146] 0.1%~0.3% of (2) Cromiton

[0147] 1%~2% by mass of (3) isopropyl myristate

[0148] 0.05%~0.3% by mass of (4) peppermint oil

[0149] 0.2%~0.6% by mass of (5)-l-menthol

[0150] 0.3%~0.6% by mass of (6) polysorbate 80

[0151] 0.1%~0.3% by mass of (7) sorbitan sesquioleate

[0152] 0.1%~0.3% by mass of (8) titanium dioxide

[0153] 25%~32% (9) concentrated glycerol

[0154] 5%~7% by mass of (10) polyacrylic acid partial neutralizer

[0155] 4%~6% by mass of (11) starch-grafted acrylic acid 300

[0156] 0.3%~0.7% by mass of (12) sodium carboxymethyl cellulose

[0157] 5%~7% by mass of (13) methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion

[0158] 0.5%~0.7% by mass of (14) tartaric acid

[0159] 4%~7% by mass of (15) talc

[0160] 0.03%~0.06% by mass of (16) dried aluminum hydroxide gel

[0161] 40%~50% (17) purified water

[0162] <Support>

[0163] As the support for the patch of the present invention, nonwoven fabrics, woven fabrics, knitted fabrics, films, sheets, and laminates thereof can be used.

[0164] Materials used as supports include, for example, polyesters such as polyethylene terephthalate or polybutylene terephthalate; and polyolefins such as polyethylene or polypropylene.

[0165] In this invention, polyethylene terephthalate nonwoven fabric is preferably used as the support.

[0166] <Insulating Layer (Release Layer)>

[0167] The patch of the present invention may also have a padding layer laminated on the above-mentioned paste layer. By laminating the padding layer, the adhesive layer can be protected until the patch is used.

[0168] As a backing layer, for example, films and laminates thereof made of polyolefins such as polyethylene or polypropylene; polyesters such as polyethylene terephthalate or polybutylene terephthalate can be listed.

[0169] In this invention, a polypropylene film is preferred as the liner layer.

[0170] In addition, the side of the padding layer that contacts the ointment layer can be treated with silicone or fluorine. This makes it easier to peel the padding layer off the ointment layer when using the patch.

[0171] [Manufacturing method of the patch]

[0172] The patch of the present invention can be manufactured using conventionally known methods. As an example of a method for manufacturing the patch of the present invention (e.g., a patch comprising a support, a paste layer laminated on the support, and a padding layer laminated on the paste layer), a manufacturing method including steps (a) to (c) below can be cited:

[0173] (a) A process for preparing a paste-forming composition by mixing flurbiprofen, a partially neutralized polyacrylic acid compound, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, a methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, water, and additives as needed.

[0174] (b) A process of spreading the paste layer forming composition prepared in step (a) onto the surface of a film or the like constituting a liner layer, thereby forming a paste layer on the liner layer; or a process of spreading the paste layer forming composition prepared in step (a) onto the surface of a support, thereby forming a paste layer on the support; and

[0175] (c) A process of bonding the paste layer formed on the liner layer in step (b) to the support, or bonding the paste layer formed on the support in step (b) to the film or the like constituting the liner layer.

[0176] Example

[0177] The present invention will now be described in detail based on embodiments, but the present invention is not limited to these embodiments.

[0178] [Example 1]

[0179] According to the proportions shown in Table 1, flurbiprofen, cromatathan, isopropyl myristate, peppermint oil, l-menthol, polysorbate 80, sorbitan sesquioleate, titanium dioxide, concentrated glycerin, partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, tartaric acid, talc, dried aluminum hydroxide gel, and purified water were mixed to prepare a paste-forming composition.

[0180] The obtained paste-forming composition is uniformly spread on the demolded surface of a 30 μm thick polypropylene film at a rate of 12 g per patch (10 cm × 14 cm) to form a paste layer. Next, a polyethylene terephthalate nonwoven fabric is laminated onto this paste layer to obtain the patch (adhesive).

[0181] [Table 1]

[0182]

[0183] [Experiment Example 1: Corrosion Protection Effect Test]

[0184] Using the ointment layer of the patch obtained in Example 1, the preservative effect of the patch obtained in Example 1 was evaluated according to the reference information "Test Method for Preservative Effect" in the Sixteenth Revised Japanese Pharmacopoeia. The results are shown in Table 2.

[0185] [Table 2]

[0186]

[0187] Based on the results shown in Table 2, the patch of the present invention meets the criteria for "Item IB" in the reference information "Test Method for Preservative Efficacy" of the Sixteenth Revised Japanese Pharmacopoeia. Therefore, it can be concluded that the patch of the present invention has a preservative effect even without preservatives.

[0188] [Experimental Example 2: Adhesion Test]

[0189] (1) Initial tack test of rolling ball on inclined plane

[0190] The initial tack test of the inclined plane rolling ball was conducted according to the test method described on pages 116-117 of the Japanese Pharmaceutical Manufacturing and Sales Guidelines 2010 (DRUG APPROVAL ANDLICENSING PROCEDURES IN JAPAN 2010), at a temperature of 24±2℃, using the adhesion tester [rolling ball initial tack tester (model PI-1201 manufactured by TESTER SANGYO CO,. LTD.)] described on pages 116-117 of the Japanese Pharmaceutical Manufacturing and Sales Guidelines 2010.

[0191] The patch obtained in Example 1 was cut into pieces approximately 5cm × 14cm in size to prepare test pieces. Figure 1 As shown, a resin film of the same thickness as the test piece was used to cover approximately 13 cm of the upper part of the inclined surface (30° inclination angle) of the rolling ball initial tack tester. To ensure no step difference or gap between the resin film and the test piece, the test piece was fixed to the inclined surface of the rolling ball initial tack tester with the polypropylene film side facing upwards using double-sided tape. A series of steel balls with diameters ranging from 3.2 mm to 15.9 mm (ball numbers 1 to 9), thoroughly dried after being cleaned with methanol, were positioned on the rolling ball initial tack tester with their centers located 10 cm from the top of the test piece. After peeling the polypropylene film off the test piece, the positioned steel balls were quickly rolled. The number (No.) of the largest steel ball that stopped at the paste layer of the test piece (the ball remained stationary for more than 5 seconds) was determined. The average value of the test results for n=3 was calculated. The results are shown in Table 3.

[0192] (2) Probe initial adhesion test

[0193] The probe initial tack test was conducted according to the test method described in ASTM D2979, at a temperature of 24±2℃, using a small benchtop testing machine (EZ Test manufactured by SHIMADZU CORPORATION).

[0194] The patch obtained in Example 1 was cut into approximately 25 mm squares to prepare test pieces. Using double-sided tape, a polyethylene terephthalate film (approximately 25 mm × approximately 25 mm) was tightly adhered to the non-woven fabric surface of the test piece. Next, the polypropylene film was peeled off from the test piece, and the test piece was attached to the upper part of a weight ring [contact load 9.79 ± 0.10 kPa (weight approximately 19.6 g)] without loosening, with the weight ring resting on the test table with the paste layer facing down. The tip of a cylindrical substrate (probe) (304 stainless steel, 5 mm diameter) was cleaned with methanol and thoroughly dried. The probe was passed through the lower part of the hole in the weight ring, stopping its tip approximately 1 mm below the paste layer of the test piece (the upper end of the ring). The probe was brought into perpendicular contact with the paste layer from below at a constant speed (10 ± 0.01 mm / s), lifting the test piece until the tip of the probe was approximately 1 mm higher than the top of the counterweight ring. After holding the probe in this lifted position for 1 second, the probe was pulled away from the paste layer at a constant speed (10 ± 0.01 mm / s). The maximum test force (N / φ5 mm) when the probe was pulled away vertically from the paste layer was measured. The average value of the measurements for n=3 was calculated and taken as the initial tack force of the probe. The results are shown in Table 3.

[0195] (3) 90-degree peel test

[0196] The 90-degree peel test was conducted according to the test method described in ASTM D3330, at a temperature of 24±2℃, using a small benchtop testing machine (SHIMADDZU CORPORATION EZ Test).

[0197] The patch obtained in Example 1 was cut into pieces approximately 24 mm wide and 100 mm long to prepare test pieces. A portion 10 mm from one end along the long side of the test piece was designated as the adhesive portion, and this portion was extended and reinforced with non-stretchable tape to make the gripping area approximately 50 mm. A stainless steel plate (304 stainless steel, 125 mm × 50 mm, 1.5 mm thick) was cleaned with methanol and allowed to dry completely. The polypropylene film was peeled off from the test piece, and the test piece was attached to the stainless steel plate from the other end along its length, making the adhesive area 24 mm wide and 90 mm long. The test piece was then pressed from above using a manual pressing device [a 45 mm wide, approximately 95 mm in diameter (including the rubber layer), and 2000 ± 50 g weight pressing roller covered with a 6 mm thick rubber layer]. The test piece was pressed back and forth at a speed of 10 ± 0.5 mm / s once per pass. The stainless steel plate was fixed to the test bench of the testing machine, with the bent portion of the test piece perpendicular to the test bench. The gripping part was then installed on the upper clamp of the testing machine. While maintaining a pull-out angle of 90 degrees, the test piece was peeled off at a constant speed (5.0 ± 0.2 mm / s). The test force was measured between 25 mm and 75 mm from the end of the test piece, and the adhesive force per unit width (N / 10 mm) was calculated. The results are shown in Table 3.

[0198] (4) Holding power test

[0199] The holding power test was conducted according to the test method described in ASTM D3654, at a temperature of 24±2℃, using a simple holding power tester (manufactured by TESTER SANGYO CO,. LTD.: model BE-502).

[0200] The patch obtained in Example 1 was cut into pieces 24 mm wide and approximately 40 mm long to prepare test pieces. A stainless steel plate (304 stainless steel, 50 mm × 100 mm, 1.5 mm thick) was cleaned with methanol and allowed to dry completely. The polypropylene film was peeled off the test piece, and the test piece was attached to the stainless steel plate from one end to the other, so that the adhesive area was 24 mm wide and 24 mm long. The portion of the test piece not in contact with the stainless steel plate was used as the gripping part. Then, the test piece was pressed using a pressing device [a pressing roller with a 45 mm wide, approximately 95 mm diameter (including the rubber layer), and a mass of 2000 ± 50 g, covered with a 6 mm thick rubber layer] (reciprocating twice at a speed of 10 ± 0.5 mm / s). The stainless steel plate was vertically hung on the testing instrument so that the gripping part drooped towards the lower end of the stainless steel plate. A weight (500 ± 2 g) was quietly attached to the gripping part. The moment when the load is applied to the test piece is set as the start time of the measurement. The elapsed time from the start of the measurement until the test piece completely falls off the test plate is measured. The results are shown in Table 3.

[0201] [Table 3]

[0202]

[0203] As shown in Table 3, the patch of the present invention has good adhesion.

Claims

1. A patch comprising a support and a paste layer laminated on the support, wherein, The paste layer contains flurbiprofen, partially neutralized polyacrylic acid, starch-grafted acrylic acid 300, sodium carboxymethyl cellulose, methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, and water. This paste layer does not contain preservatives.

2. The patch according to claim 1, wherein, Based on the total mass of the ointment layer The content of the polyacrylic acid neutralizer is 5% to 8% by mass. The content of starch-grafted acrylic acid 300 is 4% to 6% by mass. The sodium carboxymethyl cellulose content is 0.1% to 1% by mass. The content of the methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion is 5% to 10% by mass.

3. The patch according to claim 1 or 2, wherein, The ointment layer contains clomiphene, isopropyl myristate, peppermint oil, l-menthol, polysorbate 80, sorbitan sesquioleate, titanium dioxide, concentrated glycerin, tartaric acid, talc, and dried aluminum hydroxide gel.

4. The patch according to claim 3, wherein, The ointment layer contains the following components (1) to (17): 0.1%~0.5% by mass of (1) flurbiprofen, 0.1%~0.5% by mass of (2) Cromiton, 1%~2% by mass of (3) isopropyl myristate, 0.05%~0.5% by mass of (4) peppermint oil, 0.2%~1% by mass of (5)-l-menthol, 0.3%~0.7% by mass of (6) polysorbate 80, 0.1%~0.3% by mass of (7) sorbitan sesquioleate, 0.1%~0.3% by mass of (8) titanium dioxide, 25%~35% by mass of (9) concentrated glycerol, 5%~8% by mass of (10) polyacrylic acid partial neutralizer, 4%~6% by mass of (11) starch grafted with acrylic acid 300, 0.1%~1% by mass of (12) sodium carboxymethyl cellulose, 5%~10% by mass of (13) methyl acrylate-2-ethylhexyl acrylate copolymer resin emulsion, 0.5% to 1.0% by mass of (14) tartaric acid, 3%~7% by mass of (15) talc, 0.03%~0.08% by mass of (16) dried aluminum hydroxide gel, 33%~55% (17%) of purified water, The total mass of components (1) to (17) is 100.

5. The patch according to claim 4, wherein, The patch is a patch having a padding layer on top of the ointment layer.

6. The patch according to claim 5, wherein, The support is made of polyethylene terephthalate nonwoven fabric. The liner layer is a polypropylene film.

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