JP2011026210A - Patch - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a patch in which a plaster layer containing an acrylic adhesive as an adhesive has an excellent anchoring property to a support, and which is not peeled from during adhesion to skin, can easily be peeled from the skin, little irritates the skin, and can suitably be used at a site needing stretchability. <P>SOLUTION: This patch comprising a plaster layer integrally laminated to one side of a support comprising a non-woven fabric, a woven fabric or a knitted fabric is characterized in that the plaster layer comprises 0.1 to 10 wt.% of an acidic antiphlogistic-sedative action medicine or a salt thereof, 0.5 to 20 wt.% of polyethylene glycol having a number-average mol.wt. of ≤10,000, 5 to 30 wt.% of a diester of a ≤3C aliphatic alcohol with a ≤10C aliphatic dicarboxylic acid, and an acrylic adhesive. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a patch to be applied locally, and in particular, has excellent anchoring properties for a support containing an acrylic pressure-sensitive adhesive as a pressure-sensitive adhesive and having a plaster layer made of a nonwoven fabric, a woven fabric or a knitted fabric. The present invention relates to a patch that can be easily peeled off from the skin and has little skin irritation while it does not peel during sticking to the skin.

  Conventionally, in a patch in which a plaster layer is laminated and integrated on one surface of a support composed of a nonwoven fabric, a woven fabric, or a knitted fabric, the contact area between the support and the paste layer is small. There is a problem that the anchoring property of the plaster layer to the support is insufficient.

  Therefore, there is a method of adding a large amount of plasticizer to the plaster layer to soften the plaster layer and sinking the plaster layer into the support to ensure anchoring properties, but the plaster layer sinks into the support. Since the thickness of the plaster layer is reduced by the amount of inclusion, another problem arises that the adhesive strength of the patch is insufficient.

  In order to solve this problem, it is conceivable to give the plaster layer appropriate elasticity so that the plaster layer does not sink into the support, but the plaster layer has insufficient anchorage to the support. To do.

  In order to solve this problem, a rubber adhesive such as styrene-isoprene-styrene copolymer is used as the adhesive constituting the plaster layer, and this rubber adhesive is laminated on the support by a hot melt coating method. The method of making it become is mentioned.

  In the hot melt coating method, a hot and soft paste layer is laminated and integrated on the support so that the paste layer does not sink into the support more than necessary, even when moderate elasticity is given to the paste layer. Therefore, the plaster layer is easily entangled with the fibers of the support, and good anchoring properties are obtained.

  However, since the polarity of the rubber-based adhesive is low, there is a problem that some drugs have insufficient solubility in the plaster, and the percutaneous absorption amount and medicinal effect of the expected drug cannot be obtained. Furthermore, the drug decomposes because the coating solution containing the drug is exposed to a high temperature for a long time when applied to the support, and a patch having a desired drug concentration cannot be obtained, or Problems such as drug breakdown products may cause skin irritation.

  On the other hand, when an acrylic pressure-sensitive adhesive is used as the pressure-sensitive adhesive constituting the plaster layer, a solvent coating method is used for stacking and integrating the plaster layer on one surface of the support. In this method, since the coated body is laminated on the support at a low temperature, the anchoring property of the plaster layer to the support is insufficient, so another solution must be performed.

  Therefore, as proposed in Patent Documents 1 to 4, there is a method of applying a primer to the support surface on which the plaster layer is laminated and integrated, but when using a primer for a patch that is a pharmaceutical, In many cases, the type and application amount of the primer are limited from the viewpoint of ensuring the safety of the drug and ensuring the stability of the drug contained in the plaster layer.

  As another solution, there is a method of forming a continuous layer by heat-sealing and integrating fibers on a support surface on which a plaster layer is laminated and integrated. Certainly, by forming a continuous layer on the surface of the support, the contact area between the paste layer and the support is increased, and the anchoring property of the paste layer to the support is improved. Since the continuous layer formed on the base plate reduces the stretchability of the support, there is a problem that the patch easily peels off when the patch is applied to a joint such as an elbow or knee.

  As described above, when an acrylic pressure-sensitive adhesive is used as the pressure-sensitive adhesive constituting the plaster layer, the anchoring property of the plaster layer to the support composed of a nonwoven fabric, a woven fabric or a knitted fabric is ensured. A patch having an appropriate physical property to the skin has not been obtained.

  In addition, if an acidic anti-inflammatory analgesic drug is included in a low-polarity adhesive, acidic anti-inflammatory analgesic drug crystals may precipitate in the plaster layer. The precipitation state of the active drug changes, and there arises a problem that the dispersion of the acidic anti-inflammatory analgesic drug in the plaster layer becomes uneven.

  Therefore, by using an adhesive containing a copolymer of a monomer containing a pyrrolidone group and an alkyl (meth) acrylate as an adhesive constituting the plaster layer, and increasing the polarity of the adhesive, Although it is conceivable to keep the anti-inflammatory analgesic drug in a state of being dissolved in the plaster layer, it is not possible to obtain the expected medicinal effect because the release of the acidic anti-inflammatory analgesic drug from the plaster layer is reduced. Cause problems.

JP-A-5-310559 JP-A-8-92074 JP 2000-327955 A JP 2004-18393 A

  In the present invention, an acidic anti-inflammatory analgesic drug or a salt thereof (hereinafter collectively referred to as “anti-inflammatory analgesic drug”) is contained in a stable dissolved state in the plaster layer, and the anti-inflammatory analgesic action The transdermal absorbability of drugs is high, and the plaster layer containing an acrylic adhesive as an adhesive has excellent anchoring properties for a support made of a nonwoven fabric, a woven fabric or a knitted fabric. Provided is a patch that can be suitably used for a site that can be easily peeled off from the skin, has little skin irritation, and requires stretchability, while it does not peel off during the sticking.

  The patch of the present invention is a patch in which a plaster layer is laminated and integrated on one surface of a support composed of a nonwoven fabric, a woven fabric, or a knitted fabric, and the plaster layer is an acidic anti-inflammatory analgesic drug or 0.1 to 10% by weight of the salt, 0.5 to 20% by weight of polyethylene glycol having a number average molecular weight of 10,000 or less, an aliphatic dicarboxylic acid having 10 or less carbon atoms, and an aliphatic alcohol having 3 or less carbon atoms It contains 5 to 30% by weight of a diester and an acrylic pressure-sensitive adhesive.

  The support constituting the patch is composed of a nonwoven fabric, a woven fabric or a knitted fabric. In addition, the support may include a configuration other than a nonwoven fabric, a woven fabric, or a knitted fabric. The above support has strength to give self-supporting property to the patch, and can be expanded and contracted according to the movement of the movable part when the patch is applied to the movable part such as joints such as elbows and knees What is necessary is just to have the elasticity.

  The material of the fiber constituting the support is not particularly limited. For example, polyolefin resin such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, ethylene-methyl (meth) acrylate copolymer, nylon, etc. Polyamide resin, polyester resin, polyvinyl alcohol, styrene-isoprene-styrene copolymer (SIS copolymer), styrene-ethylene-butylene-styrene copolymer (SEBS copolymer), rayon, cotton, etc. Polyester resins are preferred. In addition, the raw material of a fiber may be used independently, or 2 or more types may be used together.

  A plaster layer is laminated and integrated on one surface of the support. This plaster layer is composed of 0.1 to 10% by weight of an acidic anti-inflammatory analgesic drug or salt thereof, 0.5 to 20% by weight of polyethylene glycol having a number average molecular weight of 10,000 or less, and an aliphatic having 10 or less carbon atoms. It contains 5 to 30% by weight of a diester of a dicarboxylic acid and an aliphatic alcohol having 3 or less carbon atoms, and an acrylic pressure-sensitive adhesive.

  The acidic anti-inflammatory analgesic drug is not particularly limited, and examples thereof include indomethacin, felbinac, ketoprofen and the like. Moreover, it does not specifically limit as a salt of an acidic anti-inflammatory analgesic drug, For example, a diclofenac sodium, loxoprofen sodium, etc. are mentioned. The acidic anti-inflammatory analgesic drug or salt thereof may be used alone or in combination of two or more.

  If the content of the acidic anti-inflammatory analgesic drug or salt thereof in the plaster is small, the absorbed amount to the skin is reduced and the expected anti-inflammatory analgesic effect cannot be obtained. Since skin absorption increases and skin irritation occurs, it is limited to 0.1 to 10% by weight, preferably 0.5 to 5% by weight.

  The plaster layer contains polyethylene glycol. Examples of polyethylene glycol include the product names “Macro Goal 300”, “Macro Goal 400”, “Macro Goal 600”, “Macro Goal 1000”, “Macro Goal 1500”, “Macro Goal 1540” from Sanyo Chemical Industries, Ltd. It is commercially available at “Macro Goal 4000” and “Macro Goal 6000”. In addition, polyethylene glycol may be used independently or 2 or more types may be used together.

  When the number average molecular weight of polyethylene glycol is low, the compatibility with the acrylic pressure-sensitive adhesive that makes up the plaster layer decreases and polyethylene glycol exudes from the plaster layer. When it is high, polyethylene glycol has anti-inflammatory analgesic action. Since it does not act as an absorption promoter for drugs, the percutaneous absorption of anti-inflammatory analgesic drugs is reduced, so it is limited to 10,000 or less, preferably 300 to 5,000. The number average molecular weight of polyethylene glycol refers to a value measured by gel permeation chromatography using high performance liquid chromatography. The number average molecular weight of polyethylene glycol is, for example, a column (trade name “Shodex OHpak SB-806M HQ 8.0 × 300 mm” manufactured by Showa Denko KK), column temperature: room temperature, mobile phase: water, flow rate 1.0 ml. / Min, detector: It can be measured under the condition of RI.

  If the content of polyethylene glycol in the plaster layer is small, the adhesive strength of the patch will increase, causing skin irritation at the time of peeling, or the percutaneous absorption of anti-inflammatory analgesic drugs will be high. Then, since polyethylene glycol oozes out from the paste layer and the anchoring property of the paste layer to the support is lowered, it is limited to 0.5 to 20% by weight, and preferably 3 to 15% by weight.

  Further, the plaster layer contains a diester of an aliphatic dicarboxylic acid having 10 or less carbon atoms and an aliphatic alcohol having 3 or less carbon atoms. In addition, a diester body may be used independently or 2 or more types may be used together.

  The aliphatic dicarboxylic acid having 10 or less carbon atoms is not particularly limited, and examples thereof include adipic acid, sebacic acid, glutaric acid, and adipic acid and sebacic acid are preferable. If the aliphatic dicarboxylic acid has a large number of carbon atoms, compatibility with polyethylene glycol is lowered, and uniformity is impaired in the plaster layer, so it is limited to 10 or less.

  The aliphatic alcohol having 3 or less carbon atoms is not particularly limited, and examples thereof include methyl alcohol, ethyl alcohol, isopropyl alcohol, and n-propyl alcohol, and ethyl alcohol and isopropyl alcohol are preferable. If the aliphatic alcohol has a large number of carbon atoms, the compatibility with polyethylene glycol decreases, and the uniformity in the plaster layer is impaired, so it is limited to 3 or less.

  If the content of the diester body in the plaster layer is small, the anchoring property of the plaster layer to the support will decrease, or the adhesive strength of the patch to the skin will become too strong, and the patch will be removed from the skin. When it peels, it causes skin irritation, and if it is too much, the plaster layer is excessively plasticized, and an appropriate adhesive property cannot be obtained as a patch, so it is limited to 5 to 30% by weight, and 5 to 20% by weight preferable.

  In the plaster layer, if the total number of moles of the diester is small, the anchoring property of the plaster layer to the support may be reduced, or the adhesive strength of the patch to the skin may be increased, causing skin irritation at the time of peeling. Yes, if it is large, the liquid component may ooze out from the plaster layer, and the stability of the patch may be lowered. Therefore, 1 to 10 times is preferable and 1 to 9 times is more than the total number of moles of polyethylene glycol. preferable. The number of moles of polyethylene glycol refers to a value obtained by dividing the weight by the number average molecular weight.

  In addition, if the total weight of the diester body in the plaster layer is small, the anchoring property of the plaster layer to the support may be lowered. In some cases, the stability of the resin may decrease, so that it is preferably 0.3 to 6 times, more preferably 0.3 to 4 times the total weight of polyethylene glycol.

  The plaster layer contains an acrylic pressure-sensitive adhesive as a pressure-sensitive adhesive. Such an acrylic pressure-sensitive adhesive is not particularly limited, but an acrylic polymer containing an alkyl (meth) acrylate component having an alkyl group with 2 or more carbon atoms and not containing a pyrrolidone group is preferable. More preferred is an acrylic polymer containing an alkyl (meth) acrylate component having a number of 2 to 18 and not containing a pyrrolidone group, containing 60 to 90% by weight of a 2-ethylhexyl methacrylate component and having a carbon number of 2 to 18 An acrylic polymer containing 1 to 40% by weight of an alkyl acrylate component is particularly preferable. In addition, (meth) acrylate means a methacrylate or an acrylate.

  Examples of the alkyl (meth) acrylate having 2 or more carbon atoms in the alkyl group include ethyl (meth) acrylate, n-butyl (meth) acrylate, hexyl acrylate, 2-ethylbutyl (meth) acrylate, isooctyl (meth) acrylate, Examples include 2-ethylhexyl (meth) acrylate, decyl (meth) acrylate, and dodecyl (meth) acrylate.

  In order to prevent the loss of the drug in the plaster layer of the patch of the present invention and to protect the plaster layer, it is preferable that release paper is laminated and integrated on the surface of the plaster layer of the patch in a peelable manner.

  Examples of the release paper include resin films and paper made of polyethylene terephthalate, polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, and the like, and a release treatment is performed on the surface facing the plaster layer. It is preferable. The release paper may be a single layer or a plurality of layers.

  Further, for the purpose of improving the barrier property of the release paper, the release paper may be provided with an aluminum foil or an aluminum vapor deposition layer. Furthermore, when the release paper is made of paper, the release paper may be impregnated with a resin such as polyvinyl alcohol for the purpose of improving the barrier property of the release paper.

  Next, the manufacturing method of the patch of this invention is demonstrated. The method for producing the patch is not particularly limited. For example, an acidic anti-inflammatory analgesic drug or a salt thereof, polyethylene glycol, a diester and an acrylic pressure-sensitive adhesive, and an additive added as necessary, are mixed with ethyl acetate. In a solvent such as the above, stir until uniform to obtain a paste layer solution. After this plaster layer solution is uniformly applied to one side of the support by a coater, the plaster layer is laminated and integrated on one side of the support by drying, and the release paper is released from the release paper as necessary. The plaster layer solution is applied onto the surface on which the release paper is released by the method of laminating and integrating so that the treated surface faces the plaster layer, or by the same coating method as described above. By applying and drying, a paste layer is formed on the release paper, a support is laminated on the paste layer, and the paste layer is transferred to one surface of the support to be laminated and integrated. Can be mentioned.

  Since the patch of the present invention has the above-described configuration, an acidic anti-inflammatory analgesic drug or a salt thereof is contained in a state in which it is stably dissolved uniformly in the plaster layer over a long period of time. Therefore, the transdermal absorbability of acidic anti-inflammatory analgesic drugs or salts thereof is high.

  In addition, the patch of the present invention has an excellent anchoring property for a support in which a plaster layer containing an acrylic pressure-sensitive adhesive as a pressure-sensitive adhesive is made of a nonwoven fabric, a woven fabric, or a knitted fabric. While it does not peel inside, it can be easily peeled off from the skin, has little skin irritation, and can be suitably used for a part requiring elasticity such as a movable part such as an elbow or a knee.

  Examples of the present invention will be described below, but the present invention is not limited to these examples.

(Examples 1-6, Comparative Examples 1-10)
A reaction solution consisting of 13 parts by weight of dodecyl methacrylate, 78 parts by weight of 2-ethylhexyl methacrylate, 9 parts by weight of 2-ethylhexyl acrylate, and 50 parts by weight of ethyl acetate was supplied to a 40 liter polymerization machine, and the inside of the polymerization machine was subjected to nitrogen at 80 ° C. The atmosphere. Then, polymerization is carried out while adding a polymerization initiator solution obtained by dissolving 0.5 parts by weight of benzoyl peroxide in 50 parts by weight of cyclohexane to the reaction solution over 24 hours, and after the polymerization, ethyl acetate is further added to the acrylic adhesive. An acrylic pressure-sensitive adhesive solution having an agent content of 35% by weight was obtained.

  The weight ratio of indomethacin, ferbinac, diclofenac sodium, polyethylene glycol, diethyl sebacate, diisopropyl adipate, isopropyl myristate, hexadecyl isostearate, isopropyl palmitate, triacetin, stearic acid and acrylic adhesive solution in the paste layer The mixture was mixed as shown in Nos. 1 and 2, and ethyl acetate was added so that the non-volatile content was 23% by weight, followed by mixing until uniform, to obtain a paste layer solution.

  In Tables 1 and 2, “Macro Goal 400”, “Macro Goal 1500”, “Macro Goal 1540” and “Macro Goal 4000” are polyethylene glycols commercially available from Sanyo Chemical Industries. The number average molecular weight of each polyethylene glycol is shown in parentheses after each trade name in Tables 1 and 2.

  Next, a 38 μm-thick polyethylene terephthalate film having been subjected to silicon release treatment was prepared, and the paste layer solution was applied to the silicon release treatment surface of the polyethylene terephthalate film. Were dried for 30 minutes to produce a laminate in which the paste layer having the thickness shown in Tables 1 and 2 was formed on the silicon release treatment surface of the polyethylene terephthalate film.

Then, a stretchable knitted fabric with a basis weight of 100 g / m ² is prepared as a support, and is laminated so that one side of the support and the plaster layer of the laminate face each other. The patch was manufactured by transferring the body layer onto one surface of the support and stacking and integrating them. The contents of each component in the plaster layer of the patch are shown in Tables 1 and 2. The content of each component in Tables 1 and 2 was expressed as% by weight in the plaster layer.

  About the obtained patch, absorptivity, peeling, skin irritation, ball tack, peel strength, anchoring property, stability and solubility were measured in the following manner, and the results are shown in Tables 1 and 2.

(Absorbency)
^Two flat square test pieces having an area of 10 cm ² were punched from the patch. The paste layer of one test piece was dissolved in ethyl acetate and the amount of anti-inflammatory analgesic drug was measured using HPLC (high performance liquid chromatography), and the amount of anti-inflammatory analgesic drug before testing (μg / cm ² ) and did.

The polyethylene terephthalate film was peeled from the other test piece so that the plaster layer was completely exposed, and then the test piece was attached to the upper arm of the tester for 24 hours. After peeling the test piece from the upper arm of the tester, the paste layer of the test piece is dissolved in ethyl acetate and the amount of anti-inflammatory and analgesic drugs is measured using HPLC (high performance liquid chromatography). The amount of active drug (μg / cm ² ) was used.

A value obtained by subtracting the amount of the anti-inflammatory / analgesic drug after the test from the amount of the anti-inflammatory / analgesic drug before the test was defined as an absorption amount (μg / cm ² ), which was used as an absorption index.

(Peeling)
A plane square test piece having an area of 30 cm ² was punched from the patch. After the polyethylene terephthalate film was peeled from the test piece so that the plaster layer was completely exposed, the patch was peeled from the skin when 8 hours passed after the test piece was attached to the upper arm of the tester. The area (peeling area) of the portion being measured was measured, and the ratio of the peeled area to the total area of the test piece was calculated and evaluated based on the following criteria.
A: The peeled area was less than 5%.
○: The peeled area was 5% or more and less than 10%.
Δ: The peeled area was 10% or more and less than 30%.
X: The peeled area was 30% or more.

(Skin irritation)
A plane square test piece having an area of 30 cm ² was punched from the patch. After peeling the polyethylene terephthalate film from the test piece so that the plaster layer was completely exposed, the condition of the skin surface was visually observed when 12 hours had passed after the test piece was attached to the upper arm of the tester. Observed and evaluated based on the following criteria.
◎ ・ ・ ・ No erythema ○ ・ ・ ・ There was very weak erythema.
X: There was clear erythema.

(Ball tack)
A flat square test piece having a side of 40 mm was cut out from the patch. On the other hand, the tester described in the pharmaceutical manufacturing and sales guideline 2005 (Part IV: Application for manufacturing and marketing approval of pharmaceuticals, Chapter 1 Adhesive strength test) was prepared. The inclined surface of the tester was held in an inclined state at an angle of 30 ° with respect to the horizontal plane.

  Next, after peeling the polyethylene terephthalate film from the test piece so that the plaster layer is completely exposed, the test piece is placed on the inclined surface of the tester with the plaster layer facing upward. I put it. Thereafter, the upper end portion between the upper end of the test piece and the portion located 5 mm below the upper end of the inclined surface from the upper end, and the lower end of the test piece and the lower end of the test piece by 5 mm in the inclined direction of the inclined surface. The lower end portion between the upper portion and the upper portion was covered with paper, and the paste layer portion excluding the upper and lower end portions of the test piece was exposed. The vertical width of the exposed plaster layer portion was 30 mm along the inclined surface of the tester.

  Subsequently, from the upper end of the inclined surface of the test device, the steel balls No. 1 to No. 10 defined in the Pharmaceutical Manufacturing and Sales Guidelines 2005 (Part IV: Manufacturing and Sales Approval Application, Chapter 1 Adhesion Test) The number of balls that were rolled and stopped for 5 seconds or more on the exposed plaster layer portion of the test piece was measured.

(Peeling force, anchoring property)
A flat rectangular test piece having a width of 15 mm and a length of 35 mm was cut out from the patch. The polyethylene terephthalate film on the plaster layer of the test piece was peeled off to expose the plaster layer entirely. Next, after sticking a polyester film over the entire width of the test piece in the lengthwise direction of 5 mm, the test piece is stuck to the central portion of the phenol resin test plate by the plaster layer. I let you.

  Subsequently, a 2000 g rubber roller was passed twice over the test piece at a speed of 300 mm per minute, and then left to stand at 25 ° C. ± 3 ° C. for 40 minutes with the test piece stuck to the test plate. did.

  Next, the test piece is continuously peeled off from the test plate at a speed of 300 mm per minute by folding the polyester film 180 ° at the free end and pulling the polyester film, and the 180 ° peeling force using a rheometer. Was measured.

  In the obtained chart, a straight line parallel to the vertical axis was drawn at 20% and 80% of the time from the start of measurement until the test piece was completely peeled from the test plate. A straight line for dividing the section between the straight lines drawn in the 20% portion and the 80% portion into three equal parts in the horizontal axis direction is drawn in parallel to the vertical axis, and the four straight lines intersect with the recording lines. The 180 ° peeling force was read, and the arithmetic average value of these four 180 ° peeling forces was taken as the peeling force.

Furthermore, in the test piece after measuring the peeling force, the laminated state of the support and the plaster layer was visually observed, and the anchoring property was evaluated based on the following criteria.
A: The plaster layer was entirely laminated and integrated on the support.
○ The plaster layer was entirely laminated and integrated on the support.
There was a problem.
Δ: Area where the plaster layer was partially peeled from the support and the plaster layer was peeled from the support
Was less than 5% with respect to the total area of the test piece stuck on the test plate.
×: Area where the paste layer was partially peeled from the support and the paste layer was peeled from the support
It was 5% or more with respect to the total area of the test piece stuck on the test plate.

(Stability)
Six test pieces having an area of 10 cm ² were punched from the patch, and the polyethylene terephthalate film was peeled off from each test piece to expose the plaster layer entirely. Next, two aluminum bags each having an inner surface made of polyethylene were prepared, and three test pieces were placed in each of the aluminum bags. Then, one aluminum bag was stored at 4 ° C. for 30 days, and the other aluminum bag was stored at 60 ° C. for 30 days.

  Next, the paste layer of the test piece taken out from the aluminum bag was dissolved in ethyl acetate, and the amount of anti-inflammatory analgesic drug was measured using HPLC (high performance liquid chromatography). For each aluminum bag, the arithmetic average value of the amount of anti-inflammatory analgesic drugs in the plaster layer of the test piece was calculated, and this arithmetic average value was used as the anti-inflammatory analgesic drug amount.

  And the amount of anti-inflammatory analgesic drugs in the plaster layer in the test piece in the aluminum bag stored at 4 ° C., in the paste layer of the test piece in the aluminum bag stored at 60 ° C. A value obtained by dividing by the amount of anti-inflammatory analgesic drug and multiplying by 100 was taken as the rate of change and used as an indicator of stability.

  When the rate of change is 95% or more, it can be determined that the film has extremely excellent stability. When the rate of change is 90% or more and less than 95%, it can be determined that the material has excellent stability.

(Solubility)
A test piece having an area of 10 cm ² was punched from the patch, and the polyethylene terephthalate film was peeled from the test piece to expose the plaster layer entirely. Next, the test piece was put into an aluminum bag having an inner surface made of polyethylene. And after storing the bag made from aluminum for 30 days at 40 degreeC, it takes out a test piece from the bag made from aluminum, visually observes the surface of the paste layer of the test piece, and extinguishes the surface of the paste layer. The case where the crystals of the analgesic drug were not deposited was evaluated as “◯”, and the case where the crystals of the anti-inflammatory drug were deposited on the surface of the plaster layer was evaluated as “x”.

Claims (5)

A patch in which a plaster layer is laminated and integrated on one surface of a support composed of a nonwoven fabric, a woven fabric, or a knitted fabric, wherein the plaster layer is an acidic anti-inflammatory analgesic drug or salt thereof. 5% to 30% by weight of a diester of 0.5 to 20% by weight of polyethylene glycol having a number average molecular weight of 10,000 or less, an aliphatic dicarboxylic acid having 10 or less carbon atoms, and an aliphatic alcohol having 3 or less carbon atoms % And an acrylic pressure-sensitive adhesive. The acrylic pressure-sensitive adhesive contains an acrylic polymer containing an alkyl (meth) acrylate component having an alkyl group with 2 or more carbon atoms, and the acrylic polymer does not contain a pyrrolidone group. The patch described in 1. The number of moles of a diester of an aliphatic dicarboxylic acid having 10 or less carbon atoms and an aliphatic alcohol having 3 or less carbon atoms is 1 to 10 times the number of moles of polyethylene glycol. The patch according to 1. The weight of a diester of an aliphatic dicarboxylic acid having 10 or less carbon atoms and an aliphatic alcohol having 3 or less carbon atoms is 0.3 to 6 times the weight of polyethylene glycol. The patch according to 1. The patch according to any one of claims 1 to 3, wherein the diester body contains diisopropyl adipate or diethyl sebacate.