JP5459834B2 - Patch - Google Patents

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. As a result, 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.

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

  In the present invention, the plaster layer containing an acrylic pressure-sensitive adhesive as a pressure-sensitive adhesive has excellent anchoring properties with respect to a support made of a nonwoven fabric, a woven fabric or a knitted fabric, and does not peel off during sticking to the skin. On the other hand, the present invention provides a patch that can be easily peeled from the skin, has little skin irritation, and can be suitably used for a site that requires stretchability.

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 contains 1 to 8% by weight of salicylic acid ester. And 0.5 to 4% by weight of tocopherol acetate, 1% by weight or less of glycyrrhetinic acid, polyethylene glycol having a number average molecular weight of 10,000 or less, polypropylene glycol having a number average molecular weight of 10,000 or less, and polyoxy having a number average molecular weight of 10,000 or less. Diesters 5 to 30 of at least one glycol selected from the group consisting of ethylene polyoxypropylene glycol and 1 to 10% by weight of an aliphatic dicarboxylic acid having 10 or less carbon atoms and an aliphatic alcohol having 3 or less carbon atoms wt%, and contains an acrylic adhesive, and the total weight of the salicylic acid ester, relative to the total weight of the total weight of the glycol The total weight of the serial diester is characterized in that it is a 0.4 to 6 times.

  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 1 to 8% by weight of salicylic acid ester, 0.5 to 4% by weight of tocopherol acetate, 1% by weight or less of glycyrrhetinic acid, polyethylene glycol having a number average molecular weight of 10,000 or less, and a number average molecular weight of 10,000 or less. 1 to 10% by weight of at least one glycol selected from the group consisting of polypropylene glycol and polyoxyethylene polyoxypropylene glycol having a number average molecular weight of 10,000 or less, an aliphatic dicarboxylic acid having 10 or less carbon atoms, and a carbon number It contains 5 to 30% by weight of a diester with 3 or less aliphatic alcohol and an acrylic pressure-sensitive adhesive.

  Examples of the salicylic acid ester include methyl salicylate and glycolic salicylate. In addition, a salicylic acid ester may be used independently or 2 or more types may be used together.

  If the salicylic acid ester content in the plaster layer is low, the amount of absorption into the skin will decrease and the expected medicinal effects such as anti-inflammatory effects will not be obtained, and if it is large, the salicylic acid ester will exude from the plaster layer. Since the storage stability of the agent is lowered and the anchoring property of the plaster layer on the support is lowered, it is limited to 1 to 8% by weight, and preferably 2 to 6% by weight. This is because the storage stability is lowered and the anchoring property to the support is lowered. Examples of salicylic acid esters include methyl salicylate and glycolic salicylate.

  If the content of tocopherol acetate in the plaster layer is small, the expected medicinal effects such as improvement of blood flow cannot be obtained, and if it is large, the plaster layer may be excessively plasticized to obtain appropriate adhesive properties as a patch. Since it is not possible, it is limited to 0.5 to 4% by weight, preferably 1 to 3% by weight.

  If the content of glycyrrhetinic acid in the plaster layer is large, unexpected symptoms such as skin irritation may occur, so it is limited to 1% by weight or less, preferably 0.1 to 0.5% by weight.

  If the content of nonyl acid vanillylamide in the plaster layer is large, excessive warm feeling stimulating action works and skin irritation accompanied by strong erythema occurs, so 0.5 wt% or less is preferable, 0.1 wt% The following is more preferable, and 0.005 to 0.08% by weight is more preferable.

  In the plaster layer, at least one selected from the group consisting of polyethylene glycol having a number average molecular weight of 10,000 or less, polypropylene glycol having a number average molecular weight of 10,000 or less, and polyoxyethylene polyoxypropylene glycol having a number average molecular weight of 10,000 or less. Of 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.

  Polypropylene glycol is commercially available from NOF Corporation under the trade name “polypropylene glycol 2000”, for example. Examples of the polyoxyethylene polyoxypropylene glycol include polyoxyethylene (3) polyoxypropylene (17) glycol, polyoxyethylene (20) polyoxypropylene (20) glycol, polyoxyethylene (42) polyoxypropylene ( 67) glycol, polyoxyethylene (54) polyoxypropylene (39) glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (120) polyoxypropylene (40) glycol and the like.

  If the number average molecular weight of glycol is high, it does not act as an absorption promoter for nonylic acid vanillylamide, so the warming sensation does not continue, so it is limited to 10,000 or less, and if low, the compatibility with the plaster layer decreases. Then, since there is a possibility that glycol exudes from the plaster layer, 300 to 5000 is preferable. The number average molecular weight of glycol refers to the number average molecular weight in terms of polyethylene glycol measured by gel permeation chromatography using high performance liquid chromatography. In addition, the number average molecular weight of 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 / Minute, detector: can be measured under the condition of RI.

If the content of glycol in the plaster layer is small, the adhesive strength of the patch will increase, causing skin irritation at the time of peeling, and the warming irritation effect of nonylic acid vanillylamide will continue during patch application. However, if the amount is too large, glycol exudes from the plaster, so that the anchoring property of the plaster layer to the support is lowered, so it is limited to 1 to 10% by weight.

  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. 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, the compatibility with glycol decreases, and the uniformity in the plaster layer is impaired, 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 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 is reduced, or the adhesive strength of the patch to the skin is increased, causing skin irritation at the time of peeling. And, since the plaster is excessively plasticized, it is not possible to obtain appropriate adhesive properties as a patch, so it is limited to 5 to 30% by weight, and preferably 8 to 20% by weight.

  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. If the amount is too large, the liquid component may ooze out from the plaster layer and the stability of the patch may be lowered, so that the total number of moles of salicylic acid ester and the total number of moles of glycol is 0. 5 to 4 times is preferable, and 0.8 to 3.5 times is more preferable. In addition, the number of moles of glycol refers to a value obtained by dividing 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. However, the total weight of the salicylic acid ester and the total weight of the glycol is limited to 0.4 to 6 times , but 0.6 to 4.5 times. but good Masui.

  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. An acrylic polymer containing an alkyl (meth) acrylate component having a number of 2 to 18 and not containing a pyrrolidone group is more preferred, 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.

  If the acrylic polymer that constitutes the acrylic adhesive contains a pyrrolidone group, the polarity of the plaster layer increases, so the release of salicylic acid ester from the plaster layer is reduced, and anti-inflammatory effects are expected. This is because the medicinal effect may not be obtained.

  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, salicylic acid ester, tocopherol acetate, glycyrrhetinic acid, nonyl acid vanillylamide, glycol, aliphatic dicarboxylic acid having 10 or less carbon atoms, and 3 carbon atoms. Add the following diesters with aliphatic alcohol, acrylic adhesive, and additives added as necessary to a solvent such as ethyl acetate and 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, the plaster layer containing an acrylic pressure-sensitive adhesive as the pressure-sensitive adhesive has excellent anchoring properties with respect to a support made of a nonwoven fabric, a woven fabric, or a knitted fabric. Suitable for parts that need to be stretchable, such as elbows and knees, while being easy to peel off from the skin while not sticking to the skin while sticking to the skin. Can be used.

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

(Examples 1-11, Comparative Examples 1-11)
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.

  Salicylic acid glycol (ethylene glycol monosalicylate), tocopherol acetate, glycyrrhetinic acid, nonyl acid vanillylamide, polyethylene glycol, polyoxyethylene (20) polyoxypropylene (20) glycol, polyoxyethylene (54) polyoxypropylene (39) The weight ratio of glycol, diethyl sebacate, diisopropyl adipate, isopropyl myristate, hexadecyl isostearate, isopropyl palmitate, triacetin, stearic acid and acrylic adhesive solution in the plaster layer as shown in Tables 2 and 3 Further, ethyl acetate was added so that the non-volatile content concentration became 23% by weight and then mixed until uniform, to obtain a paste layer solution.

  In Tables 2 and 3, “Macro Goal 400”, “Macro Goal 1500”, “Macro Goal 1540” and “Macro Goal 4000” are polyethylene glycols commercially available from Sanyo Chemical Industries. In addition, the number average molecular weight of each polyethylene glycol and polyoxyethylene polyoxypropylene glycol is shown in parentheses after each trade name in Tables 2 and 3.

  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. Was dried for 30 minutes to produce a laminate in which the paste layer having the thickness shown in Tables 2 and 3 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 2 and 3. The content of each component in Tables 2 and 3 was expressed as% by weight in the paste layer.

  About the obtained patch, medicinal effect, peeling, skin irritation, ball tack, peel strength, anchoring property, and stability of glycol salicylate were measured in the following manner, and the results are shown in Tables 2 and 3.

(Medication)
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 test piece was attached to the upper arm of the tester, and the warmth and persistence after 8 hours The sex was evaluated based on the criteria shown in Table 1.

  In Table 1, the vertical axis represents “intensity of warmth” and the horizontal axis represents “duration of warmth”. On the horizontal axis, a column between “0” and “1” means “duration is less than 1 hour”, and a column between “1” and “6” is “duration 1”. Means more than the time and less than 6 hours ”, and the column between“ 6 ”and“ 8 ”means“ the duration is more than 6 hours and less than 8 hours ”.

(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, a 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 of glycolic salicylate)
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.

  Thereafter, the test piece in the aluminum bag was taken out, the paste layer of the test piece was dissolved in ethyl acetate, and the amount of glycol salicylate was measured using HPLC (high performance liquid chromatography). For each aluminum bag, the arithmetic average value of the amount of glycol salicylate in the paste layer of the test piece was calculated, and this arithmetic average value was taken as the amount of glycol salicylate.

  The amount of glycol salicylate in the paste layer in the test piece in the aluminum bag stored at 4 ° C. is the amount of glycol salicylate in the paste layer in the test piece in the aluminum bag stored at 60 ° C. The value obtained by dividing by 100 and multiplying by 100 was taken as the rate of change and used as an index of the stability of the salicylate glycol.

  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.

Claims (5)

A patch in which a plaster layer is laminated and integrated on one surface of a support made of a nonwoven fabric, a woven fabric, or a knitted fabric, and the plaster layer includes 1 to 8% by weight of salicylic acid ester and 0.5 tocopherol acetate. -4% by weight, 1% by weight or less of glycyrrhetinic acid, polyethylene glycol having a number average molecular weight of 10,000 or less, polypropylene glycol having a number average molecular weight of 10,000 or less, and polyoxyethylene polyoxypropylene glycol having a number average molecular weight of 10,000 or less 1 to 10% by weight of at least one glycol selected from the group, 5 to 30% by 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, and an acrylic adhesive An agent , and
The patch , wherein the total weight of the diester is 0.4 to 6 times the total weight of the total weight of the salicylic acid ester and the total weight of the glycol .   The patch according to claim 1, wherein the plaster layer contains 0.5% by weight or less of nonylic acid vanillylamide.   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 patch according to claim 1, wherein the number of moles of the diester is 0.5 to 4 times the total number of moles of the salicylic acid ester and the total mole of glycol. The patch according to any one of claims 1 to 4 , wherein the diester contains diisopropyl adipate or diethyl sebacate.