JPH0733646A - Skin patch sheet - Google Patents

Abstract

(57) [Summary] [Purpose] A skin patch sheet that has excellent followability to skin movement and drug transfer prevention properties, high mechanical strength, and does not transfer adhesive to the skin after peeling and is inexpensive To provide. [Structure] A skin patch sheet comprising a base material sheet and an adhesive layer containing a drug, wherein the base material sheet has a thickness of 30 to 200 µm and a soft vinyl chloride resin film and a thickness of 3 A skin patch sheet, wherein a soft fluororesin layer having a thickness of up to 30 μm is laminated via an adhesive layer, and an adhesive layer containing a drug is formed on the soft fluororesin layer.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a skin patch sheet. More specifically, the present invention relates to a skin patch sheet that can be suitably used, for example, in a region such as an elbow, a knee, or a shoulder that is required to follow the movement of the skin.

[0002]

2. Description of the Related Art Conventionally, a vinyl chloride resin such as polyvinyl chloride has been used for a base sheet of a skin patch sheet.

However, although the base sheet made of the vinyl chloride resin certainly has flexibility and conformability to the movement of the skin, it is inferior in adhesiveness to a pressure-sensitive adhesive containing a drug, so that the drug is poor. If the permeation / diffusion property is high, the drug migrates to the base sheet, causing not only swelling and deterioration of the base sheet but also a reduction in the therapeutic effect.

Therefore, in order to solve the above problems, it has been attempted to use polyethylene terephthalate or aluminum foil as a drug transfer preventing layer between the base sheet and the adhesive containing the drug. The migration prevention layer has no flexibility (elongation) and is not suitable for practical use.

Further, it has been proposed to use a film made of polychlorotrifluoroethylene as the drug transfer preventing layer (JP-A-2-237915), but a film made of such a copolymer is applied to the skin. It has the drawbacks that it is insufficient in flexibility for use as a drug sheet, the adhesive force between the adhesive containing the drug and the film is small, and the adhesive migrates to the skin after peeling.

Further, it has been proposed to use a fluorine-treated polyolefin film such as polyethylene or polypropylene as the drug migration preventing layer (Japanese Patent Laid-Open No. 290811/1990), but such a polyolefin film is formed. Further, since the fluorine-treated layer is thin and the treatment density is low, it has a drawback that the effect of preventing drug migration is insufficient.

In addition to the above, it has been attempted to use a soft fluororesin capable of exhibiting a drug transfer preventing effect for a base sheet, but such a base sheet is not suitable for use as a skin patch sheet. Has insufficient flexibility and is expensive.

[0008]

The inventors of the present invention have conducted extensive studies in view of the above-mentioned prior art, and as a result, a soft vinyl chloride resin film having a specific thickness and a soft fluororesin layer are laminated. When using a base sheet that has been used, the adhesiveness to the skin movement is excellent, and the adhesiveness between the base material sheet and the adhesive layer containing the drug is excellent. The inventors have found that a skin patch sheet that does not migrate, is excellent in the ability to prevent drug migration to the base sheet, has high mechanical strength, and is inexpensive, and has completed the present invention.

[0009]

Means for Solving the Problems That is, the present invention is a skin patch sheet having a pressure-sensitive adhesive layer containing a drug on a base sheet, the base sheet having a thickness of 30 to 200.
μm soft vinyl chloride resin film and thickness 3 to 30 μm
And a soft fluororesin layer of (1) are laminated via an adhesive layer, and a pressure-sensitive adhesive layer containing a drug is formed on the soft fluororesin layer.

[0010]

FUNCTION AND EXAMPLE The skin patch sheet of the present invention is, as described above, a skin patch sheet having a pressure-sensitive adhesive layer containing a drug provided on the base sheet, wherein the base sheet is A soft vinyl chloride resin film having a thickness of 30 to 200 μm and a soft fluororesin layer having a thickness of 3 to 30 μm are laminated via an adhesive layer, and an adhesive layer containing a drug is formed on the soft fluororesin layer. It is characterized by being formed.

Since the base sheet used in the present invention comprises a soft vinyl chloride resin film and a thin soft fluororesin layer provided on the soft vinyl chloride resin film, the amount of expensive fluororesin used is very small and the cost is low. Moreover, a skin patch sheet is obtained in which the flexibility of the soft vinyl chloride resin is utilized.

The soft vinyl chloride resin film constituting the base sheet has excellent flexibility, and the vinyl chloride resin used for the soft vinyl chloride resin film is, for example, vinyl chloride alone. Blends, copolymers containing 50% by weight or more of vinyl chloride, blending resins that are compatible with vinyl chloride resins, such as chlorinated vinyl chloride resins, chlorinated polyethylene, ethylene-vinyl acetate copolymers, etc. It may be a mixture with at least one of The proportion of the blending resin in the mixture is preferably small, usually 50% by weight or less, preferably 30% by weight or less.

If the average degree of polymerization of the vinyl chloride resin is too small, the resulting soft vinyl chloride resin film tends to have insufficient mechanical strength, and if it is too large. , The melt viscosity tends to be too high, making it difficult to process.
It is preferably about 0 to 3000, especially about 800 to 2000.

Stabilizers, chelating agents, plasticizers, etc. are appropriately added to the vinyl chloride resin, and then the mixture is kneaded at about 130 to 200 ° C. using a roll or the like,
A soft vinyl chloride resin film can be obtained by extrusion molding.

The thickness of the soft vinyl chloride resin film is 30 to 200 μm, preferably 50 to 140 μm. When the thickness of such a soft vinyl chloride resin film is less than 30 μm, the mechanical strength of the obtained base sheet becomes insufficient, and when it exceeds 200 μm, the flexibility of the base sheet is increased. Will be insufficient.

The soft vinyl chloride resin film has a Shore D hardness of 30 to 60, especially 35 because of its excellent flexibility and sufficient mechanical strength.
Those having .about.50 are preferred.

The soft fluororesin layer constituting the base sheet has a function of preventing the drug in the pressure-sensitive adhesive layer from migrating to the base film, and the soft fluororesin layer used for the soft fluororesin layer. Examples of the resin include a copolymer obtained by graft-copolymerizing a fluorine-containing elastic copolymer and a vinylidene fluoride monomer.

Examples of the fluorine-containing elastic copolymer include vinylidene fluoride-hexafluoropropene copolymer, vinylidene fluoride-hexafluoropropene-tetrafluoroethylene terpolymer, vinylidene fluoride-chlorotrifluoroethylene copolymer and tetrafluoroethylene. Examples thereof include a propylene copolymer and a copolymer of tetrafluoroethylene and fluorine-containing vinyl ether, but the present invention is not limited to these examples.

The above-mentioned fluorine-containing elastic copolymer is obtained by copolymerizing each monomer component using, for example, an unsaturated peroxide having a double bond and a peroxy group in the molecule, and then washing with n-hexane or the like. It can be obtained by removing unreacted unsaturated peroxide.

The elastic fluorocopolymer preferably has a glass transition temperature of room temperature or lower, particularly about 0 ° C. or lower, from the viewpoint that the obtained soft fluororesin has sufficient flexibility at room temperature.

A soft fluororesin can be obtained by graft-copolymerizing the fluorine-containing elastic copolymer and vinylidene fluoride monomer by a conventional method. The fluorine-containing elastic copolymer and vinylidene fluoride monomer are obtained. The compounding ratio is preferably 30 to 80 parts, more preferably 40 to 70 parts, with respect to 100 parts by weight of the fluorine-containing elastic copolymer (parts by weight, the same applies hereinafter). When the blending amount of the vinylidene fluoride monomer is less than 30 parts, a soft fluororesin obtained by dissolving the soft fluororesin obtained in a polar solvent described below is coated on the soft vinyl chloride resin film. When a layer is to be formed, it tends to be difficult to dissolve the soft fluororesin with the polar solvent to form a gel, and when it exceeds 80 parts, the flexibility of the obtained base film is Tends to be insufficient.

A base sheet can be obtained by laminating the soft vinyl chloride resin film and the soft fluororesin layer via an adhesive layer.

The method for obtaining the base sheet is not particularly limited, and a usual processing method can be used. For example, the following method can be adopted.

First, a resin solution prepared by dissolving the soft fluororesin in a polar solvent is applied to a release paper surface-treated with polyethylene, for example, and dried to form a soft fluororesin layer (casting. Method), an adhesive is applied to the soft fluororesin layer surface provided on the surface of this release paper to form an adhesive layer, and after being dried to some extent, laminated with the soft vinyl chloride resin film (dry lamination), The base sheet is obtained by peeling the release paper from this.

As the polar solvent for dissolving the soft fluororesin, for example, N, N-dimethylformamide,
N, N-dimethylacetamide, N-methylpyrrolidone, 1,3-dimethyl-2-imidazolidinone and the like can be mentioned. Among them, N, N-dimethylformamide and N, N- Dimethylacetamide is preferred.

The concentration of the fluororesin solution using the polar solvent is 100 to 300 g / liter, especially 150.
It is preferably about 250 g / liter. When the concentration of the fluororesin solution is less than 100 g / liter, a large amount of solvent is evaporated when the fluororesin solution is applied and dried, which tends to be uneconomical.
If it exceeds g / liter, the viscosity of the fluororesin solution increases, and it tends to be difficult to develop it during coating.

The drying temperature for forming the soft fluororesin layer is preferably 50 to 150 ° C, especially 70 to 120 ° C. When the drying temperature is lower than 50 ° C., not only does it take a long time to dry, but there is a tendency that whitening occurs in the formed soft fluororesin layer,
If the temperature is higher than 150 ° C., the surface smoothness of the soft fluororesin layer formed by the bumping phenomenon of the fluororesin solution used tends to be poor.

The thickness of the soft fluororesin layer is 3
-30 μm, preferably 5-25 μm. When the thickness of the soft fluororesin layer is less than 3 μm, the drug transfer preventive property is deteriorated, and the thickness is 30 μm.
When it exceeds m, the flexibility of the obtained base sheet becomes insufficient.

The adhesive used in the adhesive layer is not particularly limited as long as it can bond the soft vinyl chloride resin film to the soft fluororesin layer, and is not particularly limited, and for example, NB-91B (a joint chemical) Acrylic adhesives such as (manufactured by K.K.), polyurethane adhesives such as N-3110, N-3113, N-5111 (above, manufactured by Nippon Polyurethane Co., Ltd.),
Examples thereof include polyester adhesives such as H-7031L (manufactured by Hitachi Chemical Polymer Co., Ltd.), which can be appropriately selected and used according to the types of the soft vinyl chloride resin film and the soft fluororesin to be used.

If the drying temperature for forming the adhesive layer is too low, the molten adhesive tends to remain and the adhesive strength tends to be insufficient. When it is high, the adhesive, the soft fluororesin, and the release paper tend to be thermally deteriorated. Therefore, the temperature is preferably about 50 to 180 ° C, particularly about 80 to 150 ° C.

The skin patch sheet of the present invention can be obtained by providing an adhesive layer containing a drug on the soft fluororesin layer of the base sheet thus obtained.

Examples of the pressure-sensitive adhesive used in the pressure-sensitive adhesive layer include homopolymer-type and copolymer-type pressure-sensitive adhesives containing rubber and / or synthetic resin as a main component.

As such an adhesive, one having a glass transition temperature of -70 to -10 ° C, especially -60 to -25 ° C is preferable. When the glass transition temperature of such an adhesive is higher than -10 ° C, the adhesive becomes hard and the diffusion mobility of the drug in the adhesive decreases, and the adhesiveness to the skin becomes poor. Tend. When the glass transition temperature of such an adhesive is lower than -70 ° C,
As the adhesive becomes soft and inferior in cohesiveness, it is inferior in shape retention over time, and when peeling the skin patch sheet from the skin surface, the adhesive migrates to the skin, giving physical irritation Tends to become.

Typical examples of the pressure-sensitive adhesive include styrene-isoprene-styrene block copolymer rubber,
Rubber such as styrene-butadiene-styrene block copolymer rubber, styrene-butadiene rubber, butene rubber, isoprene rubber, butyl rubber, silicone rubber, natural rubber, synthetic isoprene rubber and / or poly (meth)
Acrylic resin, polyvinyl ether, polyurethane,
Examples thereof include those containing a synthetic resin such as polyester, polyamide, and ethylenic copolymer as a main component, and can be appropriately selected and used from these. It is possible to adjust the glass transition temperature to fall within the above range by adding a compounding agent such as tackifying resin, liquid rubber or a softening agent to these.

The drug contained in the adhesive is not particularly limited as long as it can be absorbed and administered into the body by percutaneous absorption. For example, anti-inflammatory analgesics, hypnotic sedatives, tranquilizers, antihypertensive agents, Antihypertensive diuretics, antibiotics, anesthetics, antibacterial substances, antifungal substances, vitamins, antiepileptics, coronary vasodilators, antihistamines, antitussives, sex hormones, antidepressants, cerebral circulation improvers, antiemetics, anti It can be appropriately selected and used among biomedical agents such as ulcer agents and polypeptides according to the purpose. In the present invention,
Among these drugs, nandrolone decanoate (steroidal anti-inflammatory drug), nitroglycerin, propatil nitrate, isosorbide dinitrate (above coronary vasodilator), salicylic acid, salicylic acid, which easily volatilize and sublime during storage. Even when methyl, 1-menthol (above, anti-inflammatory analgesic) is used, the drug loss can be significantly prevented.

The content of the drug in the pressure-sensitive adhesive layer is
It cannot be unconditionally determined because it depends on the type of drug or adhesive, the condition of the disease to be treated, etc., but it is usually 1 to 3000 μg / cm ² in the adhesive layer, especially 5 to
It is preferable to appropriately determine the concentration within the range of about 1000 μg / cm ² .

There is no particular limitation on the method for providing the pressure-sensitive adhesive layer containing the drug on the base sheet, and for example, after the pressure-sensitive adhesive containing the drug is applied to a release paper surface-treated with polyethylene. Alternatively, a method in which a base material sheet is attached so that the soft fluororesin layer surfaces are in contact with each other and the release paper is peeled off can be employed.

If the thickness of the pressure-sensitive adhesive layer containing the above-mentioned chemicals is too small, the adhesiveness to the skin tends to be poor, and if it is too large, the pressure-sensitive adhesive layer is too thick. The cohesive force is weakened, and the adhesive tends to migrate onto the skin when it is peeled off after being applied to the skin. Therefore, it is usually about 5 to 500 μm, preferably about 10 to 300 μm.

The skin patch sheet of the present invention is a pressure-sensitive adhesive containing a drug on a soft fluororesin layer of a base sheet in which a soft vinyl chloride resin film and a soft fluororesin layer are laminated via an adhesive. Although a layer is provided, in the present invention, in order to further improve the adhesiveness between the base sheet and the pressure-sensitive adhesive layer containing a drug, a soft fluororesin layer and a pressure-sensitive adhesive layer containing a drug are provided. In between, it is preferable to provide a primer layer made of a saturated polyester resin.

Examples of the saturated polyester resin include aromatic dicarboxylic acids such as terephthalic acid, isophthalic acid and mixtures thereof, aromatic dicarboxylic acids and aliphatic dicarboxylic acids such as adipic acid, sebacic acid and mixtures thereof. A mixture of, for example, ethylene glycol, neopentyl glycol, 1,
Examples thereof include resins obtained by condensation polymerization of a saturated aliphatic diol such as 4-cyclohexanediol or a mixture thereof with a conventional method.

In the present invention, the saturated polyester resin preferably has a weight average molecular weight of about 5,000 to 40,000, particularly about 10,000 to 30,000, from the viewpoint that a film having sufficient strength can be formed.

The method for forming the primer layer using the saturated polyester resin is not particularly limited. For example, the saturated polyester resin may be formed of, for example, toluene, ethyl acetate, xylene, benzene, methyl ethyl ketone,
It is possible to employ a method in which a material dissolved in an organic solvent such as acetone is applied on the soft fluororesin layer of the base sheet and then dried.

If the thickness of the primer layer thus formed is too small, there is a tendency that improvement in adhesiveness due to the use of such a primer layer cannot be expected, and if it is too large, Since the drug contained in the pressure-sensitive adhesive layer tends to be absorbed by the primer layer and the efficacy of the drug may not be sufficiently exhibited, it is usually about 1 to 20 μm, preferably about 3 to 15 μm.

When the primer layer is provided on the soft fluororesin layer, a pressure-sensitive adhesive layer containing a drug may be provided on the primer layer by, for example, the method described above.

Thus, the skin patch sheet of the present invention can be obtained. The surface of the pressure-sensitive adhesive layer containing the drug of the skin patch sheet is treated with, for example, a silicone-based or fluorine-based conventional release agent. It is preferable that the surface is covered with and the surface is protected until use.

Next, the skin patch sheet of the present invention will be described in more detail based on examples, but the present invention is not limited to these examples.

Example 1 15 kg of water was placed in a stainless steel autoclave having a volume of 30 liters.
30 g of potassium persulfate, 40 g of ammonium perfluorooctanoate and 30 g of t-butyl peroxyallyl carbonate are added, and after evacuation, vinylidene fluoride monomer 3.
8 kg and chlorotrifluoroethylene monomer 2.3 kg
Was charged and the polymerization reaction was carried out at 51 ° C. for 19 hours while stirring, and at the end of the reaction, the number of rotations of stirring was increased to precipitate the polymer, and a powdery copolymer was obtained. This was washed with water and dried, then washed with n-hexane to remove unreacted t-butylperoxyallyl carbonate, and dried again to give a fluorine-containing elastic copolymer (glass transition temperature -20 ° C) 5 kg.
I got it.

200 g of the obtained fluorine-containing elastic copolymer and 1500 g of Freon gas R113 were charged into a stainless steel autoclave, and after evacuation, 100 g of vinylidene fluoride monomer.
Was charged (50 parts of vinylidene fluoride monomer to 100 parts of the fluorine-containing elastic copolymer), and a copolymerization reaction was carried out at 98 ° C. for 22 hours to obtain a graft copolymer. This was separated from the solvent, washed with water and dried to obtain 250 g of a white powdery soft fluororesin.

Next, 1 liter of N, N-dimethylformamide was added to 200 g of the obtained soft fluororesin, stirred and dissolved to obtain a soft fluororesin solution. The obtained soft fluororesin solution was applied on a release paper surface-treated with polyethylene using a reverse coater and dried at 100 ° C. to form a soft fluororesin layer (film) having a thickness of 20 μm.

An adhesive agent (NB-91B) was applied on the soft fluororesin film by using a gravure coater so that the thickness after drying was 10 μm, and dried at 120 ° C., and then a soft vinyl chloride resin film. (Thickness 100 μm, Shore D hardness 35) was adhered to obtain a laminated sheet. Then, the release paper was peeled off from this laminated sheet to obtain a base sheet.

The soft vinyl chloride resin film comprises 100 parts of polyvinyl chloride (average degree of polymerization 1300), 2 parts of calcium-zinc stabilizer, 0.5 part of phosphorus chelating agent,
It was obtained by kneading and mixing 3 parts of epoxidized soybean oil and 50 parts of a polyester-based plasticizer (weight average molecular weight 2500) with a two-roll roll at 180 ° C. and extrusion molding.

Next, 30 parts of a styrene-isoprene-styrene block copolymer (Califlex TR1107, manufactured by Shell Chemical Co., Ltd.), 35 parts of a terpene resin (YS resin, manufactured by Yasuhara Chemical Co., Ltd.), and 10 parts of liquid paraffin. And 1 part of 1-menthol were mixed to prepare an adhesive containing a drug.

A pressure-sensitive adhesive containing this agent was melt-coated at 150 ° C. on a release paper surface-treated with polyethylene by using an extruder, and the soft fluororesin film surface of the above-mentioned base sheet was pasted and then released. The paper pattern was peeled off to obtain a skin patch sheet.

The properties of the obtained skin patch sheet were examined for flexibility, drug transfer prevention property, adhesiveness between the base sheet and the pressure-sensitive adhesive layer and mechanical strength according to the following methods.
The results are shown in Table 1.

(A) Flexibility (following movement of skin) A skin patch sheet (8 cm × 5 cm) was attached to the shoulder of a subject, and the state after 24 hours of daily living was examined, and the following evaluation criteria were used. It was evaluated based on.

(Evaluation Criteria) A: No peeling or floating is observed. B: Partially floating. C: The whole thing is a little floating. D: The whole is floating and part is peeling off. E: Peeling is remarkable overall.

(B) Drug transfer preventive property A skin patch sheet (8 cm × 5 cm) is sealed with an aluminum foil, left at 40 ° C. for 6 months, and then the adhesive layer is peeled off from the base material sheet. The concentration of the drug in the layer is measured by gas chromatography, and the ratio of the drug remaining in the adhesive layer after being left with respect to the drug in the adhesive layer before being left is determined, based on the following evaluation criteria. evaluated.

(Evaluation Criteria) A: 90% or more. B: 80% or more and less than 90%. C: 70% or more and less than 80%. D: 60% or more and less than 70%. E: Less than 60%.

(C) Adhesiveness between base sheet and adhesive layer A skin patch sheet (8 cm × 5 cm) was stuck on the skin of a subject and peeled after 1 hour, the state of transfer of the adhesive to the skin Was evaluated and evaluated based on the following evaluation criteria.

(Evaluation Criteria) A: The adhesive has not migrated at all. B: The pressure-sensitive adhesive was transferred only slightly. C: The adhesive was partially transferred to some extent. D: The pressure-sensitive adhesive is transferred as a whole. E: The migration of the pressure-sensitive adhesive is remarkable overall.

(D) Mechanical Strength A strip-shaped skin patch sheet (width 2 cm, length 8 cm) was pulled at room temperature at a pulling rate of 200 mm / min to measure the breaking strength (kg). In the present invention, a skin patch sheet having a breaking strength of 5 kg or more is practically preferable.

Example 2 In Example 1, on the soft fluororesin film of the obtained base sheet, a saturated polyester resin (Vylon 30
SS, manufactured by Toyobo Co., Ltd., resin solid content concentration 30% by weight, weight average molecular weight 22000) is applied so that the thickness after drying is 10 μm, and dried at 120 ° C. to form a primer layer, A skin patch sheet was obtained in the same manner as in Example 1 except that this primer layer surface was bonded to the surface coated with the adhesive containing the drug.

The characteristics of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Examples 3 to 5 In Example 2, when a soft fluororesin was obtained, 30 parts of vinylidene fluoride monomer (Example 3) and 70 parts (Example 4) were used with respect to 100 parts of the fluorine-containing elastic copolymer. ) Or 90 parts (Example 5) was used to obtain a skin patch sheet in the same manner as in Example 2.

The characteristics of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Examples 6 and 7 In the same manner as in Example 2 except that the thickness of the soft vinyl chloride resin film was changed to 50 μm (Example 6) or 150 μm (Example 7). I got a skin patch sheet.

The characteristics of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Examples 8 and 9 In Example 2, the thickness of the soft fluororesin layer was 5 μm.
A skin patch sheet was obtained in the same manner as in Example 2 except that (Example 8) or 25 μm (Example 9) was used.

The characteristics of the obtained skin patch sheet were examined in the same manner as in Example 1. The results are shown in Table 1.

Examples 10 to 12 In Example 2, the thickness of the primer layer was 5 μm (Example 10), 15 μm (Example 11) or 40 μm (Example 12).
A skin patch sheet was obtained in the same manner as in Example 2 except that

The characteristics of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Comparative Examples 1 and 2 In the same manner as in Example 2 except that the thickness of the soft vinyl chloride resin film was changed to 20 μm (Comparative Example 1) or 300 μm (Comparative Example 2). I got a skin patch sheet.

The properties of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Comparative Examples 3 and 4 In Example 2, the soft fluororesin layer had a thickness of 2 μm.
A skin patch sheet was obtained in the same manner as in Example 2 except that (Comparative Example 3) or 50 μm (Comparative Example 4) was used.

The properties of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Comparative Example 5 A skin patch was prepared in the same manner as in Example 1 except that only the soft vinyl chloride resin film (thickness 100 μm) used in Example 1 was used as the substrate sheet. I got a sheet.

The properties of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

Comparative Example 6 A polyethylene terephthalate film (manufactured by Lumirror Toray Co., Ltd., thickness: 50 μm) was used as a substrate sheet in Example 2.
A skin patch sheet was obtained in the same manner as in Example 2 except that m) which had been subjected to corona discharge treatment on one side was used and a primer layer was provided on the corona discharge treated surface.

The characteristics of the obtained skin patch were examined in the same manner as in Example 1. The results are shown in Table 1.

[0080]

[Table 1]

From the results shown in Table 1, the skin patch sheets obtained in Examples 1 to 12 were different from the skin patch sheets obtained in Comparative Examples 1 to 6 in flexibility and base sheet. It can be seen that it has excellent drug transfer prevention property, adhesiveness between the base material sheet and the pressure-sensitive adhesive layer at the same time, and also has practically preferable high mechanical strength.

Further, from the results shown in Table 1, the skin patch sheets obtained in Examples 2 to 12 provided with the primer layer were particularly superior to the skin patch sheets obtained in Example 1. It can be seen that the adhesiveness between the material sheet and the pressure-sensitive adhesive layer is excellent.

[0083]

The skin patch sheet of the present invention has flexibility,
Since it has excellent adhesiveness between the base sheet and the adhesive layer containing a drug and prevention of drug transfer to the base sheet, and also has high mechanical strength, for example, elbows, knees, shoulders. Especially, it can be suitably used for a site requiring conformability to the movement of the skin and the like, and has an effect that the adhesive does not migrate to the skin after peeling.

Further, the skin patch sheet of the present invention uses a very small amount of expensive fluororesin, so that it is extremely inexpensive as compared with conventional sheets.

Claims (4)

[Claims] 1. A skin patch sheet comprising an adhesive layer containing a drug on a base sheet, the base sheet comprising a soft vinyl chloride resin film having a thickness of 30 to 200 μm and a thickness of 30 to 200 μm. 3. A skin patch sheet, wherein a soft fluororesin layer having a thickness of 3 to 30 μm is laminated via an adhesive layer, and an adhesive layer containing a drug is formed on the soft fluororesin layer. 2. The soft fluororesin is a copolymer obtained by graft-copolymerizing 30 to 80 parts by weight of a vinylidene fluoride monomer with 100 parts by weight of an elastic fluorocopolymer having a glass transition temperature of room temperature or lower. Item 2. The skin patch sheet according to item 1. 3. The skin patch sheet according to claim 1 or 2, wherein the soft vinyl chloride resin film has a Shore D hardness of 30 to 60. 4. The skin patch sheet according to claim 1, wherein a primer layer made of a saturated polyester resin is provided between the soft fluororesin layer and the pressure-sensitive adhesive layer.