JP2002275056A - Percutaneous patch material and method for producing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a percutaneous patch material produced by using a plastic film as a substrate and enabling sure spreading of a water-containing gel, and provide a method for producing the patch material. SOLUTION: A hydrophilic and water-insoluble anchor agent layer 14 is formed on one surface of a plastic film 12 and a water-containing gel 16 produced by crosslinking a water-soluble polymer with metallic ion, or the like, is applied to the surface of the anchor agent layer 14. The anchor agent 14 is a polymer produced by polymerizing one or more monomers selected from acrylic acid, methacrylic acid and their derivatives having amino group, sulfonyl group, phosphoric acid group or amide group.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates directly to the skin, such as pharmaceuticals, quasi-drugs, medical supplies, and other cosmetics to be applied to fever or inflamed parts of the body, cosmetics used for moisturizing and refreshing the skin, etc. It relates to a sticking material to be stuck.

[0002]

2. Description of the Related Art Conventionally, there has been used a patch in which a drug or a cooling agent is mixed with a hydrogel made of a water-soluble polymer, and the hydrogel is applied to a nonwoven fabric as a support. However, the nonwoven fabric has a large gap between the fibers, and the drug, the cooling agent, and the moisture in the hydrogel leak out or evaporate to the surface of the nonwoven fabric. During the use or storage of this patch, if the evaporation of water or chemicals becomes excessive, the composition of the hydrogel changes, and as a result,
The medicinal effect is disturbed, and the long-term therapeutic effect, cooling effect, and sustainability of the compressing effect cannot be expected.

In order to solve this problem, a method using a resin film as a support may be considered. By using a resin film, it is possible to suppress evaporation of water and maintain a therapeutic effect or a compressing effect over a long period of time.

[0004]

When a hydrogel is directly applied to the resin film of the prior art described above, since the resin film is hydrophobic and the hydrogel is hydrophilic, the adhesiveness between the resin film and the hydrogel is obtained. However, there is a problem that the hydrogel is easily peeled off from the resin film at the time of production and use during use.

In order to solve this problem, Japanese Patent Laid-Open No.
There was a transdermal patch disclosed in JP 08469. This transdermal patch is an adhesive containing, as essential components, a water-soluble polymer, a humectant, water, crotamiton, peppermint oil and estradiol on the nonwoven fabric surface of a support obtained by laminating a nonwoven fabric on a porous film having moisture permeability. It is a spread of the agent layer.

However, the laminate of the nonwoven fabric and the plastic film easily delaminates and does not always have a sufficient attachment strength.

SUMMARY OF THE INVENTION The present invention has been made in view of the above-mentioned problems of the prior art, and provides an adhesive material using a resin film as a support and capable of reliably applying a hydrogel, and a method for producing the same. With the goal.

[0008]

According to the present invention, a hydrophilic and water-insoluble anchor agent layer is provided on one surface of a resin film, and a water-soluble polymer is coated on the surface of the anchor agent layer with metal ions or the like. It is a patch on which a crosslinked hydrogel is plastered.

Further, the above-mentioned anchoring agent layer is formed of acrylic acid, methacrylic acid and their amino, sulfonyl,
It is a polymer obtained by polymerizing one or two or more monomers among derivatives having a phosphate group or an amide group.

As the resin film, a thermoplastic resin film of polyurethane, polyester, polyethylene, polyethylene terephthalate (PET), polypropylene (PP), polystyrene (PS), polyvinyl chloride or the like is used. Further, a moisture-permeable resin film or a resin film in which fine pores are formed may be used. Further, the resin film may be a simple substance mainly composed of polyurethane, polyester, PET, PP or PS, or a transparent resin film in which two or more of these resins are laminated.

[0011] The present invention also provides a resin film having one side,
Applying a hydrophilic and water-insoluble polymer to form an anchor agent layer, and applying a water-containing gel obtained by crosslinking a water-soluble polymer with a crosslinking agent such as a metal ion to the surface of this anchor agent layer. It is a manufacturing method. The water-containing gel mainly contains sodium polyacrylate, polyacrylic acid, an aluminum compound and water, and is gelled by the cross-linking of aluminum ions with the carbonyl group of sodium polyacrylate and polyacrylic acid.

The adhesive material of the present invention can be laminated in a state where the resin film and the hydrogel are securely bonded by providing a hydrophilic anchor agent layer between the hydrophobic resin film and the hydrogel. . The anchor agent layer is water-insoluble and does not swell or dissolve with water contained in the hydrogel even when it comes into contact with the hydrogel.

[0013]

Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 shows an embodiment of the present invention.
Is provided with a resin film 12 as a support.
The resin film 12 retains the shape-retaining property of the hydrogel 16 described later and can be smoothly applied to the curved surface of the skin, and is formed by molding a polymer material, particularly a thermoplastic resin, into a film or sheet. is there. This resin film 12
The moisture permeability may be appropriately set according to the intended use, and may be a resin film having no moisture permeability, a resin film having water repellency and moisture permeability, or a resin film having fine pores formed therein. As a method of forming the moisture-permeable resin film,
There are a method of foaming and processing into a film, a method of stretching a film, a method of extracting a soluble component from the stretched sheet, and a method of perforating with a fine needle or the like.

As the thermoplastic resin, polyurethane, polyester, polyethylene, polyethylene terephthalate, polypropylene, polystyrene, polyvinyl chloride,
Examples thereof include polyvinylidene chloride, polyamide, saponified ethylene-vinyl acetate copolymer, and ethylene-vinyl acetate copolymer. The thickness of the resin film 12 is desirably 200 μm or less, most preferably about 100 μm.
１５15 μm. And the production of the resin film 12
It is performed by an inflation method, a casting method, a coextrusion method, or the like, and a carrier film may be used in the process as needed. When the carrier film is peeled off before the step of manufacturing the adhesive material 10, the material such as paper is optional.

An anchor agent layer 14 is provided on one side of the resin film 12. The polymer of the anchor agent layer 14 is formed of a polymer obtained by polymerizing one or two or more of acrylic acid, methacrylic acid, and a monomer having a derivative having an amino group, a sulfonyl group, a phosphate group, or an amide group. Have been. This polymer is hydrophilic and water-insoluble (less than 20% dissolved in pure water at a water temperature of 20 ° C. within 60 minutes after drying at 105 ° C. for 1 hour). The thickness of the anchor agent layer 14 is preferably 50 μm or less, and more preferably 20 μm or less.
It is about μm to 2 μm.

On the surface of the anchor agent layer 14, the hydrogel 1
6 are stacked. The water-containing gel 16 is obtained by crosslinking a water-soluble polymer with metal ions to form a gel. For example, it contains sodium polyacrylate, polyacrylic acid, an aluminum compound, and water, and is formed into a gel by crosslinking the carbonyl groups of sodium polyacrylate and polyacrylic acid with aluminum ions. Aluminum compounds include, for example, dried aluminum hydroxide, aluminum chloride, aluminum sulfate, aluminum magnesium sulfate, dihydroxyaluminum aminoacetate, allantochlorohydroxyaluminum, potassium alum and the like. The water-containing gel 16 may be combined with other water-soluble polymers such as polyvinyl alcohol, CMC (sodium carboxymethylcellulose), and polyvinylpyrrolidone. Also, preservatives,
An emulsifier, a pH adjuster, an absorption enhancer, a medicinal ingredient, a humectant, etc. may be added. The method of addition may be performed by various methods well known from the viewpoint of stability, safety, and medicinal effects in the adhesive patch field. Can be.

Before using the patch 10, the hydrogel 1
A separator 18 to be peeled off is attached to the surface of No. 6. The patch 10 to which the separator 18 is attached is individually wrapped with sterile paper, a transparent film, or the like.

Next, a method for manufacturing the patch 10 of this embodiment will be described. First, an aqueous solution, an organic solution, and a polymer serving as the anchor agent layer 14 are formed on one surface of the resin film 12.
Alternatively, it is applied as a mixed solution of water and an organic solvent. Then, the polymer becomes a water-insoluble coating by heat drying, self-aggregation reaction, cross-linking reaction, catalytic reaction, and the like, and is fixed to the resin film 12 to form the anchor agent layer 14. At this time, if necessary, heating air is blown. Alternatively, an anchor agent layer 14 may be formed by attaching a film of the above polymer to one surface of the resin film 12 in advance.

The hydrogel 16 is applied to the surface of the anchor agent layer 14 by kneading or continuous mixing. A separator 18 is attached to the surface of the hydrogel 16 and punched or half-cut into an arbitrary shape and size to obtain a shape suitable for a user and a site to be used.

Next, a method of using the patch 10 will be described. First, the patch 10 is taken out of the individual packaging (not shown), and the separator 18 is peeled off from the patch 10. Then, the exposed hydrogel 16 is brought into contact with the affected part of the body, and the hydrogel 1
Adhere to the body by the adhesive force of 6.

According to the adhesive material 10 of this embodiment, since the functional group of the polymer of the anchor agent layer 14 has an effect of bonding to the hydrogel 16, the hydrogel 16 is securely laminated on the resin film 12. Adhere to. Therefore, the resin film 12 and the hydrogel 16 can be used comfortably without peeling, and the production is easy. Since the anchor agent layer 14 is water-insoluble, it is not dissolved by the water content of the hydrogel 16.

The adhesive material 10 can adjust the moisture permeability and air permeability by selecting the material of the resin film 12, moisture permeability, density and the like. As a result, it is possible to adjust the amount of water evaporation, and to control the water evaporation of the cooling sheet using heat of vaporization, thereby providing a cooling effect,
The duration can be controlled. Also, pharmaceuticals,
In the case of quasi-drugs and cosmetics, it is expected to enhance the percutaneous absorption effect referred to as sealing therapy and on-clusion effect.

Further, the resin film 12, the anchor agent layer 1
4. The water-containing gel 16 can be made transparent, the application site can be easily observed, and the appearance can be made inconspicuous.

The adhesive material of the present invention is not limited to the above embodiment, but can be arbitrarily set in a preferred shape according to the body part to be used. The materials of the resin film, the anchor agent layer, and the hydrogel can be freely selected other than the above embodiment. Further, a resin film having no moisture permeability may be used according to the application. The patch of the present invention can be appropriately used for medicines, quasi-drugs, cosmetics, and the like.

[0025]

Next, the adhesive material 10 according to an example of the present invention was tested for the presence or absence of delamination between the resin film 12 and the hydrogel 16. The test method is as follows:
Is stored at room temperature for 2 days, and the presence or absence of delamination between the resin film 12 and the hydrogel 16 is observed. The test was performed on the following Comparative Examples 1, 2, and 3 and Examples 1, 2, and 3.

Comparative Example 1 A polyurethane film (80 μm) was previously coated with 10 parts by weight of sodium polyacrylate (partially neutralized product), 20 parts by weight of glycerin, 0.2 parts by weight of dry aluminum hydroxide, 2 parts by weight of citric acid, and purified. A mixture obtained by kneading 67.8 parts by weight of water was plastered. (Amount of plaster 1000 g / m ² ).

Example 1 A methacrylic acid polymer containing a quaternary amino group was coated on a polyurethane film (80 μm) to form an anchor agent layer (2
0 μm), and 10 parts by weight of sodium polyacrylate (partially neutralized product), 20 parts by weight of glycerin, 0.2 parts by weight of dry aluminum hydroxide, 2 parts by weight of citric acid, 67.8 parts by weight of purified water Was kneaded and plastered.
(Amount of plaster 1000 g / m ² ).

Comparative Example 2 In polyethylene terephthalate (75 μm), 10 parts by weight of sodium polyacrylate (partially neutralized product), 20 parts by weight of glycerin, 0.2 parts by weight of dry aluminum hydroxide, 2 parts by weight of citric acid, purification A mixture obtained by kneading 67.8 parts by weight of water was plastered. (Amount of plaster 1000 g / m ² ).

Example 2 A methacrylic acid polymer containing a quaternary amino group was applied to polyethylene terephthalate (75 μm) to provide an anchor agent layer (20 μm), and sodium polyacrylate (partially neutralized) 10 Parts by weight, glycerin 20 parts by weight, dry aluminum hydroxide 0.2 parts by weight, citric acid 2
The mixture obtained by kneading 6 parts by weight of purified water and 67.8 parts by weight of purified water was applied. (Amount of plaster 1000 g / m ² ).

Comparative Example 3 A polyurethane film (80 μm) was laminated with a polyvinyl alcohol film (having a mass of 20% or more dissolved within 60 minutes under a temperature condition of 20 ° C.), and sodium polyacrylate (partially neutralized) Product) 10 parts by weight,
A mixture of 20 parts by weight of glycerin, 0.2 parts by weight of dihydroxyaluminum aminoacetate, 2 parts by weight of citric acid, and 67.8 parts by weight of purified water was plastered. (Amount of plaster 1
000g ^{/ m} 2).

Example 3 A methacrylic acid polymer containing a quaternary amino group was coated on a polyurethane film (80 μm) to form an anchor agent layer (2
0 μm), and 10 parts by weight of sodium polyacrylate (partially neutralized product), 20 parts by weight of glycerin, 0.2 parts by weight of dry aluminum hydroxide, 2 parts by weight of citric acid, and 67.8 parts by weight of purified water are kneaded. The combination was plastered. (Amount of plaster 1000 g / m ² ). Table 1 shows the results of this test.

[0032]

[Table 1]

From the above results, in Comparative Examples 1 and 2 in which the hydrogel 16 was directly plastered on the resin film 12, the adhesion was weak because the resin film 12 was hydrophobic and the hydrogel 16 was hydrophilic. , Easily delaminated. Comparative Example 3 in which a water-soluble polyvinyl alcohol film was laminated on the resin film 12 and the hydrogel 16 was applied thereto.
In the above, the polyvinyl alcohol film was dissolved by the water content of the hydrogel and delaminated while sticking. On the other hand, in Examples 1 to 3, there was no delamination and the state was favorable. From this, it was found that the resin film 12 and the hydrogel 16 were surely adhered to each other.

[0034]

The adhesive material of the present invention can reliably attach a hydrogel to a resin film, and can be applied to a body for a long time in a favorable condition. And since a hydrogel can be attached to various resin films, the moisture permeability and air permeability are adjusted by selecting the material and moisture permeability of the resin film, and the presence or absence of micropores, and the cooling effect of the adhesive material and the medicinal effect Control of duration etc. becomes possible.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a patch according to an embodiment of the present invention.

[Description of Signs] 10 Adhesive material 12 Resin film 14 Anchor agent layer 16 Hydrogel 18 Separator

Claims (4)

[Claims] The present invention is characterized in that a hydrophilic and water-insoluble anchor agent layer is provided on one surface of a resin film, and a water-containing gel obtained by crosslinking a water-soluble polymer is laminated on the surface of the anchor agent layer. Sticking material. 2. The polymer obtained by polymerizing one or two or more of acrylic acid, methacrylic acid, and monomers of these derivatives having an amino group, a sulfonyl group, a phosphoric acid group, and an amide group. The patch according to claim 1, wherein: 3. The resin film according to claim 1, wherein the resin film is polyurethane,
The adhesive material according to claim 1, wherein the adhesive material is a simple substance mainly composed of polyester, PET, PP, or PS, or a transparent resin film in which the resin is laminated in two or more layers. 4. A hydrophilic and water-insoluble polymer is applied to one surface of a resin film to form an anchor agent layer, and a water-containing gel obtained by crosslinking a water-soluble polymer is applied to the surface of the anchor agent layer. The hydrated gel mainly contains sodium polyacrylate, polyacrylic acid, an aluminum compound and water, and is characterized in that the carbonyl group of sodium polyacrylate and polyacrylic acid and aluminum ions are cross-linked to form a gel. Manufacturing method of the adhesive material to be applied.