JP2006320358A - Film base material for adhesive skin patch and adhesive skin patch - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a film base material for an adhesive skin patch with little gloss not to be noticeable when pasted to the skin, and the adhesive skin patch using the same. <P>SOLUTION: The film base material for the adhesive skin patch has irregular recesses and projections at least on one surface of an elastomer film, with the maximum difference between the bottom and top of the unevenness being 5 μm and the minimum difference being 0.1 μm. The average roughness of ten points on the surface is at least 0.5 μm and not more than 3 μm. The material of the elastomer film is preferably at least one selected from the group consisting of polyethylene, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide, polyester, polyurethane, and acrylic polymer. The adhesive skin patch can be manufactured by forming an adhesive layer on one surface of the film base material for the adhesive skin patch. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a film base material for skin patch and a skin patch, for example, a film base material for skin patch and a skin patch used for medical and hygiene materials.

  Adhesive tapes for medical use and hygiene materials must be able to prevent entry of water, bacteria, viruses, and the like from the outside, and have flexibility to follow the curved surface and movement of the skin. Therefore, a thin elastomer film having a low elastic modulus similar to that of the skin is generally used as a support for such an adhesive tape. In addition, adhesive tapes for medical use and hygiene materials, such as dressing materials, are required to have a low gloss and are not noticeable when applied to the skin.

  In order to reduce the glossiness of the film and make it unnoticeable, for example, embossing or the like is performed on the film surface to give unevenness to the film surface.

  However, since the unevenness formed on the film surface by the embossing is uniform, the irregular reflection on the film surface becomes large and may become glossy, which may be noticeable.

JP 2003-190205 A

  The present invention has been made to solve the above problems, and the present invention provides a film base material for a skin patch that is less noticeable when applied to the skin with less gloss on the film surface, and It aims at providing the skin patch which uses this film base material for skin patches.

  The film base material for skin patch of the present invention has unevenness on at least one surface of the elastomer film, and the height difference between the bottom of the unevenness and the peak is 5 μm at the maximum, 0.1 μm at the minimum, The ten-point average roughness of the surface is 0.5 μm or more and 3 μm or less.

In the present invention, the material forming the elastomer film is at least one selected from the group consisting of polyethylene, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide, polyester, polyurethane, and acrylic polymer. it can.
The polyurethane may be an ether urethane resin.

The skin patch of the present invention is characterized by having an adhesive layer on one side of any one of the above-mentioned film bases for skin patches.
Here, the pressure-sensitive adhesive forming the pressure-sensitive adhesive layer includes an acrylic pressure-sensitive adhesive mainly composed of (meth) acrylic acid ester, a silicone pressure-sensitive adhesive mainly composed of polyorganosiloxane, and polyether polyurethane and / or Or it is preferable that it is at least 1 type chosen from the group which consists of a urethane type adhesive which has polyester polyurethane as a main component.

  ADVANTAGE OF THE INVENTION According to this invention, there can be provided the film base material for skin patches, and a skin patch which have few glossiness of surfaces and are not conspicuous when stuck on skin etc.

BEST MODE FOR CARRYING OUT THE INVENTION

  The film base material for skin patches of the present invention comprises an elastomer film having unevenness on the surface. It is preferable that the elastomer film has good flexibility to follow the skin and has flexibility to follow the unevenness and expansion / contraction of the skin accompanying bending of the body and the like. Examples of the material for forming such an elastomer film include polyethylene, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide, polyester, polyurethane, acrylic polymer, and the like. In the present invention, the elastomer film is preferably one that does not prevent sweating from the skin. For example, a polyamide, polyester, polyurethane, or acrylic polymer in which the formed film is excellent in water vapor permeability is preferably used. Ether-based urethane resins such as polyester polyurethane and polyether polyurethane, polyether polyester, and polyether polyamide are preferably used.

When the elastomer film is formed from an ether urethane resin such as polyether polyurethane, the ether urethane resin is obtained by reacting a polyol component and a polyisocyanate component. Here, as the polyol component, polyoxytetramethylene glycol (hereinafter also abbreviated as “OTMG”), butanediol (hereinafter also abbreviated as “BD”), polyethylene glycol (hereinafter “PEG”). And at least one selected from the group consisting of polypropylene glycol (hereinafter sometimes abbreviated as “PPG”) is preferably used. Further, as the polyisocyanate component, for example, diphenylmethane diisocyanate (hereinafter sometimes abbreviated as “MDI”) is preferably used.
In the present invention, “film” includes a sheet, and “sheet” includes a film.

  The polyoxytetramethylene glycol, polyethylene glycol, and polypropylene glycol used as the polyol component are preferably selected so as to have an appropriate molecular weight depending on the application. For example, the weight average molecular weight is 500 to 3,000. Are mentioned as preferred.

  In the present invention, it is preferable to use polyoxytetramethylene glycol and polyethylene glycol and / or polypropylene glycol as the polyol component. In particular, the ether-based urethane resin preferably contains 5 to 60% by weight of polyoxytetramethylene glycol and 10 to 50% by weight of polyethylene glycol, 5 to 45% by weight of polyoxytetramethylene glycol, and polyethylene glycol. It is more preferable to contain 20 to 45% by weight.

  In addition, for example, by using a random copolymer of polyoxytetramethylene glycol and polyethylene glycol as the polyol component, it is possible to ensure high moisture permeability while suppressing water swellability. In this case, it is desirable to use a random copolymer of polyoxytetramethylene glycol and polyethylene glycol.

  In the present invention, a chain extender can be further used. As the chain extender, conventionally known materials can be used, and examples thereof include diols such as ethylene glycol, propylene glycol, and butanediol, and diamines such as ethylenediamine.

  In the present invention, additives usually used for the film, for example, an ultraviolet absorber, an anti-aging agent, a filler, a pigment, a colorant, a flame retardant, an antistatic agent and the like can be added as necessary. These additives are used in normal amounts depending on the type.

The ether urethane resin can be polymerized using, for example, a one-shot method or a prepolymer method. Moreover, even if it is bulk polymerization which does not use a solvent, you may superpose | polymerize in a solution for viscosity reduction.
Below, bulk polymerization is demonstrated concretely. A diol component is put into a reaction vessel, and an isocyanate component is added to cause urethanization while adjusting the temperature to 50 to 80 ° C. and stirring. Further, after adding a chain extender and reacting, the reaction product is transferred to a tray and held at 100 to 150 ° C. for 4 hours or longer to complete the reaction, thereby obtaining a bulky ether urethane resin. Can do.

  Next, the ether-based urethane resin is pulverized and pelletized, and the resin pellet is melted and then extruded into a sheet using a T-die extruder or an inflation die extruder. The film base material which consists of can be formed. In addition, the film base material extruded into the sheet form is usually wound up. Alternatively, a film base made of an ether urethane resin is formed by calendering, rolling and stretching an ether urethane resin between two heated rolls, and forming into a sheet. It is wound up. Alternatively, the resin pellets are dissolved in a solvent such as N, N-dimethylamide, and this solution is applied onto a release liner such as a polyester film using a bar coater or the like, and dried to remove the solvent. A film substrate made of an ether urethane resin may be formed.

In the present invention, the thickness of the film substrate made of an ether-based urethane resin is preferably in the range of 10 to 150 μm in the case of a pressure-sensitive adhesive sheet (skin patch) used for medical or hygiene materials. . When the thickness of the film is less than 10 μm, the film tends to be difficult to handle when being applied to the skin or peeled off, and the operability is lowered to a level that is impractical in normal usage. On the other hand, if the thickness of the film is greater than 150 μm, sufficient moisture permeability cannot be obtained, so that the film is not suitable as a skin patch on the premise that it is applied to the skin. When the skin patch is used for dressing applications, the thickness of the film is particularly preferably in the range of 20 to 60 μm. Moreover, in the case of the use which requires a thin skin patch, it is preferable that it is 10-50 micrometers.
In addition, the film base material for skin patches can be made into a multilayer structure, for example, it is good also as a laminated body of an ether type urethane resin film.

  In the present invention, the elastomer film has unevenness on its surface unevenly. Here, “having unevenness unevenly” means that the height and size of the unevenness are not uniform, and the positional relationship where the unevenness is arranged is not uniform. This unevenness has a maximum height difference of 5 μm between the valley bottom and the peak, and a minimum of 0.1 μm. The ten-point average roughness of the surface is 0.5 μm or more and 3 μm or less. Thus, by designing the film surface to have unevenness unevenly, it is possible to realize a skin patch that has less gloss and is not noticeable when stuck to the skin.

  In the present invention, unevenness can be formed unevenly on the surface by, for example, stacking a film extruded from an extruder on the mat-treated surface of the mat-treated film and applying pressure to bring it into close contact. . In addition, it is preferable that the surface shape of the mat processing surface is appropriately designed and the magnitude of pressure to be adhered is appropriately adjusted so that the height difference between the concave and convex valley bottoms and peak tops is within a predetermined range.

  The skin patch of the present invention has an adhesive layer on one surface of the film base for skin patch. Specifically, an adhesive layer is provided on the film base material for skin patch made of the ether urethane resin. The pressure-sensitive adhesive layer is composed of an acrylic pressure-sensitive adhesive mainly composed of an acrylate ester, a silicone pressure-sensitive adhesive mainly composed of polyorganosiloxane, and a urethane-based pressure-sensitive adhesive mainly composed of polyether polyurethane and / or polyester polyurethane. It is preferably formed from at least one selected from the group.

  When the pressure-sensitive adhesive layer is formed from an acrylic pressure-sensitive adhesive, for example, an acrylic acid ester-based polymer is mixed with a carboxylic acid ester compatible with the acrylic acid ester-based polymer, if necessary, and a crosslinking agent to crosslink. It can be obtained by processing. However, the carboxylic acid ester has 16 or more carbon atoms and is liquid or pasty at room temperature.

  An acrylic ester polymer is a copolymer of a (meth) acrylic ester as a main component and a copolymerizable monomer as required. As the (meth) acrylic acid ester, a (meth) acrylic acid alkyl ester having 2 or more carbon atoms, preferably 2 or more and 18 or less carbon atoms is preferable. Examples include (meth) acrylic acid ethyl ester, propyl ester, butyl ester, pentyl ester, hexyl ester, octyl ester, nonyl ester, decyl ester, dodecyl ester, and the like. Among these (meth) acrylic acid esters, it is preferable to use one or more kinds. These alkyl ester chains may be linear or branched.

  As a monomer copolymerizable with (meth) acrylic acid ester, for example, a monomer containing a carboxyl group such as (meth) acrylic acid, itaconic acid, maleic acid, (meth) acrylic acid 2-hydroxyethyl, (meth) Monomers containing hydroxyl groups such as 2-hydroxypropyl acrylate, methoxyethyl (meth) acrylate, ethoxyethyl (meth) acrylate, butoxyethyl (meth) acrylate, methoxypolyethylene glycol (meth) acrylate, (meth ) Monomers containing an alkoxy group such as ethoxydiethylene glycol acrylate, vinyl monomers such as styrene and styrene derivatives, vinyl acetate and N-vinyl-2-pyrrolidone. One or more of these monomers can be used by copolymerizing with (meth) acrylic acid ester as required.

  The acrylate polymer preferably has a glass transition temperature of 260 ° K or lower. By setting the glass transition temperature of the acrylic ester polymer to 260 ° K or lower, the skin adhesiveness can be sufficiently expressed, which is desirable as a pressure-sensitive adhesive layer of a pressure-sensitive adhesive sheet for medical or hygiene materials.

  The acrylic ester polymer can be obtained, for example, by a known polymerization method such as a solution polymerization method, an emulsion polymerization method, or a suspension polymerization method. Moreover, it can obtain by performing radical polymerization using radical polymerization initiators, such as a peroxide type compound and an azo type compound.

  The carboxylic acid ester that is compatible with the acrylate polymer is preferably liquid or pasty at room temperature. When a pressure-sensitive adhesive layer is formed by mixing a solid carboxylic acid ester such as wax, the adhesiveness may be lowered.

  In the present invention, a gel-like pressure-sensitive adhesive layer can be obtained by mixing an acrylic ester polymer, a carboxylic acid ester, and a crosslinking agent to form a crosslinked body at least partially. The pressure-sensitive adhesive layer thus obtained can reduce the elastic modulus in the micro-deformation region, and improves the adhesion (wetability) of the surface of the pressure-sensitive adhesive layer with respect to the unevenness of the skin surface. Can exhibit excellent adhesiveness. In addition, when peeling the skin patch, the stress on the skin surface can be relaxed or dispersed, so there is almost no physical irritation to the skin surface when peeling, and the skin surface is keratinous. Peeling and the like hardly occur, and the skin damage is extremely small.

  Examples of the carboxylic acid ester preferably used in the present invention include phthalic acid, maleic acid, adipic acid, stearic acid, esters of various fatty acids and alkyl alcohols, esters of polyhydric alcohols such as ethylene glycol and glycerin, and the like. Can be used. For example, ethyl myristate, isopropyl myristate, isopropyl palmitate, butyl stearate, isopropyl isostearate, hexyl laurate, cetyl lactate, myristyl lactate, diethyl phthalate, dioctyl phthalate, octyldodecyl myristate, octyldodecyl oleate, Esters using monohydric alcohols such as hexyldecyl dimethyloctanoate, cetyl 2-ethylhexanoate, isocetyl 2-ethylhexanoate, stearyl 2-ethylhexanoate, dioctyl succinate, propylene glycol dicaprylate, propylene glycol dicaprate , Propylene glycol diisostearate, glyceryl monocaprylate, glyceryl tricaprylate, glyceryl tri-2-ethylhexanoate, tricaprin Glyceryl, mention may be made trilaurate, glyceryl triisostearate, glyceryl trioleate glyceryl, an ester with a bivalent or higher polyvalent alcohol such as tri-2-ethylhexanoate trimethylolpropane.

  In this invention, when mix | blending the said carboxylic acid ester, at least 1 sort (s) is dissolved in an acrylic ester polymer. Although a compounding quantity is not specifically limited, For example, it is preferable to contain carboxylic acid ester within the range of 30-100 weight part with respect to 100 weight part of acrylic ester polymer.

  In the present invention, in the case of using an acrylate ester-based polymer in which the carboxylic acid ester is dissolved, it is necessary that a crosslinked body is formed in a part thereof. In order to form a crosslinked body, a crosslinking treatment is performed. For example, an organic peroxide, an isocyanate compound, an organic metal salt, a metal chelate, an epoxy compound, or the like may be used, and a chemical crosslinking treatment may be performed. Physical crosslinking treatment may be performed using actinic radiation.

  If necessary, the resin composition (adhesive) forming the adhesive layer may be a plasticizer such as glycerin or polyethylene glycol, a water-soluble or water-absorbing resin such as polyacrylic acid or polyvinylpyrrolidone, rosin, or terpene. Various additives such as tackifiers such as petroleum and petroleum, various softeners, fillers, and pigments can be blended. In particular, when a carboxylic acid ester having an unsaturated bond is used, there is a concern that a change in physical properties may occur due to oxidative degradation due to oxygen in the atmosphere, and the desired properties may not be exhibited. It is preferable to mix | blend an inhibitor in a resin composition (adhesive).

  The thickness of the pressure-sensitive adhesive layer is preferably set in the range of 10 to 100 μm. If the thickness of the pressure-sensitive adhesive layer is less than 10 μm, sufficient adhesion may not be exhibited during application to the skin, and if it exceeds 100 μm, the level of water vapor permeability required for a skin patch cannot be obtained. Sometimes.

  In the present invention, a medical tape or sheet such as a bandage can be formed using this skin patch. For example, cut the skin patch to an appropriate size to form an adhesive bandage, or a covering material for covering a wound part, a post-surgical patch, a catheter needle insertion part, a cover material for gauze, etc. A medical product such as a fixing tape or a device holding tape can be formed by forming a tape or a sheet, or by combining another base material with the skin patch. In addition, it goes without saying that the base material for skin patch and the skin patch of the present invention can be used other than the above medical applications as long as they are applied to the skin. For example, adhesive piercings, tattoo tapes, wig fixing It can also be used for tapes and artificial hair transplantation tapes.

  Hereinafter, the present invention will be described in detail using examples, but the present invention is not limited thereto. The measurement methods and evaluation methods used in the following examples are shown below.

<Measurement method and evaluation method>
(1) Measurement of surface shape of surface of film base material for skin patch material Cut out the film base material for skin patch material into a size of 10 mm x 10 mm and fix it on a glass plate with double-sided tape. Using a stylus type surface shape measuring instrument (Tencor P-11, manufactured by KLA-Tencor Corporation), the surface shape is measured under the conditions of a measurement length of 300 μm, a scanning speed of 100 μm / sec, a scanning frequency of 150 times, and a load of 3 mg. The ten-point average roughness of the surface was obtained. Moreover, the maximum value and minimum value of the height difference between the valley bottom and the peak of the unevenness on the surface were obtained.

(2) Evaluation of surface gloss at the time of sticking The skin patch was attached to the skin and visually observed to evaluate whether it was glossy and noticeable.

Example 1
In a reaction vessel equipped with a cooling tube, a heating device, a thermometer, and a stirring device, as a polyol, 38 g of polyoxytetramethylene glycol (OTMG) having a weight average molecular weight of 1,000 and a weight average molecular weight of 2,000 are used. 26 g of polyethylene glycol (PEG) and 6 g of 1,4-butanediol (BD) are added and mixed. The temperature was adjusted to 70 ° C., and 30 g of methylene diphenyl diisocyanate (MDI) adjusted to 50 ° C. was added as a polyisocyanate while stirring and stirred for 5 minutes. Thereafter, the reaction product was transferred to a tray, placed in a hot air dryer and aged at 140 ° C. for 5 hours to obtain a bulky ether-based urethane resin. The obtained bulk ether-based urethane resin was put into a twin-screw type kneader, heated and melted, then extruded using a T-die extruder to a thickness of 30 μm, and the matte-treated stretched polypropylene film A film base material for skin patch having an uneven surface was prepared by overlapping the mat-treated surface and using a rubber roll.

  About the obtained film base material for skin patches, surface shape measurement was performed and ten-point average roughness and the height difference between a valley bottom and a mountain top were calculated | required. In addition, the result obtained by surface shape measurement is shown in FIG.1 and FIG.2. FIG. 1 is a diagram showing a measurement result of a three-dimensional surface shape of the surface, and FIG. 2 is a diagram showing a two-dimensional profile of the surface.

Next, an adhesive layer is formed on the obtained film base material for skin patch.
Isonyl acrylate (NA), methoxyethyl acrylate (MEA), and acrylic acid (AA) were copolymerized to obtain an alkyl acrylate polymer. However, the blending ratio of the acrylic acid alkyl ester polymer is NA: MEA: AA = 65: 30: 5 in weight ratio. 100 parts by weight (solid content) of the resulting alkyl acrylate ester polymer, 60 parts by weight of caprylic acid triglyceride (GTC) as a carboxylic acid ester component, and 0.2 parts by weight of a trifunctional isocyanate compound as a crosslinking agent component It mixed in toluene and the solution for an adhesive layer (concentration 33%) was created. This pressure-sensitive adhesive layer solution was applied on the release-treated surface of the paper separator subjected to the release treatment so that the thickness after drying was 30 μm, and dried in a hot air dryer at 110 ° C. for 3 minutes. A layer was formed.

  After bonding the film base material which consists of the produced ether type urethane resin on the obtained adhesive layer, it preserve | saved for 3 days in 60 degreeC atmosphere in a hot-air dryer, and performs aging, and the adhesive layer of The cross-linking reaction was completed to prepare a skin patch for dressing material. When the obtained skin patch was affixed to the skin and the surface gloss was evaluated, the surface of the skin patch did not cause diffuse reflection, and the gloss was not so noticeable when applied. It turns out that.

  As is clear from FIG. 1, it was found that the film base material for skin patch of Example 1 had unevenness on the surface. Further, it was found from FIG. 2 that the film base material for skin patch of Example 1 had a maximum height difference of 2.3 μm and a minimum value of 0.3 μm between the valley bottom and the peak. Furthermore, the ten-point average roughness of the film base material for skin patch of Example 1 was 1.8 μm. That is, the irregularity of the surface may be reduced by having unevenness in which the height difference between the valley bottom and the mountain top is 0.1 μm or more and 5 μm or less and the ten-point average roughness is 0.5 μm or more and 3 μm or less. As a result, since the surface gloss can be reduced, it has been found that an unobtrusive skin patch can be realized.

  This skin patch had an appropriate adhesive strength and was excellent in followability to the skin and the like.

  The skin patch of the present invention can be used in the form of sheets and tapes of various sizes, and can also be stored in a roll form. These skin patch materials can be used in the fields of skin patch application, for example, medical hygiene field, external use, and the like. Specifically, they are suitably used for bandages, adhesive bandages, dressing materials and the like.

It is a figure which shows the three-dimensional surface shape measurement result of the surface of the film base material for skin patches of Example 1. FIG. It is a figure which shows the two-dimensional profile of the surface of the film base material for skin patches of Example 1. FIG.

Claims (5)

  There is uneven unevenness on at least one surface of the elastomer film, the height difference between the valley bottom and the peak of the unevenness is 5 μm at the maximum, 0.1 μm at the minimum, and the 10-point average roughness of the surface is 0.5 μm or more. A film base material for skin patch, characterized by being 3 μm or less.   The material for forming the elastomer film is at least one selected from the group consisting of polyethylene, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide, polyester, polyurethane, and acrylic polymer. Item 14. The film base material for skin patch according to Item 1.   The film base material for a skin patch according to claim 2, wherein the polyurethane is an ether urethane resin.   A skin patch having a pressure-sensitive adhesive layer on one side of the film substrate for skin patch according to any one of claims 1 to 3. The pressure-sensitive adhesive forming the pressure-sensitive adhesive layer is an acrylic pressure-sensitive adhesive mainly composed of (meth) acrylic acid ester, a silicone pressure-sensitive adhesive mainly composed of polyorganosiloxane, and polyether polyurethane and / or polyester polyurethane. The skin patch according to claim 4, which is at least one selected from the group consisting of urethane-based pressure-sensitive adhesives mainly comprising