JPH08104622A - Support and application agent for external use using the same - Google Patents

Abstract

PURPOSE: To obtain a support and an application agent for external use, having excellent follow-up properties to the skin, readily handleable and excellent in barrier properties of a medicine without depositing or exuding the medicine to the surface of the support during the preservation and deteriorating the merchandise value. CONSTITUTION: This support uses a laminate of a polymeric film having 0.1-2.5kg/5cm 50% modulus to a nonwoven or a woven fabric having 0.1-1.5kg/5cm 50% modulus and 0.3-0.7 drape coefficient. The 50% modulus of the whole support is 0.1-2.5kg/5cm.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a support and an external patch using the support.

[0002]

2. Description of the Related Art Generally, in patches, it is desired that the patches follow the movements of the human body's skin and are not easily peeled off from the skin. The knitted cloth is used. In JP-A-3-161432, the 50% modulus, which is an index of elasticity, is 0.1 to 2.0 kg / 5 cm.
And the drape coefficient, which is an index of bending resistance, is 0.200 to
It is described to use a support of 0.650, for example:
Non-woven fabrics such as polyester fibers, polyethylene fibers and polyvinyl alcohol fibers, or non-woven fabrics obtained by mixing these materials with rayon, hemp, silk or the like, or urethane films are mentioned.

However, since nonwoven fabrics, woven fabrics, and knitted fabrics have high air permeability and low drug barrier properties, when used as a support for patches, the drug in the pressure-sensitive adhesive layer migrates to the support during storage of the preparation. However, there is a problem that the commercial value is impaired, such as precipitation or exudation on the side opposite to the adhesive layer. Moreover, the sealing effect is not sufficient. Further, these stretchable supports have a problem that they are difficult to handle due to lack of rigidity depending on the material used, even if the stretchable support and the flexibility as a whole are satisfied.

[0004]

DISCLOSURE OF THE INVENTION The present invention is intended to solve the above problems, and its object is to have excellent followability to the skin, easy handling, and excellent drug barrier properties. Another object of the present invention is to provide a support and a patch for external use using the support.

[0005]

The support of the present invention is a laminate of a polymer film and a non-woven fabric or a woven fabric. In the present invention, when the patch is applied to a portion of human skin such as an elbow, a knee, or a neck that is often bent and stretched, the maximum stretch of the skin is 1.5 times in order for the patch to follow the skin. Is a load (50%) that stretches the support 1.5 times (50% elongation).
Modulus) is used as an index of elasticity.

The above-mentioned polymer film and the above-mentioned non-woven fabric or woven fabric have lower strength when the 50% modulus becomes smaller,
There is a problem such as breakage of the support at the time of coating or laminating, and the larger the size, the poorer the ability to follow the skin.
50% modulus of polymer film is 0.1-2.5k
g / 5 cm, 50% modulus of non-woven or woven fabric is limited to 0.1-1.5 kg / 5 cm. Further, the above-mentioned non-woven fabric or woven fabric has a 50% modulus value and a drape coefficient which is an index of bending resistance becomes small and becomes difficult to handle, and when the drape coefficient becomes large, flexibility is deteriorated and followability is deteriorated. Since there is a problem such as peeling when used as an agent, it is limited to 0.3 to 0.7.

When the above polymer film is used alone,
When the 0% modulus is 0.1 to 2.5 kg / 5 cm, although it varies depending on the material, the ability to follow the skin is excellent, but the thickness of the support becomes thin, making it difficult to handle. In addition, when the above-mentioned non-woven fabric or woven fabric is used alone, 5
When the 0% modulus is 0.1 to 1.5 kg / 5 cm and the drape coefficient is 0.3 to 0.7, the stretchability is excellent, but the drug barrier property is low and the sealing effect is not sufficient.

Therefore, by laminating the above-mentioned polymer film and a non-woven fabric or a woven fabric, a support which is easy to handle and has excellent stretchability, barrier properties and sealing effect can be obtained, and the total weight of the support is 50%. Modulus is 0.1
More preferably, it is 2.5 kg / 5 cm.

The 50% modulus in the present invention is a value obtained by the following measurement. That is, with respect to a test piece of 50 mm × 300 mm, a test length is 200 mm and a pulling speed is 200 mm / mi using a tensile tester.
The test piece is stretched 100 mm by n (elongation of 50%), and the load (kg) at this time is set to 50% modulus. The drape coefficient is a value measured according to a bending resistance test (G method) according to JIS L 1096 general woven fabric test method.

The material of the polymer film is not particularly limited as long as it is substantially drug-impermeable, and examples thereof include polyethylene, plasticized vinyl acetate-vinyl chloride copolymer, ethylene-acetic acid. Examples thereof include a vinyl copolymer, an ethylene-methyl methacrylate copolymer, an ethylene-ethyl acrylate copolymer, and the like.

The material of the above-mentioned non-woven fabric or woven fabric is not particularly limited and known ones are used, and examples thereof include polystyrene, polyester, polypropylene, rayon, polyolefin and pulp.

The patch for external use of the present invention 3 comprises an adhesive layer formed on the above support. As the base material of the pressure-sensitive adhesive layer, known base materials are used, but they differ depending on the dosage form of the patch. Examples of the dosage form of the patch for external use of the present invention include tapes, patches, poultices, plasters and the like. Further, the adhesive layer may contain a drug, an additive, etc., if necessary.

The above tape preparation has a pressure-sensitive adhesive layer containing a drug, an additive, etc., which is added as necessary, on one side of a support. The patch is composed of a non-adhesive reservoir layer and an adhesive layer, which are sequentially laminated on one surface of a support, and the reservoir layer is non-adhesive to drugs, additives, etc. added as necessary. It is held in the base. This reservoir layer is attached to the skin via the adhesive layer, and the drug or the like in the reservoir layer is transdermally absorbed through the adhesive layer. However, the drug or the like in the reservoir layer may be contained in the adhesive layer.

The poultice is a layer of paste-like base containing a drug, an additive, etc., which is added as necessary, on the surface of a support. Since patches are generally less sticky than tapes and patches, they are fixed to the skin surface with a plaster or the like. The plaster agent is obtained by applying a pressure-sensitive adhesive base containing a drug, an additive, etc., which is added as necessary, in a layered form on the surface of a support. Crimping base is
For example, specific rubber adhesives, synthetic or natural resins, Z
It is obtained by kneading nO and the like.

As the non-adhesive base material forming the reservoir layer of the patch agent, known ones are used, for example, white petrolatum, silicone oil, carboxyvinyl polymer, polyvinyl alcohol, polyethylene glycol,
Liquid paraffin and the like can be mentioned. The base of the pressure-sensitive adhesive layer of the tape and patch is not particularly limited as long as it has excellent compatibility with drugs and the like, and has an adhesive force capable of fixing the patch on the skin surface at room temperature for a long time. Examples include acrylic adhesives, rubber adhesives, silicone adhesives, and the like.

As the acrylic pressure-sensitive adhesive, a (co) polymer of an alkyl (meth) acrylate obtained from an aliphatic alcohol having 4 to 18 carbon atoms and (meth) acrylic acid and / or the above (meth) is particularly preferable. Copolymers of alkyl acrylate and other functional monomers are preferred.

Examples of the (meth) acrylic acid alkyl ester include butyl (meth) acrylic acid, isobutyl (meth) acrylic acid, hexyl (meth) acrylic acid, octyl (meth) acrylic acid, and (meth) acrylic acid 2 Examples include ethylhexyl, isooctyl (meth) acrylate, decyl (meth) acrylate, isodecyl (meth) acrylate, lauryl (meth) acrylate, stearyl (meth) acrylate, and dodecyl (meth) acrylate.

Examples of the functional monomer include a monomer having a hydroxyl group, a monomer having a carboxyl group, a monomer having an amide group, a monomer having an amino group, and a monomer having a pyrrolidone ring. Examples of the monomer having a hydroxyl group include hydroxyalkyl (meth) acrylate such as 2-hydroxyethyl (meth) acrylate and hydroxypropyl (meth) acrylate. Examples of the monomer having a carboxyl group include α, β-unsaturated carboxylic acids such as acrylic acid and methacrylic acid, maleic acid monoalkyl esters such as butyl maleate, (anhydrous) maleic acid,
Examples include fumaric acid and crotonic acid.

As the above-mentioned amide group-containing monomer,
Examples thereof include alkyl (meth) acrylamides such as acrylamide, dimethyl acrylamide and diethyl acrylamide, alkyl ether methylol (meth) acrylamides such as butoxymethyl acrylamide and ethoxymethyl acrylamide, and diacetone acrylamide. Examples of the monomer having an amino group include dimethylaminoethyl acrylate and the like. Examples of the monomer having a pyrrolidone ring include vinylpyrrolidone.

Examples of monomers other than the above include vinyl acetate, styrene, α-methylstyrene, vinyl chloride,
Acrylonitrile, ethylene, propylene, butadiene, etc. can be used. In order to produce a (meth) acrylic acid alkyl ester copolymer, it is preferred that the (meth) acrylic acid alkyl ester is contained in an amount of 50% by weight or more in all the copolymerization components.

If necessary, a polyfunctional monomer is added to the monomer component for producing the acrylic pressure-sensitive adhesive,
Copolymerized with the above monomer components. The addition of this polyfunctional monomer causes only slight cross-linking between the resulting polymers, which increases the internal cohesive strength of the adhesive. Therefore, the so-called adhesive residue phenomenon at the time of peeling the pressure-sensitive adhesive is almost eliminated irrespective of the property of the applied skin and the amount of perspiration. Moreover, the addition of this polyfunctional monomer has no influence on the drug release property and the mildness. The polyfunctional monomer is not particularly limited, and examples thereof include di (meth) acrylic acid, tri (meth) acrylic acid,
Examples thereof include tetra (meth) acrylic acid.

Examples of the di (meth) acrylic acid include di (meth) acrylic acid and polyethylene glycol obtained by binding polymethylene glycols such as hexamethylene glycol and octamethylene glycol with (meth) acrylic acid. , And di (meth) acrylic acid obtained by binding polyalkylene glycols such as polypropylene glycol and (meth) acrylic acid.
Examples of the tri (meth) acrylic acid include trimethylolpropane tri (meth) acrylic acid and glycerin tri (meth) acrylic acid. Examples of the tetra (meth) acrylic acid include pentaerythritol tetra (meth) acrylic acid.

The above polyfunctional monomers may be used in combination of two or more kinds. When the amount of the polyfunctional monomer is small, the effect of improving the internal cohesive force by cross-linking is small, and when the amount is large, the adhesive obtained by the polymerization easily causes gelation, and the diffusion and release of the drug are also affected. It is preferable to use it in a proportion of 0.005 to 0.5% by weight based on all the monomers used in the production of

If desired, a tackifier such as a rosin resin, a polyterpene resin, a coumarone-indene resin, a petroleum resin, or a terpene-phenol resin may be added to the acrylic pressure-sensitive adhesive. The acrylic pressure-sensitive adhesive base is polymerized by a commonly known method, and is prepared, for example, by mixing the above monomers in the presence of a polymerization initiator and carrying out solution polymerization. However, the polymerization conditions are appropriately selected mainly depending on the type of the monomer.

Examples of the rubber-based pressure-sensitive adhesive include natural rubber, synthetic isoprene rubber, polyisobutylene, polyvinyl ether, polyurethane, polyisoprene, polybutadiene, styrene-butadiene copolymer, styrene-
100 parts by weight of rubber elastic material such as isoprene copolymer, styrene-isoprene-styrene block copolymer, styrene-isoprene-butylene block copolymer, for example, rosin resin, polyterpene resin, coumarone-indene resin, petroleum resin 20 to 200 parts by weight of a tackifier such as terpene-phenol resin, and if necessary, liquid polybutene, mineral oil, lanolin, liquid isobutylene, a softening agent such as liquid polyacrylate, a filler such as titanium oxide, butylhydroxytoluene. Those to which an antiaging agent and the like are appropriately added are used.

As the above-mentioned silicon-based pressure-sensitive adhesive, for example, one containing polyorganosiloxane as a main component is used. A compounding agent such as a plasticizer, a filler, and an anti-aging agent is added to each of the above pressure-sensitive adhesives as needed.

Examples of the base of the poultice include natural polymers such as alkali metal alginate, gelatin, corn starch and tragacanth gum, methyl cellulose,
Synthesis of cellulose-based polymers such as hydroxyethyl cellulose and carboxymethyl cellulose, starch-based polymers such as dextrin and carboxymethyl starch, polyvinyl alcohol, sodium polyacrylate, methoxyethylene-maleic anhydride copolymer, polyvinyl ether and polyvinylpyrrolidone Examples thereof include polymers.

The pasty base used for the preparation of poultices contains, in addition to drugs such as drugs and absorption promoters, which are added as necessary, moisturizing agents such as purified water, glycerin and propylene glycol, Inorganic fillers such as kaolin, bentonite, zinc white, titanium dioxide, etc., viscosity modifiers, cross-linking agents, anti-aging agents and the like may be appropriately added. As the base of the plaster agent, for example, a pressure-sensitive adhesive base obtained by kneading a specific rubber adhesive, synthetic or natural resin, ZnO, or the like is used.

The drug is not particularly limited as long as it can permeate the biological membrane transdermally, and examples thereof include antipyretic and analgesic anti-inflammatory agents, steroidal anti-inflammatory agents, vasodilators, arrhythmia agents,
Antihypertensive agent, antitussive expectorant, antineoplastic agent, local anesthetic,
Hormonal agents, antihistamines, anticoagulants, antispasmodic agents, general anesthetics, sleep / analgesics, antiepileptics, stimulants / stimulants, tranquilizers, neuropsychiatric agents, skeletal muscle relaxants, autonomic agents, antiparkinson agents , Diuretics, vasoconstrictors, respiratory stimulants, peptic ulcer remedies, biliary agents, genitourinary and anal agents, agents for parasitic skin diseases, emollients, vitamins, mineral agents, hemostatic agents, Liver disease agents, addictive agents, gout remedies, diabetes agents, antibiotics, chemotherapeutic agents, narcotics,
Cardiotonic agents, arteriosclerotic agents, radiopharmaceuticals, Kampo preparations, anthelmintic agents, antiprotozoal agents and the like can be mentioned.

Examples of the antipyretic analgesic and anti-inflammatory agent include acetaminophen, phenacetin, mefenamic acid, diclofenac sodium, flufenamic acid, aspirin, sodium salicylate, aminopyrine, alchlorfenac, ibuprofen, naproxen, flurbiprofen, ketoprofen. , Amphenac sodium, mepyrizole, indomethacin, pentazocine, piroxicam and the like. Examples of the steroidal anti-inflammatory agent include hydrocortisone, triamcinolone, dexamethasone, prednisolone and the like.

Examples of the vasodilators include diltiazem hydrochloride, pentaerythritol tetranitrate, isosorbide nitrate, trazivir, nicorandil, nitroglycerin, prenylamine lactate, molsidomine, amyl nitrite and tolazoline hydrochloride. Examples of the agent for arrhythmia include procainamide hydrochloride, lidocaine hydrochloride, propranolol hydrochloride, alprenolol hydrochloride, atenolol,
Examples thereof include nadolol, metoprolol tartrate, azimarin, disopyramide, and mexiletine hydrochloride. Examples of the antihypertensive agent include ecarazine hydrochloride, indapamide, clonidine hydrochloride, pnitrolol hydrochloride, labetalol hydrochloride, captopril, guanabenz acetate, meptamate, betanidine sulfate and the like.

Examples of the antitussive and expectorant agents include carbetapentane citrate, cloperastine, oxerazine tannate, clobutynol hydrochloride, clofedanol hydrochloride, noscapine hydrochloride, ephedrine hydrochloride, isoproterenol hydrochloride, chlorprenaline hydrochloride, hydrochloric acid. Methoxyphenamine, procaterol hydrochloride, tulobuterol hydrochloride, clenbuterol hydrochloride, ketotifen fumarate and the like can be mentioned. Examples of the antineoplastic agent include cyclophosphamide, fluorouracil, degafur, mitomycin C, procarbazine hydrochloride, doxyfluridine,
Ranimustine and the like can be mentioned.

Examples of the local anesthetic include ethyl aminobenzoate, tetracaine hydrochloride, procaine hydrochloride, dibucaine hydrochloride, oxybuprocaine hydrochloride, propitocaine hydrochloride and the like. Examples of the hormone agent include propylthiouracil, thiamazole, metenolone acetate,
Eltradiol, estriol, progesterone and the like can be mentioned. Examples of the antihistamine include the following:
Examples thereof include diphenhydramine hydrochloride, chlorpheniramine maleate, promethazine, cyproheptadine hydrochloride, diphenylpyraline hydrochloride.

Examples of the blood coagulation inhibitor include warfarin potassium, ticlopidine hydrochloride and the like. Examples of the antispasmodic include methylatropine bromide, spocolamine and the like. Examples of the general anesthetic include thiopental sodium and pentobarbital sodium. Examples of the hypnotic / analgesic include bromvalenyl urea, amobarbital, phenobarbital and the like.

Examples of the above antiepileptic agents include phenytoin sodium and the like. Examples of the stimulant / stimulant include methamphetamine hydrochloride and the like.
Examples of the anti-pain agents include difendol hydrochloride, betahistine mesylate and the like. Examples of the psychiatric agents include chlorpromazine hydrochloride, thioridacin, meprobamate, imipramine hydrochloride, chlordiazepoxide, diazepam and the like. Examples of the skeletal muscle relaxant include suxamethonium hydrochloride and the like. Examples of the agent for autonomic nerve include neostigmine bromide, bethanechol hydrochloride and the like.

Examples of the above anti-Parkinson's agents include
Amantadine hydrochloride and the like can be mentioned. Examples of the diuretics include hydroflumethiazide, isosorbide, furosemide and the like. Examples of the vasoconstrictor include phenylephrine hydrochloride and the like. Examples of the respiratory stimulants include lobeline hydrochloride, dimoriphoramine, and nalloxone hydrochloride. Examples of the therapeutic agent for peptic ulcer include glycopyrronium bromide, proglumide,
Examples include cetraxate hydrochloride, cimetidine, spizofron and the like. Examples of the choleretic agent include ursodesoxylolic acid and osalmid.

Examples of the secretory genital and anal agents include hexamine, sparteine, dinoprost, ritodrine hydrochloride and the like. Examples of the above-mentioned agents for parasitic skin diseases include salicylic acid, ciclopirox olamine, croconazole hydrochloride and the like. Examples of the emollient include urea and the like. Examples of the vitamin agent include calcitriol, thiamine hydrochloride, sodium riboflavin phosphate, pyridoxine hydrochloride, nicotinic acid amide, panthenol, and ascorbic acid.

Examples of the above-mentioned inorganic preparations include calcium chloride, potassium iodide, sodium iodide and the like. Examples of the hemostatic agent include ethanesylate and the like. Examples of the liver disease agent include, for example,
Examples include tiopronin. Examples of the drug for addiction include cinnamide and the like. Examples of the ventilation agent include colchicine, probenecid, sulfinpyrazone and the like. Examples of the diabetes drug include tolbutamide, chlorpropamide, sodium glymidine, glybsol, buformin hydrochloride, insulin and the like.

Examples of the above antibiotics include benzylpenicillin potassium, propicillin potassium, cloxacillin sodium, ampicillin sodium, bacampicillin hydrochloride, carbenicillin sodium, cephaloridine, cefoxitin sodium, erythromycin, chloramphenicol, tetracycline. , Kanamycin sulfate, cycloserine and the like. Examples of the chemotherapeutic agent include isoniaside, pyraminazide, ethionamide and the like. Examples of the drug include, for example,
Examples include morphine hydrochloride, codeine phosphate, cocaine hydrochloride, pethidine hydrochloride and the like.

When the content of the above-mentioned drug is small, the transdermal absorption effect per unit area of the drug is not sufficient, and the blood is sufficient to exert a medicinal effect in a practical patch area (150 cm ² or less) of the patch. When it becomes impossible to obtain a medium concentration and when it becomes too large, the adhesive patch is likely to be cracked in the base material and the adhesive property is deteriorated. Therefore, 0.05 to 30% by weight is preferable in the pressure-sensitive adhesive layer.

Further, in the pressure-sensitive adhesive layer, an appropriate absorption promoter may be contained, if necessary, for the purpose of improving the transdermal permeability of the drug. Examples of the absorption enhancer include isopropyl myristate, diethyl sebacate, sorbitan monolaurate, glycerin monooleate, sodium oleyl phosphate, sodium lauryl sulfate, octyl phenyl ether, octyl phenyl ether with polyethylene glycol, lauryl ether, polyethylene. Glycol-added lauryl ether,
Sorbitan monooleate, polyethylene glycol addition sorbitan monooleate, lauroyl diethanolamide, lauroyl sarcosine, oleoyl sarcosine sugar ester, lecithin, glycyrrhetin, urea,
Examples thereof include salicylic acid, calcium thioglycolate, lactic acid, lactic acid ester, olive oil, squalene, lanolin, liquid paraffin and glycerin.

If the content of the above-mentioned absorption enhancer increases, the skin irritation of the obtained preparation becomes large, and redness and itching occur when administered to the skin. Therefore, it is preferably 10% by weight or less in the adhesive layer, More preferably, it is 0.1 to 10% by weight.

The patch for external use of the present invention is usually provided with a release paper on the sticking surface in order to protect the surface of the pressure-sensitive adhesive layer until use. As the release paper, polyethylene terephthalate film treated with silicon is often used, but it is not particularly limited. The thickness of the release paper is preferably 100 μm or less, more preferably 5 to 5
0 μm.

In the patch for external use of the present invention, an adhesive layer containing a compounding agent such as a drug and an absorption promoter is formed on one surface of the support, if necessary. The pressure-sensitive adhesive layer may be formed so as to be in contact with the film surface of the support or may be formed so as to be in contact with the surface of the non-woven fabric or the woven fabric. As a method for forming the pressure-sensitive adhesive layer, an ordinary pressure-sensitive adhesive tape manufacturing method can be applied,
For example, a solvent coating method, a hot melt coating method, an electron beam curing emulsion coating method and the like can be mentioned.

To form the pressure-sensitive adhesive layer by the solvent coating method, for example, the above-mentioned base is diluted with a suitable solvent, and if necessary, a drug, a tackifier, a plasticizer, a filler, an antiaging agent, An absorption promoter and the like are added and mixed uniformly, and the obtained liquid is applied to the surface of the support and dried. Alternatively, the liquid may be directly applied to the release paper instead of being directly applied to the surface of the support, dried and then brought into close contact with the support.

The thickness of the pressure-sensitive adhesive layer varies depending on the dosage form and purpose of use, but if the thickness is small, the required amount of drug cannot be contained and the adhesiveness becomes insufficient. Since the contained drug does not diffuse sufficiently and the drug in the preparation is not effectively used, it is usually 30 to 200.
0 μm. The patch prepared as described above is
It is used by attaching it to the affected area.

[0047]

EXAMPLES The present invention will be described below with reference to examples. (Example 1) 2-ethylhexyl acrylate 75.5% by weight, N-vinyl-2-pyrrolidone 24.5% by weight,
Hexamethylene glycol dimethacrylate (0.04 parts by weight) was charged into a separable flask with respect to 100 parts by weight of the total amount, and ethyl acetate was further added to adjust the monomer concentration to 85% by weight. This solution was heated to a temperature of 60 ° C. under a nitrogen atmosphere, lauroyl peroxide and ethyl acetate as a polymerization initiator were added little by little, and a polymerization reaction was carried out for 32 hours to obtain a base solution having a solid content of 36% by weight. Got This base solution was applied onto a polyethylene terephthalate release paper having a thickness of 75 μm so that the thickness after drying was 80 μm, and then dried in a gear oven at 60 ° C. for 20 minutes to form an adhesive layer.

A non-woven fabric (100% by weight of polyester) having a 50% modulus of 0.6 kg / 5 cm and a drape coefficient of 0.403 and an ethylene-vinyl acetate copolymer film having a 50% modulus of 0.8 kg / 5 cm are laminated on a support ( The film side having a 50% modulus of 1.4 kg / 5 cm was brought into close contact with the pressure-sensitive adhesive layer to prepare an external patch.

(Example 2) Styrene-isoprene-styrene block copolymer (KRATON manufactured by Shell Chemical Co., Ltd.)
D1107) 100 parts by weight, polybutene (Nippon Petrochemical Co., Ltd., HV-300) 15 parts by weight, alicyclic saturated hydrocarbon resin (Arakawa Chemical Co., Ltd., Alcon P-90) 160 parts by weight, and butylhydroxytoluene 3 parts by weight. Parts were added to cyclohexane and mixed to obtain a base solution having a solid content of 45% by weight. This base solution was placed on a polyethylene terephthalate release paper having a thickness of 75 μm and the thickness after drying was 80 μm.
After being applied so as to obtain a pressure sensitive adhesive layer, it was dried in a gear oven at 60 ° C. for 20 minutes to form an adhesive layer.

Nonwoven fabric having a 50% modulus of 0.4 kg / 5 cm and a drape coefficient of 0.359 (styrene-hydrogenated propylene block copolymer 80% by weight, polypropylene 20
%) And a polyethylene (50% modulus 1.0 kg / 5 cm) polyethylene film laminated (50% modulus 1.3 kg / 5 cm) film side was brought into close contact with the pressure-sensitive adhesive layer to prepare an external patch.

(Comparative Example 1) 50% modulus 0.4 kg
/ 5 cm, non-woven fabric with a drape coefficient of 0.215 (100% by weight of polyester), and 50% modulus 0.7 kg /
The film side of the support (50% modulus 1.1 kg / 5 cm) on which a 5 cm ethylene-vinyl acetate copolymer film was laminated was brought into close contact with the pressure-sensitive adhesive layer prepared in Example 1,
An external patch was prepared.

Comparative Example 2 A non-woven fabric (50% by weight of polyester and 50% by weight of rayon) having a drape coefficient of 0.452 and no stretch, and a 50% modulus of 0.9 kg / 5 cm.
The film side of the support (not stretched at all) laminated with the ethylene-vinyl acetate copolymer film of 1 was brought into close contact with the pressure-sensitive adhesive layer prepared in Example 1 to prepare an external patch.

(Comparative Example 3) 50% modulus 0.8 kg
/ 5 cm, non-woven fabric with a drape coefficient of 0.641 (95% by weight of polypropylene, 5% by weight of rayon) and a polypropylene film having a 50% modulus of 2.8 kg / 5 cm (50% modulus of 3.6 kg / 5c).
The film side of m) was brought into close contact with the pressure-sensitive adhesive layer prepared in Example 2 to prepare an external patch.

(Comparative Example 4) 50% modulus 2.4 kg
/ 5 cm, non-woven fabric with drape coefficient 0.774 (100% by weight of polyester), 50% modulus 0.9 kg /
Support (5 50 cm) laminated with 5 cm polyethylene film
The adhesive film prepared in Example 1 was brought into close contact with the film side having a% modulus of 3.2 kg / 5 cm) to prepare an external patch.

(Comparative Example 5) A non-woven fabric was not laminated and a single layer film of ethylene-vinyl acetate copolymer having a 50% modulus of 0.8 kg / 5 cm was used as a support, and the pressure-sensitive adhesive layer prepared in Example 1 was used. They were brought into close contact with each other to prepare a patch for external use.

<Test Example 1> Examples 1 and 2 and Comparative Examples 1 to 1
50 cm ² (71 mm × 71
Each test piece cut into 10 mm) was stuck on the backs of 10 healthy men for 24 hours, and evaluated for ease of sticking, sticking (peeling), and feeling of use (feeling of foreign matter) based on the following evaluation criteria. Table 1 shows the number of respondents in each evaluation.

Ease of sticking ○: Easy to stick △: Neither can be said ×: Hard to stick Sticking property (peeling) ○: No peeling at all △: Peeling at about 10% portion ×: About 20% or more There was peeling on the part Feeling of use (feeling of foreign matter) ○: No feeling of foreign matter △: Feeling of foreign matter slightly ×: Feeling of foreign matter

[0058]

[Table 1]

Example 3 4 parts by weight of isosorbide dinitrate (manufactured by Sigma) was added to 100 parts by weight of the base solution prepared in Example 1 and thoroughly mixed with a dissolver to prepare a drug-containing base solution. Except for doing the same as in Example 1,
An external patch containing 10% by weight of isosorbide dinitrate was prepared.

(Example 4) To 100 parts by weight of the base solution prepared in Example 2, 5 parts by weight of aspirin (manufactured by Sigma) was added and thoroughly mixed with a dissolver to prepare a drug-containing base solution. An external patch containing 10% by weight of aspirin was prepared in the same manner as in Example 2 except for the above.

Comparative Example 6 A polymer film was not laminated,
Isosorbide dinitrate is contained in an amount of 10% by weight in the same manner as in Example 3 except that a nonwoven fabric (100% by weight of polyester) having a 50% modulus of 0.6 kg / 5 cm and a drape coefficient of 0.403 is used as a single layer. An external patch was prepared.

Comparative Example 7 A polymer film was not laminated,
Example 4 except that a non-woven fabric having a 50% modulus of 0.4 kg / 5 cm and a drape coefficient of 0.359 (styrene-hydrogenated propylene block copolymer 80% by weight, polypropylene 20% by weight) was used as a support in a single layer. Similarly to the above, an external patch containing 10% by weight of aspirin was prepared.

<Test Example 2> Examples 3 and 4 and Comparative Example 6,
50 cm ² (71 mm × 71
(mm) each test piece was sealed in an aluminum bag, and
After storing at 6 ° C for 6 months, the appearance on the support side was observed. In the evaluation, those in which the deposition or exudation of the drug was not recognized on the surface of the support were evaluated as ◯, and those in which they were recognized were evaluated as x. Table 2 shows the results.

[0064]

[Table 2]

[0065]

EFFECTS OF THE INVENTION The support of the present invention and the external patch using the same are as described above, and are excellent in the ability to follow the skin, have good patchability and feeling of use, and are easy to handle. Furthermore, because of its excellent barrier properties, the drug in the pressure-sensitive adhesive layer does not migrate through the support and deposit on the surface or exude during storage of the preparation, and there is no possibility of impairing commercial value.

Claims (3)

[Claims] 1. A 50% modulus is 0.1 to 2.5 kg /
5cm polymer film and 50% modulus is 0.1
~ 1.5kg / 5cm, and drape coefficient is 0.3 ~
A support characterized in that a non-woven fabric or a woven fabric of 0.7 is laminated. 2. The 50% modulus of the whole support is 0.1 to 10.
The support according to claim 1, which has a weight of 2.5 kg / 5 cm. 3. An external patch comprising the support according to claim 1 or 2 and an adhesive layer.