JP3525272B2 - Skin sticking sheet - Google Patents

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to stretchability, flexibility,
The present invention relates to a skin patch sheet having excellent adhesion.

[0002]

2. Description of the Related Art Skin patch sheets are widely used as disease treatment sheets, medical aid tapes and the like. Of these, the disease-treating sheet comprises a drug in an adhesive layer, and is constituted by applying this adhesive layer to a base material sheet, which is attached to the skin, mucous membrane, skin, It is used for the purpose of treatment by directly absorbing the drug from the mucous membrane or the like, and is used, for example, as plaster. Further, the medical aid tape comprises a base sheet and an adhesive layer, and is used for fixing gauze, bandages, catheters, blood transfusion tubes, etc., covering surgical sites, suturing, and the like, for example, surgical tape, dressing tape,
It is used as a bandage.

Such a skin patch sheet is required to have good adhesiveness and elasticity when it is stuck to the skin, and to be easily peeled without causing irritation to the skin at the time of peeling.

As a base sheet in such a skin patch sheet, a resin which is soft and conforms well to the skin is suitable, and conventionally, a soft polyvinyl chloride resin has been often used. However, the base sheet made of a soft polyvinyl chloride resin has a strong modulus and when applied to the skin,
There was a feeling of bracing.

On the other hand, it is known that a diene type copolymer, a rubber type, an acrylic type or the like is preferable as an adhesive used for an adhesive layer in a skin patch, but a soft polyvinyl chloride resin base sheet There was a problem such as poor affinity with and poor adhesion.

JP-B-4-30428 discloses a primer coating as an anchor agent for melt-adhering and adhering a pressure-sensitive adhesive composed of a diene copolymer to a soft polyvinyl chloride resin base sheet. , A technique for increasing the affinity for a diene block copolymer is disclosed,
According to this method, there is a drawback that the manufacturing cost becomes high with an increase in the number of steps, and in addition, when the primer is omitted, there is a problem such as poor adhesion.

Further, when a plasticizer is used to further soften the soft polyvinyl chloride resin, the tackiness of the film surface becomes strong, and when the roll material is developed, blocking becomes strong and it cannot be peeled off. was there. Furthermore, increasing the amount of the plasticizer causes a problem that the transfer to the pressure-sensitive adhesive layer becomes large and the pressure-sensitive adhesive force is lowered.

[0008]

SUMMARY OF THE INVENTION In view of the above, it is an object of the present invention to provide a skin patch sheet which is excellent in stretchability and flexibility and firmly adheres to an adhesive layer. .

[0009]

The gist of the present invention is to provide a skin patch sheet comprising a base sheet and an adhesive layer,
The base sheet is made of an acrylic-styrene-acrylonitrile resin.

The above-mentioned acrylic-styrene-acrylonitrile (ASA) resin is used as the base sheet in the skin patch sheet of the present invention. The ASA resin is
Consisting of acrylate monomer, styrene monomer and acrylonitrile monomer, having rubber-like properties and thermoplasticity, polyvinyl chloride (PVC), halogenated polyethylene (CPE), acrylonitrile-styrene copolymer (SAN), acrylonitrile-butadiene-styrene Good compatibility with resins such as copolymer (ABS), Stinelix (ASA), ethylene-vinyl acetate copolymer (EVA), polyamide, low modulus, stretchability,
It has excellent flexibility and excellent heat and UV resistance without the addition of stabilizers. Examples of the above-mentioned ASA resin include Sani gum elastomer manufactured by Goodyear Chemical Europe Ltd.

The above-mentioned ASA resin is capable of a wide range of processing temperatures of 150 to 250 ° C., powder is made into a sheet by a two-roll type mill and compression molded at 150 ° C. for 10 minutes, extrusion molding, calender molding, etc. To form a base sheet. The thickness of the base material sheet is appropriately selected depending on the application, but is preferably 0.05 to 0.10 mm.
If it is less than 0.05 mm, the strength is insufficient and it tends to be too soft and wrinkle easily. If it exceeds 0.20 mm, the flexibility is insufficient.

[0012] The above-mentioned base sheet further has a design property such that the surface opposite to the coated surface of the pressure-sensitive adhesive layer does not shine and looks good. In order to increase the blocking property and prevent stickiness, as shown in FIG. 1, embossing or the like may be used for drawing.
As the above-mentioned diaphragm, among them, a silk pattern in which the height of the diaphragm of the substrate sheet 1 in FIG. 1 is 30 to 40 μm is preferable.

The skin patch sheet of the present invention is the above-mentioned ASA.
A base material sheet made of a resin is coated with an adhesive to form an adhesive layer and used as a skin patch. Examples of the adhesive include styrene-isoprene-styrene (SIS) block copolymer rubber, styrene-butadiene-styrene block copolymer rubber, styrene-butadiene rubber, polybutene rubber, polyisoprene rubber, butyl rubber, silicone rubber, Examples thereof include rubber such as natural rubber and synthetic isoprene rubber; synthetic resins such as poly (meth) acrylate, polyvinyl ether, polyurethane, polyester, polyamide, and ethylene copolymers. Among them, styrene-isoprene-styrene type, natural rubber type, and acrylic type are preferable. These may be used alone or as a mixture, and may be used in combination with a plasticizer, a tackifying resin, a filler, an antioxidant, etc.

The thickness of the adhesive layer is 0.05 to 0.2.
0 mm is preferable. If it is less than 0.05 mm, the adhesive strength will be weak, and if it exceeds 0.20 mm, it will become thick and the cohesive strength will decrease, so that the adhesive residue remains on the skin after peeling off, and the function of the skin patch sheet cannot be satisfied. The economy is even worse.

As the method of applying the above-mentioned pressure-sensitive adhesive, a method of directly melt-coating on a base sheet, a method of melting and extruding into a sheet form from an extruder and laminating to a base sheet, and a method of applying on release paper It is possible to use a method such as laminating with a base material sheet.

In the present invention, the pressure-sensitive adhesive layer may contain a drug. The drug is a transdermal drug and is not particularly limited as long as it exerts a pharmacological effect after absorption, and examples thereof include a local stimulant, an anti-inflammatory agent and an analgesic, and a central nervous system acting agent (sleep sedative, Antiepileptic agent,
Psychiatry and nerve agents), diuretics, blood pressure lowering agents, coronary vasodilators,
Antitussive expectorant, antihistamine, antiarrhythmic agent, cardiotonic agent, sex hormone agent, corticosteroid agent, local anesthetic agent, and
Examples thereof include antifungal agents. These medicinal components may be used alone or in combination of two or more depending on the purpose of treatment.

Examples of the above local stimulants, anti-inflammatory agents, and analgesics include salicylic acid, methyl salicylate, glycol salicylate, 1-menthol, camphor, peppermint oil, thymol, nicotinic acid benzyl ester, capsicum extract, capsaicin, nonyl acid. Vanillyl amide, felbinac, butyl flufenamic acid, piroxicam, indomethacin, ketoprofen, pranoprofen, feprazone, loxoprofen, amfenac sodium, oxaprozin, emorfazone, fentiazac, diclofenac sodium, diflunisal, ibuprofen, bendazac, suprofen, these ester derivatives , Buprenorphine hydrochloride, pentazocine,
Examples thereof include butorphanol tartrate.

Examples of the central nervous system acting agents include fluphenazine, thioridazine, diazepam, chlorpromazine, nitrazepam, estazolam, triazolam,
Examples include nimetazepam, flunitrazepam, flurazepam, clonazepam, propericiadine, oxazepam, oxazolam, cloxazolam, prazepam, flutazolam, mexazolam, lorazepam, fludiazepam, promazepam, metazepam and the like.

Examples of the above-mentioned diuretics include hydrothiazide, pendroflunathiazide, ethiazide, cyclopenthiazide, hydrochlorothiazide, penfluzide, methylcloazide, furosemide, metrazone,
Examples thereof include polythiazide and bendroflumethiazide.

Examples of the antihypertensive agent include clonidine, dihydroergotoxin mesylate, resel, pinprazosin, captopril, pindolol, enalapril maleate and the like.

Examples of the coronary vasodilators include nitroglycerin, isosorbite dinitrate, papaperine hydrochloride, dipyridamole, efloxaate, trimethazine, nicorandil, cinnarizine, molsidomine, nifedipine and the like.

Examples of the antitussive and expectorant agents include codeine phosphate, dihydrocodeine phosphate, ephedrine hydrochloride, chlorprenaline hydrochloride, phenotenol hydrobromide, salbutamol sulfate, dimemorphan phosphate, azelastine hydrochloride, clenpterol hydrochloride, and the like. Examples thereof include tulobuterol hydrochloride, trimethoquinol hydrochloride, procaterol hydrochloride, bromhexine hydrochloride, tranilast, tipepidine hibenzate, ketotifen fumarate, formoterol fumarate, and oxatomide.

Examples of the above antihistamines include diphenhydramine hydrochloride, triprolidine hydrochloride, isothipendyl hydrochloride, promethazine hydrochloride, chlorpheniramine maleate, cyproheptadine hydrochloride, clemastine fumarate, carbinoxamine maleate and dimethindene maleate.

Examples of the arrhythmic agents include alprenolol hydrochloride, oxprenolol hydrochloride, bucumolol hydrochloride, bupranolol hydrochloride, pindolol, indenolol hydrochloride, carteolol hydrochloride, bufetrol hydrochloride, propranolol hydrochloride, timolol maleate and the like. Can be mentioned.

Examples of the above-mentioned sex cardiotonic agents include digitalis, ubidecarenone, digoxin, methyldigoxin,
Destronoside etc. can be mentioned. Examples of the sex hormone agent include estradiol, estriol, progesterone, norethisterone and the like.

Examples of the corticosteroids include hydrocortisone acetate, hydrocortisone, prednisolone, triamcinolone acetonide, methylprednisolone, dexamethasone acetate, dexamethasone, fluorometholone, betamethasone sodium phosphate, betamethasone phosphate, betamethasone valerate, beclomethasone propionate, and Fludroxycortide, hydrocortisone acetate,
Examples thereof include fluocinonide, clobetasol propionate, diflucortron valerate, halcinonide, amcinonide, and prednisolone valerate.

Examples of the above local anesthetics include lidocaine hydrochloride, ethyl aminobenzoate, procaine hydrochloride, dipcaine hydrochloride and the like. Examples of the antifungal agent include amorolfine, terbinafine, butenafine, lanoconazole, ketoconazole, neticonazole, fluconazole, miconazole, liranaphthate, omoconazole nitrate and the like.
As a method of applying the pressure-sensitive adhesive containing the above-mentioned drug, a method of dissolving it in a solvent together with the pressure-sensitive adhesive, coating and drying, a method of melting and coating with the pressure-sensitive adhesive, and the like can be used.

The skin patch sheet of the present invention can be used as a medical aid tape such as a surgical tape or a dressing tape without containing the above drug. When the skin patch sheet of the present invention is used as a medical tape, the base material sheet is squeezed on the surface opposite to the coated surface of the pressure-sensitive adhesive layer by embossing or the like, similarly to the skin patch sheet. It may have been done. Among the above diaphragms, the diaphragm height of the base material sheet 1 in FIG.
A satin pattern with a thickness of 6 μm is preferable. Further, the medical aid tape may have a small hole for facilitating the ventilation of the skin.

The base sheet for medicated skin patches of the present invention comprises A instead of soft polyvinyl chloride, which has been widely used in the past.
By using the SA resin, a skin patch sheet having a low modulus, excellent elasticity and flexibility can be obtained. In the skin patch sheet of the present invention, since the ASA resin does not contain a liquid component, there is no adverse effect on the pressure-sensitive adhesive layer.

The skin patch sheet of the present invention is AS
Although the blocking of the resin A is slightly strong, the developability of the material roll is good by inserting a silk mesh on the surface. ASA
Since the acrylic component is the main component of the resin, SIS type,
It has excellent affinity and adhesion to natural rubber-based and acrylic rubber-based adhesives, and firmly adheres to the adhesive layer even without a primer.

[0031]

The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

Example 1 A material consisting of 100% of ASA resin (Goodyear Chemical Europe, Sanigam P7395) was calendered at a processing temperature of 170 ° C. to a thickness of 0.07.
A base sheet of mm was obtained. A SIS adhesive (Califlex TR-1107, manufactured by Ciel Chemical Co., Ltd.) was applied to a surface-treated silicon release paper having a thickness of 50 μm to a thickness of 0.0.
After coating at 150 ° C to a thickness of 5 mm, about 30 ° C
Then, the release paper and the above-mentioned base material sheet were bonded together and aged at 40 ° C. for 24 hours to obtain a skin patch sheet.

Example 2 Styrene-isoprene-styrene block copolymer 20
Parts by weight, 15 parts by weight of polyisobutylene, 20 parts by weight of rosin-modified resin, and 35 parts by weight of liquid paraffin are heated to 140 to 150 ° C. in a nitrogen gas stream and melted. After cooling this melt (about 150 ° C.) to about 120 ° C., 5 parts by weight of glycol salicylate and 5 parts by weight of L-menthol were added and mixed to obtain a uniform mixture. This was coated on a release paper with a thickness of about 100 μm, and then laminated with the substrate sheet of Example 1 and aged to obtain a skin patch sheet.

Example 3 35 parts by weight of natural rubber, 20 parts by weight of rosin modified resin, 15 parts by weight of polybutene and 15 parts by weight of zinc oxide were added at 70 to 90 ° C.
Heat to melt. This melt (about 80 ° C) is heated to about 70 ° C
After cooling to 5 parts by weight, 5 parts by weight of methyl salicylate, 5 parts by weight of L-menthol and 5 parts by weight of glycol salicylate were added and mixed to obtain a uniform mixture. This was coated on a release paper with a thickness of about 200 μm, and then laminated with the substrate sheet of Example 1 and aged to obtain a skin patch sheet.

Example 4 To 85 parts by weight of an acrylic resin solvent-based pressure-sensitive adhesive, 7 parts by weight of L-menthol and 8 parts by weight of isosorbide sulfate were added and mixed to obtain a uniform mixture. This is a release paper with a thickness of about 100
After coating with a thickness of μm and solvent drying, the sheet was stuck to the base sheet of Example 1 and aged to obtain a skin patch sheet.

Example 5 Styrene-isoprene-styrene block copolymer 30
By weight, 10 parts by weight of polyisobutylene, 20 parts by weight of hydrogenated rosin ester, and 30 parts by weight of liquid paraffin are heated to 140 to 150 ° C. in a nitrogen gas stream and melted. After cooling this melt (about 150 ° C.) to about 120 ° C., 3 parts by weight of ketoprofen and 7 parts by weight of L-menthol were added and mixed to obtain a uniform mixture. Thereafter, the same procedure as in Example 2 was carried out to obtain a skin patch sheet.

Example 6 Styrene-isoprene-styrene block copolymer 30
By weight, 10 parts by weight of polyisobutylene, 20 parts by weight of hydrogenated rosin ester, and 30 parts by weight of liquid paraffin are heated to 140 to 150 ° C. in a nitrogen gas stream and melted. After cooling this melt (about 150 ° C.) to about 120 ° C., 5 parts by weight of tetracaine and 5 parts by weight of crotamiton were added and mixed to obtain a uniform mixture. Thereafter, the same procedure as in Example 2 was carried out to obtain a skin patch sheet.

Example 7 Styrene-isoprene-styrene block copolymer 25
By weight, 15 parts by weight of polyisobutylene, 40 parts by weight of hydrogenated rosin ester, and 14 parts by weight of liquid paraffin are heated to 140 to 150 ° C. in a nitrogen gas stream and melted. After cooling this melt (about 150 ° C.) to about 120 ° C., 1 part by weight of estradiol and 5 parts by weight of crotamiton were added and mixed to make a uniform mixture. Thereafter, the same procedure as in Example 2 was carried out to obtain a skin patch sheet.

Comparative Example 1 Polyvinyl chloride resin (P = 1300, manufactured by Chisso Corporation) 10
A composition comprising 0 part by weight, 57 parts by weight of a polyester plasticizer (Polynizer W305EL manufactured by Dainippon Ink and Chemicals, Inc.), and 3 parts by weight of a Ca-Zn stabilizer was calendered at a processing temperature of 170 ° C. , Thickness 0.07
A base sheet of mm was obtained. In the same manner as in Example 1, a release paper was coated with a SIS-based pressure-sensitive adhesive, and then bonded to the above-mentioned base sheet and aged to obtain a skin patch sheet.

Comparative Example 2 40 parts by weight of ASA resin (Sani gum, manufactured by Goodyear), polyvinyl chloride resin (P = 3600, manufactured by Chisso)
A composition comprising 100 parts by weight, 100 parts by weight of a polyester-based plasticizer (manufactured by Dainippon Ink and Chemicals, Polycizer W305EL), and 3 parts by weight of a Ca—Zn-based stabilizer was calendered at a processing temperature of 175 ° C. A substrate sheet having a thickness of 0.07 mm was obtained. Similar to Example 1,
After the release paper was coated with the SIS-based pressure-sensitive adhesive, the release paper was laminated with the above-mentioned base sheet and aged to obtain a skin patch sheet.

Evaluation (1) Flexibility measuring machine: Autograph pulling speed: 300 mm / min Sample size: 19 mm × 150 mm Gripping width: 100 mm Under the above conditions, 10 of the substrate sheets prepared in Examples and Comparative Examples were used. The% modulus, 30% modulus and 50% modulus were measured vertically and horizontally, respectively. ○ Horizontal width of 200 g / 19 mm or less at 50% modulus △ Horizontal width of 200 to 500 g / 19 mm at 50% modulus × Horizontal width of 500 g / 19 mm or more at 50% modulus

(2) Recovery rate Vertical length of the base material sheet 19 m prepared in Examples and Comparative Examples
A sample having a width of m and a width of 150 mm was prepared, pulled by 50% under the flexibility evaluation conditions, and then opened, and the length of the base sheet was measured. Based on the result, the recovery rate was calculated by the following formula. 8
0% or more is excellent in shrinkability. Recovery rate (%) = {[100 mm− (length after measurement−100
mm)] / 100mm} × 100

(3) Adhesive Strength (T-Type Peeling Test) The release paper was peeled off from the skin patch sheets prepared in Examples and Comparative Examples, and the pressure-sensitive adhesive surfaces were pressure-bonded to each other so as to form a T-shape. Was peeled off with an arbitrary pulling force, and the adhesive residue was visually evaluated. ◎ No peeling ○ No adhesive residue △ Partial adhesive residue × Adhesive residue on the front surface These test results are shown in Table 1.

(4) Skin sticking test The skin sticking sheets obtained from Examples 1 to 7 and Comparative Example 1 were molded into a size of 60 mm in length and 80 mm in width, and after peeling off the release paper, shoulders of 60 healthy adult men and women It was pasted on for 6 hours. The feeling of smoothness when applied and the pain when peeled off were evaluated. The evaluation criteria are as follows, and the average score of 60 persons is shown in Table 1.

Toughness 1 point Strongly felt 2 points A little felt 3 points Not felt Pain during peeling 1 point Strong pain 2 points Feeling a little pain 3 points Not felt

[0046]

[Table 1]

[0047]

EFFECT OF THE INVENTION Since the skin patch sheet of the present invention comprises a base material sheet made of ASA resin and a pressure-sensitive adhesive layer, it is excellent in stretchability and flexibility and is firmly adhered to the pressure-sensitive adhesive layer. Sheet can be obtained.

[Brief description of drawings]

FIG. 1 is a schematic view showing a cross section of a skin patch sheet of the present invention.

[Explanation of symbols]

1 Base sheet 2 Adhesive layer

─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Kazuo Tanaka, 3-2-15 Meiwatsu, Hyogo-ku, Kobe City Bando Kagaku Co., Ltd. (72) Inventor, Kazuya Igawa, 3-2- Meiwatsu, Hyogo-ku, Kobe City 15 Band Chemical Co., Ltd. (56) Reference JP-A-9-124464 (JP, A) JP-A-7-195409 (JP, A) (58) Fields investigated (Int.Cl. ⁷ , DB name) A61L 15/00-15/64 A61K 9/70

Claims (3)

(57) [Claims] 1. A skin patch sheet comprising a base material sheet and an adhesive layer, wherein the base material sheet contains an acrylic-styrene-acrylonitrile resin. 2. The skin patch sheet according to claim 1, wherein the pressure-sensitive adhesive layer has a pressure-sensitive adhesive containing at least one component selected from the group consisting of styrene-isoprene-styrene type, natural rubber type and acrylic type. 3. The skin patch sheet according to claim 1, wherein the adhesive layer contains a drug.