JP7412906B2 - patch - Google Patents

Description

Application of Article 30, Paragraph 2 of the Patent Act (1) February 27, 2019: Delivered at Kowa Co., Ltd. Tobu Logistics Center (1052-1 Imoku, Kazo City, Saitama Prefecture) (2) February 28, 2019: Kowa Co., Ltd. Delivered at Kyushu Logistics Center (1628 Hasuhara, Himekata-cho, Tosu City, Saga Prefecture) (3) March 2, 2019 To Kowa Co., Ltd. West Japan Logistics Center (9-7 Tonoshima-cho, Kadoma City, Osaka Prefecture) (4) March 8, 2019 Delivered at Kowa Co., Ltd. Hokkaido Logistics Center (Sapporo Sanshin Warehouse Headquarters Logistics Building, 1-2-30 Higashi Sapporo Rokujo, Shiroishi-ku, Sapporo, Hokkaido)

The present invention relates to a patch.

In Japan, which has long been an aging society, many elderly people suffer from joint pain, lower back pain, and neuralgia in the knees, elbows, ankles, hips, etc. as chronic diseases. As a means of treating these chronic diseases, oral medications and patches are applied, but oral medications contain anti-inflammatory analgesics such as NSAIDs, and when taken, they can cause side effects such as gastrointestinal disorders. may be done.
On the other hand, the above-mentioned side effects can be avoided by applying a patch, especially a locally acting preparation.

Japanese Patent Application Publication No. 2005-281202 International Publication No. 2014/171538

Patch agents are required to be difficult to peel off from the skin, that is, to have adhesion to the skin. Various adhesive patches have been developed for this purpose (for example, Patent Documents 1 and 2), but in conventional adhesive patches, when the adhesive base layers come into contact with each other, the adhesive base layers that are stuck together are difficult to peel off, There are problems such as wrinkles and detachment of the adhesive base when it is forcibly removed, making it difficult to reapply. It was difficult to simultaneously satisfy the requirements of ease of peeling.
An object of the present invention is to provide a patch that has excellent adhesion to the skin and allows the adhesive base layers to be easily peeled off when they come into contact with each other.

Therefore, as a result of extensive studies, the present inventors found that by incorporating a sorbitan-based nonionic surfactant and one or more selected from macrogol and dicarboxylic acid diester into the adhesive base layer, the adhesion to the skin could be improved. The present invention has been completed based on the discovery that a patch with excellent adhesive properties and in which the adhesive base layers can be easily peeled off when they come into contact with each other can be obtained.

That is, the present invention provides a patch in which an adhesive base layer is laminated on a support, and the adhesive base layer contains the following components (A) and (B).
(A) Sorbitan nonionic surfactant (B) One or more selected from macrogol and dicarboxylic acid diester

The adhesive patch of the present invention has excellent adhesion to the skin, and the adhesive base layers can be easily peeled off when they come into contact with each other.

FIG. 3 is a diagram showing a state in which the adhesive patch 1 is fixed to a test plate of a tensile tester in Test Example 1. FIG. 7 is a diagram showing a state in which two sheets of the preparation with their plaster surfaces overlapped were sandwiched between the probe of the tensile tester in Test Example 2.

The adhesive patch of the present invention has an adhesive base layer laminated on a support, and the adhesive base layer contains the above-mentioned components (A) and (B).

<Adhesive base layer>
(Component (A))
As the sorbitan-based nonionic surfactant, a sorbitan fatty acid ester-based nonionic surfactant is preferable from the viewpoint of achieving both adhesion to the skin and ease of peeling between adhesive base layers. Examples of sorbitan fatty acid esters include sorbitan monofatty acid esters, sorbitan difatty acid esters, and sorbitan trifatty acid esters. These can be used alone or in an appropriate combination of two or more.

The "fatty acid" in the sorbitan fatty acid ester is preferably a saturated or unsaturated fatty acid having 8 to 26 carbon atoms, from the viewpoint of achieving both adhesion to the skin and ease of peeling between adhesive base layers, and saturated or unsaturated fatty acids having 12 to 26 carbon atoms. Saturated or unsaturated fatty acids having 22 carbon atoms are more preferred, saturated or unsaturated fatty acids having 14 to 20 carbon atoms are even more preferred, and saturated or unsaturated fatty acids having 16 to 20 carbon atoms are particularly preferred. Further, the fatty acid may be a straight chain fatty acid or a branched fatty acid.

Examples of the sorbitan nonionic surfactant include sorbitan isostearate, sorbitan oleate, sorbitan sesquiisostearate, sorbitan sesquioleate, sorbitan triisostearate, and sorbitan trioleate. The sorbitan nonionic surfactants can be used alone or in an appropriate combination of two or more.
Among these, sorbitan oleate, sorbitan sesquioleate, and sorbitan trioleate are preferred, and sorbitan oleate is particularly preferred, from the viewpoint of achieving both adhesion to the skin and ease of peeling between the adhesive base layers.

The sorbitan nonionic surfactant may be a commercially available product or one synthesized by a conventional method.
Commercially available sorbitan oleate products include NIKKOL SO-10, NIKKOL SO-10R, NIKKOL SO-10V (manufactured by Nikko Chemicals), Ionet S-80 (manufactured by Sanyo Chemical Industries), and Sorgen 40V (manufactured by Dai-ichi Kogyo Seiyaku). ), Nonion OP-80R (manufactured by NOF Corporation), and the like. Commercial products of sorbitan sesquioleate include NIKKOL SO-15MV (manufactured by Nikko Chemicals), Sorgen 30V (manufactured by Daiichi Kogyo Seiyaku), Nonion OP-83R (manufactured by Nippon Oil & Fats), and Rheodol AO-83R (manufactured by Kao). Can be mentioned. Commercial products of sorbitan trioleate include NIKKOL SO-30, NIKKOL SO-30V (manufactured by Nikko Chemicals), Ionet S-85 (manufactured by Sanyo Chemical Industries), Sorgen 20V (manufactured by Daiichi Kogyo Seiyaku), and Nonion OP. -85R (manufactured by NOF Corporation) and the like.

The content of the sorbitan-based nonionic surfactant should be set to an appropriate amount that provides sufficient adhesive strength to adhere to the affected area for a long time, while also allowing for easy peeling when the adhesive base layers (plaster surfaces) adhere to each other. From the viewpoint of imparting adhesive strength, it is preferably 0.01 to 20% by mass, more preferably 0.03 to 10% by mass, even more preferably 0.05 to 5% by mass, based on the total mass of the adhesive base layer. Particularly preferred is 0.1 to 3% by weight.

(Component (B))
-Macro goal-
Macrogol refers to an addition polymer of ethylene oxide and water.
The macrogol is preferably a macrogol with an average molecular weight of 100 to 35,000, more preferably a macrogol with an average molecular weight of 200 to 20,000, from the viewpoint of achieving both adhesion to the skin and ease of peeling between the adhesive base layers. Macrogol having a molecular weight of 300 to 6,000 is more preferred, and macrogol having an average molecular weight of 400 to 6,000 is particularly preferred. The average molecular weight of macrogol can be measured by the "average molecular weight test" described in the "Macrogol 400" section of the 17th revised Japanese Pharmacopoeia monograph.

Examples of the macrogoals include macrogoals 200, macrogoals 300, macrogoals 400, macrogoals 600, macrogoals 1000, macrogoals 1500, macrogoals 1540, macrogoals 2000, macrogoals 4000, macrogoals 4000NF, and macrogoals 6000. , Macrogol 6000EP, Macrogol 6000NF, Macrogol 20000, Macrogol 35000, Macrogol ointment, and the like. Macrogol can be used alone or in an appropriate combination of two or more.
Among these, from the viewpoint of achieving both adhesion to the skin and ease of peeling between adhesive base layers, Macrogol 200, Macrogol 300, Macrogol 400, Macrogol 600, Macrogol 1000, Macrogol 1500, Macrogol Goal 1540, macrogoal 4000, macrogoal 6000, and macrogoal 20000 are preferable, and macrogoal 300, macrogoal 400, macrogoal 600, macrogoal 1500, macrogoal 1540, and macrogoal 6000 are particularly preferable.

Macrogol is PEG-200, PEG-300, PEG-400, PEG-600, PEG-1000, PEG-1500, PEG-1540, PEG-2000, PEG-4000N, PEG-4000S, PEG-6000N, PEG- 6000S, PEG-10000, PEG-20000, PEG-20000P (manufactured by Sanyo Chemical), Macrogol 200, Macrogol 300, Macrogol 400, Macrogol 600, Macrogol 1000, Macrogol 1500, Macrogol 1540, Macro It is available as commercial products such as Goal 4000, Macrogol 6000, and Macrogol 20000 (all manufactured by NOF Corporation).

The content of the macrogol mentioned above is such that it provides sufficient adhesive strength to adhere to the affected area for a long time, and also provides an appropriate adhesive strength that allows easy peeling when the adhesive base layers (plaster surfaces) adhere to each other. From this point of view, it is preferably 0.01 to 30% by mass, more preferably 0.05 to 20% by mass, even more preferably 0.05 to 10% by mass, and even more preferably 0.1 to 5% by mass, based on the total mass of the adhesive base layer. % by weight is particularly preferred.

In the present invention, the content ratio of the sorbitan-based nonionic surfactant and macrogol in the adhesive base layer is such that the adhesive base layer (plaster surface) has sufficient adhesive strength to adhere to the affected area for a long time. From the viewpoint of imparting a suitable adhesive force that allows easy peeling when they are adhered to each other, it is preferable to contain 0.01 to 20 parts by mass of macrogol per 1 part by mass of the sorbitan nonionic surfactant. It is more preferable to contain 0.05 to 10 parts by weight, even more preferably 0.1 to 5 parts by weight, and particularly preferably 1 to 5 parts by weight.

-Dicarboxylic acid diester-
The diester dicarboxylic acid is preferably one represented by the following formula (1) from the viewpoint of achieving both adhesion to the skin and ease of peeling between the adhesive base layers.

[In formula (1),
R ¹ represents a linear or branched alkanediyl group having 1 to 16 carbon atoms,
R ² and R ³ each independently represent a linear or branched alkyl group having 1 to 16 carbon atoms, or a group represented by the following formula (2). ]

[In formula (2),
R ⁴ represents a linear or branched alkyl group having 1 to 8 carbon atoms,
R ⁵ represents a linear or branched alkanediyl group having 2 or 3 carbon atoms,
n represents an integer from 1 to 4,
* indicates the bonding position with the oxygen atom in formula (1). ]

In formula (1), the number of carbon atoms in the alkanediyl group represented by R ¹ is preferably 1 to 12, more preferably 2, from the viewpoint of achieving both adhesion to the skin and ease of peeling between the adhesive base layers. -8, particularly preferably 3-6. For example, methane-1,1-diyl group, ethane-1,1-diyl group, ethane-1,2-diyl group, propane-1,1-diyl group, propane-1,2-diyl group, propane-1 ,3-diyl group, propane-2,2-diyl group, butane-1,1-diyl group, butane-1,2-diyl group, butane-1,3-diyl group, butane-1,4-diyl group , pentane-1,5-diyl group, hexane-1,6-diyl group, heptane-1,7-diyl group, octane-1,8-diyl group, and the like.

In addition, the number of carbon atoms in the alkyl group represented by R ² and R ³ in formula (1) and R ⁴ in formula (2) is determined to achieve both adhesion to the skin and ease of peeling between the adhesive base layers. From this point of view, the number is preferably 1 to 12, more preferably 2 to 8, particularly preferably 2 to 4. For example, methyl group, ethyl group, n-propyl group, isopropyl group, n-butyl group, isobutyl group, sec-butyl group, tert-butyl group, n-pentyl group, n-hexyl group, n-heptyl group, n- -octyl group, etc.

The alkanediyl group represented by R ⁵ in formula (2) is preferably an ethane-1,2-diyl group or a propane-1,2-diyl group.
Further, n is preferably 1 or 2. When n is an integer of 2 to 4, n R ⁵ 's may be the same or different.

Examples of the diester dicarboxylate include diisopropyl adipate, diisobutyl adipate, diethoxyethyl adipate, dioctyl adipate, diethoxyethyl succinate, dioctyl succinate, diethyl sebacate, and diisopropyl sebacate. These dicarboxylic acid diesters can be used alone or in an appropriate combination of two or more.
Among these, diisopropyl adipate, diisobutyl adipate, diethyl sebacate, and diisopropyl sebacate are preferred, and diisopropyl adipate is particularly preferred, from the viewpoint of achieving both adhesion to the skin and ease of peeling between the adhesive base layers.

Commercially available diisopropyl adipate products include NIKKOL DID (manufactured by Nikko Chemicals), diisopropyl adipate (Nippon Fine Chemicals), and Crodamol DA (Croda Japan). Commercially available diisobutyl adipate products include KAK DIBA (Kyoku Alcohol Kogyo) and Vinicizer 40 (Kao). Commercially available diethyl sebacate products include NIKKOL DES-SP (manufactured by Nikko Chemicals), Crodamol SE (Croda Japan), and diethyl sebacate (Nippon Fine Chemical). Commercially available diisopropyl sebacate products include NIKKOL DIS (manufactured by Nikko Chemicals) and diisopropyl sebacate (Nippon Fine Chemicals).

The content of the dicarboxylic acid diester mentioned above is such that it provides sufficient adhesive strength to adhere to the affected area for a long time, while also providing an appropriate adhesive strength that allows easy peeling when the adhesive base layers (plaster surfaces) adhere to each other. From the viewpoint of the total weight of the adhesive base layer, the amount is preferably 0.01 to 30% by mass, more preferably 0.05 to 20% by mass, even more preferably 0.1 to 10% by mass, and 0.5 to 30% by mass. Particularly preferred is 5% by weight.

In the present invention, the content ratio of sorbitan nonionic surfactant and dicarboxylic acid diester in the adhesive base layer is determined such that the adhesive base layer (plaster surface ) It is preferable to contain 0.01 to 20 parts by mass of dicarboxylic acid diester per 1 part by mass of sorbitan-based nonionic surfactant from the viewpoint of imparting a suitable adhesive force that can be easily peeled off when they are adhered to each other. , more preferably 0.05 to 10 parts by weight, even more preferably 0.1 to 5 parts by weight, particularly preferably 1 to 5 parts by weight.

Furthermore, from the viewpoint of achieving both adhesion to the skin and ease of peeling between the adhesive base layers, the patch of the present invention preferably contains both macrogol and dicarboxylic acid diester in the adhesive base layer.
When macrogol and dicarboxylic acid diester are used in combination, the content ratio of macrogol and dicarboxylic acid diester in the adhesive base layer is determined such that the content ratio of macrogol and dicarboxylic acid diester in the adhesive base layer is such that it provides sufficient adhesive strength to adhere to the affected area for a long time. From the viewpoint of imparting an appropriate adhesive force that allows easy peeling when the (plaster surfaces) are adhered to each other, it is preferable to contain 0.01 to 20 parts by mass of diester dicarboxylate per 1 part by mass of macrogol. It is more preferable to contain 0.05 to 10 parts by weight, even more preferably 0.1 to 5 parts by weight, and particularly preferably 1 to 5 parts by weight.

The adhesive base contained in the adhesive base layer is not particularly limited, but includes, for example, polyacrylic acid, sodium polyacrylate, partially neutralized polyacrylic acid, N-vinylacetamide/sodium acrylate copolymer, polyvinyl alcohol, Examples include polyvinylpyrrolidone, hydroxymethylcellulose, sodium carboxymethylcellulose, alginic acid, sodium alginate, gum arabic, dextrin palmitate, and those crosslinked with metal salts such as aluminum, zinc, magnesium, and calcium. These can be used alone or in combination of two or more.
The content of the adhesive base is usually 1 to 60% by mass, preferably 2 to 40% by mass, more preferably 3 to 30% by mass, and 4 to 15% by mass based on the total mass of the adhesive base layer. is particularly preferred.

In addition to the above-mentioned components, the adhesive base layer also contains drugs, organic solvents, tackifying resins, fillers, water-soluble/water-swellable polymers, transdermal absorption enhancers, ultraviolet absorbers, pH Conditioners, stabilizers, preservatives, water, etc. may also be included. Note that one type of these may be used alone or two or more types may be used in combination.

The above drugs are not particularly limited, but include, for example, actarit, acemethacin, ampiroxicam, amphenac sodium hydrate, ibuprofen, indomethacin, indomethacin farnesil, etodolac, camphor, ketoprofen, methyl salicylate, glycol salicylate, zaltoprofen, diclofenac sodium, sulindac, Celecoxib, tiaprofenic acid, tenoxicam, naproxen, piroxicam, felbinac, pranoprofen, flurbiprofen, flurbiprofen axetil, mefenamic acid, medicoxib, meloxicam, mofezolac, refecoxib, loxoprofen sodium hydrate, lobenzarit disodium, Anti-inflammatory analgesics such as lornoxicam; local irritants such as menthol, capsicum extract, and vanillylamide nonylate; peripheral blood flow improving agents such as tocopherol acetate and tocopherol nicotinate; antihistamines such as diphenhydramine, chlorpheniramine maleate, and isothipendyl hydrochloride; Extracts and powders of anti-inflammatory herbal medicines, such as , auricularis, arnica, and horse chestnut; Topical steroids, such as prednisolone, hydrocortisone, dexamethasone, and fluocinolone acetonide; Antipruritic and scabies treatments, such as crotamiton; lidocaine, dibucaine, etc. local anesthetics; disinfectants such as chlorhexidine gluconate, cetylpyridinium chloride, and benzalkonium chloride; therapeutic agents for Alzheimer's dementia such as donepezil hydrochloride and memantine hydrochloride; therapeutic agents for asthma such as tulobuterol; and isosorbide nitrate, etc. Examples include therapeutic agents for ischemic heart disease. These can be used alone or in combination of two or more.
The content of the drug is usually 0.01 to 20% by weight, preferably 0.1 to 10% by weight, more preferably 0.5 to 7.5% by weight, based on the total weight of the adhesive base layer. Mass%.

Examples of the organic solvents include liquid paraffin, light liquid paraffin, cetyl octanoate, hexyl laurate, isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, butyl stearate, myristyl lactate, octyldodecanol, hexyldecanol, and almond. Oil, olive oil, camellia oil, castor oil, peanut oil, peppermint oil, diethylene glycol, propylene glycol, dipropylene glycol, polypropylene glycol, triacetin, triethyl citrate, glycerin, sorbitol, and the like. These can be used alone or in combination of two or more.
The content of the organic solvent is usually 0.5 to 60% by weight, preferably 1 to 55% by weight, and more preferably 20 to 50% by weight, based on the total weight of the adhesive base layer.

Examples of the tackifying resin include rosin, hydrogenated rosin glycerin ester, ester gum, maleated rosin glycerin ester, terpene resin, petroleum resin, alicyclic saturated hydrocarbon resin, and aliphatic hydrocarbon resin. , these can be used alone or in combination of two or more.
When the above-mentioned tackifying resin is contained, its content is usually 0.1 to 20% by mass, preferably 0.5 to 10% by mass, and more preferably 0.5 to 10% by mass, based on the total mass of the adhesive base layer. is 1 to 5% by mass.

Examples of the filler include zinc oxide, aluminum oxide, titanium oxide, magnesium oxide, iron oxide, zinc stearate, calcium carbonate, kaolin, silica, dihydroxyaluminum aminoacetate, talc, etc., which may be used alone or Two or more types can be used in combination.
When the filler is contained, its content is usually 0.1 to 20% by mass, preferably 0.2 to 10% by mass, based on the total mass of the adhesive base layer.

Examples of the water-soluble/water-swellable polymer include polyvinyl alcohol, povidone, hypromellose, hydroxypropylcellulose, carboxyvinyl polymer, methylcellulose, hydroxyethylcellulose, carboxymethylethylcellulose, carmellose, carmellose potassium, carmellose calcium, and carmellose. Examples include sodium, sodium alginate, propylene glycol alginate, sodium carboxymethyl starch, xanthan gum, dextran, dextrin, gelatin, and the like, and these can be used alone or in combination of two or more.
When the above-mentioned water-soluble/water-swellable polymer is contained, its content is usually 0.5 to 20% by mass, preferably 1 to 10% by mass, based on the total mass of the adhesive base layer.

Examples of the percutaneous absorption enhancer include polyoxyethylene (2) 2-ethylhexyl ether, polyoxyethylene (4) 2-ethylhexyl ether, polyoxyethylene (3) decyl ether, and polyoxyethylene (3.5). Isodecyl ether, polyoxyethylene (2) lauryl ether, polyoxyethylene (2.2) lauryl ether, polyoxyethylene (3) lauryl ether, polyoxyethylene (3) tridecyl ether, polyoxyethylene (3) myristyl ether, polyoxyethylene (2) cetyl ether, polyoxyethylene (2) stearyl ether, polyoxyethylene (3.3) stearyl ether, polyoxyethylene (4) stearyl ether, polyoxyethylene (4) isostearyl ether, Polyoxyalkylene alkyl ethers such as polyoxyethylene (2) oleyl ether, polyoxyethylene (4) oleyl ether, polyoxyethylene (3) octylphenyl ether, polyoxyethylene (1) polyoxypropylene (1) cetyl ether; Terpenes such as camphor, geraniol, citronellal, terpineol, borneol, menthol, limonene; ylang-ylang oil, fennel oil, orange oil, chamomile oil, cinnamon oil, perilla oil, citronella oil, ginger oil, camphor oil, peppermint oil, Contains terpenes such as geranium oil, clove oil, turpentine oil, spruce oil, neroli oil, peppermint oil, palmarosa oil, bergamot oil, eucalyptus oil, lavender oil, linaloe oil, lemon oil, rose oil, rosemary oil, Roman chamomile oil, etc. Essential oils include higher alcohols such as octyl alcohol, nonyl alcohol, decyl alcohol, isodecyl alcohol, undecyl alcohol, lauryl alcohol, tridecyl alcohol, isostearyl alcohol, oleyl alcohol, and linoleyl alcohol, which may be used alone or in combination. More than one species can be used in combination.
When the transdermal absorption enhancer is contained, its content is usually 0.01 to 20% by mass, preferably 0.05 to 10% by mass, based on the total mass of the adhesive base layer.

Further, the water content is usually 20 to 50% by mass, preferably 30 to 40% by mass, based on the total mass of the adhesive base layer.

<Support>
The support used in the patch of the present invention is preferably a support made of a knitted fabric made of fibers.
The crimp rate of the fibers used in the above support is determined from the viewpoints of adhesion to the skin, ease of peeling between the adhesive base layers, ease of handling, feeling of use, prevention of back staining, extensibility, and anchoring ability of the adhesive base. Therefore, it is preferably 20 to 80%, more preferably 30 to 60%, still more preferably 35 to 55%, and particularly preferably 40 to 50%.
In the present invention, the crimp ratio means the percentage of the difference between the length of the fiber when it is crimped and stretched and its original length, relative to the length when it is stretched.

The denier number of the fibers used for the support is preferably 5 or more, from the viewpoint of adhesion to the skin, ease of peeling between adhesive base layers, feeling of use, prevention of back staining, and reduction of burden on the skin. It is preferably 10 or more, more preferably 15 or more, particularly preferably 20 or more, and from the viewpoint of adhesion to the skin, preferably 55 or less, more preferably 53 or less.
In addition, in the present invention, the denier number means the weight (g) of the fiber per 9000 m length. For example, the denier number of 1 g of fiber per 9000 m length is 1.

The material of the fiber used for the support is not particularly limited as long as it is used as a support for the patch, but synthetic fibers such as nylon, polyester, acrylic, polyurethane, polypropylene, vinylon, polyethylene, etc., and silk, etc. Examples include filaments made of natural materials derived from animals and plants. Among these, synthetic fibers are preferred from the viewpoint of stable supply and cost, and polyester is preferred from the viewpoints of drug migration from the adhesive base layer to the skin, dimensional stability, and dyeability.
Specific examples of the synthetic fibers mentioned above include nylon 6, nylon 6,6, ethyl cellulose, cellulose acetate, polyethylene terephthalate, etc., and they are suitable for drug migration from the adhesive base layer to the skin, dimensional stability, and dyeability. Therefore, polyethylene terephthalate is preferred.

In addition, the knitted fabric constituting the support used in the present invention has a stress at 50% elongation in the course direction and wale from the viewpoint of suppressing the discomfort of the skin at the application part and from the viewpoint of conformability to the skin. The absolute value of the difference from the stress at 50% elongation in the direction is preferably 0 to 800 gf, more preferably 0 to 700 gf, and still more preferably 0 to 600 gf.
Further, it is preferable that the stress at 50% elongation in the course direction and the stress at 50% elongation in the wale direction are both 300 to 2000 gf, more preferably 400 to 1500 gf. By setting these stresses within the above ranges, poor layer transfer between the adhesive base layer and the support during patch production and shrinkage after lamination are less likely to occur, and the anchoring properties of the adhesive base are improved. be done.
The stress at 50% elongation is the stress when the support (length before elongation: 50 mm) is fixed to a tensile tester and elongated by 25 mm at a speed of 1 mm/sec (length after elongation: 75 mm). This is an indicator of extensibility.

Further, the ratio of the stress at 50% elongation in the course direction to the stress at 50% elongation in the wale direction [course direction/wale direction] is preferably 0.2 or more from the viewpoint of followability to the skin. , more preferably 0.2 to 2, particularly preferably 0.3 to 1.

In addition, from the viewpoint of preventing reverse staining, the knitted fabric constituting the support used in the present invention preferably has either the number of courses or the number of wales of 45 or more per inch, and more preferably either one of them. Only one of them has a density of 45 to 80 per inch, more preferably only one of them has a density of 45 to 70 per inch, particularly preferably only one of them has a density of 50 to 60 per inch.
The other number of courses or wales is preferably from 30 to 54 per inch, more preferably from 35 to 53 per inch, particularly preferably from 40 to 50 per inch, from the same viewpoint as above.

Further, the thickness of the knitted fabric constituting the support used in the present invention is preferably 1 mm or less, and 0.2 mm or less, from the viewpoint of adhesion to the skin, ease of peeling between adhesive base layers, and suppressing the thickness of the patch. ~0.7 mm is more preferable.

Further, the knitted fabric constituting the support used in the present invention preferably has a coefficient of static friction and a coefficient of dynamic friction of 0.35 or less, both of 0.1 to 0. 35 is more preferable, and both are particularly preferably 0.15 to 0.35.
Note that by setting the crimp ratio and denier number within the above ranges, the static friction coefficient and the dynamic friction coefficient can be set within such ranges.

The above-mentioned knitted fabric may be manufactured according to a conventional method, and may be warp-knitted or weft-knitted. Examples of warp knitting include atlas knitting, chain stitching, cord knitting, Denby knitting, etc., and examples of weft knitting include rubber knitting, purl knitting, flat knitting, etc.

Further, a specific example of the adhesive patch of the present invention includes the support, the adhesive base layer, and a release liner (release paper), the adhesive base layer is laminated on the support, and the adhesive base layer has a release liner. One example is one in which a liner (release paper) is laminated. The content ratio of the adhesive base layer in this case is not particularly limited, but is preferably 40 to 99% by mass, more preferably 50 to 90% by mass, particularly preferably 60 to 85% by mass, based on the total mass of the patch.

<Release liner>
The above-mentioned release liner is not particularly limited, and examples thereof include films of polyester, polyethylene terephthalate separator, polyethylene, polypropylene, ethylene/vinyl acetate copolymer, cellophane, and the like.

The shape and size of the patch of the present invention may be appropriately adjusted depending on the affected area, but rectangular or substantially rectangular ones are preferable, and these may have rounded corners. Specifically, rectangles or approximately rectangles such as 14 cm x 20 cm, 14 cm x 10 cm, 10 cm x 7 cm, 7 cm x 5 cm, 1.6 cm x 1.6 cm, 2.25 cm x 2.25 cm, 3.2 cm x 3.2 cm, etc. Examples include:

The adhesive patch of the present invention can be manufactured based on known methods such as the 17th revised Japanese Pharmacopoeia General Rules for Preparations. For example, based on a known method, an adhesive base layer prepared by adding component (A), component (B), an adhesive base, and other components such as drugs as necessary is spread on a support or a release liner. A release liner can be produced when the composition is spread and then spread on a support, or by laminating the support when it is spread on a release liner.

The patch of the present invention has excellent adhesion to the skin and is difficult to peel off from the skin.Moreover, if the adhesive base layers stick together, they can be easily peeled off and wrinkles can be removed. It can be easily reapplied without causing the adhesive base to come off. In addition, it is easy to apply, and there is less chance of exfoliation and pain when removing the patch.

EXAMPLES Hereinafter, the present invention will be explained in detail with reference to Examples, but the present invention is not limited to these Examples.

(Example 1)
1 part by mass of indomethacin, 2 parts by mass of crotamiton, 3.5 parts by mass of partially neutralized polyacrylic acid, 3 parts by mass of carmellose sodium, 22 parts by mass of concentrated glycerin, 3 parts by mass of kaolin, 1 part by mass of gelatin, dihydroxyaluminum aminoacetate An indomethacin-containing mixture was obtained by mixing 0.3 parts by mass and 1.25 parts by mass of lactic acid with 25 parts by mass of purified water.
Separately, 1 part by mass of ester gum, 2 parts by mass of dextrin palmitate, 25 parts by mass of D-sorbitol solution, 1 part by mass of sorbitan monooleate (trade name: Nikkor SO-10V, Nikko Chemicals Co., Ltd.), Macrogol 6000 (product name) 2 parts by mass of Macrogol 6000 (trade name: NOF Corporation) and 2 parts by mass of diisopropyl adipate (trade name: DID, Nikko Chemicals Corporation) were dissolved under heating in 2.5 parts by mass of light liquid paraffin. This was added to the above-mentioned indomethacin-containing mixture, purified water was added to make the total amount 100 parts by mass, and the mixture was stirred with a stirrer until the mixture became homogeneous throughout, thereby obtaining a composition for an adhesive base layer.
This adhesive base layer composition was spread and coated on a polyester release liner film, and the adhesive base layer side of this was coated with a polyester stretchable woven fabric (support material) having the properties shown in Table 1 below. After coating with 1), each patch was cut into 10 cm x 7 cm to obtain patch 1.

The stress at 50% elongation in Table 1 was determined by fixing the support (length before elongation: 50 mm) on a tensile tester (texture analyzer manufactured by Hideko Seiki Co., Ltd.) and elongating it by 25 mm at a speed of 1 mm/sec. (length after elongation: 75 mm).
Moreover, the "absolute value" in Table 1 means the absolute value of the difference between the stress at 50% elongation in the course direction and the stress at 50% elongation in the wale direction.
The static friction coefficient and dynamic friction coefficient in Table 1 are those measured according to JIS K 7125 (mate material: glass plate).

<Test Example 1 (180° peel adhesion measurement test method)>
As shown in FIG. 1, the patch 1 was fixed on the test plate (artificial leather (Sapure) pasted on a stainless steel plate) of a tensile tester (Texture Analyzer TA. XTplus (Hideko Seiki Co., Ltd.)). Adhesion was measured according to the Japanese Pharmacopoeia 180° peel adhesion test method.
As a result, the peel adhesive force required for peeling off the patch 1 was as high as 17 N/cm, confirming that the patch of the present invention has excellent adhesion to the skin and is difficult to peel off from the skin.

<Test Example 2 (Peeling force measurement test between plasters)>
Patch 1 was cut into two pieces of 2 cm x 7 cm, and a 2 cm x 5 cm portion of the liner was peeled off from each edge, and the adhesive base layers (paste surfaces) of the two preparations were stacked on top of each other, and a pressure roller with a mass of 2 kg was applied. I crimped it with As shown in Figure 2, 2 cm above and below the sample was sandwiched between the probes of a tensile tester (Texture Analyzer TA. Formulation 1 and Formulation 2) were pulled until they separated, and the maximum load was measured as the peeling force between the plasters.
Inter-paste peeling force is the amount of force required to peel off the adhesive base layers (paste surfaces) of a patch when they stick together, and the smaller the value, the easier it is to peel off and the easier it is to reapply. I can say that.
As a result of Test Example 2, the inter-paste peeling force of Patch 1 was a very small value of 1400 gf, and when the adhesive base layers (paste surfaces) of the patch of the present invention stuck together, the adhesive base layer It was confirmed that the plaster surfaces could be peeled off from each other with very little force, making it easy to reapply.

<Test Example 3 (Sensory test)>
For patch 1, the liner was peeled off, the long side was folded in half, the plasters were pasted together, and a load of 2 kg was applied for 1 minute. After one minute had elapsed, a man (55 years old) was asked to manually peel off the bonded plaster, and it was easily peeled off without deforming the support.
This confirmed that the patch of the present invention can be easily reapplied even if the plaster surfaces stick together.

<Test example 4 (sensory test)>
A man (43 years old) was asked to apply one patch of Patch 1 to his arm and waist, and check to see if it had peeled off after 12 hours. As a result, it was confirmed that the patch did not peel off even after 12 hours and had high adhesion to the skin. It was also confirmed that there was almost no pain when the patch was removed, and that it was easy to apply.

Claims (2)

An adhesive base layer is laminated on a support, the support is composed of a knitted fabric made using fibers with a crimp ratio of 20 to 80%, and the adhesive base layer contains the following components (A) and (B) , a patch containing partially neutralized polyacrylic acid, and carmellose sodium .
(A) One or more sorbitan-based nonionic surfactants selected from sorbitan isostearate, sorbitan oleate, sorbitan sesquiisostearate, sorbitan sesquioleate, sorbitan triisostearate, and sorbitan trioleate (B) Macrogol and one or more dicarboxylic acids selected from diisopropyl adipate, diisobutyl adipate, diethoxyethyl adipate, dioctyl adipate, diethoxyethyl succinate, dioctyl succinate, diethyl sebacate, and diisopropyl sebacate. Combination with acid diester The patch according to claim 1 , wherein the macrogol is a macrogol with an average molecular weight of 100 to 35,000.