WO2010073327A1 - Patch - Google Patents

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Publication number
WO2010073327A1
WO2010073327A1 PCT/JP2008/073488 JP2008073488W WO2010073327A1 WO 2010073327 A1 WO2010073327 A1 WO 2010073327A1 JP 2008073488 W JP2008073488 W JP 2008073488W WO 2010073327 A1 WO2010073327 A1 WO 2010073327A1
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WO
WIPO (PCT)
Prior art keywords
patch
support
release sheet
bending resistance
patch according
Prior art date
Application number
PCT/JP2008/073488
Other languages
French (fr)
Japanese (ja)
Inventor
誠二郎 山
直樹 村井
Original Assignee
リードケミカル株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by リードケミカル株式会社 filed Critical リードケミカル株式会社
Priority to PCT/JP2008/073488 priority Critical patent/WO2010073327A1/en
Publication of WO2010073327A1 publication Critical patent/WO2010073327A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene

Definitions

  • the present invention is a patch in which a portion having a high bending resistance is provided on a support and a pressure-sensitive adhesive layer is present on the support, and more specifically, bending of a preparation or adhesion between pastes is performed.
  • An object of the present invention is to provide a patch that is easy and easy to control, with little failure in the work of applying to the affected area.
  • the preparation described above has improved followability, the shape-retaining property of the preparation itself is reduced, and as a result, the portion exposed by the removal of the release sheet is likely to be bent or twisted, and applied to the affected area.
  • the preparation is used in a state where the preparation is bent or wrinkled in the preparation as it is, the application area is reduced and the medicinal effect as a patch cannot be fully exhibited.
  • the bent part or wrinkled part is the starting point, and during the application period, the exfoliation and removal of the preparation was promoted, and the application time prescribed in the usage could not be completed.
  • a preparation using a support with high stiffness is also sold.
  • a patch with high stiffness is applied, (1) it is pulled during application due to a decrease in followability to the skin. There may be a sense of incongruity, such as a feeling of feeling or tension.
  • the formulation may be sheared, peeled off or dropped during application. In order to improve this problem, it may be possible to increase the adhesive strength to the skin. In this case, however, (3) after use, when the preparation is peeled off, the skin is damaged by peeling off the stratum corneum and the pain at the peeling is caused. It becomes a problem such as increasing.
  • Patent Document 3 Patent Document 4, Patent Document 5 and Patent Document 6.
  • the plaster exposed during the pasting operation may adhere to each other.
  • the exposed plaster part may adhere to the release sheet side of the preparation, and the problem has not been solved.
  • JP 2000-297032 A specification JP 2001-328935 A International Publication No. 00-69422 Pamphlet Japanese Patent Application Laid-Open No. 2002-306530 Japanese Utility Model Publication No. 3-59327 Japanese Utility Model Publication No. 5-54515
  • the present invention provides a highly flexible part on the support of the preparation, prevents bending of the preparation and adhesion of the plaster during the application work, and reduces the failure of the application work.
  • An object of the present invention is to provide a patch capable of simply and easily performing a pasting operation.
  • the inventors of the present invention have reached the present invention as a result of diligent search to solve the above-mentioned problems.
  • the present invention solves the above-mentioned problems and provides a patch that can reduce the failure of the pasting operation to the affected area without being restricted by the application area or shape of the preparation.
  • the present invention is to provide the following patches.
  • a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface;
  • a patch wherein two or more parts having different stiffness are formed on one support.
  • the part having different bending resistance of the support is a part having higher bending resistance than the other part of the support.
  • the highly flexible portion is localized at a support portion corresponding to a portion where the release sheet is divided and the plaster is exposed.
  • a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface; a) A patch for forming two or more parts having different stiffness on a single support, b) A portion of the support having higher rigidity than other portions is localized at a support portion corresponding to a portion where the release sheet is divided and the plaster is exposed, c) A patch characterized in that the bending resistance of the low stretchable part is 120% or more higher than the bending resistance of other parts.
  • a patch having two cuts substantially parallel to the release sheet The patch according to any one of items (1) to (4), wherein the highly flexible portion of the support is located in a central portion of the support sandwiched between cuts substantially parallel to the release sheet.
  • a support made of a knitted fabric having a bending resistance of 5 mm or more according to a 45 ° cantilever method specified in JIS L 1096-1999 is used for the portion having high bending resistance.
  • the patch according to Item The support according to any one of the patches, which has different stiffness and softness, wherein the area of the portion having high stiffness and softness is 5% to 60% of the whole, (1) to (5) Patch.
  • the patch is a patch in which portions with high flexibility are scattered over the entire surface, b) having a portion where the release sheet is divided and the plaster is exposed; c)
  • the support is a support having a bending resistance of 6 mm or more according to a 45 ° cantilever method defined in JIS L 1096-1999.
  • a patch characterized by that.
  • the patch comprises a release sheet adhered to the surface of the pressure-sensitive adhesive layer, and the bending resistance of the release sheet is 60 to 160 mm.
  • the patch according to (13) to (14), wherein the support is made of polyester fiber having a fiber thickness of 30 to 75 denier and having a basis weight of 80 to 120 g / m 2 .
  • An embodiment of the present invention is a patch in which a pressure-sensitive adhesive layer is spread on a support having portions having different stiffness and flexibility in one preparation.
  • a single preparation is a patch in which a pressure-sensitive adhesive layer is spread on a highly rigid support.
  • the part having high stiffness and softness is preferably a part, that is, a part that is localized in a part where the plaster is first exposed at the time of application near the cut of the release sheet.
  • a highly rigid portion it may be provided in accordance with the cut portion of the release sheet, and there may be one or two cuts. In the case of two, what can cover the part pinched by the cut
  • the release sheet part to be peeled off first described in the sticking method or the like that is, the part where the plaster is first exposed at the time of sticking can be covered by a highly rigid part, and the shape of the part is not limited.
  • preferred examples include the range of the pattern portion shown in FIGS. 5 (a) and 5 (b).
  • the support of the part having high rigidity and softness covers the part where the plaster is first exposed at the time of application, so that the rigidity of the support is suppressed.
  • the shape of the portion having high bending resistance is not particularly limited.
  • the portion having high stiffness and softness may be on one side or both sides of the support (FIG. 6). In the case of localizing partly, it is preferable to make the part to be localized solid, spot or linear.
  • one whole preparation has high rigidity and flexibility.
  • a pattern as shown in FIG. 5 for maintaining the height of bending resistance may be applied to the entire support.
  • the pattern of the part where the stiffness of the support is changed, but considering the stiffness in the biaxial directions (longitudinal and lateral directions), the uniform longitudinal and lateral stiffness is considered. Then, a dot, a lattice pattern, etc. like FIG. 5 etc. are preferable. In addition, it is also preferable to use a stripe pattern or the like in consideration of bending / softening only in the vertical direction or only in the horizontal direction. Furthermore, it is also preferable to use another pattern that utilizes the difference in flexibility, for example, a logo pattern.
  • the highly flexible part of the present invention is such that the pastes adhere to each other at the time of applying the patch, and the exposed part of the paste does not adhere to the release sheet side on the preparation. It means having the bending and softness. In addition, if the bending resistance is too high, it is not preferable because it causes wrinkles due to application of the patch, uncomfortable feeling during application, and a decrease in motility.
  • the bending resistance in the highly flexible portion of the present invention refers to a property having moderate stretchability.
  • the bending resistance can be measured by a 45 ° cantilever method defined in JIS L 1096-1999.
  • the preferred bending resistance of the support of the present invention is 5 mm or more.
  • the bending resistance of the portion having high bending resistance is 6 mm or more. It is preferable that the bending resistance of the portion having high bending resistance is 120% or more higher than that of the untreated portion.
  • the means for changing the stiffness of the support is not particularly limited.
  • the method of changing the structure of the support fibers, materials, etc.
  • the method of pressing the method of applying resin, ink, etc., than the support The method etc. which stick a tape etc. with high bending resistance are mentioned.
  • a method by pressing, a method of applying a resin or ink, or a method of changing the structure of the support is preferable.
  • Examples of means for applying a resin or ink in order to change the bending resistance of the support include, but are not limited to, the following methods. Although it does not specifically limit as resin applied in order to change the bending resistance of the support body which can be used in this invention, A natural resin or a synthetic resin is mentioned. These resins can be used alone or in combination of two or more.
  • Examples of the ink applied to change the stiffness of the support that can be used in the present invention include pigments (organic pigments, inorganic pigments), dyes (dispersion dyes, acid dyes, reactive dyes, etc.), pearls (mica), Although foil (aluminum etc.) is mentioned, it is not limited to these.
  • organic pigments and inorganic pigments that do not require a washing step are preferably used.
  • the resin treatment method may be any of textile printing, gravure, thermal transfer, ink jet, spraying, and the like, and textile printing is particularly preferred, but is not limited thereto.
  • Examples of the tape or the like when a tape is applied to change the bending resistance of the support include, but are not limited to, polyolefin film, polyester film, polyurethane film, and the like.
  • the method of sticking a film can consider the method of using an adhesive, the method of heat processing, etc.
  • the pressure-sensitive adhesive component that can be used in the present invention is not particularly limited, and both a non-hydrated base and a hydrous base can be used.
  • non-water-containing base examples include, but are not limited to, rubber adhesives, acrylic adhesives, silicone adhesives, and the like.
  • the rubber component of the rubber-based adhesive was selected from, for example, natural rubber, polyisoprene, styrene-isoprene-styrene block copolymer, styrene-butanediene-styrene block copolymer, styrene-butadiene rubber, and polyisobutylene. Although it is preferable to use one kind alone or two or more kinds in combination, it is not limited to these.
  • acrylic adhesive examples include (acrylic acid-2-ethylhexyl acrylate) copolymer, (acrylic acid-butyl acrylate) copolymer, (acrylic acid-octyl acrylate) copolymer, (acrylic) Acid-acrylic acid 2-ethylhexyl-vinyl acetate) copolymer, (acrylic acid-2-ethylhexyl acrylate-hydroxyethyl acrylate) copolymer, (acrylic acid-hydroxyethyl acrylate-vinyl pyrrolidone) copolymer, (Acrylic acid-2-ethylhexyl acrylate-hydroxyethyl acrylate-vinyl pyrrolidone) copolymer and the like.
  • DURO-TAK 87-2194 commercial products such as DURO-TAK 87-2194, 87-2510, 87-2516 (manufactured by National Starch and Chemical Co., Ltd.) can also be used.
  • a copolymer containing an acrylate ester having a hydroxy group in the side chain in the monomer structural unit is preferred.
  • the crosslinking agent include amino compounds, phenol compounds, epoxy compounds, isocyanate compounds, organic peroxides, metal alcoholates, and metal chelates.
  • silicone pressure-sensitive adhesive examples include silicone rubber such as polyorganosiloxane.
  • the plasticizer that can be used in the present invention is not particularly limited, and examples thereof include petroleum oil (paraffinic process oil, naphthenic process oil, aromatic process oil, etc.), squalane, squalene, vegetable oil (olive oil). , Camellia oil, castor oil, tall oil, peanut oil), silicon oil, dibasic esters (dibutyl phthalate, dioctyl phthalate, etc.), liquid rubber (polybutene, liquid isoprene rubber), liquid fatty acid esters (isopropyl myristate, lauric acid) Hexyl, diethyl sebacate, diisopropyl sebacate, etc.), diethylene glycol, polyethylene glycol, polyethylene glycol, glycol salicylate, propylene glycol, dipropylene glycol, triacetylene, quee Triethyl citrate, crotamiton and the like.
  • liquid paraffin, isopropyl myristate liquid paraffin, is
  • plasticizers may be used alone or in combination of two or more.
  • the blending amount of these plasticizers is not particularly limited, but is preferably 5 to 70% by weight, more preferably 10 to 60% by weight based on the total amount of compounds contained in the pressure-sensitive adhesive layer, and 10 to 50%. It is particularly preferred that it is wt%. If the blending amount of the plasticizer is less than 5% by weight, the effect of improving the cohesive force of the patch by blending the plasticizer tends to be insufficient. On the other hand, if it exceeds 70% by weight, the skin permeability of the drug is poor. It tends to be sufficient.
  • the adhesive layer in the transdermal absorption preparation of the present invention can further contain a tackifier.
  • the tackifier that can be used in the present invention is not limited, and examples thereof include rosin derivatives (such as rosin, rosin glycerin ester, hydrogenated rosin, hydrogenated rosin glycerin ester, rosin pentaerythrester).
  • Aromatic saturated hydrocarbon resin (Alcon P100 (Arakawa Chemical Industries, Ltd.)), aliphatic hydrocarbon resin (Quinton B-170 (Nippon Zeon Corporation, etc.)), terpene resin (Clearon P-125 (Yasuhara Chemical Co., Ltd.)) Etc.), maleic acid resin, etc., among which glycerin ester of hydrogenated rosin, aliphatic hydrocarbon resin, and terpene resin are preferable.
  • tackifiers may be used alone or in combination of two or more, and the blending amount is not particularly limited, but is 5 to 5 on the basis of the total amount of compounds contained in the pressure-sensitive adhesive layer. It is preferably 70% by weight, more preferably 5 to 60% by weight, and particularly preferably 10 to 50% by weight. If the amount of the tackifier is less than 5% by weight, the effect of improving the adhesive strength of the patch due to the addition of the tackifier tends to be insufficient. On the other hand, if the amount exceeds 70% by weight, the patch is peeled off. The skin irritation tends to increase.
  • the pressure-sensitive adhesive layer of the percutaneous absorption preparation of the present invention can also contain an absorption enhancer for the purpose of improving the skin permeability of the drug.
  • the absorption promoter is not particularly limited as long as it is a compound that has been conventionally recognized as having an absorption promoting action on the skin, and specifically, a fatty acid, aliphatic alcohol, fatty acid ester, amide or ether having 6 to 20 carbon atoms. , Aromatic organic acids, aromatic alcohols, aromatic organic acid esters or ethers. These compounds may be saturated or unsaturated, and may be linear, branched, or cyclic.
  • absorption promoters may be used alone or in combination of two or more.
  • the amount of these absorption accelerators is not particularly limited, but is preferably 0.01 to 20% by weight, particularly 0.05 to 10% by weight, based on the total amount of compounds contained in the pressure-sensitive adhesive layer. preferable. If the blending amount of the absorption accelerator is less than 0.01% by weight, the effect of improving the skin permeability of the drug due to the blending of the absorption promoter tends to be insufficient. The skin irritation tends to increase, and the adhesion to the skin tends to decrease.
  • an antioxidant a filler, a crosslinking agent, an antiseptic, an ultraviolet absorber and the like can be blended in the pressure-sensitive adhesive layer as necessary.
  • antioxidant for example, tocopherol and their ester derivatives, ascorbic acid, ascorbic acid stearic acid ester, nordihuman rogayaretic acid, dibutylhydroxytoluene (BHT), and butylhydroxyanisole are preferable; Calcium, magnesium carbonate, silicate (for example, aluminum silicate, magnesium silicate, etc.), silicic acid, barium sulfate, calcium sulfate, calcium zincate, zinc oxide, titanium oxide are preferable; Thermosetting resins such as phenol resins, epoxy resins, alkyd resins, unsaturated polyesters, isocyanate compounds, block isocyanate compounds, organic crosslinking agents, inorganic crosslinking agents such as metals or metal compounds are preferably used. Not intended to be constant.
  • ethyl paraoxybenzoate, propyl paraoxybenzoate and butyl paraoxybenzoate are preferable; as the ultraviolet absorber, p-aminobenzoic acid derivatives, anthranilic acid derivatives, salicylic acid derivatives, coumarin derivatives, amino acid compounds , An imidazoline derivative, a pyrimidine derivative, and a dioxane derivative are preferable.
  • the formulation of each of the above antioxidant, filler, crosslinking agent, preservative, and ultraviolet absorber is not particularly limited, the total amount of the antioxidant, filler, crosslinking agent, preservative, and ultraviolet absorber is It is preferably 0 to 10% by weight, more preferably 0 to 5% by weight, and particularly preferably 0 to 2% by weight, based on the total amount of compounds contained in the pressure-sensitive adhesive layer.
  • the water-containing base contains water so that the medicinal effect on the skin can be sufficiently obtained, has adhesiveness, and softens even at room temperature or higher so that the plaster does not remain on the skin. Formed to have.
  • a thickener it is desirable that moisture can be stably maintained at 30% to 80% and that it has water retention.
  • Specific examples include guar gum, locust bean gum, carrageenan, alginic acid, sodium alginate, agar, gum arabic, tragacanth gum, karaya gum, pectin, starch and other microbial systems, sansan gum, acacia gum and other microbial systems, gelatin, collagen and the like.
  • Natural polymers such as animal systems, cellulose systems such as methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, semi-synthetic polymers such as starch systems such as soluble starch, carboxymethyl starch, and dialdehyde starch, polyvinyl alcohol, polyvinyl pyrrolidone, Vinyl-based materials such as polyvinyl methacrylate, acrylic-based materials such as polyacrylic acid and sodium polyacrylate, other polyethylene oxide, methyl vinyl ether / Water-soluble polymer of water-soluble polymers such as synthetic polymers such as water-maleic acid copolymers are suitably used. In particular, sodium polyacrylate is preferable.
  • sodium polyacrylate having an average degree of polymerization of 20000 to 70000 is preferred. As the average degree of polymerization becomes smaller than 20000, the thickening effect becomes poor and sufficient gel strength tends to be obtained. As the average degree of polymerization becomes larger than 70000, the thickening effect becomes too strong and workability tends to decrease. It appears and neither is desirable. Further, by using three or more kinds of the water-soluble polymers in combination, for example, a polymer complex with a strong ionic polymer of sodium polyacrylate can be formed, and an elastic gel with higher gel strength can be obtained.
  • Polyhydric alcohols such as glycerin, propylene glycol and sorbitol as wetting agents, and kaolin, zinc oxide, talc, titanium, bentonite, aluminum silicate, titanium oxide, zinc oxide, aluminum metasilicate, calcium sulfate, calcium phosphate as fillers Etc. may be added.
  • a solubilizer or absorption promoter propylene carbonate, crotamiton, 1-menthol, mint oil, limonene, diisopropyl adipate and the like
  • methyl salicylate, glycol salicylate, 1-menthol, thymol, mint oil, Nonyl acid vanillylamide, pepper extract, etc. may be added.
  • you may add a stabilizer, an antioxidant, an emulsifier, etc. as needed.
  • cross-linking agents and polymerizing agents may be added as necessary.
  • the plaster can be strengthened and water retention can be provided.
  • This crosslinking agent and polymerization agent are appropriately selected according to the type of thickener and the like.
  • compounds having at least two epoxy groups in the molecule hydrochlorides such as Ca, Mg, Al, sulfates, phosphates, Inorganic acid salts such as carbonate, organic acid salts such as citrate, tartrate, gluconate and stearate, oxides such as zinc oxide and anhydrous silicic acid, hydroxides such as aluminum hydroxide and magnesium hydroxide
  • a polyvalent metal compound such as is preferably used.
  • polyvinyl alcohol When polyvinyl alcohol is applied as a thickener, adipic acid, thioglycolic acid, epoxy compound (epichlorohydrin), aldehydes, N-methylol compound, Al, Ti, Zr, Sn, V, Cu, B, Cr Complexes such as compounds such as are preferably used.
  • polyvinylpyrrolidone When polyvinylpyrrolidone is applied as the thickener, methyl vinyl ether / maleic anhydride copolymer, polyacid compound or alkali metal salt thereof (polyacrylic acid, tannic acid and derivatives thereof), etc. are preferably used.
  • polyethylene oxide when polyethylene oxide is applied to the thickener, peroxide, polysulfone azide, and the like are preferably used.
  • a methyl vinyl ether / maleic anhydride copolymer when applied to the thickener, polyfunctional hydroxy compounds, polyamines, iodine, gelatin, polyvinyl pyrrolidone, iron, mercury, lead salts and the like are preferably used.
  • aldehydes such as formaldehyde, glutaraldehyde, and dialdehyde starch
  • diepoxides such as glyoxal and butadiene oxide
  • diketones such as divinyl ketone
  • diisocyanates are preferably used.
  • a polyvalent metal salt such as lithium hydroxide, zinc hydroxide, aluminum hydroxide or sodium borate is preferably added as a crosslinking agent. Particularly preferred are zinc salts and aluminum salts.
  • Cross-linking reaction is promoted.
  • the concentration of the polyvalent metal salt added as a crosslinking agent is preferably 0.5 to 1.5 equivalents relative to 1 equivalent of the thickener (or water-soluble polymer). As the concentration of the polyvalent metal salt becomes smaller than 0.5 equivalent, the reaction tends to be too slow and the gel strength tends to decrease, and as the concentration of the polyvalent metal salt becomes larger than 1.5 equivalent, the reaction becomes too fast. There is a tendency for gelation to become non-uniform and workability to deteriorate, both of which are not preferred.
  • the plaster comprises 5 to 20% by weight of a thickener, preferably 10 to 15% by weight, 5 to 40% by weight of a wetting agent, 20% by weight or less of a filler, 10 to 10% by weight of water. 80% by weight, solubilizing agent 0 to 8% by weight, drug 5% by weight or less, preferably 0.5% to 5% by weight.
  • the rigid / soft support used in the patch of the present invention can be used without any limitation as long as it can support the pressure-sensitive adhesive layer.
  • Specific examples of such a support include cloth, nonwoven fabric, polyurethane, polyethylene, polyvinyl acetate, polyvinylidene chloride, polyethylene, polyethylene terephthalate, aluminum sheet, or a laminate or composite material thereof.
  • the fiber material of the cloth or nonwoven fabric is not particularly limited, but may be a thermoplastic fiber alone or a blend of thermoplastic fiber and non-thermoplastic fiber.
  • thermoplastic fiber examples include materials made of a thermoplastic resin such as polyurethane, polyester, polypropylene, acrylic, and nylon, for example, polyester fiber, polyamide fiber, and polyvinyl chloride fiber. These may be used alone or in combination of two or more. It can be used by mixing.
  • non-thermoplastic fibers include rayon, cupola, hemp and silk.
  • the thickness of the support is not particularly limited, but the thickness is preferably in the range of 5 to 1000 ⁇ m. If the thickness of the support is less than 5 ⁇ m, the workability at the time of peeling tends to be reduced. On the other hand, if the thickness exceeds 1000 ⁇ m, it becomes difficult to cut the support or the pressure-sensitive adhesive layer in the preparation production process. The manufacturing ease tends to decrease.
  • the thermoplastic fibers of the support used in the patch of the present invention it is preferable that the basis weight of the support is in the range of from 50 200g / m 2.
  • the range is preferably 60 to 160 g / m 2 , more preferably 80 to 120 g / m 2 .
  • the thermoplastic fiber of the support used in the patch of the present invention preferably has a basis weight of 80 to 120 g / m 2 made of polyester fiber having a fiber thickness of 30 to 75 denier.
  • the basis weight is 90 to 110 g / m 2 made of 50 denier polyester fibers, and more preferably the basis weight is about 100 g / m 2 made of 50 denier polyester fibers.
  • the bending resistance of the support used in the patch of the present invention is preferably 5 mm or more according to the 45 ° cantilever method specified in JIS L 1096-1999.
  • the release sheet in which the patch is attached to the surface of the pressure-sensitive adhesive layer preferably has, for example, a bending softness of 60 to 160 mm.
  • the thickness of the adhesive layer in the patch of the present invention is not particularly limited, but is preferably 20 to 3000 ⁇ m.
  • the method for arranging the pressure-sensitive adhesive layer on the support is not particularly limited.
  • the patch of the present invention is provided with a release paper
  • a release paper it is not particularly limited. Specifically, a film such as polyester such as polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, a laminate film of fine paper and polyolefin, etc. Can be used.
  • a silicone treatment may be applied to the surface on the side in contact with the pressure-sensitive adhesive layer.
  • Drugs include methyl salicylate, glycol salicylate, 1-menthol, red pepper extract, nonylic acid vanillylamide, mint oil, diclofenac, ibupufen, indomethacin, ketoprofen, loxoprofen, sulindac, tolmetine, lobenzalite, penicillamine, fempfen, flurbiprofen, prolbiprofen , Pranoprofen, thiaprofen, suprofen, felbinac, ketorolac, oxaprozin, etodolac, zaltoprofine, piroxicam, pentazocine, buprenorphine hydrochloride, butorphanol tartrate, etc.
  • prednisolone dexamethasone, hydrocortisone, betamethasone, fluocinide, Luocinolone acetonide, prednisolone acetate valerate, dexamethasone dipropionate, diflucortron valerate, difluprednate, betamethasone valerate, hydrocortisone acetate, clobetasone butyrate, betamethasone butyrate, clobetasone propionate, dexamethasone succinate, prednisolone 21- (2E, 6E) steroidal anti-inflammatory drugs such as falsinate, hydrocortisone valerate, diflorazone acetate, dexamethasone propionate, betamethasone dipropionate, amsinonide, dexamethasone valerate, harsinonide, butesonide, alcrometasone propionate, etc.
  • steroidal anti-inflammatory drugs such as falsinate
  • Two or more kinds of drugs can be used in combination as necessary.
  • these drugs can be applied in the form of an ester-derived compound, an amide-derived compound, an acetal-derived compound, or a medically acceptable inorganic salt or organic salt as necessary. It may be contained or attached to the body.
  • the amount of the drug is appropriately selected according to the type and use of the patch so that an effective amount preset when applied to the patient can be applied to the affected area.
  • the above ingredients are mixed and mixed Then, it was coated on a release sheet, coated with the support mentioned in the above Production 1 to 4 and pressure-bonded. Furthermore, it cut
  • Comparative Example 1 Manufactured in the same manner as in Example 1 except that unprocessed circular knitted woven fabric was used.
  • Test Example 1 Method for measuring bending resistance The bending resistance of each support was measured by the 45 ° cantilever method defined in JIS L 1096-1999. In addition, for Example 1, Example 2, and Example 3, the bending resistance of the processed part was measured.
  • Test Example 2 Sticking test A sticking test was performed using the preparations produced in the above Examples and Comparative Examples. In the sticking test, each Example and Comparative Example 1 were cut into a size of 10 cm ⁇ 14 cm and used. The pasting work was carried out on the lumbar region of 10 healthy people aged 30 to 60 years old. Evaluation was performed according to the evaluation criteria shown in Table 2. Table 3 shows the evaluation results for the ease of sticking work and the uncomfortable feeling when sticking.
  • Example 2 and Example 3 were almost the same evaluation as Comparative Example 1.
  • FIG. 1 shows an example of failure in a state in which pastes are stuck to each other after removal of a release sheet during a pasting operation of a patch (state in which pastes exposed when there is one liner break are stuck together) ).
  • Fig. 2 shows an example of failure in a state where the pastes are stuck to each other after the release sheet is removed during the pasting operation of the patch (the plaster exposed when the liner has one cut sticks to the release paper)
  • FIG. FIG. 3 shows an example of failure in a state in which the pastes are stuck to each other after the release sheet is removed during the pasting operation of the patch (a state in which the exposed pastes are stuck to each other when there are two liner breaks) ).
  • FIG. 1 shows an example of failure in a state in which pastes are stuck to each other after removal of a release sheet during a pasting operation of a patch (state in which pastes exposed when there is one liner break are stuck together) ).
  • Fig. 2 shows an example of failure in a state where the
  • FIG. 4 shows an example of failure in a state in which the pastes are stuck to each other after removing the release sheet during the pasting operation of the patch (exposed paste is stuck to the release paper when there are two liner breaks.
  • FIG. 5 is a front view ((a), (b)) of the patch in the embodiment of the present invention.
  • FIG. 6 is a perspective view and a diagram schematically showing a cross section of the patch in the embodiment of the present invention.
  • 1 is a patch such as an ointment or a poultice in the embodiment of the present invention
  • 2 is a plaster layer of the patch
  • 3 is a support having rigidity and flexibility made of a woven fabric, etc.
  • FIG. 7 is a diagram showing the pattern of the support used in Production Example 1.
  • FIG. 8 is a diagram showing the pattern of the support used in Production Example 2.
  • FIG. 9 is a diagram showing the pattern of the support used in Production Example 3.
  • FIG. 10 is a diagram showing the pattern of the support used in Production Example 4.

Abstract

[PROBLEMS] The invention aims to provide a patch which is inhibited from the bending of the pharmaceutical preparation and from the adhesion of plaster areas to each other in application and which can be easily and simply applied nearly without failure. [MEANS FOR SOLVING PROBLEMS] A patch comprising a substrate, a plaster layer formed on the substrate, and a release paper lying on the plaster layer in such a way as to cover the nearly whole surface of the plaster layer, characterized in that sections different in bending resistance are formed in one substrate and a section having a bending resistance higher than those of the other sections is localized in an area where the plaster is to be first exposed in application, whereby the adhesion of plaster areas to each other is inhibited in application.

Description

貼付剤Patch
 本発明は、支持体上に剛軟度が高い部位を設け、その支持体上に感圧性接着剤層を存在させた貼付剤であり、より詳しくは、製剤の折れ曲がりや膏体同士の接着を抑制し、患部への貼付作業の失敗が少なく、簡便かつ容易とする貼付剤を提供することにある。 The present invention is a patch in which a portion having a high bending resistance is provided on a support and a pressure-sensitive adhesive layer is present on the support, and more specifically, bending of a preparation or adhesion between pastes is performed. An object of the present invention is to provide a patch that is easy and easy to control, with little failure in the work of applying to the affected area.
 従来から、支持体の全面に薬物や有効成分等を含有する感圧性接着剤層が塗布された貼付剤が多数提供されている。貼付剤は、皮膚に貼付して皮膚から有効成分を体内に吸収させて薬効を発現させるものである。よって、用法に規定される貼付(適用)時間中は、製剤の剥離や脱離や脱落を抑制する目的で、伸縮性を付与した支持体や柔軟性が高い支持体を使用したり、製剤自身の剛軟性に着目し、皮膚への追従性を高めた製剤が提案され市販されている(特許文献1、特許文献2)。 Conventionally, a large number of patches in which a pressure-sensitive adhesive layer containing a drug, an active ingredient or the like is applied to the entire surface of a support have been provided. The patch is applied to the skin and absorbs an active ingredient from the skin into the body to develop a medicinal effect. Therefore, during the pasting (application) time stipulated in the usage, a stretched support or a highly flexible support can be used for the purpose of suppressing the release, detachment or dropout of the preparation, or the preparation itself. A formulation with improved skin followability has been proposed and marketed (patent document 1, patent document 2).
 しかしながら、このような上記製剤は、追従性を高めたがために製剤自身の保形性が低下し、その結果、剥離シートの除去により露出した部分は折れ曲がり或いは捩れが生じ易く、患部への貼付作業の際に露出した膏体同士が貼り付いてしまうなど、貼付作業時に失敗が多いものであった(図1乃至図4参照)。このように貼付作業時において製剤が折れ曲がった状態や製剤に皺が入った状態の製剤をそのまま使用した場合、適用面積が減少することで貼付剤としての薬効を十分に発揮することができなくなるばかりか、折れ曲がった部分や皺が入った部分が起点となり、適用期間中に製剤の剥離、脱落が助長され、用法に規定される適用時間を完了できないことがあった。 However, since the preparation described above has improved followability, the shape-retaining property of the preparation itself is reduced, and as a result, the portion exposed by the removal of the release sheet is likely to be bent or twisted, and applied to the affected area. There were many failures during the pasting work, such as the pastes exposed during the work sticking to each other (see FIGS. 1 to 4). In this way, when the preparation is used in a state where the preparation is bent or wrinkled in the preparation as it is, the application area is reduced and the medicinal effect as a patch cannot be fully exhibited. Or, the bent part or wrinkled part is the starting point, and during the application period, the exfoliation and removal of the preparation was promoted, and the application time prescribed in the usage could not be completed.
 これを解決するために、剛軟性の高い支持体を使用した製剤も販売されているが、剛軟性が高い貼付剤を適用した場合、(1)皮膚への追従性の低下から適用中に引っ張り感、つっぱり感など違和感を生じることがある。(2)加えて適用中に製剤のずり、剥離あるいは脱落が引き起こされるといった問題が生じることがある。この問題を改善するために、皮膚への接着力を上げることも考えられるが、この場合は(3)使用後、製剤を剥離する際に角質層の剥離による皮膚の損傷や剥離時の痛みが増すなど問題となる。 In order to solve this, a preparation using a support with high stiffness is also sold. However, when a patch with high stiffness is applied, (1) it is pulled during application due to a decrease in followability to the skin. There may be a sense of incongruity, such as a feeling of feeling or tension. (2) In addition, there may be a problem that the formulation may be sheared, peeled off or dropped during application. In order to improve this problem, it may be possible to increase the adhesive strength to the skin. In this case, however, (3) after use, when the preparation is peeled off, the skin is damaged by peeling off the stratum corneum and the pain at the peeling is caused. It becomes a problem such as increasing.
 一方、貼付作業時に折れ曲がりや皺が入る等の失敗を改善する目的で、剥離シートに着目し、切れ目や折れ線部分等を設けることにより、適用面の一部分を予め露出させて患部に貼付する方法を考案するなどの工夫がなされてきている(特許文献3、特許文献4、特許文献5及び特許文献6)。 On the other hand, for the purpose of improving failures such as bending or wrinkles during the pasting operation, paying attention to the release sheet, and providing a cut line or a broken line part, etc., a method of applying a part of the application surface in advance and sticking it to the affected part Some ideas have been devised (Patent Document 3, Patent Document 4, Patent Document 5 and Patent Document 6).
 しかしながら、剥離シートに切れ目等を施し、膏体の一部を露出させて貼付する方法を採用した場合であっても、(4)貼付作業時に露出させた膏体同士が接着してしまうことや、露出させた膏体部分が製剤上の剥離シート側に接着してしまうことがあり、問題点の解決には至っていない。 However, even when a method is used in which the release sheet is cut and a part of the plaster is exposed and pasted, (4) the plaster exposed during the pasting operation may adhere to each other. The exposed plaster part may adhere to the release sheet side of the preparation, and the problem has not been solved.
特開2000-297032号明細書JP 2000-297032 A specification 特開2001-328935号明細書JP 2001-328935 A 国際公開第00-69422号パンフレットInternational Publication No. 00-69422 Pamphlet 特開2002-306530号明細書Japanese Patent Application Laid-Open No. 2002-306530 実開平3-59327号明細書Japanese Utility Model Publication No. 3-59327 実開平5-54515号明細書Japanese Utility Model Publication No. 5-54515
 本発明は、上記の問題点を解決するために、製剤の支持体に剛軟性の高い部分を設け、貼付作業時に製剤の折れ曲がりや膏体同士の接着を防止し、貼付作業の失敗を軽減させ、貼付作業を簡便かつ容易に行うことができる貼付剤を提供することにある。 In order to solve the above problems, the present invention provides a highly flexible part on the support of the preparation, prevents bending of the preparation and adhesion of the plaster during the application work, and reduces the failure of the application work. An object of the present invention is to provide a patch capable of simply and easily performing a pasting operation.
 本発明者らは、上記の課題を解決するために鋭意探求を行った結果、本発明に到達することができた。本発明は、上記問題点を解決するものであり、かつ製剤の適用面積や形状にとらわれることなく、患部への貼付作業の失敗を軽減できるような貼付剤を提供するものである。 The inventors of the present invention have reached the present invention as a result of diligent search to solve the above-mentioned problems. The present invention solves the above-mentioned problems and provides a patch that can reduce the failure of the pasting operation to the affected area without being restricted by the application area or shape of the preparation.
 即ち、本発明は、以下の貼付剤を提供することにある。
(1)支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなる貼付剤において;
1枚の支持体に異なる剛軟性を持つ2つ以上の部分を形成することを特徴とする貼付剤。
(2)該支持体の異なる剛軟性を持つ部分が、支持体の他の部分よりも剛軟性の高い部分である(1)項に記載の貼付剤。
(3)該剛軟性の高い部分が、剥離シートが分断されて膏体が露出される部分に相当する支持体部位に局在する(1)項に記載の貼付剤。
(4)支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなる貼付剤において;
a)1枚の支持体に異なる剛軟性を持つ2つ以上の部分を形成する貼付剤であって、
b)該支持体の、他の部分よりも剛軟性の高い部分が、剥離シートが分断されて膏体が露出される部分に相当する支持体部位に局在し、
c)低伸縮性部分の剛軟度がその他の部分の剛軟度よりも120%以上高いことを特徴とする貼付剤。
(5)剥離シートに実質的に平行な切れ目が2本ある貼付剤であって、
該支持体の剛軟性の高い部分が、剥離シートに実質的に平行な切れ目に挟まれた支持体の中央部分に位置する、(1)項ないし(4)項に記載の貼付剤。
(6)該剛軟性の高い部分に、JIS L 1096-1999に規定される45°カンチレバー法による剛軟度が5mm以上の編布からなる支持体を使用する、(1)項ないし(5)項に記載の貼付剤。
(7)1枚の貼付剤中に異なる剛軟性を併せ持つ支持体であって、剛軟性の高い部分の面積が全体の5%ないし60%である(1)項ないし(5)項に記載の貼付剤。
(8)貼付剤の粘着剤層の組成が油性基剤あるいは水性基剤からなる(1)項ないし(5)項に記載の貼付剤。
(9)前記支持体の目付けが60ないし160g/m2の範囲である(1)項ないし(5)項に記載の貼付剤。
(10)前記支持体の目付けが80ないし120g/m2の範囲である(1)項ないし(5)項に記載の貼付剤。
(11)前記貼付剤が前記粘着剤層の表面に貼着された剥離シートを備えるものであって、該剥離シートの剛軟度が60ないし160mmである(1)項ないし(5)項に記載の貼付剤。
(12)前記支持体が、繊維の太さ30ないし75デニールのポリエステル繊維からなる目付80ないし120g/m2のものである(1)項ないし(5)項記載の貼付剤。
(13)支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなる貼付剤において;
該支持体が剛軟性の高い部分が全面に点在することを特徴とする貼付剤。
(14)支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなり、剥離シートに実質的に平行な切れ目が2本ある貼付剤であって;
a)該支持体が剛軟性の高い部分が全面に点在する貼付剤であって、
b)剥離シートが分断されて膏体が露出される部分を有し、
c)該支持体は、JIS L 1096-1999に規定される45°カンチレバー法による剛軟度が6mm以上の支持体である、
ことを特徴とする貼付剤。
(15)貼付剤の粘着剤層の組成が油性基剤あるいは水性基剤からなる(13)項ないし(14)項に記載の貼付剤。
(16)前記支持体の目付けが60ないし160g/m2の範囲である(13)項ないし(14)項に記載の貼付剤。
(17)前記支持体の目付けが80ないし120g/m2の範囲である(13)項ないし(14)項に記載の貼付剤。
(18)前記貼付剤が前記粘着剤層の表面に貼着された剥離シートを備えるものであって、該剥離シートの剛軟度が60ないし160mmである(13)項ないし(14)項に記載の貼付剤。
(19)前記支持体が、繊維の太さ30ないし75デニールのポリエステル繊維からなる目付80ないし120g/m2のものである(13)項ないし(14)項に記載の貼付剤。
That is, the present invention is to provide the following patches.
(1) In a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface;
A patch, wherein two or more parts having different stiffness are formed on one support.
(2) The patch according to item (1), wherein the part having different bending resistance of the support is a part having higher bending resistance than the other part of the support.
(3) The patch according to item (1), wherein the highly flexible portion is localized at a support portion corresponding to a portion where the release sheet is divided and the plaster is exposed.
(4) In a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface;
a) A patch for forming two or more parts having different stiffness on a single support,
b) A portion of the support having higher rigidity than other portions is localized at a support portion corresponding to a portion where the release sheet is divided and the plaster is exposed,
c) A patch characterized in that the bending resistance of the low stretchable part is 120% or more higher than the bending resistance of other parts.
(5) A patch having two cuts substantially parallel to the release sheet,
The patch according to any one of items (1) to (4), wherein the highly flexible portion of the support is located in a central portion of the support sandwiched between cuts substantially parallel to the release sheet.
(6) A support made of a knitted fabric having a bending resistance of 5 mm or more according to a 45 ° cantilever method specified in JIS L 1096-1999 is used for the portion having high bending resistance. (1) to (5) The patch according to Item.
(7) The support according to any one of the patches, which has different stiffness and softness, wherein the area of the portion having high stiffness and softness is 5% to 60% of the whole, (1) to (5) Patch.
(8) The patch according to any one of items (1) to (5), wherein the composition of the adhesive layer of the patch comprises an oily base or an aqueous base.
(9) The patch according to (1) to (5), wherein the basis weight of the support is in the range of 60 to 160 g / m 2 .
(10) The patch according to any one of (1) to (5), wherein the basis weight of the support is in the range of 80 to 120 g / m 2 .
(11) In the items (1) to (5), the patch includes a release sheet adhered to the surface of the pressure-sensitive adhesive layer, and the bending resistance of the release sheet is 60 to 160 mm. The patch according to the description.
(12) The patch according to any one of (1) to (5), wherein the support is made of polyester fiber having a fiber thickness of 30 to 75 denier and having a basis weight of 80 to 120 g / m 2 .
(13) In a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface;
A patch, characterized in that the support is interspersed with highly rigid portions over the entire surface.
(14) A paste layer is provided on the surface of the support, and a release sheet is laminated on the paste layer so as to cover substantially the entire surface, and there are two cuts substantially parallel to the release sheet. An agent;
a) The patch is a patch in which portions with high flexibility are scattered over the entire surface,
b) having a portion where the release sheet is divided and the plaster is exposed;
c) The support is a support having a bending resistance of 6 mm or more according to a 45 ° cantilever method defined in JIS L 1096-1999.
A patch characterized by that.
(15) The patch according to any one of (13) to (14), wherein the composition of the adhesive layer of the patch comprises an oily base or an aqueous base.
(16) The patch according to (13) to (14), wherein the basis weight of the support is in the range of 60 to 160 g / m 2 .
(17) The patch according to (13) to (14), wherein the basis weight of the support is in the range of 80 to 120 g / m 2 .
(18) In the items (13) to (14), the patch comprises a release sheet adhered to the surface of the pressure-sensitive adhesive layer, and the bending resistance of the release sheet is 60 to 160 mm. The patch according to the description.
(19) The patch according to (13) to (14), wherein the support is made of polyester fiber having a fiber thickness of 30 to 75 denier and having a basis weight of 80 to 120 g / m 2 .
 以下、本発明の詳細を説明する。
 本発明の実施態様としては、1枚の製剤中に剛軟性が異なる部分を併せ持つ支持体上に感圧性接着剤層を展延させた貼付剤である。
 また、本発明のその他の実施態様としては、一枚の製剤が剛軟性の高い支持体上に感圧性接着剤層を展延させた貼付剤である。
Details of the present invention will be described below.
An embodiment of the present invention is a patch in which a pressure-sensitive adhesive layer is spread on a support having portions having different stiffness and flexibility in one preparation.
In another embodiment of the present invention, a single preparation is a patch in which a pressure-sensitive adhesive layer is spread on a highly rigid support.
 剛軟性の高い部分は、好ましくは一部、すなわち剥離シートの切れ目付近で貼付時に最初に膏体を露出させる部分に局在するものが好ましい。例えば、剛軟性の高い部分を局在させる場合は、剥離シートの切れ目の部分に合わせて設ければよく、切れ目が1本あるいは2本であってもよい。2本の場合は、切れ目に挟まれる部分をカバーできるものが良い。また、貼付方法等に記載される最初に剥がす剥離シート部分、即ち貼付の際に最初に膏体が露出する部分を剛軟性の高い部分がカバーできれば好ましく、その部分の形状は限定されるものではないが、好ましい例としては、例えば図5(a)及び(b)に示す模様部分の範囲が挙げられる。 The part having high stiffness and softness is preferably a part, that is, a part that is localized in a part where the plaster is first exposed at the time of application near the cut of the release sheet. For example, in the case where a highly rigid portion is localized, it may be provided in accordance with the cut portion of the release sheet, and there may be one or two cuts. In the case of two, what can cover the part pinched by the cut | interruption is good. In addition, it is preferable that the release sheet part to be peeled off first described in the sticking method or the like, that is, the part where the plaster is first exposed at the time of sticking can be covered by a highly rigid part, and the shape of the part is not limited. Although not preferred, preferred examples include the range of the pattern portion shown in FIGS. 5 (a) and 5 (b).
 このように、剛軟性の高い部分の支持体が、貼付の際に最初に膏体が露出する部分をカバーしていることにより、支持体の剛軟性が抑えられ、その結果従来の貼付剤よりも貼付時の伸びが少なく伸ばした方向に皺がよりにくく、膏体同士が図1乃至4のように貼り付くことがない。 In this way, the support of the part having high rigidity and softness covers the part where the plaster is first exposed at the time of application, so that the rigidity of the support is suppressed. However, there is little elongation at the time of sticking, and wrinkles are harder in the extending direction, so that the pastes do not stick as shown in FIGS.
 剛軟性の高い部分の形状は特に限定されることはない。剛軟性の高い部分は支持体の片面であっても両面であっても構わない(図6)。一部に局在させる場合は、局在させたい部分をベタ状、スポット状もしくは線状などにすることが好ましい。 The shape of the portion having high bending resistance is not particularly limited. The portion having high stiffness and softness may be on one side or both sides of the support (FIG. 6). In the case of localizing partly, it is preferable to make the part to be localized solid, spot or linear.
 本発明のその他の実施態様としては、一枚の製剤全体が剛軟性の高いものも好ましい。例えば剛軟性の高さを保持させる図5に示したような模様を支持体全体に付すことが挙げられる。 As another embodiment of the present invention, it is also preferable that one whole preparation has high rigidity and flexibility. For example, a pattern as shown in FIG. 5 for maintaining the height of bending resistance may be applied to the entire support.
 支持体の剛軟性を変更させた部分の模様については特に限定しないが、二軸方向(縦方向及び横方向)への剛軟性を考慮して、縦方向及び横方向の均一な剛軟性を考慮すると図5等のようなドット、格子模様等が好ましい。また、縦方向のみ又は横方向のみの剛軟性を考慮してストライプ模様等とすることも好ましい。さらには、剛軟性の違いを利用させたその他の模様、例えばロゴ模様とすることも好ましい。 There is no particular limitation on the pattern of the part where the stiffness of the support is changed, but considering the stiffness in the biaxial directions (longitudinal and lateral directions), the uniform longitudinal and lateral stiffness is considered. Then, a dot, a lattice pattern, etc. like FIG. 5 etc. are preferable. In addition, it is also preferable to use a stripe pattern or the like in consideration of bending / softening only in the vertical direction or only in the horizontal direction. Furthermore, it is also preferable to use another pattern that utilizes the difference in flexibility, for example, a logo pattern.
 本発明の剛軟性の高い部分とは、貼付剤の貼付作業時に膏体同士が接着してしまうことや、露出させた膏体部分が製剤上の剥離シート側に接着してしまうことが無い程度の剛軟性を有することをいう。また、剛軟性が高すぎると貼付剤の貼付による皺の発生、貼付中の違和感及び運動性の低下を招くので、好ましくない。
本発明の剛軟性の高い部分における、剛軟度とは、適度な伸縮性を有する性質をいう。剛軟度は、JIS L 1096-1999に規定される45°カンチレバー法によって測定することができる。
 本発明の支持体の好適な剛軟度は5mm以上である。剛軟性の高い部分の剛軟度は6mm以上である。剛軟性の高い部分の剛軟度が未処理部分よりも120%以上高いことが好ましい。
The highly flexible part of the present invention is such that the pastes adhere to each other at the time of applying the patch, and the exposed part of the paste does not adhere to the release sheet side on the preparation. It means having the bending and softness. In addition, if the bending resistance is too high, it is not preferable because it causes wrinkles due to application of the patch, uncomfortable feeling during application, and a decrease in motility.
The bending resistance in the highly flexible portion of the present invention refers to a property having moderate stretchability. The bending resistance can be measured by a 45 ° cantilever method defined in JIS L 1096-1999.
The preferred bending resistance of the support of the present invention is 5 mm or more. The bending resistance of the portion having high bending resistance is 6 mm or more. It is preferable that the bending resistance of the portion having high bending resistance is 120% or more higher than that of the untreated portion.
 支持体の剛軟性を変更させる手段については特に限定しないが、支持体の組織構成(繊維及び素材等)を変更させる方法、押圧加工による方法、樹脂やインク等を塗布する方法、支持体よりも剛軟性が高いテープ等を貼付する方法等が挙げられる。支持体の製造工程や経済性を考慮すると、押圧加工による方法もしくは樹脂やインク等を塗布する方法、支持体の組織を変更させる方法が好ましい。 The means for changing the stiffness of the support is not particularly limited. However, the method of changing the structure of the support (fibers, materials, etc.), the method of pressing, the method of applying resin, ink, etc., than the support The method etc. which stick a tape etc. with high bending resistance are mentioned. In consideration of the production process and economy of the support, a method by pressing, a method of applying a resin or ink, or a method of changing the structure of the support is preferable.
 支持体の剛軟性を変更させるために支持体を押圧加工する手段については、
 例えば、押圧ロールで加工、繊維を圧縮する、エンボス加工とすることが挙げられるがこれらに限定されるものではない。
For means for pressing the support in order to change the stiffness of the support,
For example, processing with a pressing roll, compression of fibers, and embossing may be mentioned, but the invention is not limited thereto.
 支持体の剛軟性を変更させるために樹脂やインクを塗布する手段については、例えば、以下のような方法が挙げられるがこれらに限定されるものではない。
 本発明において使用できる支持体の剛軟性を変更させるために塗布する樹脂としては特に限定されないが、天然樹脂あるいは合成樹脂が挙げられる。これらの樹脂を単独で、あるいは2種以上を併用することもできる。
Examples of means for applying a resin or ink in order to change the bending resistance of the support include, but are not limited to, the following methods.
Although it does not specifically limit as resin applied in order to change the bending resistance of the support body which can be used in this invention, A natural resin or a synthetic resin is mentioned. These resins can be used alone or in combination of two or more.
 本発明において使用できる支持体の剛軟性を変更させるために塗布するインクは、例えば顔料(有機系顔料、無機系顔料)、染料(分散染料、酸性染料、反応染料等)、パール(雲母)、箔(アルミ等)が挙げられるがこれらに限定されるものではない。
 特に洗浄工程の不要な、有機系顔料及び無機系顔料が好ましく用いられる。印刷用に用いられる公知のインク樹脂であれば特に限定されず、例えば、ウレタン樹脂、アクリル樹脂、シリコン樹脂、ポリアミド樹脂、ポリエステル樹脂、エポキシ樹脂等が挙げられ、特にウレタン樹脂及びアクリル樹脂が好ましく用いられるがこれらに限定されるものではない。
 樹脂の処理方法としては、捺染、グラビア、熱転写、インクジェット、スプレー法等の何れであっても良く、特に捺染が好ましいがこれに限定されるものではない。
Examples of the ink applied to change the stiffness of the support that can be used in the present invention include pigments (organic pigments, inorganic pigments), dyes (dispersion dyes, acid dyes, reactive dyes, etc.), pearls (mica), Although foil (aluminum etc.) is mentioned, it is not limited to these.
In particular, organic pigments and inorganic pigments that do not require a washing step are preferably used. It is not particularly limited as long as it is a known ink resin used for printing, and examples thereof include a urethane resin, an acrylic resin, a silicon resin, a polyamide resin, a polyester resin, and an epoxy resin, and a urethane resin and an acrylic resin are particularly preferably used. However, it is not limited to these.
The resin treatment method may be any of textile printing, gravure, thermal transfer, ink jet, spraying, and the like, and textile printing is particularly preferred, but is not limited thereto.
 支持体の剛軟性を変更させるためにテープを貼付する場合のテープ等については、例えば、ポリオレフィン系フィルム、ポリエステル系フィルム、ポリウレタン系フィルム等が挙げられるがこれらに限定されるものではない。
 また、フィルムを貼付する方法は、粘着剤を使用する方法、加熱加工する方法等が考えられる。
Examples of the tape or the like when a tape is applied to change the bending resistance of the support include, but are not limited to, polyolefin film, polyester film, polyurethane film, and the like.
Moreover, the method of sticking a film can consider the method of using an adhesive, the method of heat processing, etc.
 支持体の剛軟性を変更させるために支持体の組織構成を変更させる場合は、例えば、剛軟性の高い部分のみ糸の太さを変更し、又は密度を変更することにより剛軟性を変更させることが挙げられるがこれらに限定されるものではない。 When changing the structure of the support in order to change the stiffness of the support, for example, changing the thickness of the yarn only in a portion having high stiffness or changing the density by changing the density. However, it is not limited to these.
 本発明において用いることができる粘着剤成分は特に限定されず、非含水基剤および含水基剤の両方が使用できる。 The pressure-sensitive adhesive component that can be used in the present invention is not particularly limited, and both a non-hydrated base and a hydrous base can be used.
 非含水基剤としては、例えば、ゴム系粘着剤、アクリル系粘着剤、シリコーン系粘着剤等が挙げられるがこれらに限定されるものではない。 Examples of the non-water-containing base include, but are not limited to, rubber adhesives, acrylic adhesives, silicone adhesives, and the like.
 上記ゴム系粘着剤のゴム成分としては、例えば、天然ゴム、ポリイソプレン、スチレン-イソプレン-スチレンブロック共重合体、スチレン-ブタンジエン-スチレンブロック共重合体、スチレン・ブタジエンゴム、ポリイソブチレンから選ばれた1種を単独で、あるいは2種以上を併用することが好ましいがこれらに限定されるものではない。 The rubber component of the rubber-based adhesive was selected from, for example, natural rubber, polyisoprene, styrene-isoprene-styrene block copolymer, styrene-butanediene-styrene block copolymer, styrene-butadiene rubber, and polyisobutylene. Although it is preferable to use one kind alone or two or more kinds in combination, it is not limited to these.
 アクリル系粘着剤の具体例としては、(アクリル酸-アクリル酸2-エチルヘキシル)共重合体、(アクリル酸-アクリル酸ブチル)共重合体、(アクリル酸-アクリル酸オクチル)共重合体、(アクリル酸-アクリル酸2-エチルヘキシル-酢酸ビニル)共重合体、(アクリル酸-アクリル酸2-エチルヘキシル-アクリル酸ヒドロキシエチル)共重合体、(アクリル酸-アクリル酸ヒドロキシエチル-ビニルピロリドン)共重合体、(アクリル酸-アクリル酸2-エチルヘキシル-アクリル酸ヒドロキシエチル-ビニルピロリドン)共重合体等が挙げられる。また市販製品であるDURO-TAK 87-2194、87-2510、87-2516(ナショナルスターチアンドケミカル社製)等も利用可能である。特に、モノマー構成単位中の側鎖にヒドロキシ基を有するアクリル酸エステルを含む共重合体が好ましい。また、必要に応じて架橋剤を加えても良い。架橋剤としては、アミノ化合物、フェノール化合物、エポキシ化合物、イソシアネート化合物、有機過酸化物、金属アルコラート、金属キレート等が挙げられる。 Specific examples of the acrylic adhesive include (acrylic acid-2-ethylhexyl acrylate) copolymer, (acrylic acid-butyl acrylate) copolymer, (acrylic acid-octyl acrylate) copolymer, (acrylic) Acid-acrylic acid 2-ethylhexyl-vinyl acetate) copolymer, (acrylic acid-2-ethylhexyl acrylate-hydroxyethyl acrylate) copolymer, (acrylic acid-hydroxyethyl acrylate-vinyl pyrrolidone) copolymer, (Acrylic acid-2-ethylhexyl acrylate-hydroxyethyl acrylate-vinyl pyrrolidone) copolymer and the like. Commercial products such as DURO-TAK 87-2194, 87-2510, 87-2516 (manufactured by National Starch and Chemical Co., Ltd.) can also be used. In particular, a copolymer containing an acrylate ester having a hydroxy group in the side chain in the monomer structural unit is preferred. Moreover, you may add a crosslinking agent as needed. Examples of the crosslinking agent include amino compounds, phenol compounds, epoxy compounds, isocyanate compounds, organic peroxides, metal alcoholates, and metal chelates.
 また、シリコーン系粘着剤の具体例としては、ポリオルガノシロキサン等のシリコーンゴムを挙げることができる。 In addition, specific examples of the silicone pressure-sensitive adhesive include silicone rubber such as polyorganosiloxane.
 本発明において用いることができる可塑剤としては、特に限定されず、例えば、石油系オイル(パラフィン系プロセスオイル、ナフテン系プロセスオイル、芳香族系プロセスオイル等)、スクワラン、スクワレン、植物系オイル(オリーブ油、ツバキ油、ひまし油、トール油、ラッカセイ油)、シリコンオイル、二塩基性エステル(ジブチルフタレート、ジオクチルフタレート等)、液状ゴム(ポリブテン、液体イソプレンゴム)、液状脂肪酸エステル類(ミリスチン酸イソプロピル、ラウリン酸ヘキシル、セバシン酸ジエチル、セバシン酸ジイソプロピル等)、ジエチレングリコール、ポリエチレングリコール、ポリエチレングリコール、サリチル酸グリコール、プロピレングリコール、ジプロピレングリコール、トリアセチレン、クエン酸トリエチル、クロタミトン等が挙げられる。これらの可塑剤の中でも、流動パラフィン、ミリスチン酸イソプロピル、セバシン酸ジエチル、ラウリン酸ヘキシルが好ましく、流動パラフィンは特に好ましい。 The plasticizer that can be used in the present invention is not particularly limited, and examples thereof include petroleum oil (paraffinic process oil, naphthenic process oil, aromatic process oil, etc.), squalane, squalene, vegetable oil (olive oil). , Camellia oil, castor oil, tall oil, peanut oil), silicon oil, dibasic esters (dibutyl phthalate, dioctyl phthalate, etc.), liquid rubber (polybutene, liquid isoprene rubber), liquid fatty acid esters (isopropyl myristate, lauric acid) Hexyl, diethyl sebacate, diisopropyl sebacate, etc.), diethylene glycol, polyethylene glycol, polyethylene glycol, glycol salicylate, propylene glycol, dipropylene glycol, triacetylene, quee Triethyl citrate, crotamiton and the like. Among these plasticizers, liquid paraffin, isopropyl myristate, diethyl sebacate and hexyl laurate are preferable, and liquid paraffin is particularly preferable.
 これらの可塑剤は、1種を単独で用いても良く、2種以上を組み合わせて用いても良い。これら可塑剤の配合量は特に限定されないが、粘着剤層に含まれる化合物全量を基準として、5ないし70重量%であることが好ましく、10ないし60重量%であることがより好ましく、10ないし50重量%であることが特に好ましい。可塑剤の配合量が5重量%未満であると、可塑剤の配合による貼付剤の凝集力向上効果が不十分となる傾向にあり、他方、70重量%を越えると薬剤の皮膚透過性が不十分となる傾向にある。 These plasticizers may be used alone or in combination of two or more. The blending amount of these plasticizers is not particularly limited, but is preferably 5 to 70% by weight, more preferably 10 to 60% by weight based on the total amount of compounds contained in the pressure-sensitive adhesive layer, and 10 to 50%. It is particularly preferred that it is wt%. If the blending amount of the plasticizer is less than 5% by weight, the effect of improving the cohesive force of the patch by blending the plasticizer tends to be insufficient. On the other hand, if it exceeds 70% by weight, the skin permeability of the drug is poor. It tends to be sufficient.
 また、本発明の経皮吸収型製剤における粘着層は、さらに粘着付与剤を含有することができる。
 本発明において用いることができる粘着付与剤としては、限定されず、例えば、ロジン誘導体(ロジン、ロジンのグリセリンエステル、水添ロジン、水添ロジンのグリセリンエステル、ロジンのペンタエリストールエステル等)、脂肪族飽和炭化水素樹脂(アルコンP100(荒川化学工業社製)等)、脂肪族系炭化水素樹脂(クイントンB-170(日本ゼオン社製)等)、テルペン樹脂(クリアロンP-125(ヤスハラケミカル社製)等)、マレイン酸レジン等が挙げられ、中でも、水添ロジンのグリセリンエステル、脂肪族系炭化水素樹脂、テルペン樹脂が好ましい。
The adhesive layer in the transdermal absorption preparation of the present invention can further contain a tackifier.
The tackifier that can be used in the present invention is not limited, and examples thereof include rosin derivatives (such as rosin, rosin glycerin ester, hydrogenated rosin, hydrogenated rosin glycerin ester, rosin pentaerythrester). Aromatic saturated hydrocarbon resin (Alcon P100 (Arakawa Chemical Industries, Ltd.)), aliphatic hydrocarbon resin (Quinton B-170 (Nippon Zeon Corporation, etc.)), terpene resin (Clearon P-125 (Yasuhara Chemical Co., Ltd.)) Etc.), maleic acid resin, etc., among which glycerin ester of hydrogenated rosin, aliphatic hydrocarbon resin, and terpene resin are preferable.
 これらの粘着付与剤は、1種を単独で用いても良く、2種以上を組み合わせて用いても良く、配合量は特に限定されないが、粘着剤層に含まれる化合物全量を基準として、5ないし70重量%であることが好ましく、5ないし60重量%であることがより好ましく、10ないし50重量%であることが特に好ましい。粘着付与剤の配合量が5重量%未満であると、粘着付与剤の配合による貼付剤の粘着力向上効果が不十分となる傾向にあり、他方、70重量%を越えると貼付剤を剥離する際の皮膚刺激性が増加する傾向にある。 These tackifiers may be used alone or in combination of two or more, and the blending amount is not particularly limited, but is 5 to 5 on the basis of the total amount of compounds contained in the pressure-sensitive adhesive layer. It is preferably 70% by weight, more preferably 5 to 60% by weight, and particularly preferably 10 to 50% by weight. If the amount of the tackifier is less than 5% by weight, the effect of improving the adhesive strength of the patch due to the addition of the tackifier tends to be insufficient. On the other hand, if the amount exceeds 70% by weight, the patch is peeled off. The skin irritation tends to increase.
 本発明の経皮吸収型製剤の粘着剤層は、薬物の皮膚透過性を向上させる目的で、吸収促進剤を含有することもできる。
 吸収促進剤としては、従来から皮膚における吸収促進作用が認められている化合物であれば特に限定されず、具体的には、炭素数6ないし20の脂肪酸、脂肪族アルコール、脂肪酸エステル、アミド又はエーテル類、芳香族有機酸、芳香族アルコール、芳香族有機酸エステル又はエーテル等が挙げられる。これらの化合物は飽和、不飽和のいずれであってもよく、また、直鎖状、分枝状、環状のいずれでもよい。
The pressure-sensitive adhesive layer of the percutaneous absorption preparation of the present invention can also contain an absorption enhancer for the purpose of improving the skin permeability of the drug.
The absorption promoter is not particularly limited as long as it is a compound that has been conventionally recognized as having an absorption promoting action on the skin, and specifically, a fatty acid, aliphatic alcohol, fatty acid ester, amide or ether having 6 to 20 carbon atoms. , Aromatic organic acids, aromatic alcohols, aromatic organic acid esters or ethers. These compounds may be saturated or unsaturated, and may be linear, branched, or cyclic.
 さらに、本発明においては、乳酸エステル類、酢酸エステル類、モノテルペン化合物、セスキテルペン系化合物、エイゾン(Azone)、エイゾン(Azone)誘導体、グリセリン脂肪酸エステル類、プロピレングリコール脂肪酸エステル類、ソルビタン脂肪酸エステル類(Span系)、ポリソルベート系化合物(Tween系)、ポリエチレングリコール脂肪酸エステル類、ポリオキシエチレン硬化ヒマシ油系化合物(HCO系)、ポリオキシエチレンアルキルエーテル類、ショ糖脂肪酸エステル類、植物油等を吸収促進剤として用いることができる。 Furthermore, in the present invention, lactic acid esters, acetic acid esters, monoterpene compounds, sesquiterpene compounds, azone, azone derivatives, glycerin fatty acid esters, propylene glycol fatty acid esters, sorbitan fatty acid esters (Span), polysorbate compounds (Tween), polyethylene glycol fatty acid esters, polyoxyethylene hydrogenated castor oil compounds (HCO), polyoxyethylene alkyl ethers, sucrose fatty acid esters, vegetable oil, etc. It can be used as an agent.
 これらの吸収促進剤の中でも、カプリル酸、カプリン酸、カプロン酸、ラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、イソステアリン酸、オレイン酸、リノール酸、リノレン酸、ラウリルアルコール、ミリスチルアルコール、オレイルアルコール、イソステアリルアルコール、セチルアルコール、ラウリン酸メチル、ラウリン酸ヘキシル、ラウリン酸ジエタノールアミド、ミリスチン酸イソプロピル、ミリスチン酸ミリスチル、ミリスチン酸オクチルドデシル、パルミチン酸セチル、サリチル酸、サリチル酸メチル、サリチル酸エチレングリコール、ケイ皮酸、ケイ皮酸メチル、クレゾール、乳酸セチル、乳酸ラウリル、酢酸エチル、酢酸プロピル、ゲラニオール、チモール、オイゲノール、テルピネオール、1-メントール、ボルネオロール、d-リモネン、イソオイゲノール、イソボルネオール、ネロール、dl-カンフル、グリセリンモルカプリレート、グリセリンモノカプレート、グリセリンモノラウレート、グリセリンモノオレエート、ソルビタンモノラウレート、ショ糖モノラウレート、ポリソルベート20、プロピレングリコール、プロピレングリコールモノラウレート、ポリエチレングリコールモノラウレート、ポリエチレングリコールモノステアレート、ポリオキシエチレンラウリルエーテル、HCO-60、ピロチオデカン、オリーブ油が好ましく、ラウリルアルコール、ミリスチルアルコール、イソステアリルアルコール、ラウリン酸ジエタノールアミド、グリセリンモノカプリレート、グリセリンモノカプレート、グリセリンモノオレエート、ソルビタンモノラウレート、プロピレングリコールモノラウレート、ポリオキシエチレンラウリルエーエテル、ピロチオデカンがより好ましい。 Among these absorption enhancers, caprylic acid, capric acid, caproic acid, lauric acid, myristic acid, palmitic acid, stearic acid, isostearic acid, oleic acid, linoleic acid, linolenic acid, lauryl alcohol, myristyl alcohol, oleyl alcohol, Isostearyl alcohol, cetyl alcohol, methyl laurate, hexyl laurate, diethanolamide laurate, isopropyl myristate, myristyl myristate, octyldodecyl myristate, cetyl palmitate, salicylic acid, methyl salicylate, ethylene glycol salicylate, cinnamic acid, Methyl cinnamate, cresol, cetyl lactate, lauryl lactate, ethyl acetate, propyl acetate, geraniol, thymol, eugenol, terpineol, 1-menthol Borneolol, d-limonene, isoeugenol, isoborneol, nerol, dl-camphor, glycerin molcaprylate, glycerin monocaprate, glycerin monolaurate, glycerin monooleate, sorbitan monolaurate, sucrose monolaurate, polysorbate 20, Propylene glycol, propylene glycol monolaurate, polyethylene glycol monolaurate, polyethylene glycol monostearate, polyoxyethylene lauryl ether, HCO-60, pyrothiodecane, olive oil are preferred, lauryl alcohol, myristyl alcohol, isostearyl alcohol, laurin Acid diethanolamide, glycerol monocaprylate, glycerol monocaprate, glycerol monoolea , Sorbitan monolaurate, propylene glycol monolaurate, polyoxyethylene lauryl er Ether, pirotiodecane are more preferable.
 これらの吸収促進剤は、1種を単独で用いても良く、2種以上を組み合わせて用いても良い。これら吸収促進剤の配合量は特に制限されないが、粘着剤層に含まれる化合物全量を基準として、0.01ないし20重量%であることが好ましく、0.05ないし10重量%であることが特に好ましい。吸収促進剤の配合量が0.01重量%未満であると、吸収促進剤の配合による薬剤の皮膚透過性向上効果が不十分となる傾向にあり、他方、20重量%を越えると、浮腫等の皮膚への刺激性が増加する傾向にあり、皮膚への付着性が低下する傾向にある。 These absorption promoters may be used alone or in combination of two or more. The amount of these absorption accelerators is not particularly limited, but is preferably 0.01 to 20% by weight, particularly 0.05 to 10% by weight, based on the total amount of compounds contained in the pressure-sensitive adhesive layer. preferable. If the blending amount of the absorption accelerator is less than 0.01% by weight, the effect of improving the skin permeability of the drug due to the blending of the absorption promoter tends to be insufficient. The skin irritation tends to increase, and the adhesion to the skin tends to decrease.
 さらに、本発明においては、必要に応じて、粘着剤層中に、抗酸化剤、充填剤、架橋剤、防腐剤、紫外線吸収剤等を配合することができる。 Furthermore, in the present invention, an antioxidant, a filler, a crosslinking agent, an antiseptic, an ultraviolet absorber and the like can be blended in the pressure-sensitive adhesive layer as necessary.
 抗酸化剤としては、例えば、トコフェロール及びこれらのエステル誘導体、アスコルビン酸、アスコルビン酸ステアリン酸エステル、ノルジヒトログアヤレチン酸、ジブチルヒドロキシトルエン(BHT)、ブチルヒドロキシアニソールが好ましく;充填剤としては、炭酸カルシウム、炭酸マグネシウム、ケイ酸塩(例えば、ケイ酸アルミニウム、ケイ酸マグネシウム等)、ケイ酸、硫酸バリウム、硫酸カルシウム、亜鉛酸カルシウム、酸化亜鉛、酸化チタンが好ましく;架橋剤としては、アミノ樹脂、フェノール樹脂、エポキシ樹脂、アルキド樹脂、不飽和ポリエステル等の熱硬化性樹脂、イソシアネート化合物、ブロックイソシアネート化合物、有機系架橋剤、金属又は金属化合物等の無機系架橋剤が好ましく使用されるが、これらに限定されるものではない。 As the antioxidant, for example, tocopherol and their ester derivatives, ascorbic acid, ascorbic acid stearic acid ester, nordihuman rogayaretic acid, dibutylhydroxytoluene (BHT), and butylhydroxyanisole are preferable; Calcium, magnesium carbonate, silicate (for example, aluminum silicate, magnesium silicate, etc.), silicic acid, barium sulfate, calcium sulfate, calcium zincate, zinc oxide, titanium oxide are preferable; Thermosetting resins such as phenol resins, epoxy resins, alkyd resins, unsaturated polyesters, isocyanate compounds, block isocyanate compounds, organic crosslinking agents, inorganic crosslinking agents such as metals or metal compounds are preferably used. Not intended to be constant.
 また、防腐剤としては、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチルが好ましく;紫外線吸収剤としては、p-アミノ安息香酸誘導体、アントラニル酸誘導体、サリチル酸誘導体、クマリン誘導体、アミノ酸系化合物、イミダゾリン誘導体、ピリミジン誘導体、ジオキサン誘導体が好ましい。 Further, as the preservative, ethyl paraoxybenzoate, propyl paraoxybenzoate and butyl paraoxybenzoate are preferable; as the ultraviolet absorber, p-aminobenzoic acid derivatives, anthranilic acid derivatives, salicylic acid derivatives, coumarin derivatives, amino acid compounds , An imidazoline derivative, a pyrimidine derivative, and a dioxane derivative are preferable.
 上記の抗酸化剤、充填剤、架橋剤、防腐剤、紫外線吸収剤のそれぞれの配合慮は特に制限されないが、抗酸化剤、充填剤、架橋剤、防腐剤及び紫外線吸収剤の合計量は、粘着剤層に含まれる化合物全量を基準として、0ないし10重量%であることが好ましく、0ないし5重量%であることがより好ましく、0ないし2重量%であることが特に好ましい。 Although the formulation of each of the above antioxidant, filler, crosslinking agent, preservative, and ultraviolet absorber is not particularly limited, the total amount of the antioxidant, filler, crosslinking agent, preservative, and ultraviolet absorber is It is preferably 0 to 10% by weight, more preferably 0 to 5% by weight, and particularly preferably 0 to 2% by weight, based on the total amount of compounds contained in the pressure-sensitive adhesive layer.
 含水基剤は、皮膚への薬効効果が十分得られるように水分を含有し、かつ粘着性を有し、常温又はそれ以上の温度においても軟化し膏体が皮膚に残らない適度な凝集性を有するように形成される。 The water-containing base contains water so that the medicinal effect on the skin can be sufficiently obtained, has adhesiveness, and softens even at room temperature or higher so that the plaster does not remain on the skin. Formed to have.
 増粘剤としては、水分を30%ないし80%安定に保持でき、かつ保水性を有することが望ましい。この具体例としては、グアーガム、ローカストビーンガム、カラギーナン、アルギン酸、アルギン酸ナトリウム、寒天、アラビアガム、トラガカントガム、カラヤガム、ペクチン、澱粉等の植物系、ザンサンガム、アカシアガム等の微生物系、ゼラチン、コラーゲン等の動物系等の天然高分子、メチルセルロース、エチルセルロース、ヒドロキシエチルセルロース、カルボキシメチルセルロースナトリウム等のセルロース系、可溶性デンプン、カルボキシメチルデンプン、ジアルデヒドデンプン等のデンプン系等の半合成高分子、ポリビニルアルコール、ポリビニルピロリドン、ポリビニルメタクリレート等のビニル系、ポリアクリル酸、ポリアクリル酸ナトリウム等のアクリル系、その他ポリエチレンオキサイド、メチルビニルエーテル/無水マレイン酸共重合体等の合成高分子等の水溶性高分子等の水溶性高分子等が好適に用いられる。特に、ポリアクリル酸ナトリウムが好ましい。ゲル強度が強く、かつ保水性に優れるからである。更に、平均重合度20000ないし70000のポリアクリル酸ナトリウムが好ましい。平均重合度が20000より小さくなるにつれ増粘効果が乏しくなり十分なゲル強度が得られなくなる傾向が現れだし、平均重合度が70000より大きくなるにつれ増粘効果が強すぎ作業性が低下する傾向が現れだし、いずれも好ましくない。また、前記水溶性高分子を3種類以上併用することにより、例えば、ポリアクリル酸ナトリウムの強イオン高分子と高分子コンプレックスを形成し、より一層ゲル強度の大きい弾性ゲルを得ることができる。 As a thickener, it is desirable that moisture can be stably maintained at 30% to 80% and that it has water retention. Specific examples include guar gum, locust bean gum, carrageenan, alginic acid, sodium alginate, agar, gum arabic, tragacanth gum, karaya gum, pectin, starch and other microbial systems, sansan gum, acacia gum and other microbial systems, gelatin, collagen and the like. Natural polymers such as animal systems, cellulose systems such as methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, semi-synthetic polymers such as starch systems such as soluble starch, carboxymethyl starch, and dialdehyde starch, polyvinyl alcohol, polyvinyl pyrrolidone, Vinyl-based materials such as polyvinyl methacrylate, acrylic-based materials such as polyacrylic acid and sodium polyacrylate, other polyethylene oxide, methyl vinyl ether / Water-soluble polymer of water-soluble polymers such as synthetic polymers such as water-maleic acid copolymers are suitably used. In particular, sodium polyacrylate is preferable. This is because the gel strength is strong and the water retention is excellent. Furthermore, sodium polyacrylate having an average degree of polymerization of 20000 to 70000 is preferred. As the average degree of polymerization becomes smaller than 20000, the thickening effect becomes poor and sufficient gel strength tends to be obtained. As the average degree of polymerization becomes larger than 70000, the thickening effect becomes too strong and workability tends to decrease. It appears and neither is desirable. Further, by using three or more kinds of the water-soluble polymers in combination, for example, a polymer complex with a strong ionic polymer of sodium polyacrylate can be formed, and an elastic gel with higher gel strength can be obtained.
 湿潤剤として、グリセリン、プロピレングリコール、ソルビトール等の多価アルコール等や、充填剤として、カオリン、酸化亜鉛、タルク、チタン、ベントナイト、珪酸アルミニウム、酸化チタン、酸化亜鉛、メタ珪酸アルミニウム、硫酸カルシウム、リン酸カルシウム等を添加してもよい。また、溶解補助剤または吸収促進剤として、炭酸プロピレン、クロタミトン、1-メントール、ハッカ油、リモネン、ジイソプロピルアジペート等や、薬効補助剤として、サリチル酸メチル、サリチル酸グリコール、1-メントール、チモール、ハッカ油、ノニル酸ワニリルアミド、トウガラシエキス等を添加してもよい。更に、必要に応じて、安定化剤や抗酸化剤、乳化剤等を添加してもよい。 Polyhydric alcohols such as glycerin, propylene glycol and sorbitol as wetting agents, and kaolin, zinc oxide, talc, titanium, bentonite, aluminum silicate, titanium oxide, zinc oxide, aluminum metasilicate, calcium sulfate, calcium phosphate as fillers Etc. may be added. Further, as a solubilizer or absorption promoter, propylene carbonate, crotamiton, 1-menthol, mint oil, limonene, diisopropyl adipate and the like, and as a medicinal aid, methyl salicylate, glycol salicylate, 1-menthol, thymol, mint oil, Nonyl acid vanillylamide, pepper extract, etc. may be added. Furthermore, you may add a stabilizer, an antioxidant, an emulsifier, etc. as needed.
 その他必要に応じて、架橋剤や重合剤等を添加してもよい。膏体を強固にするとともに保水性をもたせることができる。この架橋剤や重合剤は、増粘剤等の種類に応じて適宜選択される。例えば、増粘剤にポリアクリル酸またはポリアクリル酸塩を適用した場合は、分子中に少なくとも2個のエポキシ基を有する化合物、Ca、Mg、Al等の塩酸塩、硫酸塩、リン酸塩、炭酸塩等の無機酸塩、クエン酸塩、酒石酸塩、グルコン酸塩、ステアリン酸塩等の有機酸塩、酸化亜鉛、無水珪酸等の酸化物、水酸化アルミニウム、水酸化マグネシウム等の水酸化物等の多価金属化合物等が好適に用いられる。また、増粘剤にポリビニルアルコールを適用した場合は、アジピン酸、チオグリコール酸、エポキシ化合物(エピクロルヒドリン)、アルデヒド類、N-メチロール化合物、Al、Ti、Zr、Sn、V、Cu、B、Cr等の化合物等の錯化物等が好適に用いられる。また、増粘剤にポリビニルピロリドンを適用した場合は、メチルビニルエーテル/無水マレイン酸共重合体、ポリアシッド化合物又はそのアルカリ金属塩(ポリアクリル酸やタンニン酸およびその誘導体)等が好適に用いられる。また、増粘剤にポリエチレンオキサイドを適用した場合は、パーオキサイド、ポリスルホンアザイド等が好適に用いられる。また、増粘剤にメチルビニルエーテル/無水マレイン酸共重合体を適用した場合は、多官能ヒドロキシ化合物、ポリアミン、ヨウ素、ゼラチン、ポリビニルピロリドン、鉄、水銀、鉛塩等が好適に用いられる。増粘剤にゼラチンを適用した場合は、ホルムアルデヒド、グルタルアルデヒド、ジアルデヒドデンプン等のアルデヒド類、グリオキサール、ブタジエンオキシド等のジエポキシド類、ジビニルケトン等のジケトン類、ジイソシアネート類等が好適に用いられる。また、増粘剤にポリアクリル酸ナトリウムを適用した場合、架橋剤として、水酸化リチウム、水酸化亜鉛、水酸化アルミニウム、ほう酸ナトリウム等の多価金属塩が添加されるのが好ましい。特に、亜鉛塩、アルミニウム塩が好ましい。架橋反応が促進される。架橋剤として添加される多価金属塩の濃度は、増粘剤(又は水溶性高分子)1等量に対し0.5~1.5当量が好ましい。多価金属塩の濃度が0.5当量より小さくなるにつれ反応が遅すぎてゲル強度が低くなる傾向が現われだし、多価金属塩の濃度が1.5当量より大きくなるにつれ反応が速すぎてゲル化が不均一になり作業性が低下する傾向が現われだし、いずれも好ましくない。 Other cross-linking agents and polymerizing agents may be added as necessary. The plaster can be strengthened and water retention can be provided. This crosslinking agent and polymerization agent are appropriately selected according to the type of thickener and the like. For example, when polyacrylic acid or polyacrylate is applied to the thickener, compounds having at least two epoxy groups in the molecule, hydrochlorides such as Ca, Mg, Al, sulfates, phosphates, Inorganic acid salts such as carbonate, organic acid salts such as citrate, tartrate, gluconate and stearate, oxides such as zinc oxide and anhydrous silicic acid, hydroxides such as aluminum hydroxide and magnesium hydroxide A polyvalent metal compound such as is preferably used. When polyvinyl alcohol is applied as a thickener, adipic acid, thioglycolic acid, epoxy compound (epichlorohydrin), aldehydes, N-methylol compound, Al, Ti, Zr, Sn, V, Cu, B, Cr Complexes such as compounds such as are preferably used. When polyvinylpyrrolidone is applied as the thickener, methyl vinyl ether / maleic anhydride copolymer, polyacid compound or alkali metal salt thereof (polyacrylic acid, tannic acid and derivatives thereof), etc. are preferably used. In addition, when polyethylene oxide is applied to the thickener, peroxide, polysulfone azide, and the like are preferably used. In addition, when a methyl vinyl ether / maleic anhydride copolymer is applied to the thickener, polyfunctional hydroxy compounds, polyamines, iodine, gelatin, polyvinyl pyrrolidone, iron, mercury, lead salts and the like are preferably used. When gelatin is used as the thickener, aldehydes such as formaldehyde, glutaraldehyde, and dialdehyde starch, diepoxides such as glyoxal and butadiene oxide, diketones such as divinyl ketone, and diisocyanates are preferably used. When sodium polyacrylate is applied as the thickener, a polyvalent metal salt such as lithium hydroxide, zinc hydroxide, aluminum hydroxide or sodium borate is preferably added as a crosslinking agent. Particularly preferred are zinc salts and aluminum salts. Cross-linking reaction is promoted. The concentration of the polyvalent metal salt added as a crosslinking agent is preferably 0.5 to 1.5 equivalents relative to 1 equivalent of the thickener (or water-soluble polymer). As the concentration of the polyvalent metal salt becomes smaller than 0.5 equivalent, the reaction tends to be too slow and the gel strength tends to decrease, and as the concentration of the polyvalent metal salt becomes larger than 1.5 equivalent, the reaction becomes too fast. There is a tendency for gelation to become non-uniform and workability to deteriorate, both of which are not preferred.
 含水基剤としては、皮膚密着性がよいこと、有効成分の皮膚吸収を高めること、水分を可及的に多く含有していること、膏体中の水分が蒸発するとき皮膚から熱を奪うが、この発熱量が清涼感を与え、また角質層が内部から蒸散してくる水分子によって水和され、薬物の吸収が促進されること、常温又はその近辺の温度でもだれないこと、剥がす時に痛くなく汚れが残らないこと、べとつかないこと等が挙げられる。このため、膏体は、増粘剤5重量%ないし20重量%、好ましくは10重量%ないし15重量%、湿潤剤5重量%ないし40重量%、充填剤20重量%以下、水10重量%ないし80重量%、溶解補助剤0ないし8重量%、薬物5重量%以下、好ましくは0.5重量%ないし5重量%とされるのが好ましい。 As a water-containing base, it has good skin adhesion, enhances skin absorption of active ingredients, contains as much water as possible, and removes heat from the skin when moisture in the plaster evaporates. This calorific value gives a refreshing sensation, and the stratum corneum is hydrated by water molecules evaporating from the inside, promoting the absorption of the drug, not being at room temperature or in the vicinity, and hurting when peeling off For example, no dirt remains and it is not sticky. For this reason, the plaster comprises 5 to 20% by weight of a thickener, preferably 10 to 15% by weight, 5 to 40% by weight of a wetting agent, 20% by weight or less of a filler, 10 to 10% by weight of water. 80% by weight, solubilizing agent 0 to 8% by weight, drug 5% by weight or less, preferably 0.5% to 5% by weight.
 本発明の貼付剤に用いられる剛軟性支持体は、粘着剤層を支持し得るものであれば得に制限されず用いることができる。このような支持体としては、具体的には、布、不織布、ポリウレタン、ポリエチレン、ポリ酢酸ビニル、ポリ塩化ビニリデン、ポリエチレン、ポリエチレンテレフタレート、アルミニウムシート、又はこれらの積層体や複合素材からなるもの等が挙げられる。また布や不織布の繊維素材は、特に限定されないが、熱可塑性繊維単独、又は熱可塑性繊維と非熱可塑性繊維の混紡であってもよい。 The rigid / soft support used in the patch of the present invention can be used without any limitation as long as it can support the pressure-sensitive adhesive layer. Specific examples of such a support include cloth, nonwoven fabric, polyurethane, polyethylene, polyvinyl acetate, polyvinylidene chloride, polyethylene, polyethylene terephthalate, aluminum sheet, or a laminate or composite material thereof. Can be mentioned. The fiber material of the cloth or nonwoven fabric is not particularly limited, but may be a thermoplastic fiber alone or a blend of thermoplastic fiber and non-thermoplastic fiber.
 熱可塑性繊維としては、ポリウレタン、ポリエステル、ポリプロピレン、アクリル、ナイロンなど熱可塑性樹脂からなる素材、例えば、ポリエステル繊維、ポリアミド繊維、ポリ塩化ビニル繊維などが挙げられ、これらは単独で、または2種以上を混合して用いることができる。非熱可塑性繊維としては、レーヨン、キュポラ、麻、絹などを挙げることができる。
 また、支持体の厚みは特に制限されないが、厚みが5ないし1000μmの範囲内であることが好ましい。支持体の厚みが5μm未満であると、剥離する際の作業容易性が低下する傾向にあり、他方、1000μmを越えると製剤の製造工程において、支持体や粘着剤層の切断が困難となる等、製造容易性が低下する傾向にある。
Examples of the thermoplastic fiber include materials made of a thermoplastic resin such as polyurethane, polyester, polypropylene, acrylic, and nylon, for example, polyester fiber, polyamide fiber, and polyvinyl chloride fiber. These may be used alone or in combination of two or more. It can be used by mixing. Examples of non-thermoplastic fibers include rayon, cupola, hemp and silk.
The thickness of the support is not particularly limited, but the thickness is preferably in the range of 5 to 1000 μm. If the thickness of the support is less than 5 μm, the workability at the time of peeling tends to be reduced. On the other hand, if the thickness exceeds 1000 μm, it becomes difficult to cut the support or the pressure-sensitive adhesive layer in the preparation production process. The manufacturing ease tends to decrease.
 本発明の貼付剤に用いられる支持体の熱可塑性繊維としては、前記支持体の目付が50ないし200g/m2の範囲であることが好ましい。好ましくは60ないし160g/m2の範囲、より好ましくは、80ないし120g/m2である。
 また、本発明の貼付剤に用いられる支持体の熱可塑性繊維としては、繊維の太さ30ないし75デニールのポリエステル繊維からなる目付80ないし120g/m2のものが好ましい。
 好ましくは、50デニールのポリエステル繊維からなる目付90ないし110g/m2、より好ましくは、50デニールのポリエステル繊維からなる目付約100g/m2である。
The thermoplastic fibers of the support used in the patch of the present invention, it is preferable that the basis weight of the support is in the range of from 50 200g / m 2. The range is preferably 60 to 160 g / m 2 , more preferably 80 to 120 g / m 2 .
The thermoplastic fiber of the support used in the patch of the present invention preferably has a basis weight of 80 to 120 g / m 2 made of polyester fiber having a fiber thickness of 30 to 75 denier.
Preferably, the basis weight is 90 to 110 g / m 2 made of 50 denier polyester fibers, and more preferably the basis weight is about 100 g / m 2 made of 50 denier polyester fibers.
 本発明の貼付剤に用いられる支持体の剛軟度としては、JIS L 1096-1999に規定される45°カンチレバー法による剛軟度が5mm以上であることが好ましい。 The bending resistance of the support used in the patch of the present invention is preferably 5 mm or more according to the 45 ° cantilever method specified in JIS L 1096-1999.
前記貼付剤が前記粘着剤層の表面に貼着された剥離シートは、例えば、該剥離シートの剛軟度が60ないし160mmであるものが好ましい。 The release sheet in which the patch is attached to the surface of the pressure-sensitive adhesive layer preferably has, for example, a bending softness of 60 to 160 mm.
 本発明の貼付剤における粘着剤層の膜厚は特に制限されないが、20ないし3000μmであることが好ましい。 The thickness of the adhesive layer in the patch of the present invention is not particularly limited, but is preferably 20 to 3000 μm.
 本発明の貼付剤の製造において、粘着剤層を支持体上に配置する方法は特に制限されない。 In the production of the patch of the present invention, the method for arranging the pressure-sensitive adhesive layer on the support is not particularly limited.
 さらに、本発明の貼付剤が離型紙を備える場合、特に限定されないが、具体的には、ポリエチレンテレフタレート等のポリエステル、ポリ塩化ビニル、ポリ塩化ビニリデン等のフィルム、上質紙とポリオレフィンとのラミネートフィルム等を用いることができる。これらの剥離シートにおいては、粘着剤層と接触する側の面にシリコーン処理を施しても良い。 Further, when the patch of the present invention is provided with a release paper, it is not particularly limited. Specifically, a film such as polyester such as polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, a laminate film of fine paper and polyolefin, etc. Can be used. In these release sheets, a silicone treatment may be applied to the surface on the side in contact with the pressure-sensitive adhesive layer.
 薬物としては、サリチル酸メチル、サリチル酸グリコール、1-メントール、トウガラシエキス、ノニル酸ワニリルアミド、ハッカ油、ジクロフェナク、イブプフェン、インドメタシン、ケトプロフェン、ロキソプロフェン、スリンダク、トルメチン、ロベンザリット、ペニシラミン、フェンプフェン、フルルビプロフェン、ナプロキセン、プラノプロフェン、チアプロフェン、スプロフェン、フェルビナク、ケトロラク、オキサプロジン、エトドラク、ザルトプロフィン、ピロキシカム、ペンタゾシン、塩酸ブプレノルフィン、酒石酸ブトルファノール等及びそのエステル誘導体または塩より選ばれた少なくとも1種の非ステロイド系抗炎症薬や、プレドニッゾロン、デキサメタゾン、ヒドロコルチゾン、ベタメタゾン、フルオシニド、フルオシノロンアセトニド、吉草酸酢酸プレドニゾロン、ジプロピオン酸デキサメタゾン、吉草酸ジフルコルトロン、ジフルプレドナート、吉草酸ベタメタゾン、酢酸ヒドロコルチゾン、酪酸クロベタゾン、酪酸ベタメタゾン、プロピオン酸クロベタゾン、コハク酸デキサメタゾン、プレドニゾロン21-(2E、6E)ファルシネート、吉草酸ヒドロコルチゾン、酢酸ジフロラゾン、プロピオン酸デキサメタゾン、ジプロピオン酸ベタメタゾン、アムシノニド、吉草酸デキサメタゾン、ハルシノニド、ブテソニド、プロピオン酸アルクロメタゾン等のステロイド系抗炎症薬等が挙げられるが、これらに限定されるものではない。薬物は、必要に応じて2種類以上併用することも可能である。また、これらの薬物は必要に応じてエステル体に誘導された化合物、アミド体に誘導された化合物、アセタール体に誘導された化合物、あるいは医学的に許容される無機塩、有機塩の形態で膏体に含有または付着されてもよい。薬物の量は、患者に適用した際に予め設定された有効量を患部に適用できるように、貼付剤の種類、用途等に応じて適宜選択される。 Drugs include methyl salicylate, glycol salicylate, 1-menthol, red pepper extract, nonylic acid vanillylamide, mint oil, diclofenac, ibupufen, indomethacin, ketoprofen, loxoprofen, sulindac, tolmetine, lobenzalite, penicillamine, fempfen, flurbiprofen, prolbiprofen , Pranoprofen, thiaprofen, suprofen, felbinac, ketorolac, oxaprozin, etodolac, zaltoprofine, piroxicam, pentazocine, buprenorphine hydrochloride, butorphanol tartrate, etc. and at least one non-steroidal anti-inflammatory Drugs, prednisolone, dexamethasone, hydrocortisone, betamethasone, fluocinide, Luocinolone acetonide, prednisolone acetate valerate, dexamethasone dipropionate, diflucortron valerate, difluprednate, betamethasone valerate, hydrocortisone acetate, clobetasone butyrate, betamethasone butyrate, clobetasone propionate, dexamethasone succinate, prednisolone 21- (2E, 6E) steroidal anti-inflammatory drugs such as falsinate, hydrocortisone valerate, diflorazone acetate, dexamethasone propionate, betamethasone dipropionate, amsinonide, dexamethasone valerate, harsinonide, butesonide, alcrometasone propionate, etc. It is not limited to these. Two or more kinds of drugs can be used in combination as necessary. In addition, these drugs can be applied in the form of an ester-derived compound, an amide-derived compound, an acetal-derived compound, or a medically acceptable inorganic salt or organic salt as necessary. It may be contained or attached to the body. The amount of the drug is appropriately selected according to the type and use of the patch so that an effective amount preset when applied to the patient can be applied to the affected area.
 以下、実施例を挙げて説明するが、本発明はこれらの実施例に限定されるものではない。 Hereinafter, although an example is given and explained, the present invention is not limited to these examples.
(製造例1:支持体の製造)
 捲縮処理した50デニールのポリエステルマルチフィラメント加工糸を、目付が約100g/m2の丸編に編成した、厚みが500μmの編布に、図7に示すように10%ヒドロキシメチルセルロース水溶液を約4cm幅で塗布した後、乾燥させた。
(Production Example 1: Production of support)
A crimped 50 denier polyester multifilament processed yarn is knitted into a circular knitted fabric with a basis weight of about 100 g / m 2 , and a knitted fabric with a thickness of 500 μm is filled with 10% hydroxymethylcellulose aqueous solution of about 4 cm as shown in FIG. After applying in width, it was dried.
(製造例2:支持体の製造)
 捲縮処理した50デニールのポリエステルマルチフィラメント加工糸を、目付が約100g/m2の丸編に編成した、厚みが500μmの編布に、ポリエステル系樹脂を図8に示すように塗布した。
(Production Example 2: Production of support)
As shown in FIG. 8, a polyester resin was applied to a knitted fabric having a thickness of 500 μm in which a crimped 50 denier polyester multifilament processed yarn was knitted into a circular knitting having a basis weight of about 100 g / m 2 .
(製造例3:支持体の製造)
 捲縮処理した50デニールのポリエステルマルチフィラメント加工糸を、目付が約100g/m2の丸編に編成した、厚みが500μmの編布に、ポリエステル系樹脂を図9に示すように塗布した。
(Production Example 3: Production of support)
A polyester resin was applied to a knitted fabric having a thickness of 500 μm, in which a crimped 50 denier polyester multifilament processed yarn was knitted into a circular knitting having a basis weight of about 100 g / m 2 , as shown in FIG.
(製造例4:支持体の製造)
 捲縮処理した50デニールのポリエステルマルチフィラメント加工糸を、目付が約100g/m2の丸編に編成した、厚みが500μmの編布に、ポリエステル系粘着テープを図10のように貼付した。
(Production Example 4: Production of support)
A polyester-based pressure-sensitive adhesive tape was applied to a knitted fabric having a thickness of 500 μm, in which a crimped 50 denier polyester multifilament processed yarn was knitted into a circular knitting having a basis weight of about 100 g / m 2 as shown in FIG.
実施例1
 スチレン-イソプレン-スチレンブロック共重合体    25質量部
 流動パラフィン                       39質量部
 ポリイソブチレン                      10質量部
 ロジンエステル樹脂                    25質量部
 老化防止剤                         1質量部
 メントール                          4質量部
 サリチル酸グリコール                   4質量部
 上記成分を配合、混合し、剥離シート上に塗膏し、上記製造1ないし4に挙げる支持体を被覆し圧着した。さらに、所望の大きさに裁断した。
Example 1
Styrene-isoprene-styrene block copolymer 25 parts by weight Liquid paraffin 39 parts by weight Polyisobutylene 10 parts by weight Rosin ester resin 25 parts by weight Anti-aging agent 1 part by weight Menthol 4 parts by weight Salicylic acid glycol 4 parts by weight The above ingredients are mixed and mixed Then, it was coated on a release sheet, coated with the support mentioned in the above Production 1 to 4 and pressure-bonded. Furthermore, it cut | judged to the desired magnitude | size.
比較例1
 加工処理していない丸編み織布を使用した以外は、実施例1と同じ方法で製造した。
Comparative Example 1
Manufactured in the same manner as in Example 1 except that unprocessed circular knitted woven fabric was used.
試験例1:剛軟度測定方法
 JIS L 1096-1999に規定される45°カンチレバー法により各支持体の剛軟度を測定した。
 尚、実施例1、実施例2、実施例3については、加工部分の剛軟度について測定した。
Test Example 1: Method for measuring bending resistance The bending resistance of each support was measured by the 45 ° cantilever method defined in JIS L 1096-1999.
In addition, for Example 1, Example 2, and Example 3, the bending resistance of the processed part was measured.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
試験例2:貼付試験
 上記実施例及び比較例で製造した製剤を用いて、貼付試験を実施した。貼付試験は、各実施例及び比較例1を10cm×14cmの大きさに裁断し使用した。30歳ないし60歳の健康人10名について腰部への貼付作業を実施した。表2に示す評価基準により評価した。貼付作業時の容易性及び貼付時の違和感についての評価結果を表3に示す。
Test Example 2: Sticking test A sticking test was performed using the preparations produced in the above Examples and Comparative Examples. In the sticking test, each Example and Comparative Example 1 were cut into a size of 10 cm × 14 cm and used. The pasting work was carried out on the lumbar region of 10 healthy people aged 30 to 60 years old. Evaluation was performed according to the evaluation criteria shown in Table 2. Table 3 shows the evaluation results for the ease of sticking work and the uncomfortable feeling when sticking.
表2.評価項目及び評価
Figure JPOXMLDOC01-appb-T000002
Table 2. Evaluation items and evaluation
Figure JPOXMLDOC01-appb-T000002
表3.貼付作業時の容易性及び貼付時の違和感についての評価結果.
Figure JPOXMLDOC01-appb-T000003
Table 3. Evaluation results for ease of application and discomfort during application.
Figure JPOXMLDOC01-appb-T000003
 表3に示すように、剛軟性の高い加工を施した支持体を用いた製剤では、比較例1と比較して貼付作業時の容易性の評価が高かった。また、製剤貼付中の違和感については、実施例1及び実施例4でやや違和感を感じた場合もあったが、実施例2及び実施例3では比較例1とほぼ同等の評価であった。 As shown in Table 3, in the preparation using the support subjected to processing with high rigidity and softness, the ease of application during the pasting operation was higher than that in Comparative Example 1. Moreover, about the uncomfortable feeling during formulation sticking, although Example 1 and Example 4 felt a little uncomfortable, Example 2 and Example 3 were almost the same evaluation as Comparative Example 1.
図1は、従来の、貼付剤の貼付作業時に、剥離シートの除去後に膏体同士が張り付いた状態の失敗例(ライナーの切れ目が1本の場合に露出した膏体同士が貼りついた状態)を示す図である。FIG. 1 shows an example of failure in a state in which pastes are stuck to each other after removal of a release sheet during a pasting operation of a patch (state in which pastes exposed when there is one liner break are stuck together) ). 図2は、従来の、貼付剤の貼付作業時に、剥離シートの除去後に膏体同士が張り付いた状態の失敗例(ライナーの切れ目が1本の場合に露出した膏体が剥離紙に貼りついた状態)を示す図である。Fig. 2 shows an example of failure in a state where the pastes are stuck to each other after the release sheet is removed during the pasting operation of the patch (the plaster exposed when the liner has one cut sticks to the release paper) FIG. 図3は、従来の、貼付剤の貼付作業時に、剥離シートの除去後に膏体同士が張り付いた状態の失敗例(ライナーの切れ目が2本の場合に露出した膏体同士が貼りついた状態)を示す図である。FIG. 3 shows an example of failure in a state in which the pastes are stuck to each other after the release sheet is removed during the pasting operation of the patch (a state in which the exposed pastes are stuck to each other when there are two liner breaks) ). 図4は、従来の、貼付剤の貼付作業時に、剥離シートの除去後に膏体同士が張り付いた状態の失敗例(ライナーの切れ目が2本の場合に露出した膏体が剥離紙に貼りついた状態)を示す図である。FIG. 4 shows an example of failure in a state in which the pastes are stuck to each other after removing the release sheet during the pasting operation of the patch (exposed paste is stuck to the release paper when there are two liner breaks. FIG. 図5は本発明の実施の形態における貼付剤の正面図((a)、(b))である。FIG. 5 is a front view ((a), (b)) of the patch in the embodiment of the present invention. 図6は本発明の実施の形態における貼付剤を示す斜視図及び断面を模式的に示した図である。断面の模式図中、1は本発明の実施の形態における軟膏剤やパップ剤等の貼付剤、2は貼付剤の膏体層、3は織布等からなる剛軟性を有する支持体、4は支持体中の低伸縮部分、5は剥離紙である。FIG. 6 is a perspective view and a diagram schematically showing a cross section of the patch in the embodiment of the present invention. In the schematic view of the cross section, 1 is a patch such as an ointment or a poultice in the embodiment of the present invention, 2 is a plaster layer of the patch, 3 is a support having rigidity and flexibility made of a woven fabric, etc. A low stretchable part 5 in the support is a release paper. 図7は製造例1で用いた支持体の模様を表す図である。FIG. 7 is a diagram showing the pattern of the support used in Production Example 1. 図8は製造例2で用いた支持体の模様を表す図である。FIG. 8 is a diagram showing the pattern of the support used in Production Example 2. 図9は製造例3で用いた支持体の模様を表す図である。FIG. 9 is a diagram showing the pattern of the support used in Production Example 3. 図10は製造例4で用いた支持体の模様を表す図である。FIG. 10 is a diagram showing the pattern of the support used in Production Example 4.

Claims (19)

  1. 支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなる貼付剤において;
    1枚の支持体に異なる剛軟性を持つ2つ以上の部分を形成することを特徴とする貼付剤。
    In a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface thereof;
    A patch, wherein two or more parts having different stiffness are formed on one support.
  2. 該支持体の異なる剛軟性を持つ部分が、支持体の他の部分よりも剛軟性の高い部分である請求項1に記載の貼付剤。 The patch according to claim 1, wherein the part having different bending resistance of the support is a part having higher bending resistance than the other part of the support.
  3. 該剛軟性の高い部分が、剥離シートが分断されて膏体が露出される部分に相当する支持体部位に局在する請求項1に記載の貼付剤。 The patch according to claim 1, wherein the highly flexible portion is localized at a support portion corresponding to a portion where the peel sheet is divided and the plaster is exposed.
  4. 支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなる貼付剤において;
    a)1枚の支持体に異なる剛軟性を持つ2つ以上の部分を形成する貼付剤であって、
    b)該支持体の、他の部分よりも剛軟性の高い部分が、剥離シートが分断されて膏体が露出される部分に相当する支持体部位に局在し、
    c)低伸縮性部分の剛軟度がその他の部分の剛軟度よりも120%以上高いことを特徴とする貼付剤。
    In a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface thereof;
    a) A patch for forming two or more parts having different stiffness on a single support,
    b) A portion of the support having higher rigidity than other portions is localized at a support portion corresponding to a portion where the release sheet is divided and the plaster is exposed,
    c) A patch characterized in that the bending resistance of the low stretchable part is 120% or more higher than the bending resistance of other parts.
  5. 剥離シートに実質的に平行な切れ目が2本ある貼付剤であって、
    該支持体の剛軟性の高い部分が、剥離シートに実質的に平行な切れ目に挟まれた支持体の中央部分に位置する、請求項1ないし4に記載の貼付剤。
    A patch having two cuts substantially parallel to the release sheet,
    The patch according to any one of claims 1 to 4, wherein the highly rigid portion of the support is located in a central portion of the support sandwiched between cuts substantially parallel to the release sheet.
  6. 該剛軟性の高い部分に、JIS L 1096-1999に規定される45°カンチレバー法による剛軟度が5mm以上の編布からなる支持体を使用する、請求項1ないし5に記載の貼付剤。 6. The patch according to any one of claims 1 to 5, wherein a support comprising a knitted fabric having a bending resistance of 5 mm or more according to a 45 ° cantilever method specified in JIS L 1096-1999 is used for the portion having a high bending resistance.
  7. 1枚の貼付剤中に異なる剛軟性を併せ持つ支持体であって、剛軟性の高い部分の面積が全体の5%ないし60%である請求項1ないし5に記載の貼付剤。 6. The patch according to any one of claims 1 to 5, which is a support having different stiffness and flexibility in one patch, and the area of the portion having high stiffness is 5% to 60% of the whole.
  8. 貼付剤の粘着剤層の組成が油性基剤あるいは水性基剤からなる請求項1ないし5に記載の貼付剤。 6. The patch according to claim 1, wherein the composition of the adhesive layer of the patch comprises an oily base or an aqueous base.
  9. 前記支持体の目付けが60ないし160g/m2の範囲である請求項1ないし5に記載の貼付剤。 Patch according to 5 to basis weight of said support claims 1 ranges to the 160 g / m 2 no 60.
  10. 前記支持体の目付けが80ないし120g/m2の範囲である請求項1ないし5に記載の貼付剤。 It patches according to 5 to the basis weight of the support claims 1 ranges to the 120 g / m 2 80 no.
  11. 前記貼付剤が前記粘着剤層の表面に貼着された剥離シートを備えるものであって、該剥離シートの剛軟度が60ないし160mmである請求項1ないし5に記載の貼付剤。 The patch according to any one of claims 1 to 5, wherein the patch comprises a release sheet adhered to the surface of the pressure-sensitive adhesive layer, and the bending resistance of the release sheet is 60 to 160 mm.
  12. 前記支持体が、繊維の太さ30ないし75デニールのポリエステル繊維からなる目付80ないし120g/m2のものである請求項1ないし5に記載の貼付剤。 The patch according to any one of claims 1 to 5, wherein the support has a basis weight of 80 to 120 g / m 2 made of polyester fiber having a fiber thickness of 30 to 75 denier.
  13. 支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなる貼付剤において;
    該支持体が剛軟性の高い部分が全面に点在することを特徴とする貼付剤。
    In a patch in which a paste layer is provided on the surface of a support, and a release sheet is bonded to the paste layer so as to cover substantially the entire surface thereof;
    A patch, characterized in that the support is interspersed with highly rigid portions over the entire surface.
  14. 支持体の表面に膏体層を設け、該膏体層の上にその略全面を覆うように剥離シートを貼り合わせてなり、剥離シートに実質的に平行な切れ目が2本ある貼付剤であって;
    a)該支持体が剛軟性の高い部分が全面に点在する貼付剤であって、
    b)剥離シートが分断されて膏体が露出される部分を有し、
    c)該支持体は、JIS L 1096-1999に規定される45°カンチレバー法による剛軟度が6mm以上の支持体である、
    ことを特徴とする貼付剤。
    This is a patch in which a paste layer is provided on the surface of a support, and a release sheet is laminated on the paste layer so as to cover substantially the entire surface, and the release sheet has two cuts that are substantially parallel to each other. And
    a) The patch is a patch in which portions with high flexibility are scattered over the entire surface,
    b) having a part where the release sheet is divided and the plaster is exposed;
    c) The support is a support having a bending resistance of 6 mm or more according to a 45 ° cantilever method defined in JIS L 1096-1999.
    A patch characterized by that.
  15. 貼付剤の粘着剤層の組成が油性基剤あるいは水性基剤からなる請求項13ないし14に記載の貼付剤。 The patch according to any one of claims 13 to 14, wherein the composition of the adhesive layer of the patch comprises an oily base or an aqueous base.
  16. 前記支持体の目付けが60ないし160g/m2の範囲である請求項13ないし14に記載の貼付剤。 Patch according to claims 13 to 14 to the 60 basis weight of the support is in the range of 160 g / m 2.
  17. 前記支持体の目付けが80ないし120g/m2の範囲である請求項13ないし14に記載の貼付剤。 Patch according to claims 13 to 14 to the 80 basis weight of the support is in the range of 120 g / m 2.
  18. 前記貼付剤が前記粘着剤層の表面に貼着された剥離シートを備えるものであって、該剥離シートの剛軟度が60ないし160mmである請求項13ないし14に記載の貼付剤。 The patch according to any one of claims 13 to 14, wherein the patch comprises a release sheet adhered to the surface of the pressure-sensitive adhesive layer, and the bending resistance of the release sheet is 60 to 160 mm.
  19. 前記支持体が、繊維の太さ30ないし75デニールのポリエステル繊維からなる目付80ないし120g/m2のものである請求項13ないし14に記載の貼付剤。 The patch according to any one of claims 13 to 14, wherein the support has a basis weight of 80 to 120 g / m 2 made of polyester fiber having a fiber thickness of 30 to 75 denier.
PCT/JP2008/073488 2008-12-24 2008-12-24 Patch WO2010073327A1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
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EP3263097A4 (en) * 2015-02-24 2018-08-15 Hisamitsu Pharmaceutical Co., Inc. Adhesive skin poultice
US11903915B2 (en) 2019-02-14 2024-02-20 Hisamitsu Pharmaceutical Co., Inc. Poultice

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JPS60140732U (en) * 1984-11-21 1985-09-18 旭化成株式会社 Laminated poultice material
JPS6314530U (en) * 1987-02-14 1988-01-30
JP2004059489A (en) * 2002-07-29 2004-02-26 Toray Ind Inc Fabric for patch and patch
JP2005170828A (en) * 2003-12-10 2005-06-30 Toray Ind Inc Fabric for patch and patch
JP2007176854A (en) * 2005-12-28 2007-07-12 Lion Corp Patch substrate, method for producing the same and patch

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JPS60140732U (en) * 1984-11-21 1985-09-18 旭化成株式会社 Laminated poultice material
JPS6314530U (en) * 1987-02-14 1988-01-30
JP2004059489A (en) * 2002-07-29 2004-02-26 Toray Ind Inc Fabric for patch and patch
JP2005170828A (en) * 2003-12-10 2005-06-30 Toray Ind Inc Fabric for patch and patch
JP2007176854A (en) * 2005-12-28 2007-07-12 Lion Corp Patch substrate, method for producing the same and patch

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3263097A4 (en) * 2015-02-24 2018-08-15 Hisamitsu Pharmaceutical Co., Inc. Adhesive skin poultice
US10940121B2 (en) 2015-02-24 2021-03-09 Hisamitsu Pharmaceutical Co., Inc. Gel patch
US11903915B2 (en) 2019-02-14 2024-02-20 Hisamitsu Pharmaceutical Co., Inc. Poultice

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