JP2007204393A - Skin plaster - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a skin plaster fixable to the skin in high tackiness and hard-to-peel off the skin. <P>SOLUTION: The skin plaster is such that a base layer is formed on a substrate and the surface of the base layer is stuck with a lipid-absorbing release sheet. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a skin patch that has high adhesion to skin and is difficult to peel off.

  An outer skin patch used as a patch or a skin cooling sheet has a structure in which a base layer is formed on a support and a release sheet is adhered to the surface. In the case of a hydrophilic base, the medicinal components and absorption promoters that are oily substances are uniformly dispersed in the base by the surfactant, but the surface of the oily substance is separated from the base during storage of the patch. It is known to cause so-called bleeding. The oily substance that floats on the surface of the base due to this bleeding has a problem that the adhesive force of the applied surface is reduced and the skin tends to be peeled off. Moreover, when the application site | part of the skin which affixes a patch is a site | part with much sebum, such as a forehead, the problem of the ease of peeling from skin is larger.

  As a technique for preventing such bleeding in the skin patch and improving the sticking force, a method in which a specific acrylic copolymer is contained in the base has been proposed (Patent Document 1). However, in this method, the adhesive base is limited and a special technique is required for the production method. Further, the release sheet is difficult to peel off from the skin patch.

  In addition, it is not a technique for skin patches, but as a technique for improving the adhesive strength to oily surfaces, it is possible to add a powdery or fibrous filler or oil-absorbing pigment to the pressure-sensitive adhesive layer, or to a metal surface to which oil has adhered. Also known are pressure-sensitive adhesive sheets (Patent Documents 2 and 3) for sticking, pressure-sensitive adhesive sheets (Patent Document 4) in which a liquid-absorbing layer is laminated on the pressure-sensitive adhesive layer so that a part of the pressure-sensitive adhesive layer is exposed over the entire surface. Yes. However, these adhesive sheets are different from the skin patch in the structure of the base itself, and the object to be applied is a metal surface, etc. In addition, it is highly irritating and difficult to apply to skin patches.

JP 2005-15353 A Japanese Unexamined Patent Publication No. 07-157723 Japanese Patent Laid-Open No. 11-116904 JP 2001-207134 A

  Therefore, an object of the present invention is to provide a skin patch that has good peelability of the release sheet, maintains high adhesive strength to the skin, and is difficult to peel off from the skin application surface.

  In such a situation, the present inventors use an absorbent sheet as a release sheet to be adhered to the surface of the skin patch, and the separated oil is released even when bleeding occurs during storage. Because it is absorbed by the sheet, it is possible to prevent a decrease in the adhesive strength to the skin while maintaining the peelability of the release sheet, and this oil-absorbent release sheet is applied to the skin before the user applies it to the application site. It was also used to remove the sebum on the surface, and thus it was conceived that the difficulty of peeling off from the skin could be improved, and the present invention was completed based on this idea.

  That is, the present invention provides a skin patch in which a base layer is formed on a support, and a release sheet having absorptivity is adhered to the surface of the base layer.

  The skin patch of the present invention can maintain a high adhesive strength to the skin while the separated oil is absorbed by the release sheet even when bleeding occurs during storage, and the release sheet retains its peelability. . Moreover, if the sebum on the skin surface is removed before the user applies the oil-absorbing release sheet to the application site, the difficulty of peeling from the skin can be further improved.

[Absorbent release sheet]
In this invention, it is required for the peeling sheet stuck on the base layer surface to have absorptivity. Here, as the degree of oil absorption of the release sheet according to the present invention, from the viewpoint of appropriate adhesiveness to the skin, the oil absorption amount per unit area of the release sheet is 0.3 to 4.0 mg / cm ² , further 0.5 to 3.0 mg / cm ^2, preferably in the range particularly 0.6~2.0mg / cm ^2.

  The oil-absorbing release sheet may have a fat-absorbing property only on one side of the sheet or may be on both sides. If it has oil-absorbing properties on both sides of the sheet, it absorbs excess oil separated by bleeding, and can also absorb sebum on the skin such as the forehead using this release sheet before use, The adhesion to the skin can be further improved. However, when the base contains a fat-soluble medicinal component, the medicinal component may be absorbed by the release sheet and the effect may be reduced. From this point, the surface on the side where the release sheet contacts the base layer Is preferably non-greasy.

  Examples of the material of the oil-absorbing release sheet used in the present invention include a plastic film (boiled film) and paper (boiled paper). From the viewpoint of the peelability and the oil-absorbing ability of the release sheet, a plastic film, particularly A porous stretched plastic film is preferred.

  The porous stretched film can be manufactured according to various methods using a plastic material as a starting material. Preferably, a filler is added to a crystalline thermoplastic resin as a main raw material, which is then formed into a film. After making a plastic film, the film can be stretched to give fine pores.

  Examples of the crystalline thermoplastic resin used as a raw material for the porous stretched plastic film include high-density polyethylene, polypropylene, polybutylene, poly-4-methylpentene, and an ethylene-propylene block copolymer. A modified polypropylene is preferable in that it has a melt strength at the time of film formation.

  Examples of the filler used for providing fine pores include mineral oil, glycerin, petroleum jelly, low molecular weight polyethylene, polyethylene oxide, polypropylene oxide, polytetramethylene oxide, soft carbowax, and mixtures thereof. Among these, mineral oil is preferable because it is inexpensive. The addition amount of the filler is preferably in the range of 20 to 60% by weight, particularly 25 to 40% by weight of the thermoplastic resin. Here, if the amount of filler added to the thermoplastic resin is less than 20% by weight, the porosity of the film obtained after stretching is reduced and sufficient fat absorption cannot be obtained, and if it exceeds 60% by weight, Film formation becomes difficult, and only a fragile film can be obtained.

  Next, the plastic film after film formation is stretched to give fine pores. Stretching can be performed by uniaxial stretching or biaxial stretching according to a conventional method as in the case of film formation. For example, when biaxial stretching is performed, stretching in the longitudinal direction can be performed by changing the peripheral speed of the driving roll, and stretching in the width direction is performed by holding the left and right ends of the film with a chuck and mechanically pulling in the lateral direction. Can be done. The conditions for stretching the film are not particularly limited, but it is preferable to stretch the film so that the film has a porosity of 5 to 50% and a thickness of 5 to 200 μm. The stretching ratio is preferably in the range of 1.5 to 3.0.

The porous stretched plastic film has an empty volume per unit area represented by the following formula from the viewpoint of imparting sufficient and sufficient oil absorption to make the adhesiveness of the patch to the skin sufficient. 0.005 cm ^3, it is particularly preferably from 0.0002~0.001cm ^3.

Perforated volume per unit area = [film thickness (cm) x 1 (cm) x 1 (cm) x porosity (%)] ÷ 100
["Porosity" indicates the proportion of pores in the porous film. ]

  The oil-absorbing release sheet used in the present invention may have both oil-absorbing properties and water-absorbing properties. In this case, not only sebum but also sweat on the skin can be absorbed. However, when the base is a hydrophilic base, when water absorption is imparted to the release sheet, the moisture content in the base is absorbed and the water content of the base is reduced, thereby preventing the reduction in the adhesiveness of the base surface. Therefore, it is desirable that the water absorption is not applied to the contact surface with the base, but only on the side in contact with the skin.

  Examples of a method for imparting hydrophilicity to the release sheet include a method of applying a hydrophilic substance. Examples of hydrophilic substances include anionic surfactants such as alkyl sulfate esters, alkylbenzene sulfonates, polyoxyethylene alkyl phosphate esters, polyoxyethylene alkyl ethers, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, and the like. Examples include ionic surfactants, cationic surfactants such as alkylamine salts and quaternary ammonium salts, and hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, and polypropylene glycol. These hydrophilic substances include isopropyl alcohol, ethanol, It is preferable to prepare and use a coating solution by dissolving it in an appropriate solvent such as water, methyl ethyl ketone, toluene, ethyl acetate, heptane or the like.

  Examples of the method for applying the coating liquid to the porous stretched film include gravure coating, flexographic coating, screen coating, dip coating, and spray coating.

  The absorbent absorbent release sheet may be in the form of a laminate or the like.For example, in order to prevent the reduction of the fat-soluble medicinal components described above and the moisture content of the hydrophilic base, the contact side with the base surface is not provided. It is also possible to use a layer having no water absorption and / or oil absorption, and a layer having the outer side having oil absorption and further water absorption.

  A commercially available oil-blowing film can also be used as the porous stretched plastic film as described above. Specific examples of commercially available products include Shiromoto "STF Oil Clear Film Moisture Type" (3M Microporous Film), Shiromoto "STF Oil Clear Film Sweat Freeze Type" (3M Microporous Film), Mandom Corporation “Gatsby Oil Blotting Paper Film Type”, Johnson & Johnson “Clean & Clear Oil Control Film” and so on.

[Support]
As a support, nonwoven fabric or woven fabric such as synthetic fiber and absorbent cotton; paper; synthetic resin film such as polyethylene, polypropylene, polyurethane, vinyl chloride, polyester, polyamide, rayon; and the synthetic resin film and nonwoven fabric or woven fabric A laminated body etc. are mentioned. When using the support body of a laminated body, a water vapor transmission rate can be adjusted by selecting the material of a synthetic resin film, or giving a pore. It is also possible to produce a patch with reduced skin irritation by increasing the moisture permeability, or to produce a highly absorbent patch utilizing the ODT effect by reducing the moisture permeability. The support may be either stretchable or non-stretchable, but preferably exhibits a suitable stretchability depending on the application site.

[Base]
The base (plaster) used in the present invention is preferably a hydrophilic base. The hydrophilic base is produced by an ordinary method using other components such as a medicinal component as necessary in addition to components used for a normal cataplasm and skin cooling sheet, for example, a water-soluble polymer and water. .

  When the patch of the present invention is a medicated patch, a medicinal component can be added to the base. The medicinal component is not particularly limited, for example, anti-inflammatory analgesics (salicylic acid esters such as methyl salicylate and glycol salicylate, indomethacin, ketoprofen, felbinac, flurbiprofen, ibuprofen, zaltoprofen, diclofenac or a salt thereof, loxoprofen or a salt thereof, Azulene, sodium azulene sulfonate, glycyrrhetinic acid, dipotassium glycyrrhetinate, mefenamic acid or derivatives thereof, bufexamac, alclofenac, prednisolone or esters thereof, hydrocortisone or esters thereof, dexamethasone or esters thereof, betamethasone or esters thereof , Diflucortron or esters thereof, diflorazone or esters thereof, flumethasone or esters thereof, mometasone Is its ester, acromethasone or its ester, clobetasol or its ester, deprodon or its ester, difluprednate, triamcinolone, triamcinolone acetonide, budesonide, harsinonide, fluocinonide, beclomethasone, fluocinolone, fluocinolone acetonide, fludo Roxycortide, clobetasone, diphenhydramine hydrochloride, chlorpheniramine maleate, naproxen, piroxicam, etc., refreshing agents (dl-camphor, dl- or l-menthol, etc.), blood circulation promoters (vitamin E or its derivatives, nonylic acid vanillylamide) , Capsaicin, etc.), local anesthetics (lidocaine, bupivacaine, mepivacaine, procaine, tetracaine, etc.), cardiovascular drugs (amyl nitrite, inositol hexanicotine) , Isoxsuprine hydrochloride, ethaphenone hydrochloride, carboclonone hydrochloride, dirazep hydrochloride, diltiazem hydrochloride, trimetazidine hydrochloride, nicardipine hydrochloride, verapamil hydrochloride, dipyridamole, isosorbide nitrate, trapidyl, nicorandil, nisoldipine, nitrendipine, nitroglycerin, nifedipine, nilvadipine, hepronicartine, Acid enalapril, altron, elastase, clinofibrate, clofibrate, cholestyramine, simfibrate, nicomol, niceritrol, pravastatin sodium, probucol, bezafibrate, melinamide, argatroban, ibudilast, ethiephrine hydrochloride, nicardipine hydrochloride, meclofenoxate hydrochloride , Γ-aminobutyric acid, ifenpro tartrate , Nicergoline, pyridinol carbamate, vinpocetine, nizophenone fumarate, benoplant, cinepazide maleate, etc.), emollients (sulfur, urea, salicylic acid, etc.), hormonal agents (estradiol, etc.), bronchodilators (tulobuterol, etc.), Herbal components or extracts thereof (herbal extract such as pepper extract, herbal extract such as assembly flow extract, dried herbal extract such as dried mackerel extract, herbal powder such as prunus powder, herbal tincture such as arnica tincture, eucalyptus oil and Essential oils such as peppermint oil), keratinization improvers, moisturizers (amino acids such as alanine, serine, leucine, isoleucine, threonine, glycine, proline, hydroxyproline, glucosamine, theanine and derivatives thereof; collagen, collagen peptides, gelatin, etc. Pep Polyhydric alcohols such as glycerin, 1,3-butylene glycol, propylene glycol and polyethylene glycol; sugar alcohols such as sorbitol; phospholipids such as lecithin and hydrogenated lecithin; hyaluronic acid, heparin, heparin-like substances, chondroitin, etc. Mucopolysaccharides: In addition to NMF-derived components such as lactic acid, sodium pyrrolidonecarboxylate, urea, etc., polyglutamic acid, squalane, etc., whitening agents (L-ascorbic acid and salts thereof or derivatives thereof, hydroquinone and derivatives thereof, cysteine and derivatives thereof, Glucosamine and derivatives thereof, azelaic acid and derivatives thereof, lipoic acid and derivatives thereof and salts thereof, resorcin and derivatives thereof, γ-oryzanol and derivatives thereof, grabrizine, grabrene, liquiritin, isoliquiritin, glucose Tathion, hinokitiol and glycosides thereof, and salts thereof, ellagic acid and derivatives thereof, and salts thereof, placenta extract, genus genus, zinc genus, camellia, genus genus, genus genus, genus genus Yarrow, Chrysanthemum, Shinanoki, Iwayukinosita, Ginseng, Gamppi, Mitsumata, Button, Licorice, Mulberry, Enju, Rose, Aloe, Elder, Genus, Dokudami, Kanaooi Extracts of one or more plants belonging to the genus, genus Camellia, sunflower genus, genus Amadocora, flax genus, canto genus, moth genus, mint genus, japonica genus, gardenia genus, and the genus Caenothera, coral genus, yakuzusa Genus, Amygusa, Hijiki, Sozo, Fusunagi, Siwa Extract of one or more algae belonging to the genus Genus, Darus genus, Honda walla genus, Mok genus, Nagamatsu genus, Ishimo genus, Futomo genus, Okinawa genus, etc.) and / or a wrinkle improving agent (retinol, retinoic acid, Hyaluronic acid, hydroxy acid, etc.). Any of these medicinal ingredients can be used alone or in combination of two or more, and the amount is usually 0.01 to 30% by weight, particularly 0.05 to 25% by weight of the hydrophilic base.

  In order to enhance the absorption promotion or sustainability of these medicinal ingredients, a solubilizer or an absorption promoter can be blended. Examples of the solubilizer include oleic acid, propylene carbonate, polyethylene glycol, myristic acid esters (isopropyl myristate, butyl myristate, etc.), palmitic acid esters (isopropyl palmitate, cetyl palmitate, etc.), stearic acid esters ( Butyl stearate, isocetyl stearate, etc.), sebacic acid esters (diethyl sebacate, diisopropyl sebacate, etc.), linoleic acid esters (ethyl linoleate, isopropyl linoleate, etc.), propylene glycol, crotamiton, oleyl alcohol, dimethyl sulfoxide Mint oil, eucalyptus oil, castor oil, l-limonene, d-limonene, dl-limonene or other essential oils. Absorption enhancers include, for example, diisopropyl adipate, lecithin, squalane, squalene, azone, l-menthol, polyethylene glycol, isopropyl myristate, crotamiton, dimethyl sulfoxide, peppermint oil, eucalyptus oil, d-limonene, dl-limonene or other Examples include essential oils. These solubilizers or absorption promoters can be used alone or in combination of two or more, and the blending amount is not particularly limited, but is usually 0.5 to 30% by weight of the hydrophilic base. Is preferred.

  Moreover, in order to disperse the medicinal component uniformly in the plaster base, a surfactant (lecithin derivative, propylene glycol fatty acid ester, glycerin fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, Polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbit fatty acid ester, polyoxyethylene alkylphenyl formaldehyde condensate, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sterol, polyoxyethylene hydrogenated sterol, polyethylene glycol Fatty acid ester, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene ether It is also possible to formulate one or more kinds of kill phenyl ether). The blending amount is not particularly limited, but it is usually preferably 0.1 to 20% by weight of the hydrophilic base.

  Examples of the water-soluble polymer include gelatin, starch, agar, mannan, alginic acid, alginate, polyacrylic acid, polyacrylate, dextrin, methylcellulose, sodium methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, Examples thereof include methyl vinyl ether-maleic anhydride copolymer, carboxyvinyl polymer, gum arabic, tragacanth gum, karaya gum, locust bean gum, and the like, either of which can be used alone or in combination of two or more. These water-soluble polymers are usually preferably blended in an amount of 0.5 to 50% by weight, particularly 1 to 20% by weight, based on the entire hydrophilic base composition. If this ratio is too small, gel formation is difficult, and if it is too large, the water-soluble polymer is difficult to dissolve uniformly. Moreover, it is preferable to mix | blend water normally 20 to 80weight% of a hydrophilic base, especially 25 to 70weight%.

  The other components are not particularly limited as long as they are usually used as plaster components. For example, humectants (concentrated glycerin, glycerin, sorbitol, lactic acid, urea, propylene glycol, ethylene glycol, diethylene glycol, triethylene glycol, Polyethylene glycol, 1,3-butylene glycol, etc.), inorganic powders (kaolin, titanium oxide, talc, bentonite, zinc oxide, montmorillonite, silicic anhydride, etc.), crosslinking agents (aluminum compounds, magnesium compounds, calcium compounds, etc.), Preservatives (thymol, benzalkonium chloride, parabens, etc.), antioxidants (ascorbic acid, stearic acid ester, gallic acid ester, disodium edetate, dibutylhydroxytoluene, butylhydroxyanisole, etc.), pH adjuster ( Acid, boric acid, citric acid, acetic acid, malic acid, tartaric acid, lactic acid and their salts, sodium hydroxide, diethanolamine, triethanolamine, diisopropanolamine, etc.), perfumes, pigments, etc. It can mix | blend suitably in the range which is not.

  The hydrophilic base obtained by using these components preferably has a viscosity of 600,000 to 12 million mPa · s, particularly 700,000 to 10 million mPa · s. With low-viscosity pastes of less than 600,000 mPa · s, oozing occurs during production, and residual plaster is seen when it is too soft, so that the feeling of use is inferior. When the viscosity exceeds 12 million mPa · s, In some cases, the accuracy of the coating amount cannot be obtained, and sufficient adhesive strength cannot be obtained. Here, the viscosity is in accordance with the 14th revised Japanese Pharmacopoeia Part 1, General Test Method "45. Viscosity Measurement Method 2 Method Rotational Viscometer Method". Measured at 20 ° C.

[Production method]
The skin patch of the present invention is produced, for example, by applying a hydrophilic base on a support, further sticking a fat-absorbing release sheet, and then cutting into a size and shape according to the purpose of use. The Moreover, it can manufacture also by apply | coating a hydrophilic base on a fat-absorbing release sheet, and covering this with a support body and then cutting. Furthermore, it can manufacture also by cutting, after pinching | interposing a hydrophilic base with a support body and a greasy release sheet.

[Form / Usage]
Examples of the form of the skin patch of the present invention include a plaster using a lipophilic base, such as a cataplasm using a hydrophilic base, a cooling sheet for skin, and a cosmetic sheet. What used the agent is preferable.

  The skin patch of the present invention can be used by peeling off the release sheet and sticking it to the application site of the skin, in the same manner as a normal skin patch. Since the release sheet absorbs the separated excess oil even when the hydrophilic base causes bleeding, the base surface maintains high adhesiveness. In addition, it is possible to easily remove the sebum at the application site using the absorbent absorbent release sheet before applying to the skin, thereby making it more difficult to peel off from the skin surface.

Examples 1-4 and Comparative Examples 1-2
[Peeling sheet]
As a release sheet used in the examples, commercially available oil-blowing film Shiromoto “STF Oil Clear Film Moist Type” (3M Microporous Film) and Shiromoto “STF Oil Clear Film Sweaty Smooth Type” (3M Microporous Film) A polypropylene diamond embossed film and a polyester release film (Purex film) were used as release sheets for the comparative examples. When these fat-absorbing capacities were measured according to the following method, they were as shown in Table 1.

・ Absorbency measuring method
(1) The length and width of the sample (8-9 cm × 5-5.5 cm) were precisely measured with a caliper to determine the area.
(2) The sample weight (mg) was measured.
(3) Impregnated with mineral oil (liquid paraffin) and left for 1 minute.
(4) After the oil remaining on the surface was wiped off with a paper towel, the sample weight (mg) was measured again.
(5) The amount of oil absorption was determined from the weight change due to impregnation with mineral oil.
(6) The oil absorption capacity (oil absorption per unit area; mg / cm ² ) was determined from the area value and the oil absorption.

[Support]
The support shown in Table 2 was used.

[Base]
As the base, a hydrophilic base having the composition shown in Table 3 was used.

  The release sheet shown in Table 1, the support shown in Table 2, and the base shown in Table 3 were combined, and the poultices shown in Table 4 (Examples 1 and 4, Comparative Example 1) and the cosmetic sheet pack (Example 2). 3 and Comparative Example 2) were produced.

  In Example 1 and Comparative Example 1, Example 2 and Comparative Example 2, adhesive strength was evaluated by a sensory test that was actually used.

Sensory evaluation The poultices of Example 1 and Comparative Example 1 were affixed to the left and right upper arms of 10 subjects, and the state (adhesiveness) after 6 hours was evaluated. Moreover, the cosmetic sheet-like packs of Example 2 and Comparative Example 2 were respectively attached to the left and right cheeks of 10 subjects, and the state (adhesiveness) after 1 hour was evaluated. At this time, in Example 2 and Comparative Example 2, the test was performed after wiping off the sebum on the application surface with a release sheet before application.
The results are shown in Table 5.

Examples 5-7 and Comparative Examples 3-5
In the products shown in Table 6 (one year after production), the existing release sheet was peeled off, and instead of this, the release sheet shown in Table 1 was attached to each application surface, and Examples 5 to 7 shown in Table 7 and Comparative Examples 3 to 5 were produced. In addition, the adhesive strength was evaluated in each of the samples left at room temperature for 2 days.

[Adhesive strength evaluation method]
In Examples 5 to 7 and Comparative Examples 3 to 5, the adhesive strength was evaluated by the following ball tack test method.

・ Ball tack test
Follow the tilting ball tack test of JISZ-0237 standard. The inclination angle at this time is 30 °.
The results are shown in Table 8.

Claims (5)

  An outer skin patch in which a base layer is formed on a support, and a release sheet having absorptivity is adhered to the surface of the base layer. Oil absorption capacity of oil absorption release sheet, dermatological patch according claim 1 is 0.3~4.0mg / cm ^2.   The skin patch according to claim 1 or 2, wherein the oil-absorbent release sheet comprises a porous stretched plastic film.   The skin patch according to any one of claims 1 to 3, wherein the base layer is made of a hydrophilic base.   The skin patch according to claim 4, wherein the absorbent absorbent release sheet has no water absorbency on the surface in contact with the hydrophilic base layer.