JPH06145047A - Hydrous skin patch for external use having improved utility - Google Patents

Abstract

PURPOSE:To obtain a skin patch for external use having flexibility, and no feeling of physical disorder in application, not dropping from skin, not requiring other fixation assisting means, having neither rash symptoms nor keratin layer damage during peeling. CONSTITUTION:A hydrous skin patch for external use comprises 15-60% water, 2-20% water-insoluble tackifier resin such as ester gum, 0.4-10% dissolving agent for the tackifier resin, such as liquid paraffin and 0.1-30% oil absorbing inorganic powder such as kaolin and is equipped with a tacky agent layer having 100-1,000mum thickness.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION The present invention contains water, a tackifying resin and its solubilizer, and an oil-absorbing inorganic powder as essential constituents in a pressure-sensitive adhesive layer, and is applied to skin which can be used for medicines and the like. The present invention relates to a hydrous external skin patch for direct use.

[0002]

2. Description of the Related Art Since ancient times, attempts have been made to treat systemic and local diseases by various external means. Means of applying liquids, ointments, etc. need to be applied relatively often because the drug is scraped off by clothes, and moreover, clothes are contaminated with drugs and the diseased part is protected. It has the drawback of not being able to do so, and requires an auxiliary means of covering with a bandage or the like to prevent them.

In order to solve such a problem, the form of the external skin patch is generally known. One of the forms is a rubber adhesive, an acrylic resin adhesive, etc. So-called plasters and tapes, which do not contain water, have a strong adhesive force by themselves and are relatively thin (1 mm or less even if the carrier and the adhesive layer are combined), so it is applied to the diseased site. Even though it does not come off easily, it has the advantage that it can protect the diseased part, which is not found in the application agent, but it causes rash symptoms due to the obstruction of the skin surface for a long time, and strong adhesion. Due to the strong force, strong physical irritation is caused during peeling, the hair is peeled off, and dermatitis due to damage to the stratum corneum of the skin is frequently seen.Because of its nature, application to the hair body part is difficult. The drawback of being hesitated To.

The so-called molded poultice having a relatively high water content, which is another form, does not have the problem of physical skin irritation that plasters and tapes have, as described above. Although the occlusion state is relieved and the frequency of occurrence of rash symptoms is considerably reduced, the adhesive strength of itself is weak, and therefore the adhesive layer must be thickened to provide adhesive strength, and Since it is relatively thick (1.5 mm or more when the carrier and adhesive layer are combined), it lacks flexibility, and it feels uncomfortable when attached and easily falls off. For reliable fixing, it is an auxiliary material such as a bandage or a fixing adhesive tape. It usually requires some means.

[0005]

Although there are no problems such as skin irritation in the conventionally known hydrous molded poultices, when the thickness of the pressure-sensitive adhesive layer is reduced, the tackiness decreases.
It is customary that it will not be practically used as a patch, and it has been impossible to provide a water-containing molded poultice that is thin and has sufficient adhesive strength. On the other hand, in the case of known plasters and tapes, it is possible to give a sufficient adhesive force even if the thickness of the adhesive layer is thin, but it is difficult to avoid the problem of skin irritation. Therefore, it has been impossible to provide a skin external patch that is not irritating to the skin, is thin and has sufficient adhesive force, and does not fall off during application, and is excellent in usability by the conventional techniques.

[0006] The present invention is intended to solve the drawbacks of the above-mentioned conventionally known external patch for skin, and its object is to make plasters and tapes have no discomfort at the time of application and to be hard to drop off. It is intended to provide a new hydrous external skin patch which is excellent in usability and which also retains the skin safety of a poultice, while maintaining excellent properties such as roughness.

[0007]

Means for Solving the Problems As a result of earnest research, the present inventors have added water, a tackifying resin and its solubilizer, and an oil-absorbing inorganic powder to the adhesive composition as essential constituents. According to the present invention, the disadvantages of the conventionally known external skin patches were solved all at once, and it was found that a new hydrous external skin patch having extremely excellent usability was obtained, and the present invention was completed. It was

That is, the present invention provides a pressure-sensitive adhesive layer containing water, a tackifying resin and its solubilizer, and an oil-absorbing inorganic powder as essential components on a support, and prepared by mixing them uniformly. The present invention is intended to provide a hydrous external skin patch having a thickness of 100 to 1000 μm.

[0009] Conventional plasters, tapes and the like cannot contain water, so that the problem of skin irritation was difficult to avoid, but the adhesive composition of the present invention is characterized by containing water. The content of the adhesive composition is 15 to 60% by weight, more preferably 20 to 50% by weight.
% By weight.

Examples of the tackifying resin used in the present invention include rosin-based resins, terpene-based resins, petroleum-based resins, and other almost water-insoluble resins. 2 to 20% by weight, more preferably 5 to 20% by weight. If it is less than 2% by weight, there is no point in blending it substantially, and if it is 20% by weight or more, the peelability from the release liner film is lowered, which causes difficulty in production.

As the tackifier resin solubilizer, tackifier resins such as animal oils such as beef tallow and lard, vegetable oils such as olive oil, sesame oil and soybean oil, mineral oils such as petrolatum and liquid paraffin, and medium chain fatty acid triglyceride can be used. Any one may be used as long as it dissolves, but those that are liquid at room temperature can be used favorably without decreasing the tackiness of the product of the present invention,
The blending amount may be any amount as long as it can dissolve a predetermined amount of tackifying resin, but an excessive amount may weaken the shape retention of the pressure-sensitive adhesive layer. It is preferable to use the necessary minimum amount, and the blending amount is 1/5 to 1/2 with respect to the predetermined amount of the tackifying resin, and 0.4 to 10% by weight in the present pressure-sensitive adhesive composition. Is.

Examples of the oil-absorbing inorganic powder include kaolin, talc, silicon dioxide, magnesium aluminometasilicate and the like, and these components are 20 to 400 v / w%.
It has an oil absorption capacity of 1), but these can be used alone or in combination of 2 or more, and the compounding amount thereof is 0.1 to 30% by weight of the pressure-sensitive adhesive composition, more preferably 1 to 1%.
It is 5% by weight. If it is less than 0.1% by weight, there is no point in blending it substantially, and if it is 30% by weight or more, the obtained patch becomes hard and loses flexibility, which is not preferable. In the present invention, this component is considered to exhibit a function of adsorbing an oil component blended as a solubilizer of a tackifying resin and stably holding the tackifying resin in a water-containing base, According to the results of Test Example 5 described later, the storage stability is poor in Comparative Examples not containing this component, and it is understood that this component is an important component constituting the present invention.

The thickness of the pressure-sensitive adhesive layer is particularly important in the hydrous external skin patch of the present invention. Generally, when the thickness of the pressure-sensitive adhesive layer is increased, the pressure-sensitive adhesive force is increased, but on the contrary, the flexibility is lowered, the discomfort at the time of sticking is increased, and the pressure-sensitive adhesive layer is easily removed. In the conventionally known hydrous molded poultices, the adhesive strength of the adhesive itself is relatively weak, and it is necessary to have a certain thickness to expect a certain degree of adhesive strength. Therefore, the problem of falling off when sticking is inevitable. It was According to the hydrous external skin patch of the present invention comprising a tackifying resin as an essential component, the adhesive layer has sufficient adhesive force even if the adhesive layer is thin, and therefore from the point of the invention of improving usability. If so, it is preferable to make it as thin as possible, but from the viewpoint of reducing the amount of drug that can be contained,
In the hydrous external skin patch of the present invention, the pressure-sensitive adhesive layer has a thickness of 100 to 1000 μm, more preferably 100 to 8 μm.
00 μm is preferable.

In the pressure-sensitive adhesive composition of the present invention, gelatin, carboxymethyl cellulose, methyl cellulose,
Water-soluble polymers such as polyvinyl alcohol, polyacrylic acid and their metal salts, glycerin, sorbitol,
Polyethylene glycol, propylene glycol, 1,
A polyhydric alcohol such as 3-butylene glycol, a zinc oxide, a metal cross-linking agent such as a synthetic aluminum silicate, and an aluminum hydroxide gel may be appropriately combined and blended as necessary.

The amount of the water-soluble polymer compounded is usually 5 to 20% by weight of the present pressure-sensitive adhesive composition. If the amount is too small, the strength of the resulting composition will be weak and the composition will easily drip when applied.
If the amount is too large, the strength of the resulting composition is too strong, which causes difficulty in production. The content of the polyhydric alcohol is usually 15 to 60% by weight of the present pressure-sensitive adhesive composition, and when the amount is too small, the water retention is insufficient, and the water easily volatilizes due to the body temperature during application,
It cannot withstand application for a long time, and if it is too much, it becomes difficult to mix other components. The content of the metal cross-linking agent is usually 0.01 to 10% by weight of the present pressure-sensitive adhesive composition, and if it is too small, the cross-linking is too weak to maintain the form as a patch, and if it is too large, the cross-linking is performed. Is too strong and causes manufacturing difficulties.

Further, in the pressure-sensitive adhesive composition of the present invention, a pH adjusting agent such as an organic acid, an organic base, an inorganic acid or an inorganic base, a stabilizer such as sodium edetate, dibutylhydroxytoluene or sodium bisulfite, Paraoxybenzoic acid esters, preservatives such as benzyl alcohol, thymol, drug dissolving agents such as crotamiton, benzyl alcohol, fatty acid esters, surfactants such as polysorbates, sucrose fatty acid esters, polyoxyethylene alkyl ethers, etc. Can also be appropriately mixed.

In order to use the product of the present invention as a medicine, a topical stimulant such as methyl salicylate, glycol salicylate, camphor, menthol, capsicum extract, vanillylamide nonylate, tocopherol acetate, tocopherol nicotinate, etc., peripheral blood flow. Improvers, antihistamines such as diphenhydramine, chlorpheniramine maleate, isothipendyl hydrochloride, etc., extracts and powders of anti-inflammatory herbal medicines such as Touki, Oataku, Sanshishi, Arnica, horse mackerel, glycyrrhetinic acid, indomethacin, piroxicam, ketoprofen, flurbiprofen , Nonsteroidal anti-inflammatory analgesics such as felbinac, external steroids such as prednisolone, hydrocortisone, dexamethasone, fluocinolone acetonide, antipruritics such as crotamiton, lidocaine, Local anesthetics such as Bukain, chlorhexidine gluconate, cetylpyridinium chloride, can be formulated disinfectant such as benzalkonium chloride.

The hydrous external skin patch of the present invention contains water, a tackifying resin dissolved in a solubilizer, and an oil-absorbing inorganic powder as essential constituents, and is prepared by uniformly mixing them. Spread the material on a smooth carrier and apply a thickness of 10
A uniform pressure-sensitive adhesive layer having a thickness of 0 to 1000 μm is formed and coated with a release liner film, or the pressure-sensitive adhesive layer is formed on a smooth liner film to a thickness of 100 to 1000 μm and coated with a carrier. can get.

In the case of a water-containing pressure-sensitive adhesive layer such as the product of the present invention, a woven fabric or a non-woven fabric is preferable as the carrier to be used from the viewpoint of anchoring property, but polyethylene is provided on the side opposite to the pressure-sensitive adhesive layer. A composite film formed with a plastic film such as vinyl chloride is also favorably used.

Although these carriers can be moisture-permeable or moisture-impermeable, it is preferable that they be moisture-permeable from the point of the present invention and the viewpoint of skin safety. Further, these carriers may be stretchable or non-stretchable, but it is preferable that they be stretchable in consideration of use in a flexed portion such as an elbow and a knee.

As the release liner film to be used, those usually used such as polyethylene, polypropylene, polyethylene terephthalate and paper can be appropriately used. If necessary, a silicone treatment may be carried out to adjust the release property, It can also be embossed.

[0022]

EFFECTS OF THE INVENTION Although there is no problem of skin irritation in hitherto known hydrous molded poultices, when the thickness of the pressure-sensitive adhesive layer is reduced, the tackiness decreases, and thus it is practically not used as a patch. It is usually lost, and it has been impossible to provide a water-containing molded poultice that is thin and has sufficient adhesive strength. On the other hand, in the case of conventionally known substantially anhydrous plasters and tapes, it is possible to give sufficient adhesive force even if the thickness of the adhesive layer is reduced, but avoid the problem of skin irritation. It was difficult. Therefore, it has been impossible to provide a skin external patch that is not irritating to the skin, is thin and has sufficient adhesive force, and does not fall off during application, and is excellent in usability by the conventional techniques.

According to the hydrous external skin patch of the present invention in which a tackifying resin is rationally blended in a hydrous base, a preparation having sufficient adhesive strength even if the thickness of the adhesive layer is reduced. Since it contains the same amount of water as the conventional hydrous molded poultice, it does not cause skin irritation.

That is, according to the present invention, it has sufficient flexibility, does not feel uncomfortable when applied, and does not fall off,
Therefore, an ideal external patch for external use having extremely excellent usability, which does not require other auxiliary means for fixation, does not cause rash symptoms, and does not damage the stratum corneum during peeling Obtainable. Hereinafter, the present invention will be specifically described with reference to examples. The present invention is not limited to these examples.

[0025]

【Example】

 Examples 1-8

[0026]

[Table 1] Table 1: Composition of the adhesive composition (unit: g) Example No. 1 2 3 4 5 6 7 8 Component ester gum * 2.5 2.5 5.0 5.0 7.5 7.5 15.0 15.0 Liquid paraffin 0.5 1.25 1.0 2.5 1.5 3.75 3.0 7.5 Polyacrylic acid 5 5 5 5 5 5 5 5 Sodium dry aluminum hydroxide 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 Nigel lactic acid 1 1 1 1 1 1 1 1 Concentrated glycerin 30 30 30 30 30 30 30 30 D- Sorbitol solution 15 15 15 15 15 15 15 15 Purified water 35.7 34.95 32.7 31.2 29.7 27.45 20.7 16.2 Carboxymethyl cell 3 3 3 3 3 3 3 3 3 Sodium sucrose Kaolin 5 5 5 5 5 5 5 5 5 Purified gelatin 2 2 2 2 2 2 2 2 2 * KE-311: Arakawa Chemical Industry Co., Ltd.

In the composition shown in Table 1, sodium polyacrylate, dried aluminum hydroxide gel, lactic acid, concentrated glycerin, D-sorbitol acid, sodium carboxymethyl cellulose, kaolin, purified gelatin and purified water were mixed, and liquid paraffin was added to the mixture. The ester gum dissolved in the above was added, and the composition obtained by stirring with a stirrer until the quality became uniform was spread-coated on a release liner film made of polyethylene terephthalate to a thickness of 500 μm. The skin external patch of the present invention is obtained by coating with a stretchable woven fabric.

Example 9 The procedure of Example 6 was repeated except that the pressure-sensitive adhesive layer had a thickness of 750 μm. Example 10 The same procedure as in Example 6 was carried out except that the pressure-sensitive adhesive layer had a thickness of 1000 μm. Example 11 The same procedure as in Example 6 was carried out except that the thickness of the pressure-sensitive adhesive layer was 100 μm.

Example 12 In Example 5, the ester gum was changed from KE-311 (Arakawa Chemical Industry Co., Ltd.) to AAG (Arakawa Chemical Industry Co., Ltd.).
It was made in the same manner except that it was replaced with. Example 13 The same procedure as in Example 5 was performed except that the ester gum was changed from KE-311 (manufactured by Arakawa Chemical Industry Co., Ltd.) to DS-90S (manufactured by Harima Chemicals Co., Ltd.).

Example 14 The procedure of Example 5 was repeated except that the solvent for the tackifying resin was changed from liquid paraffin to medium-chain fatty acid triglyceride Triester F-810 (manufactured by Nikko Chemicals Co., Ltd.). did. Example 15 In the same manner as in Example 5, except that the solvent for the tackifying resin was changed from liquid paraffin to sesame oil (JP), the same production was carried out.

Example 16 The procedure of Example 5 was repeated except that the solvent for the tackifying resin was changed from liquid paraffin to Coconade MK (Kao Corporation), which is a medium-chain fatty acid triglyceride.

Example 17 Sodium polyacrylate 5 g, zinc oxide 1 g, phosphoric acid 1 g, concentrated glycerin 30 g, D-sorbitol liquid 15
g, sodium carboxymethylcellulose 3g, kaolin 5g, purified gelatin 2g, purified water 29g,
To this, 7.5 g of ester gum (KE-311: manufactured by Arakawa Chemical Co., Ltd.) dissolved in 1.5 g of liquid paraffin was added,
Compositions obtained by stirring with a stirrer until the quality became uniform were produced in the same manner as in Examples 1 to 8 below.

Example 18 5 g of sodium polyacrylate, 2 g of synthetic aluminum silicate, 0.3 g of sodium metaphosphate, 30 g of concentrated glycerin, 15 g of D-sorbitol solution, 7 g of kaolin, 2 g of purified gelatin, and 29.7 g of purified water were mixed. , An ester gum dissolved in 1.5 g of liquid paraffin (KE-
311: Arakawa Chemical Co., Ltd.) (7.5 g) was added, and a composition obtained by stirring with a stirrer until the quality became uniform was produced in the same manner as in Examples 1 to 8 below.

Comparative Example 1 Sodium polyacrylate 5 g, dried aluminum hydroxide gel 0.3 g, lactic acid 1 g, concentrated glycerin 30 g, D-
15 g of sorbitol liquid, 3 g of sodium carboxymethyl cellulose, 5 g of kaolin, 2 g of purified gelatin, and 38.7 g of purified water were mixed, and the mixture was stirred with a stirrer until the quality became uniform, so that the composition had a thickness of 100 μm. Comparative Example 1 was obtained by spreading on a release liner film made of polyethylene terephthalate and covering with a stretchable woven fabric made of polyester.

Comparative Example 2 Comparative Example 2 was obtained in the same manner as Comparative Example 1 except that the pressure-sensitive adhesive layer had a thickness of 500 μm. Comparative Example 3 Comparative Example 3 was obtained in the same manner as Comparative Example 1 except that the pressure-sensitive adhesive layer had a thickness of 1000 μm. Comparative Example 4 Comparative Example 4 was obtained in the same manner as Comparative Example 1 except that the thickness of the pressure-sensitive adhesive layer was 1500 μm.

Comparative Example 5 Comparative Example 5 was prepared in the same manner as in Example 17, except that the ester gum and liquid paraffin were removed. Comparative Example 6 Comparative Example 6 was obtained in the same manner as in Example 18, except that the ester gum and liquid paraffin were removed. Comparative Examples 7 to 9 Comparative Examples 7, 8 and 9 were prepared by removing kaolin from Examples 5, 17 and 18, supplementing the amount with water, and otherwise making the same.
Got

Test Example 1 <Adhesion Test> Examples 1 to 18, Comparative Examples 1 to 6, commercially available tape preparations (tape preparations (A), (B) and (C)) and commercially available poultice preparations (puppet preparations). 5 using (A) and (B))
The horizontal peeling load from the stainless steel plate after a load of 00 g / cm ² · min was measured. The results are shown in Tables 2 and 3.

Test Example 2 <Rat Skin Damage Test> Examples 1 to 18 and Comparative Examples 1 to 1
6. A rat skin damage test was carried out using commercially available tape preparations (tape preparations (A), (B) and (C)) and commercially available poultice preparations (Pap preparations (A) and (B)). Test method: Each sample is cut into 2 × 2 cm ^2, and the operation of sticking to the shaved rat abdominal skin and immediately peeling is repeated at the same site, and the number of times of sticking until the stratum corneum is peeled off is measured. However, when the peeling did not occur even after 20 times, it was judged as "no peeling". The results are shown in Tables 4 and 5.

Test Example 3 <24-hour patch test> Examples 2, 6, 8, 12, 1
3,15,17,18, Patches on healthy adults using commercially available tape preparations (tape preparations (A), (B) and (C)) and commercially available poultice preparations (Pap preparations (A) and (B)) The test was conducted. Test method: Each sample cut into 1.5 cm × 1.5 cm was attached to the upper arm flexion site of 13 healthy adults, covered and fixed with elastpore tape (Nichiban Co., Ltd.), and removed after 24 hours. The condition of the skin at 1 and 24 hours after the removal was observed and scored according to the following criteria, and the skin irritation index was calculated according to the formula 1. Scoring criteria: no reaction 0 point slight erythema 0.5 point clear erythema 1 point erythema + edema or papule 2 points erythema + edema + papule, vesicle 3 points blister, necrosis 4 points The results are shown in Table 6.

[0040]

[Equation 1]

Test Example 4 <Flex extension site sticking test> Examples 2, 6, 8, 10, 1
1, 12, 13, 15, 17, 18, Comparative Examples 1 to 6, commercially available tape agents (tape agents (A), (B) and (C)) and commercially available poultice agents (poultice agents (A) and ( B)) was used to carry out a patch test on a flexion and extension site of a healthy adult. Test method: A sample cut into 7 cm x 10 cm was attached to the knee of a healthy adult during extension, and the state when the knee was immediately bent strongly was observed. Judgment: peeling off × partly peeling off Δnot peeling off ○ The results are shown in Table 7.

Test Example 5 <Storage stability test> Examples 5, 17, 18 and Comparative Example 7,
A storage stability test was carried out using Nos. 8 and 9. Test method: Each sample is placed in an aluminum bag and hermetically sealed at 50 ° C.
The sample was stored in an incubator of No. 1 and the state of exudation of the oil component on the support side after one week was observed. Judgment: With bleeding out × Without bleeding out ○ The results are shown in Table 8.

[0043]

[Table 2]

[0044]

[Table 3]

[0045]

[Table 4]

[0046]

[Table 5]

[0047]

[Table 6]

[0048]

[Table 7]

[0049]

[Table 8] Table 8: Results of storage stability test Example ratio Comparative sample No. 5 17 18 7 8 9 Judgment ○ ○ ○ × × ×

According to the above results, the comparative example not containing the tackifying resin and the commercially available poultice showed good results in the rat skin damage test and the 24-hour patch test, but the tackiness It can be seen that is small, and is greatly affected by the thickness of the pressure-sensitive adhesive layer, and that a thin one is almost useless as a patch.

The commercially available tapes show strong adhesiveness, but in the rat skin damage test, the stratum corneum was peeled off 3 to 4 times, and the skin irritation index was also found in the 24 hour patch test. It seems that there is a big problem in terms of safety. On the other hand, all of the examples of the present invention have good adhesiveness and do not damage the stratum corneum of the skin during peeling or cause skin irritation.

From this, it is understood that the present invention provides an ideal external patch for skin, which was impossible with the prior art. Hereinafter, formulation examples based on the present invention will be shown.

Formulation Example 1 Patch containing methyl salicylate, 1-menthol, etc. Methyl salicylate 1.5 g 1-Menthol 0.5 g Ester gum 7.5 g Liquid paraffin 1.5 g Sodium polyacrylate 5.0 g Dry aluminum hydroxide gel 0 .3 g Lactic acid 1.0 g Concentrated glycerin 30 g D-sorbitol solution 15 g Purified water 32.7 g Carboxymethyl cellulose sodium 3.0 g Purified gelatin 2.0 g Total amount 100 g

Formulation Example 2 Patch containing ethylene glycol salicylate, 1-menthol, etc. Ethylene glycol salicylate 1.5 g 1-menthol 0.5 g Mint oil 1.0 g Ester gum 7.5 g Liquid paraffin 1.5 g Sodium polyacrylate 5. 0 g Synthetic aluminum silicate 2.0 g Sodium metaphosphate 0.3 g 1N-hydrochloric acid 3.5 g Concentrated glycerin 30 g D-sorbitol solution 15 g Purified water 27.2 g Carboxymethylcellulose sodium 3.0 g Purified gelatin 2.0 g Total amount 100 g

Formulation Example 3 Patch containing fluocinolone acetonide Fluocinolone acetonide 0.01 g Ester gum 7.5 g Liquid paraffin 1.5 g Sodium polyacrylate 3.5 g Zinc oxide 0.5 g Phosphoric acid 1.0 g Concentrated Glycerin 30 g D-sorbitol solution 15 g Purified water 35.99 g Sodium carboxymethyl cellulose 3.0 g Purified gelatin 2.0 g Total amount 100 g

Formulation Example 4 Patch containing oat, etc. Oat powder 2.0 g Acetate dl-α-tocopherol 0.3 g Diphenhydramine 0.1 g Ester gum 7.5 g Coconard MK 1.5 g Sodium polyacrylate 5.0 g Dry aluminum hydroxide Gel 0.2 g Concentrated glycerin 30 g D-sorbitol solution 15 g Purified water 33.4 g Carboxymethylcellulose sodium 3.0 g Purified gelatin 2.0 g Total amount 100 g

Formulation Example 5 Lidocaine-containing patch Lidocaine 2.5 g Ester gum 7.5 g Liquid paraffin 1.5 g Sodium polyacrylate 5.0 g Dry aluminum hydroxide 0.3 g Tartaric acid 0.5 g Concentrated glycerin 30 g D-sorbitol liquid 15 g Purified water 32.7 g Sodium carboxymethyl cellulose 3.0 g Purified gelatin 2.0 g Total amount 100 g

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[Procedure amendment]

[Submission date] January 11, 1993

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be corrected] 0005

[Correction method] Change

[Correction content]

[0005]

Although there are no problems such as skin irritation in the conventionally known hydrous molded poultices, when the thickness of the pressure-sensitive adhesive layer is reduced, the tackiness decreases.
It is customary that it will no longer be practically used as a patch , and it has been impossible to provide a water-containing molded poultice that is thin and has sufficient adhesive strength. On the other hand, in the case of known plasters and tapes, it is possible to give a sufficient adhesive force even if the thickness of the adhesive layer is thin, but it is difficult to avoid the problem of skin irritation. Therefore, it has been impossible to provide a skin external patch that is not irritating to the skin, is thin and has sufficient adhesive force, and does not fall off during application, and is excellent in usability by the conventional techniques.

[Procedure Amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0017

[Correction method] Change

[Correction content]

Further, in order to use the product of the present invention as a medicine, a local stimulant such as methyl salicylate, glycol salicylate, camphor, menthol, capsicum extract, vanillylamide nonylate, tocopherol acetate and tocopherol nicotinate improve peripheral blood flow. Agents, antihistamines such as diphenhydramine, chlorpheniramine maleate, isothipendyl hydrochloride, etc., extracts and powders of anti-inflammatory herbal medicines such as Touki, Oataku, Sanshishi, Arnica, horse mackerel, glycyrrhetinic acid, indomethacin, piroxicam, ketoprofen, flurbiprofen, Non-steroidal anti-inflammatory analgesics such as felbinac, prednisolone, hydrocortisone, dexamethasone, external steroids such as fluocinolone acetonide, antipruritics such as crotamiton, lidocaine, Local anesthetics such as Bukain, chlorhexidine gluconate, cetylpyridinium chloride, can be formulated disinfectant such as benzalkonium chloride.

[Procedure 3]

[Document name to be amended] Statement

[Name of item to be corrected] 0027

[Correction method] Change

[Correction content]

In the composition shown in Table 1, sodium polyacrylate, dried aluminum hydroxide gel, lactic acid, concentrated glycerin, D-sorbitol solution , sodium carboxymethyl cellulose, kaolin, purified gelatin and purified water were mixed, and liquid paraffin was added to the mixture. The ester gum dissolved in the above was added, and the composition obtained by stirring with a stirrer until the quality became uniform was spread-coated on a release liner film made of polyethylene terephthalate to a thickness of 500 μm. The skin external patch of the present invention is obtained by coating with a stretchable woven fabric.

[Procedure amendment 4]

[Document name to be amended] Statement

[Name of item to be corrected] 0032

[Correction method] Change

[Correction content]

Example 17 Sodium polyacrylate 5
g, zinc oxide 1 g, phosphoric acid 1 g, concentrated glycerin 30 g,
D-sorbitol solution 15 g, sodium carboxymethyl cellulose 3 g, kaolin 5 g, purified gelatin 2 g,
29 g of purified water is mixed, and 1.5 g of liquid paraffin is added to this.
Ester gum dissolved in KE (KE-311: Arakawa Chemical Industry
The composition obtained by adding 7.5 g (manufactured by Co., Ltd.) and stirring with a stirrer until the quality became uniform was produced in the same manner as in Examples 1 to 8 below.

[Procedure Amendment 5]

[Document name to be amended] Statement

[Correction target item name] 0033

[Correction method] Change

[Correction content]

Example 18 5 g of sodium polyacrylate, 2 g of synthetic aluminum silicate, 0.3 g of sodium metaphosphate, 30 g of concentrated glycerin, 15 g of D-sorbitol solution, 7 g of kaolin, 2 g of purified gelatin, and 29.7 g of purified water were mixed. , An ester gum dissolved in 1.5 g of liquid paraffin (KE-
311: Arakawa Chemical Industry Co., Ltd. ( 7.5 g) was added, and a composition obtained by stirring with a stirrer until the quality became uniform was produced in the same manner as in Examples 1 to 8 below.

[Procedure correction 6]

[Document name to be amended] Statement

[Correction target item name] 0047

[Correction method] Change

[Correction content]

[0047]

[Table 6]

[Procedure Amendment 7]

[Document name to be amended] Statement

[Name of item to be corrected] 0057

[Correction method] Change

[Correction content]

Formulation Example 5 Lidocaine-containing patch Lidocaine 2.5 g Ester gum 7.5 g Liquid paraffin 1.5 g Sodium polyacrylate 5.0 g Dry aluminum hydroxide gel 0.3 g Tartaric acid 0.5 g Concentrated glycerin 30 g D-sorbitol Liquid 15 g Purified water 32.7 g Sodium carboxymethyl cellulose 3.0 g Purified gelatin 2.0 g Total amount 100 g

Claims (4)

[Claims] 1. A skin external patch comprising a carrier and a pressure-sensitive adhesive layer having a pressure-sensitive adhesive property at room temperature, wherein the pressure-sensitive adhesive layer comprises water, a tackifying resin and a dissolving agent thereof, and an oil-absorbing inorganic substance. It consists of powder as an essential constituent and its thickness is 100 to 10
A hydrous external skin patch having a size of 00 μm. 2. The pressure-sensitive adhesive layer contains 15 to 60% by weight of water, 2 to 20% by weight of a tackifying resin, 0.4 to 10% by weight of a solubilizer of the tackifying resin, and 0.1. The hydrous external skin patch according to claim 1, which contains 1 to 30% by weight as an essential component. 3. The hydrous external skin patch according to claim 1, wherein the tackifying resin is an ester gum. 4. The hydrous external skin patch according to claim 1, wherein the oil-absorbing inorganic powder is kaolin.