JPH10298066A - Plaster having warm feeling - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a plaster having high warming activities and hardly causing a skin irritation by forming a specific substrate layer containing water on a supporter layer comprising a foamed sheet of a synthetic resin and a woven or nonwoven fabric. SOLUTION: This plaster having warm feeling is obtained by forming a hydrophilic substrate layer containing 30-80 wt.% water on a fabric face of a supporter layer obtained by adhering a foamed sheet of a synthetic resin such as polystyrene and polyurethane to a woven or nonwoven fabric. Preferably, the foamed resin sheet has 0.1-10 mm thickness and 0.1-0.3 mm pore diameter, and the pore is preferably a closed cell. The hydrophilic substrate is exemplified by a polyacrylic acid, a gelatin, a casein, a pullulan and a dextran. Formulation of a nonsteroidal antiinflammatory agent such as indomethacin, ketoprofen and felbinac is preferable in view of the effect. The formulation of a blood flow promoter such as vitamin E acetate and a sodium polyethylenesulfonate is preferable in view of increasing effects of a skin temperature.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a patch, and more particularly, to a patch having an improved thermal effect at a site to be applied.

[0002]

2. Description of the Related Art Patches can be classified into two types according to their use. One is a cold patch which is mainly used for acute inflammation (sprain, bruise, etc.), and the other is a warm patch which is effective mainly for chronic inflammation (stiff shoulder, back pain, etc.). Treatment of acute inflammation requires cooling the affected area, whereas chronic inflammation requires conversely warming to relax muscles and increase blood flow.

JP-A-4-308527 describes a patch which exhibits a corset effect by using a support layer made of a woven or nonwoven fabric laminated on a foam layer. Patches prepared by mixing water with a base are widely used for the purpose of reducing physical irritation and increasing cool sensation when peeled in a cold sensation type. However, although a patch using a heat-retaining effect of water has been reported as a warming-type patch, a patch which is expected to have the same effect with a hydrophilic base is not known.

[0004]

SUMMARY OF THE INVENTION An object of the present invention is to provide a patch having a high thermal effect and little skin irritation.

[0005]

Means for Solving the Problems The present inventors have prepared a patch using a water-containing base layer using a foamed resin sheet provided with a woven or nonwoven fabric as a support. It has been found that such a patch has a high thermal effect when applied. In addition, they have also found out that such a patch also has an effect of reducing skin irritation caused by a nonsteroidal anti-inflammatory agent, and have completed the present invention.

That is, according to the present invention, a hydrophilic base layer containing 30 to 80% by weight of water is provided on a woven or nonwoven surface of a support layer in which a synthetic foamed resin sheet and a woven or nonwoven fabric are bonded. It is a warming patch characterized by the fact that

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION Examples of the foamed resin in the present invention include foamed resins such as polyethylene, polyethylene-vinyl acetate copolymer and mixtures thereof, polypropylene, polyvinyl chloride, polystyrene, urethane and the like. As the thickness of the foamed resin sheet, 0.1 to
It is preferably 10 mm, more preferably 0.2 to 4 mm. This is because if the sheet is too thin, the heat retaining effect is not sufficient, and if the sheet is too thick, the feeling of use deteriorates. As the foamed resin, any of closed cells and open cells can be used, but closed cells which do not hinder the heat retention are preferable in order to maximize the effect of suppressing the evaporation of water. The foamed resin used in the present invention may have a pore diameter of 0.1 to 0.3 mm. If the pore size is less than 0.1 mm, the heat insulating effect of the foamed resin is not sufficient, and if the pore size exceeds 0.3 mm,
This is because the heating effect is not sufficient.

[0008] The woven or nonwoven fabric in the present invention is not particularly limited as long as it is generally used for a patch. For example, woven or non-woven fabrics such as flannel, cotton, silk, polyester, and nylon can be used. The thickness of the woven or non-woven fabric can be from thin and coarse like gauze to thick one with a thickness of about 2 mm as long as it has an appropriate gap between eyes.

The hydrophilic base includes polyacrylic acid, gelatin, casein, pullulan, dextran, sodium alginate, soluble starch, carboxy starch,
Dextrin, carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, polyvinyl alcohol, polyethylene oxide, polyacrylamide, sodium polyacrylate, polyvinylpyrrolidone, carboxyvinyl polymer, polyvinylether, polymaleic acid copolymer, methoxyethylene maleic anhydride Conventionally used synthetic or semi-synthetic hydrophilic polymers such as acid copolymers, isobutylene maleic anhydride copolymers, and polyethyleneimines can be used. In the present invention, it is necessary to incorporate 30 to 80% by weight of water into the base, and preferably 50 to 80% by weight. 30
If the amount is less than 80% by weight, the heat retention effect is not sufficient.
If the amount is more than the above, the production becomes difficult.

In the patch of the present invention, the pH of the base is 3.
The range of 5 to 7 is preferable, and the range of 4 to 6.5 is more preferable. If the pH is out of the range of 3.5 to 7, skin irritation occurs.

In general, patches include anthranilic acids such as fenamic acid, phenylacetic acids such as diclofenac and felbinac, indoles such as indomethacin, propionic acids such as ketoprofen and flurbuprofen, and phenylbutazone. It is preferable from the viewpoint of the anti-inflammatory effect that a non-steroidal anti-inflammatory agent such as a benzothiazine-based compound such as pyrazolone or piroxicam, or a sulfonamide-based compound such as Nimeslide is blended. However, the present inventors have also found that these non-steroidal anti-inflammatory agents may themselves express skin irritation, but the patch of the present invention occurs when these anti-inflammatory agents are blended. It was also found that skin irritation was effective in reducing skin irritation caused by indomethacin. The effect of reducing skin irritation is presumed to be due to an increase in blood flow, but the specific reason is unknown.

The amount of the non-steroidal anti-inflammatory agent is preferably 0.1 to 10% by weight, more preferably 0.1 to 5% by weight in the base. In the case of a patch, the anti-inflammatory effect cannot be expected if the amount of the non-steroidal anti-inflammatory agent is less than 0.1% by weight, and if the amount exceeds 10% by weight, the skin irritates the non-steroidal anti-inflammatory agent itself. This is because there is a possibility of occurrence.

In the present invention, skin blood temperature promoting agents such as vitamin E acetate, sodium polyethylene sulfonate, vanillylamide nonylate, capsicum extract, capsicum powder, capsicum tincture, capsaicin, benzyl nicotinate, and pelargonic acid are formulated. It is preferable in terms of the ascending effect. As the blood flow promoter, vitamin E acetate, vanillyl amide nonylate, pepper extract, benzyl nicotinate or sodium polyethylenesulfonate are particularly preferable from the viewpoint of safety and efficacy. Here, the effect of increasing the skin temperature in the present invention is greatly affected by the blood flow promoting agent, so that the compounding concentration differs depending on the blood flow promoting agent. That is, vitamin E acetate is 0.1 to
5% by weight, nonylate vanillylamide is 0.001 to 0.
5% by weight, the pepper extract is 0.1% in terms of the crude drug equivalent.
1 to 30% by weight, benzyl nicotinate 0.01 to 5% by weight, sodium polyethylene sulfonate 0.01 to 5% by weight
It is preferable to mix in a range of 5% by weight. If the amount is less than the above range, the effect of blending the blood flow promoter cannot be sufficiently obtained, and if the amount exceeds the range, skin irritation may occur.

The patch of the present invention may contain a lower alcohol (methanol, ethanol, denatured ethanol,
Isopropyl alcohol, etc., dissolution aids (diisopropyl adipate, isopropyl myristate, 1,3
-Butylene glycol, propylene glycol, polyethylene glycol, glycerin, medium chain fatty acid triglycerides, fatty acid esters, various vegetable oils, various animal oils, polyhydric alcohol fatty acid esters, alkyl glyceryl ethers, hydrocarbons, lactic acid, sodium hydroxide, etc.), interface Activator (sorbitan fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, propylene glycol fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbite fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyethylene glycol fatty acid ester, polyoxyethylene Alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene alkyl Phenyl ether, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyethylene beeswax derivative, polyoxyethylene lanolin derivative, polyoxyethylene alkylamide, polyoxyethylene alkylamine, lecithin derivative, polymer emulsifier, etc.), emulsification Stabilizers (such as higher alcohols),
Commonly used base components such as gelling agents (polymers, etc.), adhesives, etc. can be blended. Depending on the purpose of use, vasodilators (carpronium chloride, assembly extract, panax ginseng extract, etc.), Hydrocortisone, hydrocortisone butyrate propionate, etc.), keratolytics (urea, salicylic acid, etc.), humectants (sodium hyaluronate, chondroitin sulfate, cordyceps extract, saffron extract, etc.), fungicides (chlorhexidine gluconate, isopropylmethylphenol, Quaternary ammonium salts, hinokitiol, etc.), antioxidants (dibutylhydroxytoluene, isopropylgallate, etc.), fresheners (menthol, peppermint oil, camphor, etc.), fragrances, pigments, etc., within the range where the effects of the present invention are not impaired. Can be blended.

[0015]

According to the present invention, it has become possible to provide a patch having a high heat retaining effect and a small skin irritation.

[0016]

The present invention will be described more specifically with reference to the following examples and test examples.

Example 1 Sodium polyacrylate 3% by weight Polyacrylic acid 7 Glycerin 5 Aluminum magnesium hydroxide 0.25 Silicic anhydride (average particle size: 10 mμ) 1.5 Nikkor TS-10 (trade name) 0.3 Indomethacin 0.5 Purified water 76.9 According to the above-mentioned formulation, a patch was obtained by a conventional method.

After this adhesive patch is spread on a polyester liner to a thickness of about 1 mm, a polyester non-woven fabric is attached thereto, and then a polyolefin synthetic foamed resin (pore diameter 0.157 mm) is applied to the non-woven fabric using a double-sided tape. Pasted. Thereafter, the patch was cut into a predetermined size to obtain a patch.

Example 2 A patch was prepared in the same manner as in Example 1 except that indomethacin in Example 1 was changed to ketoprofen.

Example 3 A patch was prepared in the same manner as in Example 1 except that indomethacin in Example 1 was changed to flurbiprofen.

Example 4 A patch was produced in the same manner as in Example 1 except that indomethacin in Example 1 was changed to verbinac.

Example 5 A patch was prepared in the same manner as in Example 1 except that indomethacin in Example 1 was changed to piroxicam.

Example 6 Sodium polyacrylate 3% by weight Polyacrylic acid 7 Glycerin 5 Aluminum magnesium hydroxide 0.25 Silicic anhydride (average particle diameter: 10 mμ) 1.5 Nikkor TS-10 0.3 Diphenhydramine 0.1 Nonylate vanillylamide 0.005 Benzyl nicotinate 0.125 Indomethacin 0.5 Purified water 76.8 With the above formulation, a patch was produced according to Example 1.

Example 7 An adhesive plaster was produced in the same manner as in Example 1, and the adhesive plaster was spread on a polyester liner to a thickness of about 1 mm, and then a polyester nonwoven fabric was laminated. Polyolefin synthetic foam resin (pore size 0.2
56 mm) and cut into a predetermined size to obtain a patch.

Example 8 An adhesive plaster was produced in the same manner as in Example 1, and the adhesive plaster was spread on a polyester liner to a thickness of about 1 mm, and a polyester nonwoven fabric was laminated. Using a double-sided tape, a synthetic foamed resin made of polyvinyl chloride (pore diameter: 0.149 mm) was attached to the nonwoven fabric, and cut into a predetermined size to obtain a patch.

Comparative Example 1 An adhesive plaster was produced in the same manner as in Example 1, and the adhesive plaster was spread on a polyester liner to a thickness of about 1 mm, and a polyester nonwoven fabric was laminated. Thereafter, the patch was cut into a predetermined size to obtain a patch.

Comparative Example 2 A patch was prepared from Example 1 except for indomethacin,
This adhesive plaster was spread on a polyester liner to a thickness of about 1 mm, and a polyester nonwoven fabric was attached.
Thereafter, the patch was cut into a predetermined size to obtain a patch.

Comparative Example 3 An adhesive plaster was produced in the same manner as in Example 7, and the adhesive plaster was spread on a polyester liner to a thickness of about 1 mm, and a polyester nonwoven fabric was laminated. Thereafter, the patch was cut into a predetermined size to obtain a patch.

Test Example 1 The patches of Example 1 and Comparative Examples 1 and 2 were closed and applied to six subjects for 24 hours. Twenty-four hours later, the patch was peeled off, and the stimulus was visually determined to obtain the immediate value. After 1 hour, 3 hours, 5 hours, and 24 hours, the same determination was made. The visual evaluation was scored as 0 for no reaction, 1 for faint erythema and 2 for clear erythema. The results are shown in Table 1.

[0030]

[Table 1]

Test Example 2 With respect to the preparations obtained in Example 6 and Comparative Example 3, an efficacy questionnaire test was conducted on 10 patients complaining of stiff shoulders. Instructed to apply a patch of an appropriate size several times a day as the dosage and administration. At the end of the application, the degree of improvement by stiff shoulder symptoms as compared with before the application was evaluated on a five-point scale of "significant improvement", "moderate improvement", "mild improvement", "unchanged", and "deterioration". The results are shown in Table 2.

[0032]

[Table 2]

Test Example 3 The preparations obtained in Example 6 and Comparative Example 3 were subjected to a sticking test to rats, and the change in indomethacin blood concentration was measured. The application method is 30cm abdomen after fixing the rat in the dorsal position.
^The patch was applied to ² and blood was collected from the cervical artery over time.
The quantification was performed using the HPLC method. At this time, the limit of quantification was 50 ng / ml. Table 3 shows the results.

[0034]

[Table 3]

Test Example 4 With respect to the preparations obtained in Example 6 and Comparative Example 3, a patch cut to 14 × 10 cm was applied to the backs of 10 male subjects, and changes in skin temperature over time were measured by thermography (Nihon Kohden). It measured using. The subject entered a room maintained at a constant temperature and humidity (temperature of 23 ° C., relative humidity of 60%) in order to keep the skin temperature constant, then undressed his upper body and waited. One hour after the subject undressed, it was confirmed that the skin temperature was constant in the room, and the measurement was started. The results are shown in Table 4 as average values of skin temperature change (° C.) from the beginning.

[0036]

[Table 4]

As is evident from the results in Table 4, it was found that the patch of the present invention could provide a heating effect at the portion to which the patch was applied.

Claims (6)

[Claims] 1. A method according to claim 1, wherein water is applied to the surface of the woven or nonwoven fabric of the support layer in which the synthetic foamed resin sheet and the woven or nonwoven fabric are bonded.
A heat-sensitive adhesive patch comprising a hydrophilic base layer containing from 80 to 80% by weight. 2. The synthetic foamed resin has an average pore size of 0.1 to 0.3.
The patch according to claim 1, wherein the patch is mm. 3. The patch according to claim 1, wherein the synthetic foamed resin is a closed-cell foam. 4. A method according to claim 1, wherein the base comprises vitamin E acetate, sodium polyethylene sulfonate, vanillyl amide nonylate,
Pepper extract, pepper powder, pepper tincture,
The patch according to any one of claims 1 to 3, wherein at least one selected from the group consisting of capsaicin, benzyl nicotinate and pelargonic acid is blended. 5. A compound comprising at least one non-steroidal anti-inflammatory agent selected from the group consisting of anthranilic acid, phenylacetic acid, indole, propionic acid, pyrazolone, benzothiazine, and sulfonamide. The patch according to any one of claims 1 to 4. 6. The patch according to claim 5, wherein the non-steroidal anti-inflammatory drug is at least one selected from the group consisting of indomethacin, ketoprofen, felbinac, piroxicam and flurbiprofen.