JP2006232770A - External use composition and external preparation containing the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an external use composition which is excellent in warm feeling effect and irritates the skin little and an external preparation containing the same. <P>SOLUTION: The external use composition consists of a base which contains a warm feeling component and a Shiunkou (an ointment for skin disease) as a drug capable of promoting warm feeling effect. The external preparation contains the composition. The warm feeling component consists of at least one material selected from among nonylic acid vanillylamide, capsicum extract, and capsicum tincture and is used by incorporating it into an external preparation such as a cataplasm or a plaster agent. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  TECHNICAL FIELD The present invention relates to an external composition comprising a warming component and purple cloud, and an external preparation containing the composition.

  Many people suffer from chronic stiff shoulders, low back pain and muscle pain. To alleviate these chronic diseases, a series of vicious cycles, ie, circulatory failure due to local blood vessel compression due to muscle contraction, concomitant accumulation of waste products in the muscle, nerve compression, pain generation, muscles due to central transmission It is considered important to improve the vicious cycle of contraction. In order to improve it, various preparations for oral administration and external preparations have been developed.

  As the above-mentioned oral administration preparation, for example, an anti-inflammatory analgesic that blocks stimulation of pain and a muscle relaxant that relieves muscle tension have been developed. However, although these oral preparations are suitable for acute diseases, they are not necessarily suitable for chronic diseases because they are symptomatic treatments rather than causal treatments.

  On the other hand, as the above-mentioned external preparations, for example, external preparations containing anti-inflammatory analgesics, and external preparations such as plasters and poultices having local stimulating action for the purpose of improving blood circulation have been developed. And they are roughly divided into a cold feeling type and a warm feeling type.

  Although the cold sensation type external preparation is effective for acute diseases such as bruises and sprains, it may not be sufficiently effective for chronic diseases such as stiff shoulders.

  On the other hand, warming-type external preparations, when used on the skin, produce a hot feeling locally due to the warming component, dilates capillaries, promotes blood circulation, enhances tissue metabolism, and exhibits anti-inflammatory and analgesic effects. So it is considered effective for chronic diseases.

  In particular, in the case of extremely chronic diseases, it is considered effective to give a strong warm feeling to local parts such as acupoints.

  However, in order to obtain a warm sensation continuously, it is necessary to add a large amount of warm sensation component, and when blood circulation in areas other than chronic diseases is promoted, on the contrary, skin irritation such as rash occurs. There was a problem. Another problem is that the degree of warmth and skin irritation differ greatly depending on age, sex, site of attachment, and individual differences.

  In order to solve such a problem, various methods have been studied. For example, a plaster agent in which Toki and Shikon are mixed with a warm sensation component has been developed and marketed. However, in the case of the above plaster agent, redness due to rash and the like can be suppressed, but there remains a problem that the warm feeling effect is felt weak.

  In addition to the above, for example, an aqueous warming plaster that adjusts the release rate of capsaicin, which is a stimulating component in pepper extract, by adding, for example, glyceryl monostearate or polyoxyethylene sorbitan trioleate (20E.O.) (For example, patent document 1), external preparation which reduced irritation by combining warm extract components such as Dutch mustard solvent extract and red pepper powder, red pepper extract, red pepper tincture, nonylic acid vanillylamide (for example, patent document 2) A low-dose with less skin irritation by combining a topical skin preparation (for example, Patent Document 3) using a combination of warm ingredients such as vanillyl alcohol, alkyl ether and red pepper extract, capsaicinoid and nonylic acid vanillylamide Even so Sex formulation (e.g., Patent Document 4) have been proposed, and the like.

However, the above method has not yet been sufficiently satisfactory in terms of warmth effect and skin irritation, and development of further improved products has been demanded.
JP 7-228537 A JP 11-35475 A JP 2000-26267 A JP 2002-299993 A

  In the present invention, as a result of various investigations to solve the above-mentioned problems, the combination of the warming component and purple cloud paste surprisingly has an extremely excellent warming effect, and the warming component is As a result, a sufficient warming effect can be obtained even if it is reduced, and as a result, it is found that the composition for external use can further reduce skin irritation, and that an external preparation having the above characteristics can be produced by including the composition for external use. The present invention has been completed.

  That is, an object of the present invention is to obtain an external composition having an excellent warm feeling effect and little skin irritation and an external preparation containing the same.

The composition for external use according to the invention described in claim 1 is a composition for external use containing a warming component and a drug having a warming effect promoting ability in a base,
The drug having the warming effect promoting ability is shion-gypsum.

  The composition for external use according to the invention described in claim 2 is characterized in that the warming component according to claim 1 is one or more selected from nonyl acid vanillylamide, pepper extract and pepper pepper tincture. Is.

  The external preparation which concerns on the invention described in Claim 3 contains the external composition of Claim 1 or 2 characterized by the above-mentioned.

  An external preparation according to the invention described in claim 4 is characterized in that the external preparation according to claim 3 is selected from a poultice or a plaster agent.

In the external preparation according to the invention described in claim 5, the external preparation described in claim 4 is a plaster agent,
The plaster agent has a rectangular shape.

  The external preparation according to the invention described in claim 6 is characterized in that one side of the rectangle described in claim 5 is 20 to 30 mm.

The external preparation according to the invention described in claim 7 has a compounding amount of nonyl acid vanillylamide according to any one of claims 3 to 6 in a range of 0.05 to 0.07 g / m ² , and a compounding amount of shiunko Is 15 to 35 g / m ² .

As described above, the present invention has an effect of being able to obtain an external composition excellent in warm feeling effect and having little skin irritation and an external preparation containing the same.
The composition for external use of the present invention and the preparation for external use contain chronic shoulder stiffness, low back pain, and joint pain because a warming effect that can be satisfactorily satisfied even if the amount of the warming component is reduced by blending purple cloud. It is useful for treating muscle fatigue. In addition, the present invention is highly safe because it has no skin irritation and other side effects.

  The warming sensation component used in the external preparation for skin of the present invention is not particularly limited as long as it is a component that can feel warmth when applied to the skin. Examples of such components include capsaicinoids (for example, N-vanillyl-9-octadecenamide), capsaicin (for example, 8-methyl-N-vanillyl-6E-nonenamide, N-vanillyl nonanamide, etc.), dihydroxycapsaicin. , Capsaicin analogs such as capsanthin (eg, N-vanillyl-alkadienamide, N-vanillyl-alkanedienyl, N-vanillyl-cis-monounsaturated alkeneamide, etc.), nonylic acid vanillyl amide, red pepper extract, chili pepper tincture, One kind or two or more kinds selected from pepper powder, benzyl nicotinate, verargonic acid and the like can be mentioned. Of these, nonyl acid vanillylamide, red pepper extract and red pepper tincture are preferred.

  Examples of the nonyl acid vanillylamide include those described in quasi-drug raw material standards (published by Yakuji Nippo Inc., 1991), page 564. The above-mentioned pepper extract can be obtained, for example, by producing the crude powder of Japanese pharmacopoeia (hereinafter referred to as JP) according to the manufacturing method of the general pharmaceutical preparation in Japan. Capsicum extract made by Alps Pharmaceutical Co., Ltd. is available. The chili pepper tincture can be obtained by producing a crude powder of Japanese chili pepper according to the general formula tincture production method in Japan, and as a commercially available product, for example, chili tincture manufactured by Matsuura Pharmaceutical Co., Ltd. can be obtained.

  On the other hand, Shiunko used in the present invention is a widely used Chinese medicine, an ointment created by Hanaoka Seisho in the Edo period, listed in “Surgery Masamune”, and is a typical topical medicine among Chinese medicines. In particular, it promotes granulation, so it accelerates healing of the affected area, smoothes the skin, and is said to be effective for burns and trauma as a hypoallergenic ointment. A number of shiungo are commercially available and are readily available.

  The composition for external use of the present invention is not particularly limited as long as it mixes a warming ingredient and purple cloud paste, and is used for a drug generally used as an external preparation in the mixture or an external preparation described later. It can also be used by mixing with a base or the like. In particular, in the present invention, shiungo is contained as a drug having a warming effect promoting ability. That is, this makes it possible to reduce the content of the warming component that provides the same warming effect. Therefore, skin irritation can be reduced, and effects such as reduction of rough skin can be achieved.

  As a drug generally used as the external preparation, a drug usually blended in the external preparation is preferably used.

  Specifically, as a drug having an analgesic action, for example, methyl salicylate, glycol salicylate, indomethacin, ferbinac, piroxicam, ketoprofen and the like, and nonsteroidal anti-inflammatory analgesics such as azulene, acetaminophen, acemetacin, alclofenac , Aluminoprofen, ampiroxicam, amphenac, isoxicam, isoxebak, ibufenac, ibuprofen, indosin, indoprofen, indomethacin, etodolac, emorphazone, oxaprozin, oxabrofen, oxicam, oxevinakam, olsenone, orthophenamic acid, carprofen, clidanac , Cliprofen, ketotifen, ketoprofen, ketorolac, aspirin, salicylic acid, methyl salicylate, salicy Salicylic acid drugs such as acid glycol, zaltoprofen, diclofenac, cycloprofen, zidometacin, diflunisal, isosorbide nitrate, sudoxicam, suprofen, sulindac, zomevirac, thiaprofen, thixaprofen, tramadol, tolmetine, tolfenamic acid, naproxen, niflumic acid, Villeprofen, piroxicam, phenidone, fenoprofen, felbinac, fenclofenac, fenthiazac, fenbufen, bucurixic acid, bufexamac, pranoprofen, fluprofen, flufenamic acid, flufenisal, flurbiprofen, flurbiprofen aki Cetyl, Frotaphenine, Protidic acid, Flofenac, Benoxaprofen, Benolylate, Bendazak, Miropro E down, meclofenamic acid, Mepirizoru, mefenamic acid, Rishibufen include loxoprofen and the like salts thereof.

  Examples of the drug having blood circulation promoting action include vitamin Es such as tocopherol acetate and tocopherol, glycyrrhizin having analgesic / anti-inflammatory action, glycyrrhizic acid, dipotassium glycyrrhizinate, glycyrrhetinic acid and the like.

  As a drug having a local stimulating action, for example, dl-camphor, l-menthol and the like can be blended.

  Examples of the drug having an antiallergic action include diphenhydramine, diphenhydramine hydrochloride, diphenhydramine salicylate, chlorpheniramine maleate, and the like.

  Examples of the herbal medicine component include, for example, Tokyo, Sikon, Sanshi, Salamander, Tokyo, and Aoba. Examples of essential oil components include peppermint oil, eucalyptus oil, and turpentine oil. Examples of the disinfectant include thymol. Examples of the drug having an astringent / protective component include zinc oxide. Examples of the blood circulation promoter include benzyl nicotinate and sodium polyethylene sulfonate.

  The dosage form of the external preparation of the present invention is not particularly limited as long as it is an external preparation containing the above external composition. Specific examples include plasters, poultices, creams, ointments, lotions and the like. Of these, plaster agents and poultices are preferably used.

  Although it does not specifically limit as a form of sticking type external preparations, such as a plaster agent and a poultice agent, A rectangular, circular, and elliptical form is preferable. More preferably, it is a plaster that has a size that can be applied only to a local part such as an acupuncture point and does not act directly on the other part, that is, a rectangular shape with one piece of 30 mm or less. More preferably, it is a plaster agent in which one piece has a rectangular shape of 20 mm to 30 mm.

  When manufacturing the external preparation of this invention, the base used for a normal pharmaceutical and a quasi-drug can be used.

  Examples of the base include, for example, water-soluble or water-insoluble natural and synthetic polymer compounds or a mixture thereof, as well as an ointment or a liquid such as a lotion. A solvent, an oil component, glycols, a surfactant, a water-soluble polymer compound, and the like can be blended. Specifically, examples of the solvent include water, ethanol, propyl alcohol, isopropyl alcohol, acetone, benzyl alcohol, As oil components, for example, lanolin, hydrogenated oil, lecithin, plastibase, liquid paraffin, oleic acid, stearic acid, myristic acid, palmitic acid, beeswax, paraffin wax, microcrystalline wax, diisopropyl adipate, isopropyl myristate, isopropyl sebastate, Palmitic acid Sopropyl, squalane, squalene, cetanol, stearyl alcohol, oleyl alcohol, hexadecyl alcohol, silicone oil, etc., as glycols, eg glycerin, propylene glycol, polyethylene glycol, polypropylene glycol etc., as surfactants, eg polyoxyethylene curing Castor oil, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyoxyethylene glycol fatty acid ester, polyoxyethylene glycol ether, polyoxyethylene alkylphenyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene phytosterol , Sorbitan fatty acid ester, glycerin fatty acid ester, etc. As a child compounds can be formulated for example carboxyvinyl polymers, sodium carboxymethyl cellulose, polyvinyl alcohol, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropylmethyl cellulose, polyacrylic acid or the like.

  When preparing plaster, rubber base such as raw rubber, polyisobutylene, titanium oxide, calcium carbonate, polybutene, ester gum, methyl acrylate / -2-ethylhexyl acrylate copolymer resin emulsion, natural rubber latex, terpene resin, etc. A plaster base is prepared by heating and mixing the tackifiers of nonyl acid, adding nonyl acid vanillylamide, purple cloud paste, and other chemicals, and rolling and applying with a rolling (calendar) roll, and cutting the release paper on top of each other. By doing so, a plaster agent is produced.

  Specifically, a rubber base made of raw rubber, polyisobutylene, titanium oxide, calcium carbonate was added to the kneader and kneaded, and then polybutene, ester gum, methyl acrylate / -2-ethylhexyl acrylate copolymer resin emulsion, A tackifier composed of natural rubber latex and terpene resin was added and kneaded.

  Active ingredients of L-menthol, methyl salicylate, nonylic acid vanillylamide, and shimogaku (or toki soft extract, shikon soft extract) were added to the obtained plaster base and kneaded to complete the plaster base. . Then, the patch was obtained by apply | coating uniformly on a support body by rolling application | coating by a rolling (calendar) roll, piled up a release paper, and cut | judging to a desired shape. The plaster base may be roll-coated on a heat-resistant release paper, and then the support may be overlaid and cut into a desired shape.

  When preparing a poultice, a release liner, a paste layer and a support are bonded together. In addition to the medicinal component, the plaster layer is added with a water-absorbing resin such as starch acrylate, a shape-retaining agent such as sodium carboxymethyl cellulose, or a pressure-sensitive adhesive such as a styrene-isoprene-styrene block copolymer. . A humectant such as propylene glycol is also added.

  When preparing a cream, generally a water-soluble component such as propylene glycol, triethanolamine or the like is added to purified water and heated to prepare an aqueous phase. On the other hand, oily components such as stearic acid, cetanol, tocopherol acetate, nonylic acid vanillylamide, mint oil and the like are dissolved under heating to form an oil phase. While stirring the prepared oil phase, it can be prepared by gradually adding a water phase, carrying out an emulsification treatment, and making it uniform.

  When preparing as an ointment, a solid base such as hydrophilic petrolatum, lanolin, or microstalin wax is heated and dissolved, and then a water-soluble base such as macrogol or propylene glycol, a preservative, and a moisturizer are added to purified water. It can be prepared by warm-dissolving and stirring to make it even. When other drugs are added to this, it can be prepared by mixing with a part of the base according to the type of the base, and then adding the remaining base and stirring and kneading until uniform throughout.

  When preparing a lotion agent, a water-soluble polymer such as hydroxypropyl cellulose or carboxyvinyl polymer is uniformly dissolved in purified water and heated. Add oil-soluble components such as methyl salicylate, thymol, peppermint oil, tocopherol acetate, surfactants such as polyoxyethylene hydrogenated castor oil, polyoxyethylene (160) polyoxypropylene (30) glycol, etc. to the oil phase and dissolve by heating. Then, the oil phase is gradually added while stirring the previously prepared aqueous phase. A lotion agent can be obtained by making the emulsified particles uniform.

  Furthermore, it can manufacture by a conventional method using the component according to the kind, such as a liquid agent, an emulsion agent, and an aerosol agent, as an external preparation of this invention besides.

  In the composition for external use characterized by containing the warming ingredient of the present invention and purple cloud, the blending ratio of each component is slightly different depending on the type used, for example, when nonyl acid vanillylamide is used as the warming ingredient, The blending amount is 0.001 to 5 parts by mass, preferably 0.01 to 0.5 parts by mass, and more preferably 0.03 to 0.3 parts by mass per 100 parts by mass of Shimo-gypsum. When using a red pepper extract, the compounding quantity is 0.01-25 mass parts per 100 mass parts of Shimo-gypsum, Preferably it is 0.1-10 mass parts, More preferably, it is 0.2-5 mass parts. When using red pepper tincture, the compounding amount is 0.1 to 500 parts by mass, preferably 1 to 100 parts by mass, and more preferably 2 to 50 parts by mass per 100 parts by mass of Shimo-gypsum.

For example, when nonyl acid vanillylamide is used as a warming ingredient in a dosage form of a plaster agent or a poultice, the amount of nonyl acid vanillylamide is 0. 0.05 to 0.07 g / m ² , and Shimogyo is 15 to 35 g / m ² .

1. Formulation Examples 1 to 9 are given below to further illustrate the present invention.

Example 1 (composition for external use)
30 g of Shiunko was dissolved by heating, 0.075 g of nonylic acid vanillylamide, 1.5 g of methyl salicylate, 4.5 g of l-menthol, 0.9 g of mint oil, 0.45 g of tocopherol acetate, and 1.8 g of dl-camphor were added and stirred. After melt | dissolving and mixing uniformly, it stood to cool gradually and obtained 39.225 g of compositions for external use of Example 1.

Example 2 (composition for external use)
30 g of Shimo-gypsum was dissolved by heating, 0.075 g of pepper extract, 3.9 g of glycol salicylate and 0.6 g of eucalyptus oil were added and dissolved by stirring. After evenly mixing, the mixture was allowed to cool gradually, and the composition for external use of Example 2 34.575 g was obtained.

Example 3 (composition for external use)
30 g of Shimogu was dissolved by heating, 0.075 g of chili pepper tin, 0.36 g of indomethacin, 4.5 g of l-menthol and 1.5 g of thymol were added and dissolved by stirring. After evenly mixing, the mixture was allowed to cool slowly. 36.435 g of composition 3 for external use was obtained.

Example 4 (plaster agent 1)
A kneader was charged with a rubber base composed of 30.1 parts by weight of raw rubber, 30.1 parts by weight of polyisobutylene, 3.2 parts by weight of titanium oxide, and 15.1 parts by weight of calcium carbonate, and then kneaded, and 45.5 parts by weight of polybutene. Part, 34.2 parts by weight of ester gum, 13.0 parts by weight of methyl acrylate / acrylic acid-2-ethylhexyl copolymer resin emulsion, 7.3 parts by weight of natural rubber latex, and 21.5 parts by weight of terpene resin The agent was added and kneaded to obtain a plaster base composition.

  To 110.775 g of the obtained plaster base composition, 39.225 g of the external composition obtained in Example 1 was added and kneaded to complete 150.0 g of a plaster base. Then, the plaster agent 1 was obtained by apply | coating uniformly on a support body by the rolling application | coating by a rolling (calendar) roll, piled up a release paper, and cut | judging to a desired shape.

Example 5 (plaster agent 2, 3)
In the same manner as in Example 4, 35.575 g of the composition for external use obtained in Example 2 was added to 115.425 g of the plaster base composition of Example 4 and kneaded to complete 150.0 g of the plaster base. It was. Then, the plaster agent 2 was obtained by apply | coating uniformly on a support body by the rolling application | coating by a rolling (calendar) roll, stacking a release paper, and cut | judging to a desired shape.

  Further, 36.435 g of the external composition obtained in Example 3 was added to 113.565 g of the plaster base composition of Example 4 and kneaded to complete 150.0 g of the plaster base. Then, the plaster agent 3 was obtained by apply | coating uniformly on a support body by rolling application | coating by a rolling (calendar) roll, piled up a release paper, and cut | judging to a desired shape.

Example 6 (a poultice)
(Prescription)
Ingredient (mass%)
1. Nonyl acid vanillylamide 0.075
2. Methyl salicylate 1.500
3. l-Menthol 4.500
4). Peppermint oil 1.120
5. Tocopherol acetate 0.500
6). dl-camphor 1.800
7). Shiunko 30.000
8). Aluminum hydroxide 0.100
9. Sodium polyacrylate 7.00
10. Sodium carboxymethylcellulose 2.500
11. Carboxyvinyl polymer 1.000
12 Glycerol 12.000
13. Titanium oxide 1.000
14 Sorbitol 15.000
15. Purified water

  Swell the carboxyvinyl polymer in purified water, add sorbitol and stir. A mixture of sodium polyacrylate, sodium carboxymethyl cellulose, titanium oxide, and aluminum hydroxide dispersed in glycerin was added and kneaded to obtain a poultice base composition. Next, Shimogu was heated and dissolved, and nonyl acid vanillylamide and below dl-camphor were added and dissolved by stirring, and the mixture was put into a poultice base composition and kneaded to obtain a poultice base. The obtained poultice base is spread and applied uniformly on a support with a spreader, and the release liner is stacked and cut into a predetermined shape to obtain the poultice of Example 6.

Example 7 (cream)
(Prescription)
Ingredient (mass%)
1. Nonyl acid vanillylamide 0.075
2. Methyl salicylate 1.500
3. l-Menthol 4.500
4). Peppermint oil 1.120
5. Tocopherol acetate 0.500
6). dl-camphor 1.800
7). Shiunko 30.000
8). Stearic acid 17.000
9. Cetanol 2.400
10. Propylene glycol 5.000
11. Triethanolamine 2.800
12 Edetate disodium 0.300
13. Hexadecyl isostearate 12.000
10. Purified water appropriate amount Total 100.0

(Production method)
Stearic acid, cetanol, hexadecyl isostearate and nonyl acid vanillylamide up to purple cloud are dissolved by heating to prepare an oil phase, which is kept at 80 to 85 ° C. On the other hand, propylene glycol, triethanolamine and edetate disodium are added to purified water and dissolved by heating to prepare an aqueous phase. Next, while stirring the oil phase, a water phase maintained at 85 ° C. to 90 ° C. is gradually added to emulsify. After emulsification, the mixture is gradually cooled and mixed evenly to obtain the cream of Example 7.

Example 8 (ointment)
(Prescription)
Ingredient (mass%)
1. Pepper extract 0.075
2. Salicylic acid glycol 4.00
3. l-Menthol 4.500
4). Eucalyptus oil 0.600
5. Tocopherol acetate 0.500
6). Shiunko 30.000
7). Sara honey bees 5.000
8). Microcrystalline wax 10.000
9. White petrolatum appropriate amount Total 100.0

(Production method)
Warm-dissolve purple cloud paste and white petrolatum at 75 ° C., add honey beeswax and microcristan wax, and dissolve with sufficient stirring. The pepper extract and the tocopherol acetate are added to this and stirred until uniform to obtain the ointment of Example 8.

Example 9 (lotion)
(Prescription)
Ingredient (mass%)
1. Pepper tincture 0.075
2. Methyl salicylate 1.500
3. l-Menthol 4.500
4). Peppermint oil 1.120
5. Glycyrrhetinic acid 0.500
6). Timor 0.500
7). Shiunko 20.000
8). Hydroxypropyl cellulose 0.500
9. Concentrated glycerin 5.000
10. Polyoxyethylene (160) Polyoxypropylene (30) Glycol 0.300
11. Ethanol 50.000
12 Purified water Appropriate amount Total 100.0
(Production method)
Pepper tincture, peppermint oil, glycyrrhetinic acid, purple cloud, polyoxyethylene (160) polyoxypropylene (30) glycol and concentrated glycerin are stirred and dissolved at 70 ° C. A solution obtained by swelling hydroxypropyl cellulose in purified water is added to this solution and stirred. Further, a solution obtained by dissolving methyl salicylate, l-menthol, and dl-camphor in ethanol is gradually added to this solution, followed by stirring until uniform to obtain the lotion preparation of Example 9.

2. Test Hereinafter, the present invention will be described in detail with reference to test examples.
In the test, a plaster which is one of the external preparations of the present invention was used.
The plaster base composition shown in Example 4 and the pharmaceutical composition shown in Table 1 were kneaded to complete 150.0 g of a plaster base, and this was supported by rolling application with a rolling (calendar) roll. The plaster agent 3, 4, and the comparison plaster agent were obtained by uniformly applying on top, overlapping the release paper, and cutting into a desired shape.

Test Example 1 (Skin surface temperature measurement test)
Plaster 4 or 5 is applied to the upper part of the upper scapula, a comparative plaster is applied to the upper part of the upper scapula, and the skin surface temperature is kept constant using a thermograph (TH9100MV, NEC Sanei Co., Ltd.). Measured every hour. The evaluation was performed by the temperature difference (ΔT) between the skin surface temperature at the applied site and the skin surface temperature at the non-applied site.

  The results are shown in FIGS. FIG. 1 is a diagram showing the change over time of the skin surface temperature difference between the comparative plaster agent and the plaster agent 4. FIG. 2 is a diagram showing the change over time of the skin surface temperature difference between the comparative plaster agent and the plaster agent 5. As is clear from FIG. 1, the skin surface temperature is increased by applying the plaster 4 and the comparative plaster, and the warming component in the plaster 4 of the plaster 4 blended with purple cloud is a component of the comparative plaster. Despite being less than that, it was found to have the same or higher skin surface temperature increasing effect. Further, as apparent from FIG. 2, as a result of performing the same test on the plaster agent 5 and the plaster agent of the comparative plaster agent, it was found that the difference in skin surface temperature was further increased.

  As described above, it can be seen that Shiungo has a warming effect promoting ability when blended simultaneously with the warming component. Thereby, content of the warming component which shows an equivalent warming effect can be reduced. Therefore, skin irritation can be reduced, and effects such as reduction of rough skin can be achieved.

Test Example 2 (Skin irritation test)
A skin irritation test was performed using Plaster 4, Plaster 5, and Comparative Plaster. The test method was that a total of four test preparations and a control preparation (plaster agent) were affixed to each forearm of 20 healthy panelists (10 males and 10 females), and 12 hours later. The skin irritation was observed and evaluated.

The evaluation criteria were divided into the four stages shown in Table 2, and the skin irritation index was calculated from the following formula from the scores of 20 subjects and evaluated.
Skin irritation index =
Σ [(score after 12 hours of each test preparation) − (score after 12 hours of control preparation)] / number of cases × 100

  The test results are shown in Table 3 below. As is apparent from Table 3, the plaster agent 4 or plaster agent 5 in which an effect equal to or higher than the plaster agent of the comparative plaster agent was obtained in the warming effect, In comparison, it was found that skin irritation was significantly reduced.

  The composition for external use of the present invention characterized by comprising a warming sensation component and purple cloud paste is excellent in the skin surface temperature increasing effect, has a comfortable warming effect, and has an effect of reducing the occurrence of skin irritation. Furthermore, the content of the warming component which shows an equivalent warming effect can be reduced by containing purple cloud as a chemical | medical agent which has warming effect promotion ability. Therefore, it can reduce skin irritation, reduce skin roughness, etc., and it can be expected to have a comfortable warm feeling effect without giving the skin an unpleasant irritation, and it can be used for stiff shoulders, low back pain, joint pain, muscle fatigue, etc. A therapeutic effect can be expected.

It is a diagram which shows a time-dependent change of the skin surface temperature difference of a comparison plaster agent and the plaster agent 4. FIG. It is a diagram which shows a time-dependent change of the skin surface temperature difference of a comparison plaster agent and the plaster agent 5. FIG.

Explanation of symbols

■ Time-dependent change in skin surface temperature difference (ΔT) of plaster agent 4 ● Time-dependent change in skin surface temperature difference (ΔT) of plaster agent 5 Δ: Time-dependent change in skin surface temperature difference (ΔT) of the comparison plaster agent 5 change

Claims (7)

A composition for external use containing a warming component and a drug having a warming effect promoting ability in a base,
The composition for external use characterized in that the drug having the warming effect promoting ability is shimo-gypsum.   The composition for external use according to claim 1, wherein the warming sensation component is one or more selected from nonylic acid vanillylamide, red pepper extract and red pepper tincture.   An external preparation comprising the external composition according to claim 1 or 2.   The external preparation according to claim 3, wherein the external preparation is selected from a poultice or a plaster. The external preparation is a plaster agent,
The external preparation according to claim 4, wherein the plaster agent has a rectangular shape.   The external preparation according to claim 5, wherein one side of the rectangle is 20 to 30 mm. The blending amount of nonylic acid vanillylamide is 0.05 to 0.07 g / m ² , and the blending amount of shiungo is 15 to 35 g / m ² . Topical agent.

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