JP2002104957A - Patch for external use - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a patch for an external use, capable of developing of a synergistic effect of pharmacodynamic effects by at least two or more kinds of percutaneously absorbable medicines by making the patch include the medicines in an adhesive layer in a patch for external use, actualizing treating effects such as early recovery of affected part, early alleviation of ache, excellent heat and cold/compress effect, etc., making the patch itself treatable not as a 'medicine' but as so-called 'miscellaneous goods' by controlling the contents of the medicines in amounts of a level neither to be specified not treated as a 'medicine' in the pharmaceutical affairs law and capable of making even a person such as needlestick and moxa cautery master, judo redressement master, chiropractic master, etc., who can not prescribe/treat a 'medicine' since the person has neither medical license nor pharmacist license, readily use the patch as an auxiliary for treatment. SOLUTION: This patch is characterized in that in the patch of epidermis adhesion type obtained by laminating an adhesive layer to one side face of a filmy or sheetlike substrate, at least two or more kinds of percutaneously absorbable medicines are contained in the adhesive layer and the total contents of the medicines are controlled in amounts of a level in which the patch is not specified as a medicine in the pharmaceutical affairs law.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a patch for external use which is used by laminating an adhesive layer on one side of a support and sticking the outer layer to the outer skin. The patch contains at least two or more kinds of drugs, and the content is controlled by the Pharmaceutical Affairs Law to a level at which the patch cannot be designated and handled as a “pharmaceutical”, whereby the patch is “ Even if a person cannot prescribe or treat a drug because he or she does not have a doctor's license or pharmacist's license, such as an acupuncturist, a judo remedy, or a manipulative surgeon, it will be treated as a so-called miscellaneous goods instead of a drug. The present invention relates to an external patch which can easily be used as an aid for treatment and can realize an early recovery of an affected part.

[0002]

2. Description of the Related Art In general, as an external patch which is applied to the outer skin and administers a drug into a living body from the applied site, an adhesive for affixing to the outer skin on one side of a film or sheet support. The adhesive layer may include a layer in which drug layers are laminated, and the pressure-sensitive adhesive layer contains a necessary kind and amount of the drug.

[0003] Another external patch is a film- or sheet-like support in which a pressure-sensitive adhesive layer containing a required amount of a poultice for exhibiting a poultice effect is laminated on one side thereof. It is used as a poultice for compressing or alleviating inflammation or the like of a local part of the human body.

[0004] That is, these external patches are formed by laminating an adhesive layer to be attached to the outer skin on one side of a film-like or sheet-like support, and various adhesives are contained in the adhesive layer. A drug is contained in a required amount, and the drug is administered into a living body by transdermal absorption.

[0005] However, since these external patches are expected to have a large drug effect and a rapid drug effect, and are intended for transdermal absorption to administer the drug to the affected area for a long period of time, the external patch is not contained in the adhesive layer. Contains a relatively large amount of drugs, requires strict care in handling and use, and uses these external patches in order to prevent side effects and other adverse effects on patients and affected areas due to misuse. Has been designated and handled as a "pharmaceutical" which requires not only production approval but also sales regulations and requires a prescription by a doctor or pharmacist when used.

[0006] On the other hand, other external patches include fever associated with illnesses such as a cold, or a fever relieving or application site in order to make the user feel refreshed and comfortable during work or daily life. There is a so-called cooling / heating sheet for cooling.

That is, this cooling / heating sheet is formed by laminating a pressure-sensitive adhesive layer mainly containing water on one side of a support, and cools (applied heat) the application site of the human body using the latent heat of evaporation of water. It gives the user a refreshing and comfortable feeling.

[0008] In addition to water, the pressure-sensitive adhesive layer of such a cooling / heating sheet is provided with a refreshing agent such as menthol, eucalyptus oil, or the like in order to further provide the user with a refreshing and comfortable feeling.
Although a small amount of vegetable oil such as peppermint oil and lavender oil is added, it does not contain drugs that may cause side effects on the human body.・ There are no special restrictions on sales,
Even those who do not have a doctor's license or a pharmacist's license are treated as so-called "miscellaneous goods" that can be used easily.

Further, as another topical patch, there is a so-called heat-generating body which utilizes heat generated by a heating element and the like, which is used for assisting treatment of diseases such as rheumatism and arthritis where it is desirable to warm the affected part. Heated sheets have been proposed.

[0010] That is, this heating sheet is obtained by laminating an adhesive layer mainly containing water on one side of a support, and further laminating a heating element and the like on the opposite side. It is intended to improve the blood circulation of the affected area and to provide the user with pain relief.

In general, such a heat sheet also does not contain a drug which may give a side effect to the human body in its pressure-sensitive adhesive layer other than water. There is no special regulation on production and sales, and this is a so-called “miscellaneous goods” that can be used easily even by those who do not have a doctor's license or a pharmacist's license. I have.

[0012] Accordingly, such a cold / hot sheet treated as “miscellaneous goods” does not have a doctor license or a pharmacist license such as an acupuncturist, a judo repositioner, or a physician, so that “medicine”
Since it can be easily used as a treatment aid even for those who cannot prescribe and treat it, it has been very popularly used in the fields of manipulative treatment, acupuncture and moxibustion, etc., and has achieved a certain effect.

[0013]

However, in other words, in the fields of manipulative treatment, acupuncture and moxibustion, etc., it is impossible to administer "medicine". In addition to cooling, only the heating of the affected area with a heating sheet, which is also treated as a "miscellaneous goods", can be given as an aid to treatment.

[0014] That is, only a cold sheet or a hot sheet cannot administer a drug having a pharmacological effect to an affected part, so that only a slow therapeutic effect can be expected. It has been difficult to effectively assist treatment such as palliative care.

[0015] Therefore, even in the fields of manipulative treatment and acupuncture and moxibustion, it is possible to effectively assist treatment such as early recovery of an affected part and relief of pain. There is a strong demand for the development of an external patch that can be easily used as a treatment aid even for those who cannot prescribe or treat the drug.

The inventor of the present invention has conducted intensive studies to solve the above-mentioned problems. As a result, in the skin-adhesive type patch in which an adhesive layer is laminated on one side of a film-like or sheet-like support, The drug layer contains at least two transdermally absorbable drugs.
By mixing more than one species and controlling the drug content to a level where the patch is not specified as a drug in the Pharmaceutical Affairs Law, the patch can be treated as a so-called `` miscellaneous goods '' instead of a `` drug '' I got the knowledge.

[0017] That is, even if the external patch is a small amount that does not become a drug designation in the Pharmaceutical Affairs Law, by incorporating at least two or more transdermally absorbable drugs into the adhesive layer, the medicinal effect of the drug can be improved. A synergistic effect has appeared, and it has been found that it is possible to effectively assist treatments such as early recovery of the affected area and relief of pain as compared with conventional cold / heated sheets treated as “miscellaneous goods”.

[0018] In addition, by adopting such a configuration, the patch can be treated as a so-called "miscellaneous goods" instead of a "pharmaceutical product". It has been found that even those who do not have a pharmacist license and cannot prescribe and treat "medicines" can easily and suitably use them as an aid for treatment.

The present invention has been completed on the basis of the above-mentioned findings, and in this kind of external patch, the adhesive layer contains at least two or more transdermally absorbable drugs, so that the patch can be used. Synergistic effect of the drug effect is exhibited, early recovery of the affected area, early fever relief, pain relief etc. are realized, and the drug content is at a level at which the patch is not specified and handled as a "pharmaceutical" under the Pharmaceutical Affairs Law. By controlling the amount of the patch to be a so-called "miscellaneous goods" instead of a "pharmaceutical product." The purpose of the present invention is to provide a topical patch which can be easily used as a therapeutic aid even for those who cannot prescribe and treat the above.

[0020]

In order to achieve the above-mentioned object, the external patch according to the present invention comprises a film-like or sheet-like support having a pressure-sensitive adhesive layer laminated on one side thereof. In the patch, the pressure-sensitive adhesive layer contains at least two or more transdermally absorbable drugs, and the drug content is controlled to a level at which the patch is not specified as a drug in the Pharmaceutical Affairs Law. It is characterized by having been done. Hereinafter, the present invention will be described in more detail.

The topical patch according to the present invention comprises at least two, more preferably at least three, transdermally absorbable drugs in the pressure-sensitive adhesive layer of the topical patch according to the present invention. The most significant feature is that the amount is controlled to a level at which the patch is not specified as a drug in the Pharmaceutical Affairs Law.

That is, by incorporating at least two or more transdermally absorbable drugs into the pressure-sensitive adhesive layer, a synergistic effect of the drug effect is exhibited by the drug, and a small amount of the patch is not specified as a drug in the Pharmaceutical Affairs Law. Even in the content, compared with the conventional cold and hot sheets treated as "miscellaneous goods",
It is possible to effectively assist treatment such as early recovery of the affected area and relief of pain. Particularly, this synergistic effect is achieved by blending at least three or more transdermally absorbable drugs in the adhesive layer. It becomes even better.

Therefore, in the external patch of the present invention, the pressure-sensitive adhesive layer contains at least two or more transdermally absorbable drugs,
Particularly preferably, three or more drugs are contained. However, the drug is not particularly limited, and a known transdermal drug can be used.

Specifically, for example, hydrocortisone,
Prednisolone, triamcinolone, corticosteroids such as triamcinolone acetonide and fluocinolone acetonide, thymol, chamomile, arnica, mefenamic acid, indomethacin, ketoprofen, felbinac, salicylic acid, methyl salicylate, l-menthol,
Antiphlogistic analgesics such as camphor, horse chestnut extract, oak, sansin and peppermint oil, antibiotics such as penicillin, tetracycline, oxytetracycline, erythromycin and chloramphenicol, vitamin A,
Vitamins such as vitamin B and vitamin C,
In addition, Ca antagonist, hypnotic sedative, tranquilizer, antihypertensive, antihypertensive diuretic, anesthetic, antibacterial, antifungal,
Two or more, more preferably 3 or more selected from the group consisting of antiepileptics, coronary vasodilators, antihistamines, antitussives, sex hormones, antidepressants, cerebral circulation improvers, antiemetic agents, antitumor agents, biopharmaceuticals, etc. It can be suitably used in combination of more than one kind.

[0025] In the present invention, the content of these drugs is not particularly limited as long as the patch is controlled to a level not specified as a drug in the Pharmaceutical Affairs Law. Although it greatly varies depending on the drug used, in general, for example, the total content of the selected transdermal absorbable drug is 0.005 to 1% by weight based on the entire pressure-sensitive adhesive layer in the external patch. If the total content of the drug is less than 0.005% by weight, there is no point in containing the drug, while if it exceeds 1% by weight, the drug may have a drug-specified level amount. From these viewpoints, the total content of the drug is preferably in the range of 0.05 to 0.5% by weight, particularly preferably in the range of 0.1 to 0.4% by weight. desirable.

That is, if the total content of the selected two or more, particularly preferably three or more drugs exceeds 1% by weight, the amount of the drug contained becomes too large, and
Under the Pharmaceutical Affairs Law, the drug is designated and handled, while the content of the selected drug is 0.00
If the amount is less than 5% by weight, the amount is too small, and the above-mentioned synergistic effect and desired medicinal effect cannot be obtained.

Of course, in the present invention, at least two or more selected from the above-mentioned drugs are, for example, two to three selected from different drug types such as corticosteroids, anti-inflammatory analgesics and vitamins. It means not only the above drugs but also two to three or more drugs selected from the same drug type, such as indomethacin, mefenamic acid or methyl salicylate in anti-inflammatory analgesics.

By the way, the “synergistic effect of drug effect” in the present invention means not only a mere increase in pharmacological effect, but also a drug
It also means a new effect expressed by mixing more than one species, for example, salicylic acid (0.15 to 0.15)
Menthol (0.05% by weight) as a solvent.
-0.10% by weight) and camphor (0.05-0.1% by weight) with respect to the entire pressure-sensitive adhesive layer of the patch for external use, increase the anti-inflammatory and analgesic effects, as well as the antiseptic and bactericidal effects. Is also expressed.

In the external patch according to the present invention, the support to be used is not particularly limited, and a known cloth substrate can be appropriately selected and used. A resin film, a synthetic resin porous film, a nonwoven fabric, a woven fabric, a felt or a knitted fabric can be suitably used.

In the external patch of the present invention, the material and type of the cloth substrate are not particularly limited, and any of natural fibers and artificial fibers can be used.

The natural fibers include, for example, cotton, kapok, flax, ramie, hemp, jute, syrup, manila hemp,
Vegetable fibers such as sisal and coyer fiber; and animal fibers such as silkworm silk, tussah silk, wool (sheep), cashmere hair, camel hair, alpaca hair, mohair, rabbit hair and the like.

The artificial fibers include, for example, regenerated fibers such as artificial silk, suf, viscose and Bemberg (registered trademark), polyamide fibers (nylon, etc.), polyester fibers (Tetron (registered trademark), terylene, etc.). , Decron, etc.), polyacrylic fibers (aulon, xlan, bonnel, cashmere, kanecaron, etc.), polyvinyl alcohol fibers (vinylon), polyalkylene paraoxybenzoate fibers (benzoate), polyurethane fibers (polyurethane) [span Tex], polyvinylidene chloride fiber (vinylidene),
Synthetic fiber such as polyvinyl chloride fiber (polyvinyl chloride), polyacrylonitrile fiber, polyethylene fiber (polyethylene), polypropylene fiber (polypropylene), polyclar, polypropylene fiber (pyrene), or artificial acetate fiber Semi-synthetic fibers produced by copolymerizing a natural substance and a synthetic substance are exemplified.

In the patch for external use according to the present invention, the air permeability of the support greatly affects the duration of the external patch, such as the cooling effect and the compressing effect, the storage stability, and the feeling of use. In addition, the occurrence of stuffiness, rash, itching, red spots and the like, and skin irritation, that is, it has a significant effect on safety and hygiene, etc. Therefore, it is preferable to manage the air permeability. Is 2,800 to 4,40 by the Lissi method
Is preferably set in the range of 0g ^/ m 2 · 24hr.

The moisture permeability is 2,800 g / m ² · 24
If it is less than hr, adverse effects such as stuffiness, rash, itching, red spots and skin irritation may occur, safety and hygiene may be reduced, the temperature of the pressure-sensitive adhesive layer may be increased, and a sufficient cooling effect may be obtained. Is not preferable because the feeling of use is deteriorated. On the other hand, if it exceeds 4,400 g / m ² · 24 hr, the drug easily seeps out of the support, and the clothes may be stained. In addition, moisture and volatile components (volatile drugs) in the pressure-sensitive adhesive layer evaporate, which hinders the medicinal effect and makes it impossible to expect a long-term cooling effect or compressing effect.

Accordingly, from these viewpoints, it is most preferable that the moisture permeability of the support is set in the range of 3,000 to 4,000 g / m ² · 24 hr.

By the way, the Lissy method (Lyssy method) is a method based on industrial standards in various countries around the world.
In IS Z 0208 and JIS K 7129, the temperature is set to be maintained at 40 ° C. and the relative humidity difference is set to 90% RH. Therefore, in this apparatus, the lower chamber in the state of 100% relative humidity and the highly sensitive humidity sensor The measurement sample is inserted into the boundary surface of the upper chamber where is installed, and the relative humidity of the upper chamber with the humidity sensor is set to 10% R.
H (100% -90%), around which is measured the time (several seconds) required for the humidity to increase from +1 to −1, ie from about 9% to about 11%. In this method, the transmittance is obtained by comparing the result of a calibration performed under the same conditions using a standard sample whose transmittance is known in advance.

The thickness of the support varies greatly depending on the use, the support and the type of the pressure-sensitive adhesive layer, and is not particularly limited.
It is preferred to be about 0 to 350 g / m ² .

When the thickness of the support is less than 60 g / m ^{2 in} terms of basis weight, necessary mechanical strength cannot be obtained, and it may be difficult to make the thickness uniform. Absent.

On the other hand, if the thickness of the support exceeds 350 g / m ² , the flexibility is reduced, the conformability to the body surface is significantly reduced, and the followability to deformation and movement of the body surface is reduced. However, it is not preferable because it makes the hand feel stiff.

Thus, in particular, the thickness of the support is preferably in the range from 90 to 250 g / m ² , particularly preferably 100 g / m ^2.
It is desirable to be within the range of 200 g / m ² , and within this range, the required mechanical strength and flexibility can be obtained.

In the present invention, various pressure-sensitive adhesive layers are formed on one side of the support. Examples of the pressure-sensitive adhesive include lipophilic or hydrophilic pressure-sensitive adhesives conventionally used in external patches. No particular limitation is imposed because any of the agents can be suitably used.In particular, for symptoms such as chronic pain, for example, cooling may lead to worsening of the symptoms. It is preferable to use an agent, on the other hand, in the case of acute bruising, sprains, etc., by evaporation of moisture like a poultice or a hot and cold sheet,
It is preferable to use a hydrophilic pressure-sensitive adhesive which has a medicinal effect, a cooling effect and a compressing effect for a long time.

The lipophilic pressure-sensitive adhesive is not particularly limited as long as it is a lipophilic pressure-sensitive adhesive. Specific examples thereof include a rubber-based pressure-sensitive adhesive, a vinyl acetate-based pressure-sensitive adhesive, and an ethylene-vinyl acetate-based pressure-sensitive adhesive. A layer formed of an adhesive containing a lipophilic material such as an adhesive, a vinyl chloride adhesive, an acrylic adhesive, a polyamide adhesive, a polyethylene adhesive, a polysulfide adhesive or a hot melt type polymer substance No.

The hydrophilic pressure-sensitive adhesive is not particularly limited as long as it is a hydrophilic pressure-sensitive adhesive. Specifically, for example, a hydrophilic acrylic polymer-based pressure-sensitive adhesive such as a polyacrylic acid-based pressure-sensitive adhesive, polyvinyl Examples of the layer include a layer formed of a pressure-sensitive adhesive containing a hydrophilic substance such as an alcohol-based pressure-sensitive adhesive, a polyvinyl acetal-based pressure-sensitive adhesive, or a cellulose-based pressure-sensitive adhesive.

The thickness of the pressure-sensitive adhesive layer depends on the use of the external patch and is not particularly limited, but is generally in the range of 25 to 1,000 μm, preferably 50 to 500 μm in the case of lipophilicity. Preferably,
Further, in the case of hydrophilicity, the thickness is preferably in the range of 500 to 4,000 μm, particularly preferably in the range of 800 to 3,000 μm.

If the thickness of the pressure-sensitive adhesive layer is less than the lower limit, the required skin adhesive strength may not be obtained in some cases. In the case of a cooling / heating sheet, the required cooling / heating effect may not be obtained. Exceeding the upper limit is not preferred because not only is it bulky and the feeling of use deteriorates, but also the economics deteriorates.

Incidentally, in the case of a hydrophilic pressure-sensitive adhesive as the pressure-sensitive adhesive, various drugs are contained depending on the application, and the drug is not particularly limited. Corticosteroids, antiphlogistic analgesics, hypertensives, anesthetics, hypnotics, tranquilizers, antihypertensives, antibiotics, antibacterials, vitamins, antiepileptics, coronary vasodilators, antihistamines, antifungals In the present invention, it is particularly preferable that the pressure-sensitive adhesive layer contains a compress, a cooling agent, or the like that exhibits a compressing effect and / or a cooling effect.

That is, in the present invention, when a hydrophilic pressure-sensitive adhesive is used to make an external patch such as a poultice or a cooling / heating sheet, it is desirable that the pressure-sensitive adhesive layer contains a poultice, a refreshing agent and the like. .

Specifically, in the cooling / heating sheet, for example, sublimable crystals, mint oil, eucalyptus oil, lavender oil,
Paraben and the like are added as needed.

In poultices, 2% aqueous boric acid, physiological saline, bitumen, alcoholic water, linseed oil, lime water, liver oil, olive oil, rivanol water, permanganese water are commonly used as poultices. Potassium acid (5,000-fold dilution) solution, mentor water, creosote, mustard, and the like are used.

In the present invention, it is not essential that the pressure-sensitive adhesive layer contains water, but when water is contained, the amount of water is 40 to 85% by weight based on the whole pressure-sensitive adhesive layer. %, Preferably in the range of 50 to 80% by weight, particularly preferably in the range of 65 to 75% by weight.

However, in the present invention, when the pressure-sensitive adhesive layer exhibits a cooling effect, the pressure-sensitive adhesive layer contains water and has excellent cooling, antipyretic and cooling effects by utilizing the heat absorption and latent heat of evaporation of the water. Those that last over time are desirable.

In the present invention, as described above, it is desirable that the pressure-sensitive adhesive layer contains a poultice which exhibits a compressing effect and / or a cooling effect, since it exhibits an extremely excellent compressing effect. Examples of the poultice include those described above.

[0053]

The external adhesive patch of the present invention has the above-mentioned structure, and is a skin-adhesive patch in which an adhesive layer is laminated on one side of a film-like or sheet-like support. At least two or more, particularly preferably three or more, transdermally absorbable drugs are blended, and the total content of the drugs is controlled by the Pharmaceutical Affairs Law to a level at which the patch is not specified as a drug. It has the effect that the agent can be treated as so-called "miscellaneous goods" instead of "medicine".

That is, at least two or more, particularly preferably three or more, transdermally absorbable drugs are blended in the adhesive layer even if the content of the patch is not specified as a drug in the Pharmaceutical Affairs Law. As a result, a synergistic effect of the medicinal effect appears, and it has an effect that it can effectively assist treatment such as early recovery of the affected part and relief of pain as compared with the conventional hot and cold sheets treated as “miscellaneous goods” It is.

Further, by employing such a constitution, the patch can be treated as a so-called “miscellaneous goods” instead of a “pharmaceutical product”. Therefore, even those who do not have a pharmacist's license and cannot prescribe and treat "medicines" have the effect that they can be easily and suitably used as a treatment aid.

[0056]

The present invention will be described below in detail with reference to examples, but the present invention is not limited to these examples.

FIG. 1 is a plan view of an external patch according to the present invention, and FIG. 2 is a sectional view thereof.

In FIG. 1 and FIG. 2, the external patch 1 according to the present invention is a cooling / heating sheet in this case, a film-like or sheet-like support 2 and a water-containing adhesive laminated on one side thereof. This support 2 has a moisture permeability in the range of 2,800 to 4,400 g / m ² · 24 hr.

The support 2 used in the present invention is not particularly limited, and generally includes a synthetic resin film, a synthetic resin porous film, a nonwoven fabric, a woven fabric, a felt or a knitted fabric.

By the way, the pressure-sensitive adhesive layer 3 is not particularly limited, but in this case, it contains water. Therefore, in the present invention, the pressure-sensitive adhesive layer 3 has a water content such as a poultice or a cooling / heating sheet. A hydrophilic pressure-sensitive adhesive is used, which has a mild medicinal effect, an excellent cooling / heating effect and a compressing effect over a long period of time due to transpiration.

The thickness of the pressure-sensitive adhesive layer 3 depends on the use of the external patch 1, and is not particularly limited, but is generally adjusted in the range of 500 to 2,000 μm.

When the pressure-sensitive adhesive layer 3 contains water, the water content is in the range of 40 to 85% by weight, preferably 50 to 85% by weight, based on the whole pressure-sensitive adhesive layer 3.
It is desirable that the content be in the range of 80% by weight, particularly preferably 65 to 75% by weight.

Further, in the present invention, as described above,
It is particularly desirable that the pressure-sensitive adhesive layer 3 contains a drug exhibiting a mild medicinal effect and a more excellent cooling effect and compressing effect.

Then, the external patch 1 according to the present invention is used as a cold sheet at the time of heat generation due to a disease such as a cold.

Example 1 As a transdermal drug, "l-menthol (0.095
Wt%) "," Methyl salicylate (0.19 wt%) "
And “Camphor (0.095% by weight)” were selected, and 14.0% by weight of glycerin, 6.2% by weight of sodium polyacrylate, and an acrylic resin emulsion (trade name: Nicazole TS-620) were selected. 5% by weight, 5% by weight of kaolin, 3.0% by weight of sorbitol solution, 3.0% by weight of polyvinyl alcohol, 0.8% by weight of carboxyvinyl polymer and 66.0% by weight of water, and further mixed with metasilicic acid / aluminic acid Magnesium (trade name Neusilin) 0.06% by weight and dry aluminum hydroxide gel 0.06% by weight were added and mixed again to obtain a pressure-sensitive adhesive composition.

This pressure-sensitive adhesive composition was used, and
(Moisture permeability is 3,650 g / m 2 · 24 hr, its size is 50 mm in length and 140 mm in width), applied and aged so that the thickness of the pressure-sensitive adhesive layer 3 is 3,200 μm. An external patch (cooling sheet) was obtained.

Example 2 As a transdermal drug, "l-menthol (0.095
Wt%) "," Methyl salicylate (0.19 wt%) "
And "Camphor (0.095% by weight)", and mixed with 87.62% by weight of SIS (styrene-isoprene-styrene copolymer) and 12% by weight of liquid paraffin (oil P refined oil) The lipophilic pressure-sensitive adhesive layer 3 prepared as described above was applied to the support 2 (having a moisture permeability of 3,650 g / m ^2.
It was applied to one surface of 24 hr (50 mm in length and 140 mm in width) so as to have a thickness of 260 μm, and was aged to obtain an external patch (for treating a disease) of the present invention.

Comparative Example 1 In Example 1, instead of using three kinds of drugs,
An external patch (cooling sheet) was obtained in the same manner as in Example 1 except that methyl salicylate (0.38% by weight) was used as a transdermally absorbable drug.

Comparative Example 2 In Example 1, instead of using three kinds of drugs,
An external patch (cooling / heating sheet) was obtained in the same manner as in Example 1 except that l-menthol (0.38% by weight) was used as a transdermal absorbable drug.

Comparative Example 3 In Example 1, instead of using three kinds of drugs,
An external patch (cooling / heating sheet) was obtained in the same manner as in Example 1 except that camphor (0.38% by weight) was used as a transdermal absorbable drug.

Comparative Example 4 A water content of 6 was obtained without any transdermally absorbable drug.
An external patch (cooling / heating sheet) was obtained in the same manner as in Example 1 except that 6.38% by weight was used.

Comparative Example 5 In Example 2, instead of using three kinds of drugs,
An external patch (for treating disease) was obtained in the same manner as in Example 2 except that methyl salicylate (0.38% by weight) was used as a transdermal absorbable drug.

Comparative Example 6 In Example 2, instead of using three kinds of drugs,
An external patch (for treating a disease) was obtained in the same manner as in Example 2 except that l-menthol (0.38% by weight) was used as a transdermal absorbable drug.

Comparative Example 7 In Example 2, instead of using three kinds of drugs,
An external patch (for treating a disease) was obtained in the same manner as in Example 2 except that camphor (0.38% by weight) was used as a transdermal absorbable drug.

Comparative Example 8 An external patch (Example 2) was prepared in the same manner as in Example 2 except that the percutaneously absorbable drug was not added at all and the compounding ratio of SIS was changed to 87.19% by weight. For disease treatment).

The external patches (cooling / heating sheets) obtained in Example 1 and Comparative Examples 1 to 4 are applied and treated to persons (25 persons each) who have a so-called fresh trauma such as a bruise or sprain. On the other hand, the external patches (for the treatment of disease) obtained in Example 2 and Comparative Examples 5 to 8 were applied to and treated with persons having the disease (25 persons each) for 24 hours. The effect of each patch on disease treatment after the lapse was examined.

Table 1 shows the results.

[0078]

[Table 1]

In Table 1, "excellent effect" means that the effect is remarkable, pain and fever disappeared, and the patient recovered to a healthy state. "Effective" hardly felt pain or fever. It means that you have recovered to a state where you are almost not bothered,
Further, "moderately effective" refers to a state in which pain and fever have recovered a little, but only a little pain still remains.

From the results shown in Table 1, it was confirmed that the treatment of each example had an extremely high therapeutic effect on the disease as compared with that of each comparative example. However, Comparative Examples 1 to 3 and Comparative Examples 5 to 7 , The effect of almost the same ratio as in Comparative Examples 4.8, in which the patch itself did not contain the drug, that is, 2-1 out of 25 patients
Although about 0 persons (8 to 40%) and only "moderately effective" or "effectively" effects could be recognized, those of Examples 1-2 were 20/25. ~
Twenty-three persons (80 to 92%) recognized the effects of "slightly effective" to "excellently effective", and thus the synergistic effect of the drug effect was remarkable in the external patch of the present invention, and as an auxiliary agent for treatment It was found to be very effective.

[0081]

According to the present invention, there is provided an external patch according to the present invention, which has the above-mentioned structure, and is a skin-adhesive type patch in which an adhesive layer is laminated on one side of a film-like or sheet-like support. The layer contains at least two or more, particularly three or more, transdermally absorbable drugs, and the total content of the drugs is controlled by the Pharmaceutical Affairs Law so that the patch is not specified as a drug. The patch can be treated not as a “pharmaceutical product” but as a so-called “miscellaneous goods”.

That is, in the external patch according to the present invention, at least two or more transdermally absorbable drugs are contained in the pressure-sensitive adhesive layer even if the content of the patch is not specified as a drug in the Pharmaceutical Affairs Law. In particular, by combining three or more types, a synergistic effect of the medicinal effect appears, and, for example, compared with the conventional cold and heat sheets treated as "miscellaneous goods", the early recovery of the affected part and the early relief of the pain are further improved. Since a therapeutic effect such as a compressing effect is remarkably exhibited, it is very effective as an auxiliary agent for the treatment.

Also, with this configuration, the patch can be treated as a so-called “miscellaneous goods” instead of a “pharmaceutical product”. Also, even those who cannot prescribe and treat "medicine" because they do not have a pharmacist's license have the effect that they can be easily and suitably used as an auxiliary for treatment.

[Brief description of the drawings]

FIG. 1 is a plan view showing one embodiment of an external patch according to the present invention.

FIG. 2 is a sectional view of the same.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 External patch 2 Support 3 Adhesive layer

Claims (7)

[Claims] 1. A skin-adhesive patch in which a pressure-sensitive adhesive layer is laminated on one side of a film or sheet-like support, wherein the pressure-sensitive adhesive layer contains at least two transdermally absorbable drugs.
An external patch characterized in that it contains at least one species and the drug content is controlled to a level at which the patch is not specified as a drug in the Pharmaceutical Affairs Law. 2. The external patch according to claim 1, wherein the pressure-sensitive adhesive layer contains at least three or more transdermally absorbable drugs. 3. Percutaneously absorbable drugs include corticosteroids, anti-inflammatory analgesics, antibiotics, vitamins, Ca antagonists, hypnotics, tranquilizers, antihypertensives, antihypertensives, anesthetics. , Antibacterial, antifungal, antiepileptic,
Coronary vasodilators, antihistamines, antitussives, sex hormones,
The external patch according to claim 1, which is selected from an antidepressant, a cerebral circulation improving agent, an antiemetic, an antitumor agent, and a biopharmaceutical. 4. The external patch according to claim 1, wherein the pressure-sensitive adhesive layer contains a total content of the transdermally absorbable drug of 0.005 to 1% by weight. 5. The support according to claim 1, wherein the support is formed of at least one kind of cloth base material selected from a synthetic resin film, a synthetic resin porous film, a nonwoven fabric, a woven fabric, a felt and a knitted fabric. Or the external patch according to item 1. 6. The external patch according to claim 1, wherein the pressure-sensitive adhesive layer is formed of a hydrophilic or lipophilic pressure-sensitive adhesive. 7. The external patch according to claim 6, wherein the water content in the pressure-sensitive adhesive layer is in the range of 40 to 85% by weight based on the whole pressure-sensitive adhesive layer.