JPH04124128A - Plaster for treating disease of anus part - Google Patents

Abstract

PURPOSE:To obtain a plaster for treating diseases of anus part, having highly protecting action on the lesion, reduced feeling of physical disorder in use and reduced irritation in releasing thereof by providing an elastic substrate with a tacky agent layer having specific peel strength. CONSTITUTION:An elastic substrate is provided with a tacky agent having 180 deg. peel strength of 50-300g/50mm width at 25 deg.C in 60% relative humidity. The tacky agent layer, for example, is obtained by coating a substrate with plaster obtained by sufficiently kneading a water-soluble polymer with mineral powder, a curing agent and water, and 180 deg. peel strength can be adjusted by controlling the composition of the plaster, especially selecting kinds of the water-soluble polymer and the curing agent and the amounts thereof.

Description

[Detailed description of the invention] L fruit Δ machine ball rise disaster The present invention relates to a patch for treating anal diseases.

Specifically, by pasting it on the anus, it is intended to protect the anal diseased area from external stimulation, prevent staining of underwear due to bleeding, etc., and improve the effectiveness of drug treatment.

Follow me! 114 Conventionally, most of the drug treatments for anal diseases have involved applying ointments and inserting suppositories, and the therapeutic effects have been limited. Therefore, the treatment of diseases in the anal region often relies on surgical means such as surgery, but in this case as well, 1. Since sutures are not usually used in anal region surgery, gauze or sanitary napkins are applied to the wound. It was necessary to wait for the epithelium to regenerate.

As described above, conventional ointments and suppositories have drawbacks such as: (1) The therapeutic effect is uncertain. (2) The effect is not durable.

■ No protective effect on the affected area ■ In case of bleeding, the bleeding cannot be stopped and the underwear gets dirty. There was a problem.

Gauze, sanitary napkins, and other items used after surgery do not have a suitable fixing method, so they slip off when you move, making it impossible to protect the affected area from external stimulation, and underwear becoming dirty due to body fluids and bleeding after surgery. There was a problem with this.

Therefore, in order to solve the above problem, a patch to be applied to the anal area is being considered. However, conventional patches are easy to peel off, and either completely peel off in a short period of time or partially peel off. There was a problem that it irritated the affected area.

The problem that Akira is trying to solve is that the present invention is difficult to peel off and is retained in the affected area for a long time.
Furthermore, the present invention provides a patch for treating anal diseases that causes less discomfort, is easily removed when removed, and does not irritate the affected area.

Look at me! The patch for treating anal diseases of the present invention includes an adhesive layer having a peel strength of 50 to 300 g/5011 m width at 180° C. at a temperature of 25° C. and a relative humidity of 60% on a stretchable support. It is characterized by

The present invention will be explained in more detail below.

The skin in the anal area of the human body is particularly mobile, so in order for the patch to adhere firmly, a base fabric that is flexible and highly stretchable is required.
A plaster with strong adhesive strength is required. However, in the case of anal diseases such as hemorrhoids, the mucous membranes are sensitive, so if the adhesive is too strong, the mucous membranes will be irritated and cause bleeding.8 Therefore, in the present invention, the temperature An adhesive layer having a peel force of 50 to 300 g/b width, preferably 100 to 250 g/50 an+ width when measured at 25° C. and 60% relative humidity, and a stretchable support are combined. used.

If the peeling force of the adhesive layer is less than 50g/50mo+width, sufficient adhesive force cannot be obtained and the adhesive layer is likely to be peeled off. On the other hand, 300
If the width exceeds g/50 mm, it may irritate the anal active membrane and cause bleeding during peeling.

Furthermore, if the support does not have elasticity, it will not be able to follow the movements of the anus and will peel off. The support of the present invention may be stretchable in only one direction, either vertically or horizontally, but it is preferably stretchable in both the vertical and horizontal directions (all directions).

In addition, the elastic support has a 50% modulus of 0.1 to
It is preferable that the weight is 2.0 kg/5 cm and the elongation recovery rate at 50% elongation is 40% or more. 50% modulus is the load required to stretch the length to 1.5 times, and the elongation recovery rate at 50% elongation is the elongation of the support when it is stretched to 1.5 times and returned to its original length. It's a return.

The 50% modulus and the elongation recovery rate at 50% elongation are measured as follows. i.e. 50am x 3
Using a tensile strength testing machine, test length 20 was applied to a 00m test piece.
It is stretched to 100 mm at a tensile rate of 0 sua and 200 mm/win, and its strength (Kg) is measured and taken as a 50% modulus. Then return it to the original position at the same speed and stretch it again at the same speed. The initial length A (100m
m), the residual elongation B (am) is read from the chart paper, and the elongation recovery rate at 50% elongation is calculated from the following formula.

-B Elongation recovery rate at 50% elongation (%) = A × 100 180° peeling force is measured as follows6, that is, 50
A sample of n+w
Using a tensile strength tester, the folded tip is pulled at a tensile speed of 200 mm/l1 inch, and the maximum tension (g) when peeled from the palm of the hand is measured, and the tension at this time is defined as 1806 peeling force.

The adhesive layer of the present invention is made of, for example, a water-soluble polymer.

It is obtained by coating a paste on a support by thoroughly kneading mineral powder, a hardening agent, and water, and by adjusting this composition, the type and amount of the water-soluble polymer and hardening agent can be adjusted. By selecting, 1800 peel force can be adjusted.

The patch having the above adhesive layer is difficult to peel off and protects the affected area for a long time. Furthermore, in the adhesive layer,
When a drug that promotes the treatment of anal diseases is combined, the therapeutic effect is enhanced because the medicinal effect lasts for a long time.

Next, each component of the adhesive layer will be explained.

Examples of water-soluble polymers include gelatin, polyacrylic acid, sodium polyacrylate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, sodium carboxymethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose, sodium alginate, and xanthan gum.

Examples include gum arabic, gum tragacanth, gum karaya, and methyl vinyl ether/maleic anhydride copolymer. It is preferable to use a mixture of two or more of these polymers, and it is particularly preferable to use a mixture of polyacrylic acid and/or sodium polyacrylate and sodium carboxymethyl cellulose with other polymers.

The blending amount of these water-soluble polymers varies depending on the selected polymer and its degree of polymerization, but is usually 5 to 25% by weight (w/
W) is blended into the plaster within the range.

As the curing agent, those that act gradually are preferable to those that act quickly, such as magnesium aluminate silicate, magnesium alumina hydroxide, magnesium aluminate metasilicate, synthetic hydrotalcite, dihydroxyaluminum aminoacetate, etc. can be mentioned.

The amount of curing agent blended in the paste is 0.03 to 1.0% by weight (
ν/oath) is preferred.

Examples of mineral powders include kaolin, bentonite, montmorillonite, zinc oxide, titanium oxide, and silicic anhydride.

3 to 10% by weight/% I) is blended into the plaster.

Medications that promote the treatment of anal diseases include local anesthetics, anti-inflammatory analgesics, corticosteroids, antihistamines,
There are sterilizing disinfectants, hemostatic agents, etc., and these may be used alone or in combination of two or more, and the blending amount is usually 0.01 to 5.0% by weight based on the plaster. Specific examples of these drugs are as follows.

(1) Local anesthetics Propyroine hydrochloride, Tetracaine hydrochloride, Chloropropylene hydrochloride, Ethyl aminobenzoate, Dizocaine hydrochloride, Lidocaine, Lidocaine hydrochloride, Mepivacaine, Bupivacaine hydrochloride, Cocaine hydrochloride, Tetracaine hydrochloride, Propyvacaine hydrochloride, Hexothiolyne, butanilicaine hydrochloride, oxypropylene hydrochloride, Qi Cain, mepril hydrochloride, piverolyne hydrochloride, etc. (2) Analgesic and anti-inflammatory agents mefenamic acid, flufenamic acid, indomethacin, diglofenac sodium, ibuprofen, ketoprofen, bufuexamasoc , tribenoside, etc. (3) Antihistamines diphenhydramine hydrochloride, diphenhydramine salicylate, clofenoxamine hydrochloride, carbinoxamine maleate, chlorpheniramine maleate, isothipendyl hydrochloride, clemizole hydrochloride, talemastine, etc. (4) Corticosteroids cortisone acetate, hydrocortisone acetate, hydrocortisone , fludrocortisone acetate, prednisone, prednisolone, prednisolone acetate, prednisolone succinate.

Methylprednisolone, trianicinolone.

Triamcinolonoacetonite, dexamethacin, dexamethacin acetate, betamethacin, betamethacin valerate, flucortron, flulandrenolone, fluocinolone acetonide, flumethacin, fluoromesolone, beclomethasone propionate, etc. (5) Bactericidal disinfectant acrinol, Acrinoflavin, nitromethacin, benzalkonium chloride, benzethonium chloride, chlorhexidine, bombidone iodine, etc. (6) Hemostatic agents thrombin, phytonadione, protamine sulfate, ε-aminocaproic acid, tranexamic acid, carbazocchrome, sodium carbazocchrome sulfonate, rutin, Hesveridin, noscanol, epinephrine, lysozyme chloride, etc. In addition to the above, glycerin, sorbitol,
Moisturizers such as propylene glycol.

Polysorbate 80. Surfactants such as polyoxyethylene hydrogenated castor oil and glycerin fatty acid ester can be blended.

The support used in the present invention may be any of woven fabrics, knitted fabrics, nonwoven fabrics, polymer films, or laminates thereof, but nonwoven fabrics or laminates of nonwoven fabrics and polymer films are particularly preferred.

The material of the nonwoven fabric is not particularly limited, but it is desirable to use thermoplastic fibers alone or a blend of thermoplastic fibers and non-thermoplastic fibers, and as the polymer film, urethane polymer films are preferred.

Examples of thermoplastic fibers include polyester fibers, polyethylene fibers, polypropylene fibers, polyamide fibers, polyvinyl chloride fibers, and polyvinyl alcohol fibers, which may be used alone or in combination of two or more. Examples of non-thermoplastic fibers include rayon, cupro, linen, and silk.

The method for manufacturing nonwoven fabrics using these fibers is not particularly limited, but for example, two types of fibers with different heat shrinkage rates are intertwined and integrated by a two-dollar punch method, and heat treatment is performed to heat them. There is a method of causing contraction to make it stretchable.

The adhesive patch of the present invention can be produced by applying a plaster to the above-mentioned support by a known method. At this time, the thickness of the plaster is 100 to 3000 μm, especially 200 to 3000 μm.
It is suitable to set it to 2000 micrometers. The shape of the patch of the present invention can be any appropriate shape, such as circular or elliptical, depending on the condition of the affected area.

According to the present invention, by combining an adhesive layer with a specific 1806 peeling force and a support to form a patch for treating anal diseases, it firmly adheres to the affected area with an appropriate adhesive force and can be applied to the affected area. It covers the affected area for a long time and reliably shields it from external stimuli, providing a high level of protection for the affected area, reducing discomfort during use and irritation when removed.

Furthermore, when a drug effective for treating anal diseases is incorporated into the patch, the therapeutic effect is high because the medicinal efficacy lasts for a long time.

Furthermore, since the patch of the present invention is properly fixed to the affected area, it is possible to prevent dirt from adhering to underwear even when bleeding occurs from the affected area.

Experimental Example 1 The product of the present invention and a comparative amount were tested for durability of local anesthetic effect and usability.

Below, (1) Preparation of the product of the present invention, (2) to (4) Comparative amount A
Preparation of ~C, (5) test method, and (6) test results will be explained in detail in this order.

(Left below) Inventive product Sodium carboxymethylcellulose 4.0 parts by weight Glycerin 20.0 parts by weight D-sorbitol liquid 10.0 parts by weight Synthetic hydrotalcite 0.1
Part by weight Polyoxyethylene monooleate 1.0
After melting and kneading the above component of sorbitan (ethylene oxide) by weight, it was spread on a biaxially stretchable polyester nonwoven fabric to a thickness of about 1000 μm, and the major diameter was 80w1.
1. The product of the present invention was obtained by cutting into an oval shape with a short axis of 50 cm.

180 at a temperature of 25°C and a relative humidity of 60% for the product of the present invention
'Peeling force was 195 g/50 mm width.

(2) Preparation of Comparative Amount A The same paste as the product of the present invention was spread on a non-stretchable lint cloth to a thickness of about 1000 μm, and the major axis was 80 mm and the minor axis was 50 mm.
A comparison amount A was obtained by cutting into a 11@ oval shape.

180 at a temperature of 25°C and a relative humidity of 60% for comparison amount A
'Peeling force was 203 g/50 mm width.

(3) Preparation of comparative amount B Dibucaine hydrochloride Hydrocortisone acetate Zinc oxide Sodium polyacrylate Gelatin Sodium carboxymethyl cellulose Glycerin Potassium Alumina Citric acid Monostearate Polyoxyethylene sorbitan (Average number of moles added of ethylene oxide = 20) Purified water 0.5 weight 0.3 parts by weight 10.0 parts by weight 5.0 parts by weight 10.0 parts by weight 50 parts by weight 20.0 parts by weight 0.05 parts by weight 05 parts by weight 10 parts by weight 47.65 parts by weight The above components were melt-kneaded. After that, it was spread to a thickness of about 1000 μl on the same nonwoven fabric as the product of the present invention, and the long axis was 80 mm and the short axis was 50 mm.
A comparative amount B was obtained by cutting into an ellipse of mm.

180 at a temperature of 25°C and a relative humidity of 60% for comparative amount B
6 peel force was 34 g/50+am width.

(4) Preparation of comparative amount C Styrene/isoprene/styrene copolymer 40.0 parts by weight Polyisobutylene 100 parts by weight Liquid paraffin 33.2 parts by weight Ester gum 3.0
Part by weight Zinc oxide 10.
0 parts by weight hydrocortisone acetate 0
3 parts by weight Dibucaine hydrochloride 0
．． 5 parts by weight Glycerin fatty acid ester 3
．． 0 parts by weight The above acid content was melted and kneaded at 130°C in a pressurized and heated mixer, spread on the same cloth as the product of the present invention, and after cooling, a large diameter of 80 mm and a short diameter of 50 mm. A comparison amount C was obtained by cutting into an elliptical shape.

180 at a temperature of 25°C and a relative humidity of 60% for comparative amount C
'Peeling force was 410 g/50 mm width.

(5) Test method Five hemorrhoid patients who have symptoms of pain and who often work while driving a car were given the adhesive side of each of the products of the present invention and comparative amounts A to C for treating anal diseases. The samples were actually pasted, and the following items were tested and evaluated.

■ Pasting time How long it stuck to the affected area without peeling off ■ Duration of local anesthesia effect No pain is felt due to the local anesthetic effect time ■ Feeling strange ×: Strong sense of discomfort Δ: Something feels strange. 0: Slightly uncomfortable O: There is no discomfort. ■ Pain when removing X: Feel the pain strongly △: There is pain ○: Feels slight pain O: I don't feel any pain. (6) Test results The test results are summarized in Table 1 below.

With the product of the present invention, the application time and the duration of the local anesthetic effect were long, and there was almost no discomfort or pain when peeling it off.
When the comparative amount C exceeds 00 g/50 mm width, the adhesive strength is too strong, causing severe pain when peeling off, and there have been cases where it has led to bleeding.

In addition, comparative amount B with a 180' peel force of less than 50 g/50 am width has a weak adhesive force and easily peels off, so that the objective cannot be achieved. Furthermore, the comparative amount A, in which the base fabric did not have stretchability, had a strong sense of discomfort and had a tendency to peel off easily because it could not follow the movements of the skin.

In this way, the effects of the product of the present invention are as follows: temperature: 25°C, relative humidity: 6.
180' peel force at 0% is 50-300g/50m
This can only be achieved by combining both an adhesive layer with a width of s+ and a stretchable support, and cannot be achieved if either one of them is missing.

(Margins below) Table 1 Example 1 Dibucaine hydrochloride 0.3 parts by weight Diphenhydramine hydrochloride 0.5 parts by weight Hydrocortisone acetate 0.2 parts by weight Tocopherol acetate 2.0 parts by weight Zinc oxide 10.0
Weight part polyacrylic fi 4
．． 0 parts by weight Sodium polyacrylate 1
．． 0 parts by weight Sodium carboxymethyl cellulose 3
．． 0 parts by weight glycerin 2
0.0 parts by weight polyoxyethylene monostearate
1.0 parts by weight Sorbitan (average number of added moles of ethylene oxide = 20) Aluminum glycinate 0.18 parts by weight Purified water 57.8 parts by weight After melting and kneading the above components, onto a biaxially stretchable polyester nonwoven fabric, Spread to a thickness of approximately 900μI.

The product of the present invention was obtained by cutting into an oval shape with a major axis of 70++o++ and a minor axis of 50++o. This stretchable nonwoven fabric had a 50% modulus of 0.5 kg/5c+a and an elongation recovery rate at 50% elongation of 55%.

The product of the present invention is used for the treatment of hemorrhoids.

Note that the 180' peeling force of the product of the present invention is 160g/50m
It was +a width.

Example 2 Dibucaine hydrochloride 0.5 parts by weight Carbazochrome 0.2 parts by weight Zinc oxide 10.0 parts by weight Polyacrylic acid 5.0
Part by weight Sodium polyacrylate 1.5
Part by weight Sodium carboxymethyl cellulose 6.0
Part by weight polyvinyl alcohol 3.0
Parts by weight Glycerin 40.
0 parts by weight synthetic hydrotalcite 0
゜2 parts by weight Polyoxyethylene hydrogenated castor oil 2
．． 0 parts by weight (average number of added moles of ethylene oxide = 60
) 31.6 parts by weight of purified water After melting and kneading the above ingredients, spread it to a thickness of 1500μ on one side of a biaxially stretchable polyethylene nonwoven fabric treated with urethane to a thickness of 10μ. After that,
The product of the present invention was obtained by cutting into a size foo x 150 mm.

The product of the present invention is used by cutting it into a size and shape appropriate for bleeding hemorrhoid diseases.

The 180° peeling force of the product of the present invention is 210g/50m.
It was wide.

Example 3 Benzethonium chloride 0.2 parts by weight Dibucaine hydrochloride 0.5 parts by weight Methyl vinyl ether/maleic acid copolymer 8.0 parts by weight Polyacrylic acid 4.0 parts by weight Sodium polyacrylate 1.0 parts by weight Gelatin 5. 0 parts by weight Sodium carboxymethylcellulose 10.0
Parts by weight Glycerin 25.
0 parts by weight synthetic hydrotalcite 0
．． 2 parts by weight purified water 4
After melting and kneading 6.1 parts by weight of the above ingredients, it was spread on a biaxially stretchable polypropylene nonwoven fabric to a thickness of about 700 μm, and cut into a circle with a diameter of 60111I to obtain a product of the present invention.

The product of the present invention can be used after hemorrhoid surgery to treat the affected area and provide pain relief.

In addition, the 1806 peel force of the product of the present invention is 165g750m
It was @ width.

Claims (1)

[Claims] 1. On a stretchable support, at a temperature of 25°C and a relative humidity of 60%.
1. A patch for treating anal diseases, comprising an adhesive layer having a peel strength at 180° C. of 50 to 300 g/50 mm width. 2. One or more drugs selected from local anesthetics, anti-inflammatory analgesics, antihistamines, adrenal corticosteroids, bactericidal disinfectants, and hemostatic agents are added to the adhesive layer as drugs to promote healing of anal diseases. The patch for treating anal diseases according to claim 1.