JPS58164506A - Adhesive tape or sheet for medical use - Google Patents

Abstract

PURPOSE:To prepare the titled tape, etc. which does not leave the adhesive on the skin after release, by applying a thin-film pressure-sensitive adhesive composed of a copolymer of an alkali or alkaline earth metal salt of an alpha,beta-unsaturated carboxylic acid and a (meth)acrylic acid ester and containing a drug component, to a substrate. CONSTITUTION:The titled adhesive tape or sheet for medical use is composed of a substrate (e.g. polyethylene film, etc.) and a pressure-sensitive adhesive layer composed of a copolymer of (A) an alpha,beta-unsaturated carboxylic acid alkali (ne earth) metal salt and (B) a (meth)acrylic acid ester and containing a drug component. Since the carboxyl group of the adhesive is converted to alkali or alkaline earth metal salt, the cohesive force of the adhesive becomes an adequate level, the residue of the adhesive to the skin is prevented, and the release of the drug component to the skin can be improved. Furthermore, there is no deterioration and discoloration with heat even if the drug component is unstable to acid. The above copolymer may contain other monomers as copolymerized components.

Description

[Detailed description of the invention] The present invention relates to a therapeutic adhesive tape or sheet.

A thin pressure-sensitive adhesive layer mixed with a therapeutic drug is provided on the base material, and when the therapeutic adhesive tape or sheet is applied to the skin, the drug oozes out from the pressure-sensitive adhesive layer for local treatment. It is attracting attention as a new treatment method to replace the conventional occlusive dressing therapy (ODT therapy).

The performance required of such therapeutic adhesive tapes or sheets is that pressure-sensitive adhesives can cause strong irritation to the skin, which is dangerous, and that when applied to the skin and then peeled off, excessive adhesive strength may occur. The adhesive does not cause sand pain, there is no mutual chemical interaction between the pressure-sensitive adhesive and the drug, and the drug easily wades out from the adhesive onto the surface so that sufficient medicinal effects can be obtained.

Conventionally, as a pressure-sensitive adhesive for this purpose, %O is used, which is composed of a copolymer containing a monomer having a carboxyl group and an acrylic acid ester or (and) a methacrylic acid ester. The adhesive layer contains a chemical, but if O is used as the chemical because it is acidic and unstable, it will become extremely unstable due to heat (the chemical deteriorated).
In addition to discoloration seen with colored drugs (9), the pressure-sensitive adhesive adheres to the adhesive (adhesive retention) due to insufficient internal cohesive force and cannot be peeled off after application. I'm so afraid.

The present invention has been made with the aim of overcoming the above drawbacks, and the point where it is stated that the present invention has been made with the aim of eliminating such drawbacks is that the base material has
In a therapeutic adhesive tape or sheet provided with a pressure-sensitive adhesive layer containing a drug, the pressure-sensitive adhesive has an α,p unsaturation force having one or two carboxyl groups.
It is a copolymer containing a homogeneous acrylic acid ester or Fi (and) methacrylic acid ester as a copolymerization component, and is considered to be a salt of a carbonaceous metal contained in the copolymer. A therapeutic adhesive tape or sheet characterized by:

Next, the therapeutic adhesive tape or adhesive sheet of the present invention will be explained in more detail.

The base material in the present invention is preferably made of a material with zero clingability, such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, soft polyvinyl chloride, cellophane, etc., and the thickness of the base material is #i0.02. The range is preferably from 0.15 m0 to 0.15 m0. If necessary, the base material is subjected to corona discharge treatment, plasma treatment, primer coating, etc. in order to increase the adhesion with the pressure-sensitive adhesive.

Pressure-sensitive adhesive layer, (4) containing α, β unsaturated carlinic acid having 1 to 2 carboxyl groups and (homogeneous acrylic ester or #i< and) methacrylic ester as copolymerization components Consists of copolymer.

Suitable examples of the prison component include acrylic acid, methacrylic acid, Kutonic acid, maleic acid, and itaconic acid.
The amount of the copolymerized component is preferably 0.1 to 20% by weight.

The component ω) may include ester residues such as meth,
Tyl group, ethyl group, propyl group, isopropyl group, n-butyl group, inobutyl group, --pentyl group, isopentyl group, 2-methylbutyl group, n-hexyl group, 2-methylpentyl group, 3-methylpentyl group, 2 Those having an -ethylbutyl group, an octyl group, an isooctyl group, a 2-ethylhenochyl group, a nonyl group, a decyl group, a lacryl group, etc. are used.

Particularly suitable acrylic esters include ethyl acrylate, n-butyl acrylate, inbutyl acrylate, (soar acrylate, 2-ethylhexyl acrylate, n-octyl acrylate, lauryl acrylate), In addition, as methacrylic acid esters, butyl methacrylate, butyl methacrylate, 2
-Ethyl methacrylate, n-octyl methacrylate, and lauryl methacrylate.

The copolymer may contain, in addition to the above-mentioned components O and Component O, a monomer capable of copolymerizing with Japanese chives as a copolymerization component.

Suitable examples of the mouth ingredients include acrdalamide, vinyl acetate, di-9-1 styrene, vinyl chloride, vinylidene chloride, ethylene, propylene butadiene, isoprene, and the like.

To obtain a copolymer in which the above-mentioned material, @component is used as a copolymerization component, or a copolymer, in which other monomers copolymerizable with these materials are used as a copolymerization component. However, it is possible to carry out polymerization, suspension polymerization, etc. by using an azobis-based compound, a peroxide-based compound, etc., but it is possible to use a chemical that is used in the fireworks process. 011 go,
Considering the dissolution process, solution polymerization is optimal. For example, in a reaction vessel, add the components (4), 俤) and optionally (q
Add the ingredients, add 100ml of ethyl acetate to make a solution with a strength of about 60% by weight, replace the atmosphere in the reaction vessel with nitrogen gas, raise the arc while stirring, and at a temperature of 60 to 80°C. The 2-radical generating catalyst is dissolved in the same solvent, and the whole solution is dropped or injected in portions, and the viscosity is suppressed while adding more solvent as the viscosity increases, and the polymerization is completed in 10 to 20 hours. The copolymers used are only unsatisfactory as pressure-sensitive adhesives for therapeutic adhesive tapes or sheets. Inside the O layer, the copolymer may lack internal cohesive force.1) Peel it off after pasting.91
Pressure-sensitive adhesive adheres to lllj pasted image (-residual) 3
It is important to note that there is a risk of harming the JL phenomenon, and that acidic and unstable O is often used in drugs, but since the copolymer has a force-hd-kifle group, I O-s O'c@degree O Heat can cause discoloration, and colored drugs can cause discoloration, which can cause 9 to 10% and 0.
This is because the copolymer has a w4m1 point.In the present invention, the carbyl group in the copolymer is a salt of an alkali metal or an alkaline earth metal.

Examples of alkali metals and alkaline earth metals include sodium, kalam, magnesium, calsilla, alkali metals (and) K used as alkaline earth metal salts, such as lithium hydroxide, sodium Ethylate, sodium hydroxide, potassium hydroxide, magnesium hydroxide, magnesium oxide, and calcium hydroxide may be brought into contact under appropriate heating conditions.

Preferably, 80 or more carboxyl groups in the copolymer are salts of alkali metals (and) alkaline earth metals. If the amount is less than 80 moles, if the drug is acid-labile, it may change color when exposed to heat, which may cause discoloration of the colored drug. This is because the internal coagulation force of the copolymer is also insufficient in 4 and 131.

As the drug, for example, sodium nalicylate, methenamic acid, flufenamic acid, a7tylsalicyl alcohol, indomethacin, etc. are used.

The amount of the drug varies depending on the thickness of the pressure-sensitive adhesive layer and the type of drug.
The pressure-sensitive adhesive is preferably applied to the base material KIk, cloth, dried, and then the release sheet is pressed through a 9-hole or the like, or a solution of the pressure-sensitive adhesive is first applied onto the release sheet OWt. By coating, drying, and pressing the substrate onto the adhesive surface through a roll, the pressure-sensitive adhesive layer is protected and a therapeutic adhesive tape or sheet is obtained.

According to the present invention, the pressure-sensitive adhesive is a copolymer containing the component (2) above as a copolymerization component, and the carboxyl group in the copolymer is an alkali metal or (and)
Since it is an alkaline earth metal salt, the pressure-sensitive adhesive has an internal cohesive force and can be applied to the adhesive.
It doesn't cause any residue, and the cross-agent OII emission performance is like that of Arashiko FK4◎J2! Even if an unstable substance is used as a chemical, it will prevent discoloration during deterioration due to heat, and the pressure-sensitive adhesive layer will prevent the precipitate from forming a layer. Even if there is no, it becomes O.

Example 1 2-ethylhexyl methacrylate 55fn-
Butyl acrylate 38F ether acrylate 4F acrylate, acid
L5f Add each of the above component tubes to reaction volume IIK, add azobisin butyronitrile Q as a catalyst, and ethyl acetate as a sy5ill agent.
Combine the solution chambers at 0°C, and 11% of the 40% by weight -〇 copolymer S
I got *.

Next, the above copolymer solution 100FK ethyl acetate 50F
Add 10f of ethyl acetate to CtL and add 10f of sodium ethyl acetate to CtL.

They were uniformly dispersed in the 1OfO ethanol mixture and added. Next, stir while heating at 70°C for 1 hour,
Furthermore, 10 tfi4 of 0.68 weight sodium ethylate and ethyl acetate and ethanol** were added. Stirring was continued for 30 minutes, 10 d of water was added, and the pH value was adjusted.The pH value was 7.77.807 of the carxyl groups in the copolymer were converted to sodium salts. No.

Next, 154 tvt of indomethacin as a drug was added to this pressure-sensitive adhesive solution (solid content 2141 G), and the obtained 9111 solution was spread on a polyethylene film and dried for 20 minutes at 70°C to obtain a therapeutic adhesive tape. The thickness of one pressure-sensitive adhesive layer of this therapeutic adhesive tape is 63.5 p-
[i] When applied to the skin, it did not peel off, nor did it cause any prickling sensation after application.

Immediately after manufacturing this therapeutic adhesive tape and after leaving it for 7 days at 60°C, the presence or absence of discoloration of the drug, and the pressure sensitivity of the drug! 1! I
The compatibility with the adhesive and the presence or absence of exudation of the drug O from the pressure-sensitive adhesive layer were determined, and the results are shown in Section 111.

The presence or absence of coloring of the drug can be determined from the change in color tone of the pressure-sensitive adhesive layer. The drug exudation property was determined by punching a circular test piece with an electric value of 6 gm from a therapeutic adhesive tape and using 25 d of methanol.
The pills were immersed in a mixture of 1 part water and 25 parts for 24 hours to extract the drug, and the amount of the extracted pills was determined by liquid chromatography.

In addition, the presence or absence of deterioration of the cross-agent O was determined by liquid mapography.

Table 1 Comparative Example 1 Using the same components as Example 1, using the same machine as Example 1.
Next, using this copolymer St, indomethacin & 54r were mixed in the same manner as in Example 1, and this solution was spread on a polyethylene film with Ilk cloth. , dry at 70'C for 20 minutes to obtain a therapeutic adhesive tape.

It can be seen from the fact that the color of the pressure-sensitive adhesive layer changes to dark brown that the drug in this therapeutic adhesive tape loses its room color after being left at 60'C for 7 days. In addition, when the drug was extracted in the same manner as in Example 1 and this extract was analyzed using liquid chromatography, it was found that the peak of the drug immediately after production was different from the standard drug peak, but the peak of the drug was 7.
If the sample was left to stand for a day, the sample peaks were found in two places, and it was confirmed that the quality had clearly changed.

patent applicant Sekisui Chemical Co., Ltd. Kinsha Representative Mototoshi Fujinuma

Claims (1)

[Scope of Claims] 1. A therapeutic adhesive tape or sheet in which a pressure-sensitive adhesive layer containing a drug is provided on a base material, wherein the pressure-sensitive adhesive has one or two Q-calcexyl groups. α, which has
A copolymer containing a β-unsaturated carboxylic acid and (6) an acrylic acid ester or (and) a methacrylic acid ester as a copolymerization component, wherein the carboxyl group in the cough copolymer is an alkali metal or (and) A therapeutic adhesive tape or sheet characterized in that it is a salt of an alkaline earth metal. Therapeutic adhesive tape or sheet 3 according to claim 11jlE1, characterized in that 080 moles or more of sil groups in the carbo in the copolymer are a salt of an alkali metal or (and) an alkaline earth metal. The therapeutic adhesive tape or sheet according to claim 1 or 2, characterized in that: