JPH0517346A - Agent for medical application - Google Patents

Abstract

PURPOSE:To obtain a repeatedly applicable agent having sufficient applicability and further with low irritancy to the skin when peeling thereof. CONSTITUTION:An agent for medical application obtained by forming on one surface of a support, a tacky agent layer comprising a tacky base containing a 10-30C paraffinic hydrocarbon and/or naphthenic hydrocarbon and an alicyclic hydrocarbon resin in an amount of 80-95wt.% total amount thereof and 5-20wt.% styrene-isoprene-styrene block copolymer at a weight ratio of the paraffinic hydrocarbon and/or naphthenic hydrocarbon to the alicyclic hydrocarbon resin within the range of (2:3) to (3:2).

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical patch having a pressure-sensitive adhesive layer provided on one surface of a support, which is particularly excellent in patchability.
The present invention also relates to a patch that can be repeatedly applied and has low skin irritation.

[0002]

BACKGROUND OF THE INVENTION Medical patches are required not only to have excellent tackiness during application, but also to be free from blistering during peeling and to have less physical irritation to the skin.
However, in a patch using a rubber-based adhesive base,
In general, although the adhesiveness is excellent, there is a tendency for peeling the stratum corneum of the skin to cause a rash due to the adhesive force at the time of peeling, or to cause an unfavorable phenomenon such as hair shaving of body hair. Therefore, the following patches have been proposed as ones that can reduce irritation to the skin.

For example, JP-A-54-138124 uses an ABA type unvulcanized elastic block copolymer as an adhesive base and contains a skin stimulant and an anti-inflammatory analgesic as a medicinal component. A patch that has been proposed is proposed. In addition, Japanese Examined Patent Publication No. 60-34922 discloses that as an adhesive base, AB-
A patch has been proposed, which contains an A-type thermoplastic rubber elastic body, fats or oils or higher fatty acids, and a tackifying resin as essential components, and further contains a medicinal component. Similarly, Japanese Patent Application Laid-Open No. 56-39014 proposes a patch containing an ABA type thermoplastic elastomer component, an oil component, a tackifying component and a medicinal component as essential components.

[0004]

However, even in the patches described in each of the above-mentioned prior arts, although the adhesiveness at the time of application is excellent, the stratum corneum of the skin is peeled off at the time of peeling, hair shaving, etc. Could occur. That is, it was not possible to sufficiently reduce the irritation to the skin while maintaining the required adhesiveness. An object of the present invention is to provide an adhesive patch which can be repeatedly applied without impairing the adhesiveness at the time of application and which is less irritating to the skin.

[0005]

Means for Solving the Problems The inventors of the present invention have made earnest studies on the above-mentioned problems in conventional patches, and as a result, in the conventional patches, in order to obtain sufficient stickiness, the rubber elastic body has an adhesive base. Since it is contained in an amount of more than 20% by weight, the adhesive force to the skin may be too strong for that reason, and various adhesive bases with a low rubber elastic compounding ratio were prepared and studied. As a result, the present invention has been accomplished.

That is, the patch of the present invention is a medical patch in which an adhesive layer containing an adhesive base is provided on one side of a support, and the adhesive base has 10 to 3 carbon atoms.
0 to 95% by weight of paraffinic hydrocarbon and / or naphtheneic hydrocarbon and alicyclic hydrocarbon resin in total, and 5 to 20% by weight of styrene-isoprene-styrene block copolymer, The weight ratio of the paraffin hydrocarbon and / or naphthene hydrocarbon to the alicyclic hydrocarbon resin is in the range of 2: 3 to 3: 2.

Paraffin hydrocarbon and / or naphthe
In the present invention, paraffinic hydrocarbons and / or naphthenic hydrocarbons are incorporated into the adhesive base in order to reduce skin irritation caused by the adhesiveness of the rubber elastic body. As the paraffin hydrocarbon and / or naphthene hydrocarbon, those having a carbon number of 10 to 30 are used. Examples of such paraffin hydrocarbons and / or naphthene hydrocarbons include light liquid paraffin and heavy liquid paraffin, which are blends of naphthene hydrocarbons and paraffin hydrocarbons, or
Examples thereof include paraffin hydrocarbons such as hexamethyltetracosane, hexamethyltetracosahexaene, and α-olefin oligomer, and one or more of these can be used.

When the paraffinic hydrocarbon and / or the naphthenic hydrocarbon has a carbon number of more than 31, it is solid at room temperature and does not have sufficient softening property, and therefore the alicyclic saturated hydrocarbon resin described later is used. And styrene-isoprene-
Even when blended with the styrene block copolymer, a patch showing good adhesive strength cannot be obtained. Further, when the carbon number is 9 or less, the softening property becomes high and the pressure-sensitive adhesive layer becomes too soft, which is not preferable.

Alicyclic Saturated Hydrocarbon Resin In the present invention, in order to reduce the skin irritation of the adhesive, the alicyclic saturated hydrocarbon resin is blended in the adhesive base within the above-specified range. As the alicyclic saturated hydrocarbon resin,
One or more alicyclic saturated hydrocarbon resins having a softening point of 65 ° C. to 130 ° C. can be appropriately used in consideration of the adhesive strength and skin irritation during application. Examples of such alicyclic saturated hydrocarbon resin include Alcon (trade name, manufactured by Arakawa Chemical Industry Co., Ltd.), Quinton (trade name, manufactured by Nippon Zeon Co., Ltd.)
Etc.

The paraffin hydrocarbon and / or naphthene hydrocarbon and the alicyclic saturated hydrocarbon resin are
The weight ratio is 2: 3 to 3: 2. this is,
This is because when the weight ratio of the paraffinic hydrocarbon and / or the naphthenic hydrocarbon is larger than 3: 2, the sticking property becomes insufficient, or the adhesive residue occurs after peeling, while the 2: 3 ratio is satisfied. If it is smaller than the above range, a phenomenon such as peeling of the hair during peeling or peeling of the stratum corneum of the skin occurs, and repeated application is not possible.

Styrene-isoprene-styrene block
Copolymer In the present invention, in order to improve the sticking property, 5 is added to the adhesive base.
The styrene-isoprene-styrene block copolymer is contained in a proportion of ˜20% by weight. The styrene-isoprene-styrene block copolymer that can be used has a solution viscosity of 300 to 2000 CPS (when a 25 wt% toluene solution is used) and a styrene / rubber ratio (weight ratio) of 14/86 to 21 /. About 79 is used.

In the present invention, styrene-isoprene-
Content of styrene block copolymer is 5 to 20% by weight
The range of 5% by weight is because when it exceeds 20% by weight, the sticking property becomes too high, and when peeling, a phenomenon such as peeling of hair or peeling of the keratin of the skin occurs. This is because if it is less than this, sufficient sticking properties cannot be obtained.

Drug The medical patch of the present invention includes not only a drug-containing drug but also a drug-free drug. Examples of the medical patch containing no drug include an emergency bandage and a surgical drape. Moreover, in the patch of the present invention, as described in claim 2, a drug may be contained in the pressure-sensitive adhesive layer. The drug that can be used is not particularly limited as long as it can penetrate the biological membrane by transdermal or transmucosal administration. For example, antipyretic and anti-inflammatory analgesics,
Steroid anti-inflammatory agent, vasodilator, hypertension / arrhythmia agent, antihypertensive agent, antitussive expectorant, antitumor agent, local anesthetic,
Hormonal agents, asthma / allergic rhinitis therapeutic agents, antihistamines, anticoagulants, anticonvulsants, cerebral circulation / metabolic agents, antidepressant / anxiety agents, vitamin preparations, oral hypoglycemic agents, antiulcer agents, sleeping agents , Antibiotics, skin stimulants, etc.

Specific examples of the antipyretic and anti-inflammatory analgesic include salicylic acid, methyl salicylate, glycol salicylate, glycyrrhetinic acid, glycyrrhizinic acid, indomethacin, ketoprofen, flurbiprofen, ampenac and the like. Specific examples of the antihistamine include diphenhydramine, diphenhydramine hydrochloride, chlorpheniramine maleate and the like.

Specific examples of the skin stimulant include:
Menthol, peppermint oil, camphor, nonyl acid vanillyl amide, benzyl nicotinate, β-butoxyethyl nicotinate, capsicum (extract), capsancin, sashimi (extract) and the like can be mentioned. The amount of the above-mentioned chemicals to be added can be mixed in the whole pressure-sensitive adhesive layer in a ratio of up to 30% by weight. This is because if the compounding amount of the drug exceeds 30% by weight, the function of the above-mentioned adhesive base is impaired, and it becomes impossible to satisfy the sufficient adhesiveness and the low irritation to the skin.

Other components contained in the pressure-sensitive adhesive layer When the pressure-sensitive adhesive layer used in the patch of the present invention is constituted,
In addition to the above-mentioned tacky base and, if necessary, drug components, a component compatible with the styrene-isoprene-styrene block copolymer such as polyisobutylene, polybutene or liquid polyisoprene may be appropriately mixed. Good. Above all, it is preferable to mix polybutene from the viewpoint of sticking property. However, styrene-
The liquid polymer component compatible with the isoprene-styrene block copolymer needs to be used in a proportion of 10% by weight or less based on the whole pressure-sensitive adhesive layer. If it exceeds 10% by weight,
This is because it is not possible to realize sufficient sticking properties and sufficient low irritation to the skin.

Further, in the adhesive layer of the patch of the present invention, an antioxidant, a filler or the like may be appropriately added in addition to the above-mentioned drug or liquid polymer component unless the action and effect of the present invention are impaired. Good.

Production Method In the production of a patch containing no drug, first, a prescribed amount of the above-mentioned components constituting the pressure-sensitive adhesive layer is blended, and the mixture is heated and stirred at a temperature of 120 ° C. to 150 ° C. under nitrogen substitution. To melt. Next, the hot-melt coater spreads the melted pressure-sensitive adhesive component on the release paper (or support), and the support (or release paper) is laminated on the spread pressure-sensitive adhesive layer to produce a patch. It is said that

When a drug is contained, the pressure-sensitive adhesive component is heated and agitated at a temperature of 120 to 150 ° C. under nitrogen substitution as described above to be melted, and then the temperature of the pressure-sensitive adhesive is set to 100.
A pressure-sensitive adhesive component is obtained by adding a drug in a state of being cooled to ˜120 ° C. and mixing them uniformly, and a patch can be obtained by spreading with a hot melt coater as described above.

A solvent coating method can also be used as a method for producing the medical patch of the present invention. For example, after dissolving each component constituting the above-mentioned adhesive base with a solvent, a drug is added as necessary to obtain a uniform solution. Next, apply the obtained solution on a release paper (or support).
The patch can be obtained by drying and laminating the support (or release paper) on the pressure-sensitive adhesive layer. In this case, as the solvent, any solvent can be used as long as it can dissolve the compounded composition described above, but it is preferable to use a solvent having a low boiling point, and it is appropriately selected depending on the composition to be compounded. . Examples of the above solvent include cyclohexane, hexane, toluene, tetrahydrofuran, methylene chloride and the like.

As the above-mentioned support, a film, nonwoven fabric, cloth or aluminum foil made of synthetic resin such as polyester, polyethylene, polyvinyl chloride, polyvinylidene chloride, polyethylene-vinyl acetate copolymer or polyurethane is used. Alternatively, a laminate or the like of these is used. As the release paper, polyester film, polypropylene film, polyethylene-coated high-quality paper, polyethylene-coated glassine paper, or the like, one side of which is subjected to a silicone release treatment, is appropriately used.

[0022]

In the medical patch of the present invention, the styrene-isoprene-styrene block copolymer, which is a rubber elastic body, is mixed in the adhesive base at a ratio of 5 to 20% by weight.
Further, since the paraffinic hydrocarbon having 10 to 30 carbon atoms and / or the naphthene hydrocarbon and the alicyclic hydrocarbon resin are contained in a total proportion of 80 to 95% by weight, the paraffinic hydrocarbon and / or Alternatively, since the weight ratio of the naphthene-based hydrocarbon to the alicyclic hydrocarbon resin is in the range of 2: 3 to 3: 2, it has sufficient sticking property and effectively reduces the irritation to the skin. Has been.

That is, styrene-which is a rubber elastic body for enhancing the cohesive force of the adhesive base and for improving the sticking property.
Since the isoprene-styrene block copolymer is contained in a proportion of 20% by weight or less, irritation to the skin is reduced. Moreover, since the above specific paraffinic hydrocarbon and / or naphthenic hydrocarbon and alicyclic hydrocarbon resin are blended in the above specific ratios, the adhesiveness which is an advantage of the styrene-isoprene-styrene block copolymer is Is not damaged.

[0024]

Description of Examples Examples 1 to 4 The components were blended as shown in Table 1 below to obtain patches of Examples 1 to 4. That is, the components excluding the drug (adhesive base component) were blended in the proportions shown in Table 1, and the components were mixed under nitrogen substitution to 12
It was heated and stirred at a temperature of 0 to 150 ° C. to melt. After melting,
The temperature of the adhesive base solution was cooled to 100 to 120 ° C., the chemicals were added, and the mixture was uniformly mixed to obtain an adhesive layer solution. In Example 3, since no drug was contained, the pressure-sensitive adhesive layer solution was obtained by melting after heating and stirring.

Next, the pressure-sensitive adhesive layer solution melted using a hot melt coater is dried to a thickness of 90 to 100 μm.
Example 1 by spreading on a release paper made of polyethylene-coated high-quality paper, and laminating a soft vinyl chloride film having a thickness of 135 μm as a support.
A patch of No. 4 was obtained.

[0026]

[Table 1]

The details of the components used in Table 1 are as follows. SIS ... Styrene-isoprene-styrene block copolymer, Shell Chemical Co., trade name: Califlex TR1107 (solution viscosity: about 1600)
CPS (value in 25 wt% toluene solution), styrene-
Rubber ratio (wt%): 14/86). Polybutene ... Average molecular weight: about 1350, manufactured by Nippon Petrochemical Co., Ltd., trade name: Nisseki Polybutene.

Alicyclic saturated hydrocarbon resin: softening point 90 ° C.,
Molecular weight 630, manufactured by Arakawa Chemical Industry Co., Ltd., trade name: Alcon P-90. Liquid paraffin… Heavy liquid paraffin, manufactured by Nikko Pharmaceutical. Drug content: The drug content in Table 1 is represented by the weight% of the content of the drug in the entire pressure-sensitive adhesive layer component formed by mixing the adhesive base and the drug.

Comparative Examples 1 to 4 As shown in Table 2 below, patches of Comparative Examples 1 to 4 were obtained in the same manner as in Examples 1 to 4 except that each component was blended.

[0030]

[Table 2]

Details of each component in Table 2 are the same as in Table 1. Evaluation Each patch of Examples 1 to 4 and Comparative Examples 1 to 4 obtained as described above was evaluated by conducting a patch test and an adhesive strength test.

Sticking Test The sticking test was conducted on the following five items. The results are shown in Table 3. Adhesiveness: A 3 × 4 cm tape-shaped adhesive patch was applied to the upper arm for 6 hours and then evaluated. The evaluation criteria are as follows. Good: 95% or more of the remaining adhesive area of the tape patch Bad: 75% or less of the remaining adhesive area of the tape patch

Adhesive residue: Whether or not the adhesive remains on the skin after peeling was evaluated. The meanings of the evaluation symbols in Table 3 are as follows. +: The adhesive remained on the skin after peeling. -: The adhesive did not remain on the skin after peeling. Peeling during peeling: The presence or absence of plucking of body hair during peeling was evaluated. In Table 3, when there is hair shaving, it is described as “present”, and when it is not present, it is described as “none”.

Pain during peeling: The pain during peeling was evaluated by a sensory test, and in Table 3, when there was no particular pain, it was described as "none", and when pain was felt during peeling, it was described as "painful". Exfoliation: The degree of exfoliation of the stratum corneum of the skin during exfoliation was evaluated. The meanings of the symbols in Table 3 are as follows. ++: Exfoliation of keratin entirely on the applied site +: Exfoliation of some keratin-: No exfoliation of keratin

[0035]

[Table 3]

Adhesion Test The tack and adhesion of each patch of Examples 1 to 4 and Comparative Examples 1 to 4 were evaluated in the following manner. Tack: Ball rolling method: Tested according to JIS Z0237 adhesive tape and adhesive sheet test method. That is, a patch having a thickness of the pressure-sensitive adhesive layer of about 50 to 100 μm is
Place the adhesive layer face up on the slope of the sample, set the sample adhesive surface length to 5 cm, the sliding distance to 10 cm, roll the steel ball, and set the size of the ball to stop on the adhesive surface. It was measured.

Adhesion: 180 degree peeling method ... JIS
The test was performed according to the Z0237 adhesive tape and adhesive sheet test method. 15 mm wide x 70 mm long patch
The test pieces were cut into the above rectangles. This test piece was attached to a stainless steel plate and pressure-bonded with a load of 1 kg / cm ² ,
The free end is folded back 180 degrees and the pulling speed is 300 mm /
The load when peeled off in minutes was determined. This load is g / 1
It was expressed in units of 5 mm, and this was expressed as adhesive force. Table 4 shows the results of tack and adhesive strength measured as described above.

[0038]

[Table 4]

[0039]

As described above, according to the present invention, paraffin hydrocarbons and / or naphthene hydrocarbons having 10 to 30 carbon atoms, saturated alicyclic hydrocarbon resins, styrene-isoprene-styrene blocks are used. The adhesive group containing the copolymer in the above-mentioned specific proportion, and the weight ratio of the paraffinic hydrocarbon and / or naphthene-based hydrocarbon to the alicyclic saturated hydrocarbon resin in the above-mentioned specific range. Since the pressure-sensitive adhesive layer is formed by using the agent, not only it has sufficient sticking property, but also the irritation to the skin is effectively reduced, and therefore it is preferable that hair peeling and the stratum corneum of the skin peel off. It is possible to provide an adhesive patch that can prevent a phenomenon that does not occur and that can be repeatedly applied.

Claims (2)

[Claims] 1. A medical patch comprising an adhesive layer containing an adhesive base on one side of a support, wherein the adhesive base is a paraffinic hydrocarbon having 10 to 30 carbon atoms and / or A total of 80 to 95% by weight of a naphthene-based hydrocarbon and an alicyclic hydrocarbon resin and a proportion of 5 to 20% by weight of a styrene-isoprene-styrene block copolymer, and the paraffinic hydrocarbon and / or A medical patch, wherein the weight ratio of the naphthene-based hydrocarbon and the alicyclic hydrocarbon resin is in the range of 2: 3 to 3: 2. 2. The medical patch according to claim 1, wherein the pressure-sensitive adhesive layer further contains a drug.