JP2008178710A - Skin patch and method for producing the same - Google Patents

Abstract

When a skin patch having a paste layer exhibiting cold flow properties such as a hydrocolloid dressing is punched into a predetermined shape, the paste layer does not protrude from the end face (side surface) of the patch. The present invention provides a skin adhesive material with good adhesiveness that does not cause curling during application, and a method for producing the same.
SOLUTION: A support film 1 having flexibility and a skin adhesive layer 2 formed on one side of the film, and the skin adhesive layer is made of a material having liquid absorbency and cold flow properties such as a hydrocolloid dressing material. The case where it is formed is effective. The thickness of the peripheral part is made thin by setting the thickness of the skin adhesive layer located in the support film center part 11 to 0.2 to 0.5 mm and setting the thickness of the peripheral part 21 to 0.05 to 0.2 mm. In manufacturing, it is preferable that the punching process is performed to a slightly larger size, and then the die is pressed to press the peripheral portion, and then the punching process is performed so that the final shape is obtained.
[Selection] Figure 1

Description

  TECHNICAL FIELD The present invention relates to a skin patch and a method for producing the same, and more particularly, a skin patch for applying to a site such as bed slips, shoe slips, wounds, surgical wounds, cuts, and abrasions to reduce pain and heal wounds. The present invention relates to a material and a manufacturing method thereof.

  There are emergency adhesive bandages, dressings, cushion sheets, etc. as the adhesive material to be applied to bedsores, shoe slippers, heel wounds, etc. Not being able to absorb well, it can not only improve symptoms, but it may also worsen. In recent years, hydrocolloid dressing materials have been developed and used as patch materials suitable for such body fluid exudation portions.

  The hydrocolloid dressing material has a skin adhesive layer having liquid absorbency as a plaster layer on one side of a support film. The plaster layer not only absorbs the body fluid that exudes from the applied site due to its liquid absorbency, but also has the property of flowing by body temperature during application, so-called cold flow property, so the skin surface shape of the applied site gradually increases. The adhesiveness (fixability) is improved.

  Since the hydrocolloid dressing material has a cold flow property as well as a liquid absorption property, it does not exhibit a sufficient effect when the thickness is small, and thus usually has a thickness of about several millimeters.

  As described above, the hydrocolloid dressing material shows excellent adhesion to the wound site, particularly the site where the body fluid exudes, but the plaster layer is uniformly applied to one side of the support during production, When this is punched into a desired shape, the plaster may flow during storage and stick out from the end face (side face). Furthermore, when such a dressing material is applied to the skin surface, since the thickness of the plaster layer is thick, the edge portion is likely to be turned due to rubbing of clothes during the application, and in order to prevent the turning, There is a problem that it must be covered and fixed with an adhesive sheet.

  The present invention was made in order to solve the above-mentioned problems of the conventionally used hydrocolloid dressing material, and preserved by setting the thickness of the peripheral and central portions of the plaster layer to a specific value range. The present inventors have found that it is possible to prevent protrusion of the plaster inside and curling of the edge portion during application, and the present invention has been completed.

  That is, the present invention relates to a skin patch comprising a flexible support film and a skin adhesive layer formed on one side of the film and having liquid absorbency and cold flow properties. The thickness of the layer is 0.2 to 0.5 mm, and the thickness of the skin adhesive layer on the periphery of the support film is 0.05 to 0.2 mm. In particular, it is a preferable aspect that the thickness of the skin adhesive layer formed on the peripheral edge of the support film is uniform or inclined thinly toward the edge.

  Further, the present invention, after extruding a skin adhesive layer-forming material having liquid absorbency and cold flow properties on one side of the release sheet, pressurizing and pressing a flexible support film on the coated surface, Punching and embossing into a shape larger than the desired size, so that the thickness of the skin adhesive layer at the center portion and the peripheral portion of the support film is 0.2 to 0.5 mm and 0.05 to 0.2 mm, respectively. In addition, the present invention provides a method for producing a skin patch characterized by punching into a final desired shape after embossing.

  Since the skin patch of the present invention has the above-described configuration, it has excellent adhesion to the skin surface, particularly the body fluid exudation site, and the edge is turned over during use and the paste is stored. The effect of not protruding from the side of the body layer is exhibited.

  Further, since the production method of the present invention performs two-stage punching, it exhibits an excellent effect in preventing protrusion from the side surface of the plaster layer.

  As the support film in the skin patch of the present invention, a film having appropriate softness and flexibility is adopted so that it can be stuck on a bent part such as a heel. In addition, when affixed to the body fluid exudation part, it is preferable to have water vapor permeability in order to diverge the body fluid to be absorbed, but the skin adhesive layer absorbs, swells or dissolves due to moisture from the outside. Therefore, it is preferable to use a moisture impermeable support film. As such a support film, specifically, various plastic films made of materials such as polyolefin, polyvinyl chloride, polyvinylidene chloride, ethylene / vinyl acetate copolymer, polyurethane, and polyester are preferable. From the viewpoint of economy, it is preferable to use a polyolefin film such as polyethylene, polypropylene, an ethylene / vinyl acetate copolymer, an ethylene / propylene copolymer, and a copolymer containing a polar group such as an acrylate ester. Moreover, it is preferable from the balance point of mechanical strength and flexibility maintenance that the thickness of the said support film uses about 50-150 micrometers normally.

  The skin adhesive layer formed on one side of the support film has liquid absorbency and cold flow properties. The cold flow property in the present invention refers to the property of having “plastic flowability” at a temperature close to the skin temperature of the human body and closely contacting the skin. The plaster having a cold flow property preferred in the present invention is a plastic deformation that is displaced to 40 to 80%, preferably 50 to 80% of the thickness before loading after 72 hours in the test method described below. It is what produces.

The cold flow test method was carried out by applying a 20 g load (14 gf) in the thickness direction of a plaster sample (skin adhesive layer) cut to a thickness of about 36 mmφ × 0.8 to 2.5 mm in an atmosphere of 40 ° C. / Cm ² , 13.5 mmφ weight), and the thickness after 72 hours is measured with a dial gauge of a 10 mmφ terminal. At the time of measurement, the measurement is performed within 10 seconds after the load is removed and no creep recovery occurs.

  The skin adhesive layer in the present invention is characterized in that the thickness is different between the central portion and the peripheral portion of the support film. That is, the thickness of the central portion is 0.2 to 0.5 mm, preferably 0.3 to 0.45 mm. If the thickness of the central part is too thick, it will not be flexible enough to follow the movement of the skin surface when it is applied to the skin surface, and may cause peeling off during use. When it is affixed to, it may not exhibit sufficient liquid absorbency. On the other hand, if the thickness of the peripheral portion is too thick, the edge portion is likely to be turned during application, and if it is too thin, sufficient adhesion to the skin surface cannot be ensured, or wrinkles are likely to occur during application.

  As described above, in the skin patch of the present invention, the thickness of the skin adhesive layer at the central portion and the peripheral portion is different, but the width of the thin peripheral portion is 3 to 9 mm, preferably 5 to 7 mm. This is effective in preventing curling of the edge and preventing protrusion of the skin adhesive layer during storage from the end face of the patch.

  Also, the thickness of the skin adhesive layer formed on the peripheral edge may be uniform, but it prevents the edge of the edge from being turned over, and it does not cause wrinkles during application or during application, and it is sufficient for the skin surface. In order to adhere and fix, it is preferable to incline so that the thickness of the skin adhesive layer formed in a peripheral part may become thin toward an edge.

  The skin adhesive layer is preferably formed of the same material as a so-called hydrocolloid dressing material in order to impart liquid absorption and cold flow properties. Specifically, a mixed dispersion of an elastomer component and a hygroscopic substance is desirable, and the ratio is 40 to 70 wt%, preferably 35 to 55 wt%, with respect to 30 to 60 wt% of the elastomer component. %: It is desirable to add approximately the same amount, such as 45 to 65% by weight, or a slightly larger amount of the water-absorbing substance from the viewpoints of skin sticking property and appropriate shape retention (preventing sticking out).

  Such an elastomer component is a component that imparts appropriate cohesiveness and shape retention to the skin adhesive layer. Specifically, polyisobutylene, polyisoprene, acrylic polymers, styrene / isoprene / styrene block copolymers One or two or more of these can be used. Other elastomer components that can be used include polybutadiene, styrene / butadiene / styrene block copolymers, natural rubber, silicone polymers based on polymethylsiloxane, polyvinyl ether polymers, and the like.

  On the other hand, the hygroscopic substance is a component that imparts liquid absorbency to the skin adhesive layer, and specifically includes sodium carboxymethyl cellulose, dextrin, pectin, gelatin, etc., and one or more of these should be used. Can do. Other hygroscopic substances that can be used include carboxymethylcellulose calcium, hydroxypropylcellulose, guar gum, locust bean gum, xanthan gum, sodium alginate, calcium alginate, carrageenan, collagen, and polyvinylpyrrolidone.

  An example of the method for producing the skin patch of the present invention is shown below.

  Extrusion coating is performed by extruding a material for forming the above-mentioned skin adhesive layer in a bar shape or extruding with a certain thickness on one side of a release sheet made of a plastic sheet or paper having one side peel-treated. Next, a flexible support film is attached to the extrusion coating surface and pressed, and the skin adhesive layer is transferred from the release sheet to the support film surface to produce a laminated sheet. At this time, the surface of the support film on the side in contact with the skin adhesive layer is subjected to corona discharge treatment or undercoating treatment so that the skin adhesive layer is sufficiently adhered to the support film surface and exhibits excellent anchoring properties. It is preferable to process so that it may have wettability. The release sheet is stuck until it is used for covering and protecting the surface of the skin adhesive layer.

Next, the obtained laminated sheet is punched in the first stage so as to be larger in size than the final shape, specifically, with a width of about 5 to 10 mm over the entire circumference, and the central portion and the peripheral portion The embossing is performed with a predetermined thickness so that the thicknesses of the two are different. The pressure when embossing is usually 30 to 50 kg / cm ² .

  Finally, the target skin patch can be obtained by performing a second-stage punching process so that the final desired shape is obtained.

  The manufacturing method of the present invention is characterized in that punching is performed in two stages, and prevents protrusion from the end face of the skin adhesive layer formed on the peripheral edge of the finally obtained skin patch. it can. In other words, when punching into the final shape in one step rather than punching in two steps as in the present invention, the laminated sheet bonded with the support film is first embossed and then punched into the final shape. It will be. In this case, as shown in FIG. 3, the skin adhesive located between the support and the release sheet is difficult to move to both sides when embossed, and even if it can move, there is no escape route, so the thickness is thin. The side of the part rises as shown. Therefore, when punching is performed in this state, the skin adhesive layer protrudes from the end face.

  On the other hand, in the case of punching in two steps as in the manufacturing method of the present invention, as shown in FIG. Extruded from the processed end face. In other words, there is an escape route. Therefore, after punching into the final shape by the second stage punching process, the skin adhesive layer does not protrude from the end face.

  Further, the shape of the skin patch of the present invention obtained by the above production method is preferably a shape having no corners, for example, a circular shape or an elliptical shape, from the viewpoint of preventing peeling and turning of the end portions. Moreover, even if it is rectangular shape, a corner | angular part may be cut roundly so that there may be no corner | angular part.

  Embodiments of the present invention will be described below with reference to the drawings.

  FIG. 1 is a plan view (a) showing an example of the skin patch of the present invention, and a sectional view taken along line X-X ′ of the plan view (a).

  FIG. 2 is a conceptual cross-sectional view illustrating the method for producing a skin patch of the present invention, and (a) to (d) show each step.

  FIG. 3 is a conceptual cross-sectional view for explaining a conventional method for producing a skin patch, and (a) to (b) show the process.

  The skin patch in FIG. 1 has an elliptical shape, and as is apparent from (a) and (b), the skin adhesive layer 2 is composed of a thick central portion 11 and a thin peripheral portion 21. is there. FIG. 2 is a conceptual cross-sectional view, although the support film 1 and the release sheet 3 are not clearly illustrated, a step (a) of obtaining a skin patch sheet having a uniform thickness, a first-stage punching step (b), It consists of a peripheral edge forming step (c) by stamping and a final shape producing step (d) by punching in the second stage.

  FIG. 3 shows a conventional manufacturing process, and shows a process (a) for obtaining a skin patch with a uniform thickness and a peripheral edge forming process (b) by embossing. In FIG. 3, although there is a final shape manufacturing process by punching after the process (b), the illustration is omitted.

  As is clear from FIG. 3, the skin adhesive located at the peripheral edge in the conventional method swells like a mountain at the boundary with the central part, so that when it is punched into the final shape, the swelled skin adhesive When the agent is about to return to its original state, it sticks out from the side surface (end surface) of the patch. In addition, when the stamping and slitting are performed sequentially or simultaneously, since the plaster is subject to plastic deformation that tends to be pushed out to the peripheral edge, the plaster sticks out and a clean peripheral edge (end face) Cannot be obtained.

  On the other hand, in the present invention, as shown in FIG. 2, the skin adhesive located at the peripheral portion is pushed out from the side surface (end surface) by punching out in advance and then embossing, As shown in FIG. 3, there is no excitement, and after punching out to the final shape, there is no protrusion from the side of the patch.

  As a specific example of obtaining the skin patch of the present invention, for example, a surface of an ethylene / vinyl acetate copolymer film (vinyl acetate content 20 mol%) having a thickness of about 90 μm is embossed with a pear satin pattern on the other side. A corona discharge treatment is applied to activate the surface until it reaches 470 μN / cm to produce a support film.

  On the other hand, a composition comprising about 45% by weight of an elastomer component comprising polyisobutylene and polycisisoprene, about 51% by weight of a hygroscopic material comprising sodium carboxymethylcellulose, pectin and gelatin, about 4% by weight of aluminum hydroxide gel and potassium alum. Are kneaded uniformly with a kneader to prepare a mixed dispersion, which is then extruded onto a release sheet with an extruder to a thickness of 450 μm to form a skin adhesive layer.

  This skin adhesive layer is bonded to the corona-treated surface of the support film to produce a raw material before embossing or punching.

  Next, the obtained raw fabric is stamped, stamped and punched in a large size in the process shown in FIG. 2, and the final dimensions are a central part 450 μm thick, a peripheral part 100 μm thick, a peripheral part width 6 mm, a short diameter 4 cm and a long diameter. A 7 cm elliptical skin patch is prepared. The thing of this shape is suitable for the shoe slip prevention use stuck on a heel part.

  When the skin patch of the present invention is a so-called hydrocolloid dressing using a mixed dispersion of an elastomer component and a hygroscopic substance as a skin adhesive layer, the paste composition itself as a skin adhesive layer is antibacterial. Therefore, it is useful as a padless emergency adhesive bandage that does not require gauze or pads against scratches, cuts, etc., and because the plaster itself has a thickness, it has a protective effect against external impacts, Since it can be protected from excellent skin adhesion and external water, dirt, and bacteria, it can create a patch environment in which warts, octopuses, beans, corns, etc. are easy to heal.

(A) is a top view which shows an example of the skin patch of this invention, (b) is sectional drawing in the X-X 'line | wire of (a). (A)-(d) is a conceptual sectional drawing explaining the manufacturing method of the skin patch of this invention. (A)-(b) is a conceptual sectional drawing explaining the manufacturing method of the skin patch of a prior art example.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Support film 11 Center part 21 Peripheral part 2 Skin adhesive layer 3 Release sheet

Claims (8)

  A skin patch comprising a flexible support film and a skin adhesive layer formed on one side of the film and having liquid absorption and cold flow properties, wherein the thickness of the skin adhesive layer at the center of the support film is 0.00. A skin patch having a thickness of 2 to 0.5 mm and a thickness of the skin adhesive layer at the periphery of the support film of 0.05 to 0.2 mm.   The skin patch according to claim 1, wherein the support film is impermeable to moisture.   The skin patch according to claim 1 or 2, wherein the support film is a polyolefin film.   The skin patch according to claim 1, wherein the skin adhesive layer is a mixed dispersion of an elastomer component and a hygroscopic substance.   The skin patch according to claim 4, wherein the elastomer component is at least one selected from polyisobutylene, polyisoprene, an acrylic polymer, and a styrene / isoprene / styrene block copolymer.   The skin patch according to claim 4, wherein the hygroscopic substance is at least one selected from sodium carboxymethylcellulose, dextrin, pectin, and gelatin.   The skin patch according to claim 1, wherein the width of the peripheral portion of the support film is 3 to 9 mm.   The skin patch according to claim 1, wherein the skin adhesive layer formed on the peripheral edge of the support film is inclined so that the thickness thereof is uniform or becomes thinner toward the edge.

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