JP2000116695A - Medical adhesive sheet - Google Patents

Abstract

(57) [Summary] [Problem] Regarding a medical patch such as a bandage or a surgical tape, when the base material surface is wet with water or the like for a long time after being stuck to the skin, water or the like hardly erodes to the stuck skin surface. above,
An object of the present invention is to provide a medical pressure-sensitive adhesive tape capable of observing the applied skin surface without removing the tape. In a medical pressure-sensitive adhesive sheet having a pressure-sensitive adhesive layer on the back surface of a substrate, the substrate is transparent or translucent, and has a moisture permeability of 10 g / at a temperature of 38 ° C. and a humidity of 90%.
A medical pressure-sensitive adhesive sheet characterized in that the pressure is 24 hrs / m ² or less.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pressure-sensitive adhesive sheet used as a plaster, a surgical tape, or another medical patch. In more detail, after applying to the skin, even if the substrate surface is wet with water for a long time, the water and the like hardly erodes to the applied skin surface, and the applied skin surface is removed without removing the tape. It relates to an observable medical adhesive tape.

[0002]

2. Description of the Related Art Conventional medical tapes use a base material having high moisture permeability in order to suppress stuffiness during application. For example, a configuration is known in which an adhesive layer is provided on the back surface of a substrate such as paper, woven fabric, nonwoven fabric, or a perforated film (JP-B-48-26202, JP-B-48-448).
No. 53, etc.).

[0003] In recent years, however, with the aging of society, the need for medical supplies for elderly care has increased. In particular, when the body cannot be freely moved on a bed or the like, the same part of the body is pressed by the body weight and the frequency of bedsores increases. In recent years, to treat such conditions,
A wet dressing method has been developed and is receiving attention.
Until now, dry dressing method of drying and treating the affected area has been used, but wet dressing method is a method of treating the affected part surface completely without drying it, compared to dry dressing method, The healing period is shorter. In this method, a conventionally used substrate having high moisture permeability cannot be used. When using such a substrate,
When manure or the like leaks, if it comes into contact with the tape attached to the affected part, manure penetrates from the surface of the tape, and if it comes into contact with the affected part, it may not only cause a delay in healing, but also worsen. Further, since the base material such as paper, nonwoven fabric and woven fabric is opaque, the state of the skin cannot be observed without peeling off the base material after application. As a result, it is necessary to peel off the tape, but it is highly likely that the skin at the application site is peeled off when peeling off, which causes a delay in healing.

[0004]

The present invention relates to a medical adhesive material such as a plaster, a surgical tape, etc., which is applied to the skin and, when the surface of the base material is wet with water or the like for a long time, the water or the like is applied to the surface of the applied skin. The present invention provides a medical pressure-sensitive adhesive tape that hardly erodes, and that allows observation of the attached skin surface without peeling off the tape.

[0005]

The inventor of the present invention has made intensive studies in view of the present situation and found that the temperature was 38 ° C. and the humidity was 90%.
10g / 24hrs /
m ² or less, and by imparting transparency to the extent that the skin is visible when the applied to the skin, after applied to the skin, when the substrate surface was wet long with water or the like, until adhered skin surface The present inventors have found that water and the like are hardly eroded and that the attached skin surface can be observed without removing the tape, thereby completing the present invention.

(1) That is, the present invention relates to a medical pressure-sensitive adhesive sheet having a pressure-sensitive adhesive layer on the back surface of a substrate, wherein the substrate is transparent or translucent and has a temperature of 38 ° C. and a humidity of 90%. A medical pressure-sensitive adhesive sheet characterized by having a moisture permeability of 10 g / 24 hrs / m ² or less.

[0007] Furthermore, as a result of repeated studies on an adhesive capable of suppressing irritation to the skin and reducing discoloration with time, the minimum molecular weight of the adhesive is 50.
It has been found that it is preferable to use zero or more base polymers and that the crosslinking agent is a metal compound. (2) The medical pressure-sensitive adhesive sheet according to (1), wherein the pressure-sensitive adhesive constituting the pressure-sensitive adhesive layer has a minimum molecular weight of the base polymer of 500 or more, and the crosslinking agent is a metal compound. Out.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION In the present invention, the base material is transparent or translucent. According to the method for measuring moisture permeability described in JIS-Z-0208, the base material surface at a temperature of 38 ° C. and a humidity of 90% is used. 10 g / 24 hrs / m ²
The following is the base material used. Note that the term “transparent to translucent” means that it has transparency enough to make the skin visible when applied to the skin. Further, when the moisture permeability from the surface of the substrate at a temperature of 38 ° C. and a humidity of 90% exceeds 10 g / 24 hrs / m ² , the surface of the substrate is contaminated when it comes into contact with the contaminated moisture for a long time. There is a risk that water may infiltrate and deteriorate the affected area.

The substrate to be used only has to have a moisture permeability within the above-mentioned range and have such a transparency that the skin can be seen when applied. The hue is not particularly limited, but is preferably colorless in order to accurately grasp the color tone of the portion to be stuck. As the material, one or more of cellophane, fluororesin, ionomer, nylon, hydrochloric acid rubber, polycarbonate, polyester, polyethylene, polypropylene, polystyrene, polyurethane, polyvinyl alcohol, polyvinylidene chloride, polyvinyl chloride, vinyl acetate, etc. Combined films can be mentioned. In addition, depending on the purpose, 2 such as coating treatment, corona treatment, etc.
The following processing may be applied. Further, in the case where the moisture permeability of the base material becomes higher than a desired range, it may be dealt with by increasing the thickness.

As the pressure-sensitive adhesive to be used, a rubber-based pressure-sensitive adhesive, an acrylic-based pressure-sensitive adhesive, a silicone-based pressure-sensitive adhesive or the like can be used, but an acrylic-based pressure-sensitive adhesive is preferable in consideration of discoloration and the like. When a rubber-based pressure-sensitive adhesive is used, discoloration with time increases, and when a silicone-based pressure-sensitive adhesive is used, the cost increases. The hue is not particularly limited, but is preferably colorless in order to accurately grasp the condition of the skin surface to be stuck.

Among them, those having a minimum molecular weight of at least 500 by GPC of the base polymer constituting the pressure-sensitive adhesive and using a metal compound as a cross-linking agent are preferred. Since the medical pressure-sensitive adhesive sheet of the present invention uses a substrate having extremely low moisture permeability, the skin is swollen by secretions such as sweat during application, and as a result, the barrier properties of the skin are significantly reduced. as a result,
The minimum molecular weight of the base polymer constituting the adhesive is 500
If it is less than 3, the adhesive may enter from the skin surface, and depending on the person, erythema, edema, papules, blisters, necrosis, and the like may occur.

Further, a metal compound is used as a crosslinking agent. Conventionally, organic compound-based cross-linking agents such as isocyanate-based cross-linking agents which are preferably used generally have a molecular weight of less than 500. The monomer of the reaction remains. Furthermore, since the reaction proceeds even at room temperature, discoloration may occur and the commercial value may be reduced. On the contrary,
Even if the metal compound-based crosslinking agent has a low molecular weight of less than 500, it does not irritate the skin and the crosslinking reaction hardly proceeds at room temperature, so that the discoloration level can be suppressed to a very low level.

For this reason, in the present invention, it is preferable to use a metal compound based crosslinking agent. Examples of the cross-linking agent include metal compound-based cross-linking agents such as metal chelates, metal oxides, metal peroxides, metal salts, and metal hydroxides.
One type or a combination of two or more types is used.
The amount to be blended is not particularly limited, but may be appropriately selected in consideration of the adhesion and the adhesive strength between the substrate and the adherend and the pressure-sensitive adhesive.

As a method for forming the pressure-sensitive adhesive layer, a known method can be used, and a direct method of directly applying a pressure-sensitive adhesive to a substrate or a method of once applying a pressure-sensitive adhesive to a release sheet and laminating the same with the substrate. Either of the forming transfer methods is possible. The pressure-sensitive adhesive sheet may be in the form of a sheet cut to a predetermined area or a tape (roll-up) finished to a predetermined width.

[0015]

The present invention will be described in detail with reference to the following examples and comparative examples, but the present invention is of course not limited thereto.

[0016]

Example 1 A fluororesin film (80 μm) was used as a substrate.
m, colorless and transparent, 1 g of moisture permeability at 38 ° C x 90% RH
/ 24 hrs / m ² ) and an adhesive (acrylic adhesive “SK Dyne MD- manufactured by Soken Chemical Co., Ltd.”) by a transfer method.
1), a minimum molecular weight of 500 or more, and 2 g of an aluminum chelate-based cross-linking agent “M-5A” manufactured by Soken Chemical Co., Ltd.) was applied as a cross-linking agent at 30 g / m ² to obtain a medical adhesive sheet. The polyethylene laminate release paper used in the transfer method was obtained by heat-sealing a polyethylene layer to a high-quality paper with a thickness of about 15 μm, applying a release agent containing a silicone resin as a main component to the polyethylene layer, and drying. .

[0017]

Example 2 Low density polyethylene film as substrate
(Tamapoli Co., Ltd., “M-10”, 50 μm, colorless transparent
Light, moisture permeability 9g / 24hr at 38 ° C × 90% RH
s / m ^Two) Was used in the same manner as in Example 1 except that
A wearing sheet was obtained.

[0018]

Example 3 As a substrate, a polyethylene / ethylene / vinyl acetate film (manufactured by Tamapoly Co., Ltd., “SB-1”)
0 ”, 80 μm, colorless and transparent, moisture permeability of 7 g / 24 hrs / m ^{2 at} 38 ° C. × 90% RH, and having an adhesive having a minimum molecular weight of less than 500 (acrylic adhesive manufactured by Soken Chemical Co., Ltd.) A medical adhesive sheet was obtained in the same manner as in Example 1 except that the agent “SK Dyne 1720”) was used.

[0019]

Example 4 A polyethylene / ethylene / vinyl acetate film (Tamapoly Co., Ltd., "SB-1") was used as a substrate.
0 ", 80 μm, colorless and transparent, moisture permeability at 38 ° C. × 90% RH 7 g / 24 hrs / m ² ), and an isocyanate-based crosslinking agent (“ L-5 ”manufactured by Soken Chemical Co., Ltd.)
5E "), except that a medical adhesive sheet was obtained in the same manner as in Example 1.

[0020]

Comparative Example 1 As a base material, an ionomer film ("HM-01", manufactured by Tamapoly Corporation, 60 μm, colorless and transparent, 38
12g / 24hrs / m moisture permeability at 90 ° C x 90% RH
An adhesive sheet was obtained in the same manner as in Example 1 except that ² ) was used.

[0021]

[Evaluation method] The moisture permeability of the substrate used was measured according to JIS-Z-0.
208, at 38 ° C.
× 90% RH. The molecular weight of the base polymer constituting the pressure-sensitive adhesive was measured by GPC.

The obtained pressure-sensitive adhesive sheet was subjected to JIS-Z-023
23 ± 2 ° C. × 65 ± 5% RH as described in 7.
For one week to obtain a sample.

"Dampproof" The sample was measured for 50 mm
After attaching the sheet cut to × 25 mm to a bakelite plate, after immersing in colored water of 40 ° C. for 48 hours,
The water was wiped off. Thereafter, the adhesive was peeled off from the bakelite plate, and the surface of the pressure-sensitive adhesive was visually observed.

"Skin irritation" Skin irritation was evaluated by attaching a sheet cut to a 15 mm x 50 mm sample to the inside of the upper arm of a subject, peeling it off the skin after 24 hours, and evaluating the skin condition after 1 hour. The number of test subjects was 20 and the skin condition was, on average, unresponsive to slight erythema: ○, evident erythema was Δ, edema, papules were ×
Was evaluated.

"Transparency over time" The transparency over time was evaluated by leaving a sample for 6 months, cutting it into a 15 mm width, and stacking 10 samples. Those with no discoloration are marked with ○, those with discoloration are stuck on the skin, and those with transparency enough to show the stuck skin surface are marked with △, and those where the stuck skin surface is hard to see are marked as ×
And

"Comprehensive evaluation" A comprehensive evaluation was performed according to the following criteria. ：: Excellent as a medical adhesive sheet. Δ: There is some difficulty as a medical adhesive sheet, but it is at a usable level. ×: There is a problem as a medical pressure-sensitive adhesive sheet, and the level cannot be used.

[0027]

[Table 1]

As shown in Examples 1 to 4, when the moisture permeability of the substrate is within a predetermined range, the moisture-proof property is at a satisfactory level. Further, as shown in Examples 1 and 2, the minimum molecular weight of the base polymer constituting the pressure-sensitive adhesive was 500 or more,
In addition, those using a metal compound as a crosslinking agent have good skin irritation and transparency over time. On the other hand, in Comparative Example 1, when the moisture permeability of the substrate exceeds a predetermined range, the moisture-proof property is poor.

[0029]

As described above, the present invention relates to a pressure-sensitive adhesive sheet having a pressure-sensitive adhesive layer on the back surface of a substrate, wherein the temperature of the substrate is 3
The moisture permeability from the substrate surface at 8 ° C and 90% humidity is 10
g / 24 hrs / m ² or less, and by using a transparent base material such that the skin can be seen when applied to the skin,
Both moisture proofing and observability are good. Further, the minimum molecular weight of the base polymer constituting the pressure-sensitive adhesive to be used is 5
When the metal compound-based crosslinking agent is used as the crosslinking agent, the skin irritation property and the discoloration with the lapse of time are improved, so that it can be favorably used as a medical patch.

Claims (2)

[Claims] 1. A medical pressure-sensitive adhesive sheet having a pressure-sensitive adhesive layer on the back surface of a substrate, wherein the substrate is transparent or translucent and has a moisture permeability of 10 g / at a temperature of 38 ° C. and a humidity of 90%.
A medical pressure-sensitive adhesive sheet characterized by being at most 24 hrs / m ² . 2. The medical pressure-sensitive adhesive sheet according to claim 1, wherein the pressure-sensitive adhesive constituting the pressure-sensitive adhesive layer has a minimum molecular weight of the base polymer of 500 or more, and the crosslinking agent is a metal compound.