JPH05253282A - Wound-curing sticking plaster - Google Patents

Abstract

PURPOSE:To provide a wound-curing sticking plaster of excellent sticking properties capable of promptly removing seeping fluids by means of absorption without being too sticky by forming a layer of ointment in contact with a support, the layer of ointment containing a water-absorptive polymer, such as a compound of poly(metha)acrylic acid and a water-swelling silicate mineral, and wax in solid state at room temperature. CONSTITUTION:A layer of ointment containing a water-absorptive polymer and wax in solid state at room temperature is formed in contact with a support, and a hydrophilic component selected from polyhydric alcohols or their polymers is contained in the layer of ointment. The water-absorptive polymer is a compound of a hydrophilic polymer and silicate mineral, consisting of poly(metha) acrylic acid and a water-swelling silicate meneral. Therefore, the layer absorbs seeping fluids sufficiently to become an elastic gel, thereby protecting a wounded surface and keeping the wounded surface in a proper dried state by means of absorption of the seeping fluids from the deseased part, while effectively exhibiting the disinfecting action of the main agent and accelerating granulation.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug for treating wounds containing a water-absorbing polymer which absorbs water and swells. More specifically, it relates to a patch for treatment of liquid exudative skin wounds such as skin ulcers such as pressure ulcers and burns.

[0002]

2. Description of the Related Art Many skin ulcers caused by pressure ulcers, burns, etc. are accompanied by bacterial infection due to the exposure of granulation tissue and an increase in exudate, which may lead to systemic infections such as sepsis and bacteremia. is there. In order to prevent these, it is necessary to promptly absorb the exudate from the ulcer site, keep the affected site dry, and promote granulation. Until now, dextrin and dextran cross-linked products, sucrose, aluminum hydroxide gel, etc. have been used as the absorber for absorbing the exudate from the wound affected area. However, all of them had to be blended in a large amount in order to sufficiently absorb the exudate while keeping the skin ulcer site at an appropriate equilibrium water content.

On the other hand, as a wound healing drug, since most of the external preparations have been ointments, it is necessary to coat the affected surface with gauze, absorbent cotton, etc. after application to the affected area, and When a certain amount of exudate is absorbed from the affected area, fluidization occurs, so there are many problems in usability and handleability.
Therefore, in recent years, an adhesive patch type wound healing drug has been developed in place of the ointment. As such a patch, for example, one in which an ointment having a specific property is formed on a support by combining an oil component which is an ointment base is known (Japanese Patent Laid-Open No. 130215/1993). The prevention of bacterial infection is insufficient because it does not contain substances that have an action. Further, as a patch containing a substance having an absorbing effect, those described in JP-A-3-206032 and JP-A-3-141229 are known, but in the former case, they are already contained in the water-absorbent gel layer. The water contained weakened the absorbability of the exudate, resulting in a poor therapeutic effect. Further, in the latter case, the adhesiveness to the affected area is poor, and in a system containing an acrylic acid polymer aqueous solution,
Although it had adhesiveness, it had the same drawbacks as the former.

As described above, various ointments, patches and the like are used as external preparations for treating wounds, but an ointment layer that absorbs the exudate of the affected area of the wound and forms an elastic gel is supported. The current situation is that a patch that is formed as a body and has good adhesiveness to the affected area has not yet been developed. The present invention has been made in response to such conventional circumstances, and is capable of promptly absorbing and removing exudate from the affected area without stickiness and having excellent adhesiveness to the affected area. The purpose is to provide.

[0005]

Means for Solving the Problems That is, the present invention provides a patch for treating wounds, characterized in that a layer of an ointment containing a water-absorbent polymer and a wax solid at room temperature is formed in contact with a support. Is.

The structure of the present invention will be described in detail below. Examples of the water-absorbing polymer in the present invention include self-crosslinking polyacrylic acid sodium, starch-acrylic acid graft polymerization neutralized polymer, acrylic acid-vinyl alcohol copolymer, sodium acrylate-acrylamide copolymer, and other polymers. Examples thereof include compounds and hydrophilic polymer / silicate mineral composites composed of poly (meth) acrylic acid and water-swelling silicate minerals. Of these, a hydrophilic polymer / silicate mineral complex is particularly preferable in terms of absorbability. A hydrophilic polymer / silicate mineral is a polymer / silica composite consisting of poly (meth) acrylic acid and swelling silica, or poly (meth) acrylic acid and a water-swelling clay mineral, The polymer / clay mineral composite is characterized in that the weight fraction of the acid is 0.3 to 0.97.
For example, as a polymer / silica composite, Hibis 10
A complex of 4 (Wako Pure Chemical Industries) and Aerosil # 300 (Japan Aerosil) can be mentioned. As the polymer / clay mineral complex, a layered silicate mineral belonging to the smectite group, the vermitite group, or the chlorite group is selected as the water-swelling clay mineral, and Hibis 104 and Laponite XLG are typical ones. (Raporte Company) complex can be mentioned. Details of these hydrophilic polymer / silicate mineral composites are described in Japanese Patent Application No. 2-514154 "Polymer / Clay Mineral Composites".

The amount of the water-absorbent polymer of the present invention is not particularly limited, but it is preferably 5% by weight or more, more preferably 10-50% by weight in order to absorb the exudate from the skin ulcer site. is there. Examples of the active ingredient in the present invention include iodine and iodine compound preparations having a wide range of bactericidal activity against bacteria and fungi. For example, as the iodine compound preparation, there are povidone iodine, iodophor, iodoform, iodine tincture, isodine sugar and the like, but povidone iodine is particularly preferable.

To the ointment base of the present invention, a wax which is solid at room temperature is blended in order to improve usability and adhesion to the affected area of the wound. As a solid wax at room temperature, for example,
Hydrocarbon waxes such as ozokerite, paraffin, ceresin, microcrystalline wax, solid fats and oils such as mokuro, hydrogenated castor oil, beeswax, candelilla wax, carnauba wax, cotton wax, whale wax, montan wax, nuka wax, jojoba wax and other animal and plant systems Wax, silicone wax and the like can be mentioned. Among these waxes, microcrystalline wax is particularly preferable. The blending amount is preferably 1 to 20% by weight. 1% by weight of wax
If it is less than 20%, the effect of improving the adhesion to the affected area is insufficient.
It is recognized that if the content exceeds 5% by weight, the absorbability of the exudate from the affected area is poor and the usability is poor.

Further, it is recognized that when wax is used in combination with higher alcohol or higher fatty acid, the adhesion to the affected area and usability are improved. Here, examples of the higher alcohol include cetanol, stearyl alcohol, cetostearyl alcohol and the like, and examples of the higher fatty acid include stearic acid, myristic acid, palmitic acid, oleic acid and the like. Further, in order to adjust the usability, liquid paraffin, hydrocarbon oil such as petrolatum, animal and vegetable oil such as squalane, olive oil, silicone oil, ester oil and the like can be added to the ointment base. Furthermore,
Surfactants, coloring materials, preservatives, fragrances and the like can also be added.

The ointment base of the present invention preferably contains a hydrophilic component such as a polyhydric alcohol in order to enhance the release of the drug and the absorption of the exudate. This is because in a system containing only a water-absorbent polymer and a wax, the water-absorbing function of the water-absorbent polymer or the medicinal effect of the active ingredient may not be sufficiently exerted after application to the affected area. Examples of the hydrophilic component include polyhydric alcohols such as glycerin, 1,3-butylene glycol and propylene glycol, and polymers of polyhydric alcohols such as polyethylene glycol. The blending amount is preferably 5 to 50% by weight.

Since the support in the present invention needs to take into consideration uniform adhesion to the wound surface, a flexible cotton,
Gauze, woven fabric made of chemical fiber, non-woven fabric, etc. are suitable, but preferably when the water-absorbing polymer during application absorbs the exudate, it does not accumulate on the contact surface between the wound surface and the patch surface, and the support side Gauze with excellent permeability, such as passing through
Stretchable and non-stretchable supports such as woven and non-woven fabrics can be used. Further, as a protective liner for protecting the plaster, paper or cloth treated with an appropriate treating agent, a plastic film, a plastic sheet or the like can be used.

The ointment of the present invention can be produced according to the general ointment section of the Japanese Pharmacopoeia formulation. For example, the base,
The emulsifier is heated and melt-mixed, the temperature is maintained at 70 to 75 ° C., a water-absorbing polymer is added thereto, and the mixture is stirred and dispersed. Stirring,
When the temperature after dispersion reaches 60 to 65 ° C, the main agent is added and mixed by stirring. When adding a hydrophilic component, a combination of separately prepared hydrophilic components is heated and melted at 65 ° C, and then added to the mixed component of the main drug and the base that have been melted and mixed first, and then 60 to 65 ° C. Stir and mix immediately while maintaining the temperature. Further cooling with stirring to an appropriate temperature gives an ointment. Application and spreading of the ointment on the support at room temperature
It can be carried out at a temperature of preferably 25 ° C. or lower by a usual method such as a roll coating method or a doctor knife method. A suitable application thickness of the ointment is about 0.5 to 5 mm, but a thickness of about 1 to 3 mm is preferable in consideration of usability. The size of the patch is not particularly limited, but it may be 10 × 10c so that it can be variously adjusted depending on the size of the diseased part.
It is desirable that the size is about m to 25 × 35 cm. Regarding the storage of these patches, they are sealed with an aluminum-laminated packaging material and usually stored in a cool place (1
It is desirable to store at 5 ° C or lower).

As a method of using the patch for wound treatment of the present invention, it is used by directly sticking it to a wound affected area such as pressure ulcer or burn. The application of this drug is carried out, for example, by the adhesive strength of the components in the ointment composition and fixing with a surgical tape. The hardness of the ointment is a factor that greatly affects the quality of the preparation in terms of operability when spread on a support, adhesion to a wound surface when applied to a wound diseased part, usability, and the like. This numerical value is a yield value when measured using a rheometer, and is a numerical value that is a standard for ease of spreading on a support when manufacturing using a spreading machine. The hardness of the ointment according to the present invention is 2.
0 × 10 ⁴ dyne / cm ^{2 to} 8.5 × 10 ⁵ dyne /
cm ² , more preferably 9.8 × 10 ⁴ dyn
e / cm ^{2 to} 3.5 × 10 ⁵ dyne / cm ² . The value is 2.0 × 10 ⁴ dyne / cm ² or less, or 8.
When it is 5 × 10 ⁵ dyne / cm ² or more, there are problems in terms of uniformity and stability during spreading.

[0014]

EXAMPLES The present invention will be described below with reference to examples.
The present invention is not limited to this. In addition,
The compounding amount is shown by weight%. Examples 1 to 3 and Comparative Examples 1 to 2 An ointment was produced with the compounding amounts shown in Table 1 below, and a patch was produced using the ointment and evaluated. (1) Evaluation criteria, (2) Method for preparing water-absorbent polymer composite, and (3) Method for producing patch are as follows. (1) Evaluation criteria [Stickiness during use] Very non-sticky ◎ Not sticky ○ Slightly sticky △ Very sticky × [Adhesion to affected area] Very close contact ◎ Slightly sticky ○ Slightly non-sticky △ Not very close contact × [Absorbability of exudate] Very absorbed ◎ Slightly absorbed ○ Slightly not absorbed △ Very not absorbed × [Dryness of affected area] Very dry ◎ Slightly dried ○ Slightly dried △ Almost not dried ×

(2) Preparation of water-absorbent polymer composite Hibis 104 (Wako Pure Chemical Industries) 2% aqueous solution and Aerosil #
300% (manufactured by Nippon Aerosil Co., Ltd.) 2% aqueous dispersion was added so that the weight fraction of Hibis 104 in terms of solid content would be 0.7, and the mixture was uniformly mixed with a homomixer, and then 2N-NaOH.
Was adjusted to pH 6.3. Next, acetone was added in a double amount with stirring to make the solution cloudy, and this was centrifuged at 3000 rpm for 10 minutes to collect a precipitate. Collected precipitate at 60 ℃ 1
Vacuum drying was performed for 6 hours to obtain a polymer composite powder (yield: 9
0% or more).

(3) Method for producing patch The propylene glycol and polyethylene glycol 4000 in the ointment formulation (Example 1) shown in Table 1 were weighed and the temperature was 70 ° C.
Melt and mix at. Separately, after weighing white petrolatum, microcrystalline wax, cetostearyl alcohol, liquid paraffin, glycerin fatty acid ester, polyoxyethylene hydrogenated castor oil and heating and melting at 75 ° C.,
Add Hibis 104 / Aerosil # 300 and stir-disperse using an Ultra Disperser. When the temperature after stirring and dispersion reached 60 ° C., povidone iodine was added and stirred and mixed until uniform. After the completion of stirring and mixing, the water-soluble components previously melted and mixed are added and kneaded until uniform, and after deaeration, cooling with stirring is carried out to obtain an ointment. When the hardness of this ointment was measured with a rheometer at room temperature, 1.
It was 2 × 10 ⁵ dyne / cm ² . The obtained ointment,
A non-woven fabric was used as a support, and a polyester film was used as a protective liner to spread the roll to a thickness of 3 mm to obtain a patch.

The patch was applied to an ulcer site of about 2 cm square formed on the back of a 6-week-old guinea pig, and the formulation was replaced once a day to appropriately absorb the exudate from the affected area and swell. Furthermore, from the third day after the preparation was applied, the diseased part was dried and granulation was started, and it was confirmed that the disease was healed after one week. On the other hand, in Comparative Example 1, even after 1 week, the exudate still came out from the affected area and the cure was not completed.

[0018]

[Table 1]

Examples 4 to 5 Ointments were produced in the amounts shown in Table 2 below, and patches were produced using the ointments and evaluated. The evaluation criteria are the same as in Example 1. Further, (1) a method for preparing the water-absorbent polymer composite, and (2) production of the patch are as follows. (1) Preparation of water-absorbent polymer composite Hibis 104 (Wako Pure Chemical Industries) 2% aqueous solution and Laponite X
LG (manufactured by La Porte) 2% aqueous dispersion was added so that the weight fraction of Hibis 104 in terms of solid content was 0.5, and the mixture was uniformly mixed with a homomixer, and then pH was adjusted to 6 with 2N-NaOH.
It was set to 3. Next, while stirring, add twice the amount of acetone to make it cloudy, centrifuge it at 3000 rpm for 10 minutes,
The precipitate was collected. The collected precipitate was vacuum dried at 60 ° C. for 16 hours to obtain a polymer composite powder (yield 90% or more).

(2) Method for manufacturing adhesive patch Glycerin and polyethylene glycol 1 in ointment formulation
Weigh 500 and polyethylene glycol 4000, and
Melt and mix at 0 ° C. Separately, white petrolatum, microcrystalline wax, stearyl alcohol, liquid paraffin, and sucrose fatty acid ester are weighed and melted by heating at 75 ° C., then Hibis 104 / Laponite XLG is added and dispersed by stirring using an ultra disperser. .. When the stirring / dispersion temperature reached 60 ° C., povidone iodine was added and mixed with stirring until uniform. After the completion of stirring and mixing, the components below the glycerin which have been melted and mixed in advance are added and kneaded until uniform, and after deaeration, cooling with stirring is performed to obtain an ointment. When the hardness of this ointment was measured with a rheometer at room temperature, it was 3.1 × 10 ⁵ dyne / cm ² . The obtained ointment was spread to a thickness of 3 mm by a doctor knife method using a nonwoven fabric as a support and a polyester film as a protective liner to obtain a patch.

The patch was applied to an ulcer site of about 2 cm square formed on the back of a 6-week-old guinea pig, and the formulation was replaced once a day to appropriately absorb exudate from the affected area and swell. In addition, it was confirmed that the diseased part was dried and granulation was started 3 days after the preparation was applied, and that it healed after 1 week.

[0022]

[Table 2]

[0023]

The patch for treating wounds of the present invention has the following effects. That is, for the treatment of a liquid exudative skin wound, the exuding liquid is sufficiently absorbed to form an elastic gel, and the wound surface can be protected. Further, by absorbing the exudate from the diseased part, the wound surface can be maintained in an appropriate dry state, and at the same time, the bactericidal action of the main ingredient can be effectively exerted and granulation formation can be promoted. Further, since it is not sticky and has an appropriate adhesiveness, it is easy to use. On the other hand, unlike conventional ointments that are in the form of preparations, a patch of an appropriate size can be selected according to the size of the diseased part, and at the same time, the handling efficiency during treatment is dramatically improved, resulting in therapeutic efficiency. Can be increased.

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Masahisa Kakimoto 1050 Shinba-cho, Kohoku-ku, Yokohama-shi, Kanagawa Stock company Shiseido Institute

Claims (3)

[Claims] 1. A patch for treating wounds, comprising a layer of an ointment containing a water-absorbent polymer and a wax solid at room temperature, which is formed in contact with a support. 2. The patch for wound treatment according to claim 1, wherein the ointment layer contains a hydrophilic component selected from polyhydric alcohols and polymers thereof. 3. The wound treatment according to claim 1, wherein the water-absorbent polymer is a composite of a hydrophilic polymer / silicate mineral composed of poly (meth) acrylic acid and a water-swellable silicate mineral. Patch.