JPS6346700B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention particularly relates to a skin composition suitable for use in protecting and treating affected areas such as cuts, eczema, burns, and ulcers. Conventionally, for cuts, eczema, burns, ulcers, etc.
Treatments include covering the affected area with gauze, non-woven fabric, oiled paper, etc. to protect it, or applying ointment to gauze, non-woven fabric, etc. and applying it to the affected area. However, gauze and nonwoven fabrics do not have any barrier properties against bacteria in the outside air, and they also absorb only a small amount of body fluids such as blood that seep out from the affected area. There are drawbacks such as gauze and non-woven fabrics sticking to each other, causing pain when removing them, and re-injuring the affected area that has been painstakingly healed, delaying the therapeutic effect.Also, gauze and non-woven fabrics have little elasticity. There was also the issue of a strong sense of discomfort. In addition, oil paper has poor water vapor permeability and has the problem of staining the affected area, often making the affected area worse. For this reason, gelatin gels, microfibers,
Alternatively, there is a treatment method using a body fluid-absorbing fine powder known as Debrisan (trade name), but
These treatments are extremely complicated to treat and handle, and there are problems in that only a skilled specialist will be able to fully demonstrate their therapeutic effects. Furthermore, recently, treatments for the affected area have been simplified,
Medical sheets obtained by combining and processing nonwoven fabrics and plastic films have also been proposed, with the aim of providing contradictory functions of gas and moisture exchangeability and bacterial barrier properties. They are not necessarily sufficient in terms of effectiveness, manufacturing method, and compatibility with drugs, etc. The inventors of the present invention have conducted extensive research to solve the above-mentioned drawbacks, and have found that a film-like material obtained by blending a water-absorbing polymer substance with nylon resin has excellent water vapor permeability and is a bacterial barrier. It has excellent properties and has a high ability to absorb body fluids, and when combined with drugs, has good drug retention and release properties.It can be effectively applied to bleeding and exudative skin injuries, and is easy to use. The inventors have discovered that it is possible to manufacture the same, and that it can be easily manufactured, leading to the present invention. The present invention will be explained in detail below. The skin composition of the present invention contains a nylon resin and a water-absorbing polymeric substance, and is particularly suitable for use against bleeding and exudative skin injuries such as cuts, eczema, burns, and ulcers. It can be prepared in the form of a sheet or a liquid that can be applied to the affected area to form a film. In the present invention, nylon resins include nylon 6, nylon 66, nylon 610, nylon 11,
All general nylon resins (polyamide resins) such as nylon 12 can be used, but alcohol-soluble nylon is particularly preferred because it is easy to manufacture the composition and the formed film has high water permeability. More preferred. In this case, the alcohol-soluble nylon includes copolymer type, modified nylon, copolymer-modified nylon, and the like. Copolymer type nylons include nylon 6/66/610, nylon 6/66/
12, nylon 6/69/12, nylon 6/612/12,
Nylon 6/66/69/12, Nylon 6/66/11/
12, nylon 6/66/612/12, nylon 6/
66/Bis(4-aminocyclohexyl)methane-
Examples include ternary or higher copolymers such as CM-4000, CM-4001, manufactured by Toray Industries, Inc.
CM-8000, Zytel-61, 63, made by Ziupon
69, BASF Ultraamide 1A, 1C, 5A,
6A, 10, Daicel's Diamid, etc. may be used. In addition, modified nylons are those in which the hydrogen at the α position of 6-nylon is replaced with a dimethylamino group, or the hydrogen in the amide group is replaced with an alkoxyal group, etc., such as Torezin F30, F30C, manufactured by Teikoku Kagaku Sangyo Co., Ltd.
F30X, etc. may be used, and the copolymerized-modified nylon is a combination of a copolymerized type and a modified type, such as Diamid X Seeds manufactured by Daicel Corporation. Note that the nylons exemplified above all have melting points in the range of 80 to 160°C. In the present invention, the above-mentioned nylons may be used singly or in combination of two or more. In addition, when preparing a composition in a liquid form using alcohol-soluble nylon, the amount added is not particularly limited;
It is preferable to set it to 20% (weight%, the same applies hereinafter). If the amount of nylon blended is too small, the film formed by one application may be too thin, and if the amount of nylon blended is too large, the composition may have a high viscosity, resulting in poor dissolution workability and usability. Furthermore, as water-absorbing polymeric substances, those that swell and disperse in water but are essentially insoluble in water can be used, such as gelatin, agar, syringa, which is the shell of the plantain grass, and gelatin. ―
Cross-linked metal salts (aluminum alum, etc.) and gelatin-aldehyde compounds (dialdehyde starch,
Formaldehyde) crosslinked products such as gelatin crosslinked products are preferably used, and furthermore, crosslinked products of synthetic water-soluble substances, products in which other water-soluble polymer substances are introduced into water-soluble main polymer substances by graft polymerization, and hydrophilic A hydrophilic synthetic polymer water-absorbing resin such as a synthetic polymer having a segment and a hydrophobic segment may be used.
Examples of hydrophilic synthetic polymer water-absorbing resins include starch-acrylonitrile graft polymers and saponified products thereof, crosslinked copolymers of starch and acrylic acid or its salts, saponified products of vinyl acetate-acrylic acid ester copolymers, and acrylonitrile Examples include hydrolysates of copolymers, hydrolysates of acrylamide polymers, and crosslinked products of acrylic acid or its salts.Specifically, commercially available products include Sunwet IM-300 manufactured by Sanyo Chemical Co., Ltd. and Sunwet IM-300 manufactured by Kao Corporation. Wondergel, Hydrogel S-50 manufactured by Sumitomo Chemical, Aquaric CA manufactured by Nippon Shokubai, PX manufactured by Showa Denko, SGP manufactured by General Mills, FX manufactured by Exlan, etc. may be used. Note that these water-absorbing polymeric substances may be used alone or in combination of two or more.
Further, the water-absorbing polymeric substance may be in the form of powder or granules, and its size is not particularly limited, but if it is in the form of powder or granules, it is preferably 150 mesh or finer; In the case of a fibrous material, it is preferable to have a diameter of 10 μm or less and a length of 1 mm or less, and the smaller the size, the better the uniformity and water absorption performance when formed into a film. The blending amount of the water-absorbing polymeric substance is not necessarily limited, but is 0.05 to 300% based on the amount of nylon resin.
%. If the amount of the water-absorbing polymer substance is too small, the effect cannot be achieved sufficiently, and if it is too large, the nylon cannot form a continuous layer when formed into a sheet, and therefore Membrane strength may decrease, flexibility may decrease, and pores may occur. In addition to the above-mentioned components, the present invention includes other polymeric compounds such as polyvinylpyrrolidone, polyvinylpyrrolidone/vinyl acetate copolymer, methyl vinyl ether, etc., for the purpose of adjusting water absorption rate, water vapor permeability, film properties, etc., if necessary. /Maleic anhydride copolymer, polyacrylic ester, polyacrylic acid/salt, carboxyvinyl polymer, hydrophilic urethane prepolymer, etc. can be blended in an amount of 0 to 30% based on the amount of nylon resin. In this case, the hydrophilic urethane prepolymer is particularly effective because it makes the nylon coating flexible, improves mechanical strength such as tensile strength, improves water permeability, and increases the stability of the nylon coating over time. . Hydrophilic urethane prepolymer has a plasticizer-like effect on nylon resin, and is not only effective as a plasticizer.
It imparts excellent properties to nylon resin, such as increasing film strength and acting as a release agent to improve peeling performance. As this hydrophilic urethane prepolymer, 2
A linear or branched polymer or random copolymer (molecular weight 500 to 2000) produced by an addition reaction between a polyhydric alcohol with a higher valence or higher and one or more types of ethylene oxide or alkylene oxide having 3 or more carbon atoms. A urethane prepolymer having two or more isocyanate groups at the molecular end or in the molecular chain obtained by reacting a polyalkylene glycol or polyether polyol with a compound having two or more isocyanate groups is preferably used. Specifically, Hycel OH made by Toho Chemical Industry Co., Ltd.
1A, UP-200 manufactured by Lion Corporation, etc. can be used. In addition, the above-mentioned urethane prepolymers may be used alone or in combination of two or more. In addition, the amount of urethane prepolymer blended is not necessarily limited, but
The amount is preferably 0.5 to 25%; if the amount of the urethane prepolymer is too small, the effect may not be sufficiently exhibited, and if it is too large, the tensile strength of the nylon coating may be reduced. The skin composition according to the present invention is particularly suitable for use in bleeding and exudative skin disorders, but in this case, in order to impart barrier properties against bacteria, antibacterial properties, and active therapeutic effects, Fungicide,
One or more types of drugs such as anti-inflammatory agents, antibiotics, tissue repair agents, etc. can also be blended in an amount of 0 to 30% based on the nylon resin. Furthermore, in order to control the release properties and percutaneous absorption of these drugs from the sheet, polyhydric alcohols such as propylene glycol, polyethylene glycol, and glycerin, esters such as isopropyl myristic acid, oils such as lanolin and petrolatum,
Waxes and surfactants can also be blended.
There is no particular restriction on the amount of the compound, but when the composition is formed into a sheet, 0 to 20% of the amount is contained in the sheet.
It can be formulated to contain. In addition, the skin composition of the present invention can be formed into a sheet shape as described above, or can be prepared into a liquid form that can form a film on the skin. Any material can be used as long as it dissolves the . However, lower alcohols such as ethanol, propanol, and isopropanol, and mixed solvents of these lower alcohols and water can be preferably used. In addition, when using a mixed solvent of lower alcohol and water, the ratio is 95:5 to 60: by weight.
It is preferable to set it to 40. There are no particular restrictions on the method for producing the skin composition of the present invention. For example, when preparing a liquid form, nylon resin is dissolved in a suitable solvent, and a water-absorbing polymer substance and, if necessary, desired ingredients are added thereto. When forming a sheet, the liquid can be applied to a sheet using a flow coater, the solvent is volatilized, and the nylon resin is dried. A method may be adopted in which a polymeric substance and other desired components are mixed, kneaded, and then formed into a sheet. Therefore, the skin composition according to the present invention has a coating film that has very good water absorption properties by blending a water-absorbing polymer substance with a nylon resin, and can quickly remove body fluids such as sweat and blood in large quantities. In addition to being able to absorb water, it has excellent moisture permeability and can smoothly dissipate moisture into the outside air, so it can be used without inconveniences such as staining the affected area, and it also has good barrier properties against bacteria, etc. It can be protected. Furthermore, the coating has high flexibility and strength, does not adhere to the affected area due to body fluids, and can be easily removed without damaging the affected area when peeled off after use. Furthermore, when a drug is retained, the drug retention and release properties are good, and the composition of the present invention is easy to use and has good manufacturability. In this way, when actually applied, a nylon coating containing a water-absorbing polymer substance prevents external physical stimulation and the invasion of bacteria for a long period of time without staining the affected area, and also prevents exudable body fluids. It can be removed quickly and in large quantities from the affected area, promoting the formation of new tissue, and there is almost no damage to the affected area when peeled off after use, so it is effective against exudative skin diseases such as cuts and burns. It can be used effectively. EXAMPLES Hereinafter, the present invention will be specifically explained with reference to examples, but the present invention is not limited to the following examples. [Example 1] Soluble nylon (Ultraamide manufactured by BASF)
1C) 20% solution (solvent: ethanol/water 90/
10 weight ratio) 100g Water-absorbing polymer material (Aquarik manufactured by Nippon Shokubai Co., Ltd.)
CA) 2g carboxyvinyl polymer 0.3g A water-absorbing polymer substance and carboxyvinyl polymer were added to a soluble nylon solution, which was applied in the form of a sheet and dried to form a sheet with a thickness of 50μ. This sheet can be used by cutting it into an appropriate size and attaching it to a predetermined affected area with adhesive tape, or by applying an adhesive to the periphery of one side of the sheet and attaching it to the affected area. In addition, by wetting the affected area with alcohol and applying it, good adhesion can be achieved without using any adhesive. As is clear from the results of the experiments described below, the sheet with the above formulation has excellent water vapor permeability, body fluid absorption,
It had excellent bacterial barrier properties and peelability, as well as excellent flexibility and strength, making it suitable for protecting affected areas. [Example 2] Soluble nylon (Teikoku Kagaku Co., Ltd. Torezin F30)
20% solution of (solvent: ethanol/water 85/15 weight ratio) 20g 20% of soluble nylon (Ultraamide 1C)
Solution (solvent: ethanol/water 90/10 weight ratio)
80g Water-absorbing polymer material (gelatin-dialdehyde starch cross-linked product) 8g Water-absorbing polymer material (Aquarik CA) 2g Hydrophilic urethane prepolymer (manufactured by Lion Corporation)
UP-200) A 50μ sheet was molded from 1.5g or more of the ingredients in the same manner as in Example 1. In addition to the features of the sheet of Example 1, this sheet has
Furthermore, it was highly flexible and showed sufficient followability to the movements of joints, etc. [Example 3] Benzalkonium chloride 0.01g Chlorhexidine gluconate 0.01g Diphenhydramine 0.1g Naphazoline hydrochloride 0.1g 20% of soluble nylon (Ultraamide 1C)
Solution (solvent: ethanol/water 85/15 weight ratio)
100.0g Water-absorbing polymer material (Shazenshi) 10.0g Polyvinylpyrrolidone (K-90) 0.5g A 50μ sheet was molded from the above ingredients in the same manner as in Example 1. This material also has excellent antibacterial properties and is highly effective as a sheet for treating wounds and exudative skin injuries, and could be removed without damaging the wound. [Example 4] Sulfazine 1.0g Chlorhexidine gluconate 0.01g Allantoin 0.5g 20% of soluble nylon (Ultraamide 1C)
Solution (solvent: ethanol/water 85/15 weight ratio)
100.0g Water-absorbing polymer material (gelatin-dialdehyde starch crosslinked product) 15.0g A 50μ sheet was molded from the above ingredients in the same manner as in Example 1. This product is extremely effective for burns and ulcers with erosive surfaces, promotes epidermal formation, and can be smoothly removed without damaging new tissue even after use. In the above examples, the gelatin-dialdehyde starch crosslinked product was 10% of gelatin.
Add 1g of dialdehyde starch to 100g of aqueous solution,
A product obtained by drying and pulverizing a gel-like product subjected to a heating reaction was used. Next, the sheets obtained in the above examples were examined for their water vapor permeability, body fluid absorption, peel strength, germ barrier properties, and antibacterial properties using the following methods. Also, for comparison, soluble nylon (Ultraamide 1C)
These properties were also investigated for 50μ nylon sheets and gauze obtained using chisel. (1) Water vapor permeability Water vapor permeability in a cylindrical cup (made of glass) with a radius of 17 mm.
After putting 10g into the cup and sealing the mouth of the cup with sheets of various samples and leaving it in a constant temperature and humidity chamber at 37°C - 65% and 37°C - 42% for 24 hours, the water loss was measured and the value was calculated using 1m of the sheet. This was converted to ² per cent and used as an index of water vapor permeability. (2) Body fluid absorption A 10cm x 10cm sheet was immersed in physiological saline for 5 minutes, taken out, sandwiched between pieces of paper to remove excess water, the amount of body fluid absorbed was measured, and this was converted to 1g of the sheet. , the amount of body fluid absorbed. (3) Peeling force Tobacco filter was created as a substitute body fluid37
The force when soaking the sample sheet in a 10% gelatin-1% polyvinylpyrrolidone solution at ℃ to fully swell it, immediately placing it on a sample sheet, drying it completely, and peeling it off at a speed of 2 cm/min using a tensilon meter. was used as an index of releasability. In order to prevent the sheet from stretching when it was peeled off, cellophane tape was attached to the back of the sheet at the time of measurement. (4) Bacterial barrier properties of the sheet Place the sheet on an agar plate (SCD for bacteria, GP for yeast). Place a paper disk (manufactured by Toyo Seisakusho Co., Ltd.) soaked in the test bacterial solution for 1 minute and leave it for 1 hour or 24 hours, then remove the disk and sheet and culture (bacteria at 37℃ for 24-48 hours; yeast at 27℃). , 6 days). After culturing, the presence or absence of growth of these bacteria is determined visually. Evaluation criteria +: Bacterial permeation -: Bacterial non-permeable (5) Antibacterial property of sheet Sterile agar medium heated to 50℃ (for bacteria, SCD,
Yeast (GP) was inoculated with the test bacteria solution at a ratio of 0.1 ml/100 ml of medium, mixed well, and then placed in a sterile petal for 15 minutes.
Dispense ~20ml and allow to solidify. Place the sheet on this plate and culture (conditions are the same as (4)). After culturing, the width of these inhibition zones is measured to determine antibacterial properties. Evaluation criteria −: No antibacterial property, width of inhibition zone 1 mm or less ±: Antibacterial property, 1 to 3 mm +: 3 to 5 mm: 5 mm or more In addition, in the experiments (4) and (5) above, The following bacteria were used as test bacteria. Bacteria Gram-positive bacteria Staphylococcus aureus (St ₁ ) Gram-negative bacteria Escherichia coli (E-Coli) Pseudomonas aeruginosa (Ps) Yeast Candida (Ca) The above results are shown in Tables 1 to 3.

【table】

【table】

[Table] From the above results, all of the sheets of the examples showed extremely high water vapor permeability, did not cause staining of the affected area, and the amount of body fluid absorbed was 4 times lower than that of conventional gauze.
It is more than twice as large and can efficiently remove rapidly exudable body fluids from the surface of the affected area. It also has a small peeling force, so it does not damage new tissue when removed after use, and it also shows bacteria barrier properties. It was found that the sheet prevents the invasion of germs from the outside air, and that the sheet containing a bactericide exhibits antibacterial properties, and that the drug is gradually released from the sheet, resulting in a sustained medicinal effect.

Claims (1)

[Scope of Claims] 1. A skin composition comprising a nylon resin and a water-absorbing polymeric substance that swells and disperses in water but is substantially insoluble in water. 2. The composition according to claim 1, wherein the nylon resin is alcohol-soluble nylon. 3 The water-absorbing polymeric substance is gelatin, agar, chazen, crosslinked gelatin, crosslinked synthetic water-soluble substance, a water-soluble main polymeric substance with another polymeric substance introduced by graft polymerization, or a hydrophilic segment. The composition according to claim 1 or 2, which is a synthetic polymer having a hydrophobic segment and a hydrophobic segment. 4. The composition according to any one of claims 1 to 3, wherein the composition is formed in a sheet form.