KR20020046619A - Multilayer Foam Dressing And Method For Manufacturing Thereof - Google Patents

Abstract

PURPOSE: A multi-layered foam dressing material and a producing method thereof are provided, therefore the foam dressing material can release not active pharmaceutical ingredients but water, and inhibit the infection with foreign bacteria, so that the injury can be effectively and rapidly treated. CONSTITUTION: The multi-layered foam dressing material has a thickness of 0.5 to 10 mm, and comprises an outer side film layer(1) having a thickness of 0.5 to 50 micrometer; an inner side absorption foam layer(2) containing a large number of open cells having a diameter of 50 to 500 micrometer; and an injury contacted film layer(3) having a thickness of 0.5 to 60 micrometer and containing pores having an average diameter of 60 micrometer, in which the outer side film layer(1) has no pore; and the injury contacted film layer(3) has 5 to 50% of the pore area. The method for producing the multi-layered foam dressing material comprises the steps of: mixing 40 to 75 wt.% of polyurethane prepolymer with 15 to 45 wt.% of a foaming agent, 5 to 35 wt.% of a bridging agent and 0.5 to 15 wt.% of additives comprising a surfactant, water a protecting agent, a releasing agent, an antimicrobial agent and a pigment; inserting the mixture into a mold; and foam shaping the mixture at 30 to 60 deg. C.

Description

Multilayer Foam Dressing And Method For Manufacturing Thereof}

The present invention relates to a foam dressing material for use as a wound dressing, and in detail, its structure includes a plurality of open cells having an outer film layer 1 having a thickness of 0.5 to 50 µm and a diameter of 50 to 500 µm. It consists of a three-layer structure of the wound surface contact film layer 3, which is a film of 0.5 to 60 µm thick, having a plurality of pores having an average diameter of 60 µm and an inner absorbent foam layer 2, The present invention relates to a foam dressing material of a closed multi-layered structure having a high moisture permeability of 500 to 5000 g / m 2/24 hrs under a high water absorption and a relative humidity of 37.5 ° C. and 10 to 100%, and preventing leakage of the exudates.

Skin is an organ that performs important functions such as body protection, temperature control, bacterial infection prevention, perception and secretion, and various wounds, wounds, burns, bedsores, etc. If the patient suffers, and extensive damage, even life threatening. In addition, secondary pain is caused by the formation of severe scars after treatment.

In general, the wound treatment process is divided into inflammatory phase, proliferative phase and mature phase. In the inflammatory phase, when tissues are damaged and blood vessels are destroyed, many cell growth factors (PDGF, TGF-β, EGF, FGF, etc.) and cytokines (IL-1, IL-6, IL-) in bleeding platelets and inflammatory cells 8, TNF, etc.) are released and epithelial cells expand and cover along the window, and in the proliferative phase, these cell growth factors and cytokines proliferate vascular endothelial cells, fibroblasts, epidermal cells, etc. The growth factor is released to form granulation tissue, which is then replaced with collagen fibers and elastic fibers to complete the treatment through the tissue reconstructor. As an environmental factor for efficient healing in the above healing process, there is no wet environment where the epithelial cells can be expanded and there is no infection, foreign substances and necrotic tissue, oxygen concentration, high cell growth factor, and normal skin around the window Further infection prevention; In other words, the requirements of the ideal dressing material include the ability to maintain adequate moisture at the contact surface with the wound, the ability to absorb exudates, the ease of attachment and removal to the wound, the high oxygen tension and the proper water vapor permeability, and the temperature of the wound area from 32 to 35 ° C. The ability to maintain the degree, the protection against the invasion of bacteria, the ability to prevent external leakage such as cell growth factor, non-toxic to human body, excellent mechanical properties, economics and the like.

Ordinary gauze dressings are easy to absorb wound secretions, but they do not have the ability to protect against infections such as bacteria from the outside and keep the wound dry so that treatment is delayed. But there are problems involving neoplastic damage and pain. In addition, since the exudates are generated in the early stages of healing, there is a disadvantage that the dressing material must be changed several times a day. Currently, various closed dressing materials have been developed and used to improve the problems of gauze dressing materials, but due to their high price and lack of controllability of absorbency and moisture permeability, they are not widely applied to various wounds and are mainly applied to specific wounds.

Types of dressing materials currently used mainly include film type, hydrocolloid type, hydrogel type, nonwoven fabric type and polyurethane foam type. In particular, the dressing material having a high therapeutic effect may include a hydrocolloid type, a hydrogel type, and a polyurethane foam type.

The hydrocolloid type shown in U.S. Patent Nos. 5,503,847 and 5,830,932 consists of a pressure sensitive adhesive composition layer, a hydrocolloid layer that mitigates impact from the outside world and absorbs the exudates, and a film layer that prevents the penetration of bacteria and foreign substances. The hydrocolloid-type dressing material absorbs a small amount of wound secretion to form a gel and provides a wet environment and maintains pH at a weak acidity for a long time, thereby preventing tissue damage and providing an environment for promoting cell growth. However, due to the lack of moisture permeability and the ability to absorb exudates, the gel adheres to the wound surface when it is replaced or removed and remains a residue, which becomes a nutrient source for the growth of bacteria. There is a disadvantage in that it is not suitable.

The hydrogel types shown in U.S. Patent Nos. 5,501,661 and 5,489,262 form a form in which a hydrogel is applied to a polymer film layer having no permeability, the polymer film layer prevents the hydrogel from being dehydrated or dried, and the hydrogel layer is applied to the wound surface. It absorbs exudates and maintains a moist environment to promote wound healing. However, due to low moisture permeability, it is impossible to use a wound with a large amount of exudates, and if the water swelling condition persists, the dressing material collapses and causes inflammation of the normal skin.

The hydrophilic polyurethane foam dressing material disclosed in US Pat. Nos. 5,445,604 and 5,065,752 has a structure in which the film is laminated on both sides of the polyurethane foam, and the film in contact with the wound surface is mechanically drilled with micropores so that the exudates are well absorbed. It was. However, when this is applied to wounds in which a large amount of exudate is generated, there is a problem that the permeability of the outer film that is not punctured is not sufficient, so that it is not suitable for long-term adhesion. There is a problem such as being attached.

In addition, the multi-layered dressing material in U.S. Patent No. 5,759,570 has an outer protective film, an intermediate absorption layer, a molecular filtration membrane, a wound surface contact layer, and an adhesive layer, and the molecular filtration membrane quickly removes exudates into the intermediate absorption layer and is cytokine. (PDGF, TGF-β, EGF, FGF, IL-1, IL-6, IL-8, TNF, etc.), Glucosaminoglycans (hyaluronic acid, chondroitin acid, heparin, dermatan, dermatanic acid, etc.), proteins (Protease, etc.) was concentrated on the wound area to maximize wound healing, and the contact surface of the wound surface became a gel after the exudation of the exudates to facilitate removal after treatment, thereby maximizing the wound healing environment. However, it has a disadvantage of complicated manufacturing process and high price, making it difficult to use universally.

Summarizing the problems of the conventional closing dressing material as described above, there are problems such as low water absorption, wound adhesion, low physical properties, high cost, and the like, and are not suitable for wounds in which a large amount of exudates are generated.

The present invention improves low absorbency, low moisture permeability, wound surface adhesion, low physical properties, etc., which are disadvantages of conventional dressing materials, and concentrates cell growth factors and cytokines to form a foam dressing material having a structure that can expect a more efficient wound healing effect. The purpose is to provide.

Thus, the inventors of the present invention, in order to solve the above problems, in the structure of the foam dressing material, to form a three-layer structure of the outer film layer, the inner absorbing foam layer and the wound surface contact film layer, the outer film layer is a pore It has a function to prevent the invasion of foreign substances and bacteria from the outside by preventing the external leakage of the exudates, and the internal absorbent foam layer has a large number of open cells having a diameter of 50 ~ 500㎛ by having a structure without And high moisture permeability, and the wound surface contact film layer has a plurality of micropores with an average diameter of 60 μm, thereby having high absorbency and non-adhesion of the wound surface, cell growth factors, cytokines, and glycosaminoglycans. , Protein, etc. to concentrate on the wound area, and was prepared by a simple processing process due to one time foaming This problem is completely solved, and also after treatment by the improved wound healing mechanisms of wound healing and minimize scar speed also provides a dressing material forms a superior multi-layer structure than the conventional products and a method of manufacturing the same.

Hereinafter, the present invention will be described in detail.

1 is a schematic cross-sectional view of a foam dressing material consisting of a three-layer structure of the outer film layer, the inner absorbing layer and the microporous wound surface contact film layer of the thin film.

Figure 2 is a scanning electron micrograph of the surface and cross section of both film layers of the foam dressing material.

<Explanation of symbols for the main parts of the drawings>

1 ... outer film layer 2 ... inner absorbent foam layer with open cell structure

3 ... contact film layer on wound surface 4 ... outer film layer surface

5 ... surface of contact film layer on wound surface 6 ... cross section of inner absorbent foam layer

The multi-layered foam dressing material of the present invention includes an inner absorbent foam layer (2) having a structure including a plurality of outer film layers (1) having a thickness of 0.5 to 50 µm and an open cell having a diameter of 50 to 500 µm, and It consists of the three-layer structure of the wound surface contact film layer 3 which is a film of 0.5-60 micrometers thickness in which many pore of 60 micrometers of average diameter exists. The thickness ranges from 0.5 to 10 mm and the width and shape can be produced in various ways depending on the application.

The outer film layer 1 having a thickness of 0.5 to 50 μm has a pore-free structure, and has a function of preventing infiltration of foreign substances and bacteria from the outside while preventing leakage of exudates. The inner absorbent foam layer 2 includes a large number of open cells having a diameter of 50 to 500 μm, an open cell ratio of 50 to 80%, a specific gravity of 0.05 to 0.5, and high exudant absorption and high moisture permeability. . In the wound surface contact film layer 3, which is a film having a thickness of 0.5 to 60 µm in which a large number of pores having an average diameter of 60 µm exist, the microporous area of the skin layer occupies 5 to 50% of the total skin layer area. It is non-adhesive when wound, and has a feature of concentrating cell growth factors, cytokines, glycosaminoglycans, proteins, and the like on wound sites.

1 is a schematic cross-sectional view of a three-layered foam dressing material according to the present invention, Figure 2 is a surface 4 of the outer film layer of the foam dressing material produced by the present invention, the surface 5 of the wound surface contact film layer, A scanning electron micrograph of the end face 6 of the inner absorbent foam layer.

Foam dressing material of the present invention is a synthetic polymer such as polyurethane, polyethylene, silicone resin, natural and synthetic rubber, polyglycolic acid, polylactic acid or copolymer thereof, polyvinyl alcohol, polyvinylpyrrolidone and collagen, gelatin, hyaluronic acid And natural polymers such as sodium alginate, chitin, chitosan, fibrin, and cellulose, or synthetic polymers derived from these may be prepared alone or in combination. Polyurethane is the most preferred material in the polyurethane prepolymer obtained by reacting at least one polyetherpolyol with diisocyanate in the range of 40 to 75% by weight of the foaming agent 15 to 45% by weight of the crosslinking agent, 5 to 35% by weight of the crosslinking agent and the surfactant, the humectant and the release agent. 0.5-15% by weight of additives such as antimicrobial agents, pigments, and cell growth factors are added, mixed and agitated, and then injected into a mold having a predetermined shape to foam. At this time, the temperature of the mold is 30 ~ 60 ℃ and 5 to 10 minutes after injection and demoulding.

In addition, the outer film layer has a pore-free structure by applying a release agent to only one surface of the mold during the foam molding.

The polyurethane prepolymer is prepared by synthesizing the polyether polyols at 0.15 to 0.5 molar ratio with respect to 1 to 3 moles of diisocyanate.

In the preparation of the polyurethane prepolymer. Diisocyanates include isophorone diisocyanate, 2,4-toluene diisocyanate and isomers thereof, diphenylmethane diisocyanate, hexamethylene diisocyanate, lysine diisocyanate, trimethylhexamethylene diisocyanate, 2,2-bis-4'- Propane isocyanate, 6-isopropyl-1,3-phenyldiisocyanate, bis (2-isocyanateethyl) -fumarate, 3,3'-dimethyl-4,4'-diphenylmethane diisocyanate, 1,6-hexane Diisocyanate, 4,4'-biphenylene diisocyanate, 3,3'-dimethylphenylene diisocyanate, p-phenylene diisocyanate, m-phenylenedi isocyanate, 1,5-naphthalene diisocyanate, 1,4- xylene diisocyanate , 1,3-xylene diisocyanate and the like can be used, preferably diphenylmethane diisocyanate, 2,4-toluene diisocyanate and isomers thereof, p-phenyl Diisocyanate, isophorone diisocyanate, it is better to use hexamethylene diisocyanate. Polyether polyols include an ethylene oxide / propylene oxide random polymer having three or more hydroxyl groups in a molecule having a molecular weight of 3,000 to 6,000 and an ethylene oxide content of 50 to 80%, and a molecular weight of 1,000 to 4,000 having two or more hydroxyl groups in a molecule. Phosphorus polypropylene glycol may be used in a mixture of 100: 0 to 30:70, preferably ethylene oxide / propylene oxide having three hydroxyl groups in a molecule having a molecular weight of 3,000 to 6,000 and an ethylene oxide content of 50 to 80%. It is better to use a random copolymer independently.

The blowing agent may be used chlorofluorocarbon (CFC-141b), methylene chloride (Methylene chloride), distilled water, it is preferable to use distilled water.

The crosslinking agent is 1,3-butanediol, 1,4-butanediol, 1,5-pentanediol, 1,6-hexanediol, neopentylglycol, propylene glycol, ethylene glycol, having a molecular weight of two or more hydroxyl groups, and has a molecular weight of 200 to 2,000 polyethylene glycol, glycerol, trimethylol ethane, trimethylol propane, pentaerythritol, sorbose, sorbitol and the like can be used alone or in combination, preferably glycerol, sorbitol And polyethylene glycol and trimethylolpropane having a molecular weight of 200 to 2,000 are preferred.

As an additive, the surfactant is L-62, L-64, P-84, P-85, P-105, F-68, F-87, F-88, F from BASF, Germany, which is an ethylene oxide / propylene oxide block copolymer. -108, F-127 or a mixture thereof and L-508, L-5305, L-5302, L-3150 of Osi, which are silicone surfactants, may be used. As moisturizers and wound healing accelerators, hyaluronic acid, keratan, collagen, Dermatan sulfate, heparin, heparan sulfate, sodium alginate, pectin, xanthan gum, guar gum, karaya gum, sodium carboxymethylcellulose, chondroitin sulfate, 3-aminopropyldihydrogen phosphate, chitin, chitosan, gelatin, locust bean gum Alternatively, these oligosaccharides may be used alone or in combination. Cell growth factors include platelet-derived growth factor (PDGF), transforming growth factor (TGF-β), epidermal cell-derived growth factor (EGF), and fibroblast-derived growth. You can use FGF alone or mixed. There.

The release agent may be L-45, L-580, L-3002, L-5309 of Osi, a silicone-based surfactant, and antibacterial agents include gluconate chlorohexidine, acetate chlorohexidine, and hydrochloride chlorohexidine. , Silversulfurdiazine, povidone iodine, benzalconium chloride, furazine, idocaine, hexachlorophene, chlorotetracycline, neomycin, penicillin, gentamicin, acrinoline and the like can be used.

Hereinafter, the present invention will be described in more detail by the synthesis examples, examples and comparative examples. The following Synthesis Examples, Examples and Comparative Examples are provided only to explain the present invention in detail, and the technical scope of the present invention is not limited thereto.

Synthesis Example 1

In preparing a polyurethane prepolymer having an isocyanate end group, 354 g of diphenylmethane diisocyanate and 314 g of isophorone diisocyanate were added to a 3 liter round bottom flask equipped with a stirrer, and the temperature was raised to 60 ° C., followed by three hydroxyl groups. And ethylene oxide / propylene oxide random copolymer and 1332 g of TR-705 (polyol Korea Co., Ltd.) of 75% ethylene oxide content was added in small portions and reacted for 7 hours until the theoretical NCO% 12 was reached. Samples were taken in the middle of the reaction to determine NCO% and NCO% was determined by titrimetry using n-butylamine standard solution.

Synthesis Example 2

In preparing a polyurethane prepolymer having an isocyanate end group, 212 g of diphenylmethane diisocyanate and 189 g of isophorone diisocyanate were introduced into a 3 liter round bottom flask equipped with a stirrer and heated to 60 ° C., followed by three hydroxyl groups. It was prepared by reacting for 7 hours until reaching the theoretical NCO% 7 while adding a small amount of 1559g of ethylene oxide / propylene oxide random copolymer and ethylene oxide content of 75%. Samples were taken in the middle of the reaction to determine NCO% and NCO% was determined by titrimetry using n-butylamine standard solution.

Synthesis Example 3

Polyurethane prepolymers having isocyanate end groups were prepared by adding 586 g of diphenylmethane diisocyanate to a 3 liter round bottom flask equipped with a stirrer and heating to 60 ° C., followed by polyhydroxyglycol GP-3000 (Korea Polyol) 680g and ethylene oxide / propylene oxide random copolymer was prepared by reacting for 7 hours until the theoretical NCO% 7 was added with a small amount of 734g L-2047 ethylene oxide content of 75%. Samples were taken in the middle of the reaction to determine NCO% and NCO% was determined by titrimetry using n-butylamine standard solution.

Example 1

The hydrophilic polyurethane foam dressing material is 60.% by weight of polyurethane prepolymer prepared in Synthesis Example 1 28.95% by weight of distilled water as a blowing agent, 9% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 (BASF) as an additive, flesh pigment (Songwon Color) 0.5% by weight, silver sulfadiazine (0.05% by weight) was added and stirred at 4,000 rpm for 5 seconds, and then injected into a mold of a constant shape treated with a release agent L-580 to prepare a foam. . At this time, the temperature of the mold was set to 35 ℃ and opened and closed demolding 10 minutes after the injection.

The obtained hydrophilic polyurethane foam dressing material was measured by the following method and the physical properties are shown in Table 1 below.

(1) Mechanical properties (tensile strength, elongation, modulus)

It measured by the tensile tester (Universal Test Machine, USA, Instron) based on JIS-K-6401.

(2) Absorbance (%)

Take the hydrophilic polyurethane foam dressing material in the size of 3cm × 3cm and measure the initial weight (A), impregnate and store it in 25 ℃ distilled water for 24 hours, remove it, wipe off the surface with a dust-free tissue, and measure the weight (B). Calculate using the following equation.

Absorbance (%) = (B-A) / A × 100

(3) moisture permeability

It is measured according to the test method of KS M 6886 using a thermo-hygrostat. At this time, the temperature was 37.5 ℃ and the relative humidity was 90% and the moisture permeability was calculated according to the following equation.

P = A / S

A = ((a ₁ -a ₀ ) + (a ₂ -a ₁ ) + (a ₃ -a ₂ )) / 3

Where P: breathability (g / m ² / 24hr)

A: average amount of increase per hour (g)

S: moisture permeation area of the test piece (m ² )

a ₀ : Weight measured after 1 hour

a ₁ , a ₂ , a ₃ : Weight measured after 2 hours, 3 hours and 4 hours

(4) Cell size and film thickness measurement

A scanning electron microscope was used to measure the cell size and film thickness of the surface and cross section of the hydrophilic polyurethane foam dressing material.

(5) Toxicity test on cells

The method of ISO 10993-5 was used to evaluate the toxicity of the hydrophilic polyurethane foam dressings to the cells. Cells were subjected to secondary culture using 3T3 cells, mouse fibroblasts provided by the National Institute of Hygiene. Rootswell Park Memorial Institute-1640 (RPS-1640) containing 10% FCS (Fetal Calf Serum) in a 12 well plastic culture dish was used to seed 3T3 cells at 2 × 10 ⁴ / cm 2, 37 ° C, 5%. Secondary incubation for 4 days under CO ₂ . The hydrophilic polyurethane foam dressing material was directly contacted and incubated for 1 day, 3 days and 5 days, respectively, and then harvested using trypsin / Ethylene Diamine Tetraacetic Acid (EDTA) solution and stained with 0.4% trypan blue solution. The number of viable cells was measured with a hemasitometer.

(6) Measurement of wound healing effect

In order to observe the wound healing effect of hydrophilic polyurethane foam dressing, rats of 6 to 8 weeks of average age and 250 to 300 g of weight were used. Rats were intraperitoneally anesthetized with rembutal, and a square skin defect with a diameter of 4 × 4 cm was formed on the back and dressing was performed. The wound healing effect was measured by the change of the size of the skin defect and the dissociation of tissue cells during histologic examination and histological examination.

Example 2

The hydrophilic polyurethane foam dressing material is 20.95% by weight of distilled water as a blowing agent, 7% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 (BASF) as an additive, 70% by weight of the polyurethane prepolymer prepared in Synthesis Example 1. (Songwon Color) 0.5% by weight, silver sulfadiazine (0.05% by weight of silver sulfadiazine) was added and stirred at 3,000 rpm for 5 seconds, and then injected into a mold of a predetermined shape treated with L-580 to prepare a foam. At this time, the temperature of the mold was 60 ℃ and opened and closed demolding 5 minutes after the injection. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Example 3

Hydrophilic polyurethane foam dressing material is 60.% by weight of polyurethane prepolymer prepared in Synthesis Example 2 28.95% by weight of distilled water as a blowing agent, 9% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 (BASF) as an additive, flesh pigment (Songwon Color) 0.5% by weight, silver sulfadiazine (0.05% by weight of silver sulfadiazine) was added and stirred at 5,000 rpm for 5 seconds, and then injected into a mold of a predetermined shape treated with L-580 to prepare a foam. At this time, the temperature of the mold was 60 ℃ and opened and closed demolding 7 minutes after the injection. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Example 4

The hydrophilic polyurethane foam dressing material is based on 60% by weight of the polyurethane prepolymer prepared in Synthesis Example 1, 28.45% by weight of distilled water as a blowing agent, 9% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 as an additive, and silver sulferazine (Silver). Sulfadiazine) 0.05% by weight, 0.5% by weight of Pigment (Songwon Color), 0.5% by weight of hyaluronic acid was stirred at 3,000rpm for 5 seconds, and then injected into a mold of a predetermined shape treated with L-580 to prepare a foam. . At this time, the temperature of the mold was 60 ℃ and opened and closed demolding 7 minutes after the injection. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Example 5

The hydrophilic polyurethane foam dressing material is based on 60% by weight of the polyurethane prepolymer prepared in Synthesis Example 2, 27.45% by weight of distilled water as a blowing agent, 9% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 as an additive, and silver sulferazine (Silver). Sulfadiazine) 0.05% by weight, 0.5% by weight of Pigment (Songwon Color), sodium Alginate (1.5% by weight) was added and stirred at 3,000 rpm for 5 seconds, and then the surface was treated with L-580 Injection was prepared by foaming. At this time, the temperature of the mold was 40 ℃ and opened and closed demolding 10 minutes after the injection. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Example 6

Hydrophilic polyurethane foam dressing material is in the 60% by weight of the polyurethane prepolymer prepared in Synthesis Example 3 28.95% by weight of distilled water as a blowing agent, 9% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 (BASF) as an additive, skin color Pigment (Songwon Color) 0.5% by weight, Silver Sulfadiazine (Silver Sulfadiazine) was mixed by stirring for 5 seconds at 4,000rpm and then injected into a mold of a predetermined shape treated with L-580 foam was prepared. At this time, the temperature of the mold was 30 ℃ and opened and closed demolding 10 minutes after the injection. Physical properties were measured by the method exemplified in Example 1 and the experimental results are shown in Table 1 below.

Example 7

Hydrophilic polyurethane foam dressing material is 45% by weight of polyurethane prepolymer prepared in Synthesis Example 3 34.95% by weight of distilled water as a blowing agent, 15% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 (BASF) as an additive, skin color Pigment (Songwon Color) 0.5% by weight, Sodium Alginate (3% by weight), Silver Sulfadiazine (0.05%) by mixing and stirring at 5,000rpm for 5 seconds and then one side treated with L-580 Foam was prepared by injection into a mold. At this time, the temperature of the mold was 50 ° C and opened and closed demolding 7 minutes after the injection. Physical properties were measured by the method exemplified in Example 1 and the experimental results are shown in Table 1 below.

Example 8

Hydrophilic polyurethane foam dressing material is 60.% by weight of polyurethane prepolymer prepared in Synthesis Example 2 28.95% by weight of distilled water as a blowing agent, 9% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-68 (BASF) as an additive, flesh pigment (Songwon Color) 0.5% by weight, Silver Sulfadiazine (0.05% by weight) was added and stirred at 3000rpm for 5 seconds, and then injected into a mold of a predetermined shape treated with L-45 was prepared by foaming. . At this time, the temperature of the mold was 60 ℃ and opened and closed demolding 5 minutes after the injection. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Example 9

Hydrophilic polyurethane foam dressing material is 26.95% by weight of distilled water as a blowing agent, 14% by weight of glycerin as a crosslinking agent, 1.5% by weight of F-108 as a foaming agent, 57% by weight of the polyurethane prepolymer prepared in Synthesis Example 1, Silver Sulfadiazine After adding 0.05% by weight and 0.5% by weight of Pigment (Songwon Color), the mixture was stirred at 4,000 rpm for 5 seconds, and then injected into a mold having a predetermined shape treated with L-580 to prepare a foam. At this time, the temperature of the mold was set to 35 ℃ and opened and closed demolding 10 minutes after the injection. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Comparative Example 1

Commercially available dressing products (Allevyn) in the form of polyurethane foam S company was applied.

Physical properties were measured by the method exemplified in Example 1 and the experimental results are shown in Table 1 below.

Comparative Example 2

Commercially available dressing product (Duoderm) in the form of C hydrocolloid was applied. Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

Comparative Example 3

Commercially available polyurethane foam dressings (Medifoam'N ') of the microporous epidermal structure were used.

Physical properties were measured by the method exemplified in Example 1, and the experimental results are shown in Table 1 below.

<Measurement result of the manufactured hydrophilic polyurethane foam dressing material> division Tensile Strength (MPa) Elongation (%) Modulus (MPa) Absorbance (%) Outer film layer thickness (㎛) Breathable degree ^*** Non-toxic Wound healing effect Example 1 0.45 736 0.114 1,753 5 2,700 ◎ ◎ Example 2 0.22 510 0.056 1,470 2 4,950 ◎ ○ Example 3 0.38 887 0.081 1,200 10 2,450 ◎ ◎ Example 4 0.41 821 0.092 1,520 20 2,210 ◎ ◎ Example 5 0.38 910 0.078 1,350 35 1,550 ◎ ◎ Example 6 0.27 475 0.075 467 5 2,840 ○ ◎ Example 7 0.54 730 0.096 655 41 520 ◎ ○ Example 8 0.37 833 0.087 1,205 7 2,150 ◎ ◎ Example 9 0.43 875 0.086 1,900 8 2,200 ◎ ◎ Comparative Example 1 ^* 0.37 809 0.074 857 25 450 × △ Comparative Example 2 ^* - - - 250 50 100 ○ ○ Comparative Example 3 ^** 0.35 855 0.070 1,100 pore film ^**** 3,500 ◎ ○

*: Existing products

**: Existing company product

***: g / m 2 / 24hr at 37.4 ° C., 90% R.H.

****: Film with Pore 30 ~ 60㎛

◎: Very good, ○: Good, △: Normal, ×: Bad

As shown in Examples 1, 3, and 6 of Table 1, when the NCO% of the polyurethane prepolymer and the amount of glycerin as a crosslinking agent were increased, the urethane bond (hard segment) increased, and the mechanical properties increased and the relatively hydrophilic part (soft segment). ), The absorbance decreases. In addition, the foaming rate depends on the NCO%. In other words, the higher the NCO%, the faster the foaming speed.

In addition, the thickness of the outer film layer formed according to the type of hydrophilicity imparting agent added during the polyurethane foam production and the release agent used for mold surface treatment can be changed, so that moisture permeability and absorption can be easily adjusted.

In Examples 5 and 6, it can be seen that the swelling degree can be adjusted according to the content ratio of the hydrophobic polypropylene glycol and the hydrophilic ethylene oxide / propylene oxide random copolymer used in preparing the polyurethane prepolymer. That is, as the content of the ethylene oxide / propylene oxide random copolymer increases, the absorbency increases.

In the toxicity test results, the polyurethane foam dressing material of the present invention (Example 2) decreased the number of living cells by 6%, 30%, and 47%, respectively, after 1 day, 3 days 5 days, and Comparative Example 1 The survival rate was superior to that of the second two. In addition, as a result of animal experiments, Comparative Examples 1 and 2, which are existing products, damaged the newly regenerated tissue during dressing exchange, and the wound healing mechanism was performed only by contraction of the window, but the polyurethane foam dressing material of the thin film skin structure of the present invention was replaced. The wound healing mechanism was not damaged, and the wound healing was progressed by a mechanism in which re-epithelialization and the contraction of the window were simultaneously performed to minimize scars after treatment, and the wound healing rate was also faster than that of Comparative Examples 1 and 2.

The foam dressing material of the multi-layered structure of the present invention includes an inner absorbent foam layer (2) (6) and a mean diameter of 60 µm including a plurality of outer film layers (1) (4) having a thickness of 0.5 to 50 µm and an open cell having a diameter of 50 to 500 µm. It consists of a three-layer structure of the wound surface contact film layer (3) (5) having a thickness of 0.5 to 60 µm containing a large number of pores, and prevents the invasion of bacteria and foreign substances from the structural characteristics, while maintaining high moisture permeability, high absorption, and wounds. It has properties such as cotton non-adhesiveness, minimizes scars after treatment, and also heals wounds faster than existing products. In addition, the water in the absorption effluent is released to the outside in the form of water vapor, but cell growth factors and cytokines, glycosaminoglycans, proteins, etc. are concentrated without leaking to the outside, thereby showing an additional effect on wound healing.

Claims (10)

In a multi-layered foam dressing material, the thickness is in the range of 0.5 to 10 mm, and the structure includes an outer film layer 1 having a thickness of 0.5 to 50 µm and a large number of open cells having a diameter of 50 to 500 µm. A multi-layered foam dressing material, comprising a three-layer structure of an absorbent foam layer (2) and a wound surface contact film layer (3) having a thickness of 0.5 to 60 µm in which a large number of pores having an average diameter of 60 µm exist. The outer film layer (1) of the foam dressing material is a pore-free structure, and the wound surface contact film layer (3) has an area of the skin layer pores occupying 5 to 50% of the total skin layer area. Multi-layered foam dressing material characterized in that. The multi-layered foam dressing material according to claim 1, wherein the inner absorbent foam layer (2) of the foam dressing material has an open cellization rate of 50 to 80%. The foam dressing material according to claim 1, wherein the foam dressing material has a water absorption of 100 to 3,000 wt% and a water vapor transmission rate of 500 to 5,000 g / m 2 / 24hrs at 37.5 ° C. and 10 to 100% relative humidity. In the method for producing a multi-layered foam dressing material, the foam dressing material is 15 to 45% by weight crosslinking agent to 40 to 75% by weight of polyurethane prepolymer synthesized in a ratio of 1 to 3 moles of diisocyanate and 0.15 to 0.5 mole of polyether polyol. 35% by weight and 0.5-15% by weight of additives such as surfactants, humectants, mold release agents, antibacterial agents, and pigments are mixed and stirred, and injected into a mold coated with a release agent on one surface thereof to prepare a foamed molding at 30 to 60 ° C. The manufacturing method of the foam dressing material of the multilayer structure of Claim 1 thru | or 4. 6. The multilayer according to claim 5, wherein the diisocyanate is diphenylmethane diisocyanate, 2,4-toluene diisocyanate and its isomers, isophorone diisocyanate and hexamethylene diisocyanate. Method for producing a foam dressing material having a structure. The ethylene oxide / propylene oxide random copolymer according to claim 5, wherein the polyether polyol has three or more hydroxyl groups in the molecule, the molecular weight is 3,000 to 6,000, and the ethylene oxide content is 50 to 80%. A polypropylene glycol having a molecular weight of 1,000 to 4,000 having the above hydroxyl group is synthesized in a weight ratio of 100: 0 to 30:70, wherein the multi-layered foam dressing material according to claim 1 to 4 above. The method of producing a foam dressing member according to claim 1, wherein the blowing agent is chlorofluorocarbon (CFC-141b), methylene chloride, or distilled water. The method for producing a foam dressing member according to claim 1, wherein the crosslinking agent is glycerol, sorbitol, polyethylene glycol having a molecular weight of 200 to 2,000, or trimethylolpropane. The surfactant according to claim 5, wherein the surfactant is an ethylene oxide-propylene oxide block copolymer L-62, L-64, P-84, P-85, P-105, F-68, F-87, F-88, F 0.1-10% by weight of -108, F-127 or a mixture thereof and L-508, L-5305, L-5302, L-3150, which are silicone surfactants, and a moisturizing agent is hyaluronic acid, sodium alginate, pectin, xanthan gum, Guar gum, karaya gum, sodium carboxymethylcellulose, chondroitin sulfate, 3-aminopropyldihydrogen phosphate, chitin, chitosan, gelatin are used at 0.1 to 10% by weight, and as a release agent, L-45, L, a silicone-based surfactant, is used. 0.1 to 10% by weight of -580, L-3002 and L-5309, and antibacterial agents include gluconate chlorohexidine, acetate chlorohexidine, hydrochloride chlorohexidine, silver sulfadiazine, povidone iodine and benz Alconium chloride, furazine, idocaine, hexachlorophene, chlorotetracycline, A method for producing a multi-layered foam dressing material according to any one of claims 1 to 4, which is produced using 0.5 to 5% by weight of neomycin, penicillin, gentamicin and acrilin.