KR200340228Y1 - Wound covering material produced from a Foam dressing using a Neutralized Chitosan foam dressing - Google Patents

Abstract

The present invention relates to a wound dressing using a neutralized chitosan foam dressing material, and more particularly, a backing layer in which the wound dressing serves to protect the foam dressing material, a pressure-sensitive adhesive layer on which the pressure-sensitive adhesive is applied, and a pressure-sensitive adhesive part which comes into contact with the skin. The present invention relates to a wound coating material composed of a release paper and a neutralized chitosan foam dressing material, which serves to protect the surface, having excellent air permeability, and excellent absorption ability and non-adhesion property of the exudates discharged from the wound site.

Description

Wound covering material produced from a Foam dressing using a Neutralized Chitosan foam dressing}

The present invention relates to a wound dressing material prepared from a neutralized chitosan foam dressing material, and more particularly, a backing layer that serves to protect the foam dressing material, an adhesive layer applied under the backing layer, and a long time under the adhesive layer. It relates to a release paper that serves to protect the pressure-sensitive adhesive portion to be in contact with the skin, and a wound coating material configured such that the neutralizing chitosan foam dressing material is positioned between the release paper and the pressure-sensitive adhesive layer.

Skin is an important organ that occupies the largest surface area in our body, and if skin is damaged extensively, it may lose its life due to dehydration.It protects from various harmful environments such as microorganisms, ultraviolet rays, and chemicals, and the body's moisture. It prevents dehydration and regulates body temperature by suppressing evaporation. It must be strong in physical stimuli, be elastic, and fully play its role while the human body maintains life.

However, skin damage due to various causes such as severe burns, trauma, wounds, bedsores and skin diseases is common. For example, wounds that are not primary sutures may leave severe defects that are inevitable. Therefore, the repair of damaged skin tissue is a very important problem and in order to speed up the healing of wounds and to minimize secondary side effects, it is necessary to treat wounds with appropriate dressings.

Conventional gauze dressing materials are inexpensive, easy to absorb wound secretions, warm to some extent, and can prevent physical stimuli from the outside, but do not have the ability to defend against infections from bacteria and the like, and a wet environment It is not easy to replace because it is not made to the wound surface, and there are problems involving the damage and pain of the new tissue. In addition, there is a disadvantage that the dressing should be changed several times a day because a large amount of exudate occurs in the early stage of healing. Therefore, it is desirable to apply such gauze dressing mainly to primary sutures or mild wounds without infection.

Various types of closed dressing materials which improve the problems of the gauze-type dressing are currently used, but since they are expensive and lack of absorbency and moisture permeability, almost all products use chemically synthesized polymers, and thus are poor in compatibility with living organisms, mechanical properties and Due to problems such as lack of adhesiveness, it is not sufficient to function as a wound dressing.

On the other hand, chitosan is a kind of polysaccharide that exists in nature. It is a compound obtained by deacetylating chitin contained in the cell walls of microorganisms such as crab, shrimp shell, squid bone, mold and bacteria. It is used in industry. In the past, chitosan was mainly used in the field of wastewater treatment such as flocculants, heavy metal adsorbents, dye wastewater purification agents, and agricultural fields such as soil modifiers, insecticides, plant antiviral agents, and pesticides. The range of food and beverage applications, health and hygiene applications, cosmetic applications, textile-related applications, and pharmaceutical applications is expanding. In particular, the use of chitosan in wound healing agents, artificial skin, pharmacologic materials, blood coagulants, artificial kidney membranes, biodegradable surgical sutures, and antimicrobial materials has been reported since the 1990s.

More specifically, a wound coating related to chitin and chitosan using a nonwoven fabric is used. Such a nonwoven fabric-like coating has the same problem as a conventional gauze dressing, and in the case of a wound coating made of a film of chitin and chitosan, It was not formed at all, lacking the moisture permeability and exudative ability, and due to the low permeability, it is impossible to use a lot of exudates, and if the water swelling state persisted, the dressing material collapsed, causing the normal skin infestation.

The present invention improves the shortcomings of the conventional dressing material by using chitosan excellent in antimicrobial activity, immune enhancing activity and biocompatibility to solve the above problems, and has high absorbency, high moisture permeability, non-stick surface adhesion, and simple manufacturing process. It is an object to provide a wound dressing having.

One aspect of the present invention is a backing layer (4) that serves to protect the foam dressing material, the pressure-sensitive adhesive layer (5) is applied, the release paper that serves to protect the adhesive portion that is in contact with the skin during the storage period (6 ), To provide a neutralized chitosan foam dressing material consisting of the chitosan foam dressing material (7).

1 is a cross-sectional wound dressing using chitosan foam dressing according to the present invention;

Figure 2a is a scanning micrograph of the outer layer surface of the chitosan foam dressing according to the present invention;

Figure 2b is a scanning micrograph of the wound surface contact layer surface of the chitosan foam dressing according to the present invention;

Figure 2c is a scanning micrograph of the cross section of the inner absorbent layer of the chitosan foam dressing according to the present invention;

3 is a schematic cross-sectional view of chitosan foam dressing consisting of an outer layer, an inner absorbent layer and a microporous wound surface contact layer of the chitosan dressing material according to the present invention;

4 is a perspective view of the wound dressing in a state where the release paper of the chitosan dressing material according to the present invention is partially peeled off;

5 is a perspective view of the wound coating material in a state in which two release sheets of chitosan dressing material according to the present invention are partially peeled off.

(Explanation of symbols for the main parts of the drawing)

1 ... outer layer 2 ... inner absorption layer of foam dressing material

3. Wound side contact layer 4 ... Back layer

5. Adhesive layer 6 ... Release paper

7. China Chitosan Foam Dressing Material

Hereinafter, the present invention will be described in more detail.

As shown in Figure 3, the wound dressing of the present invention has a backing layer (4) which serves to protect the foam dressing material during the wearing period, the pressure-sensitive adhesive layer (5) is applied under the backing layer, under the pressure-sensitive adhesive layer It is configured such that the release paper 6 serving to protect the pressure-sensitive adhesive portion contacted with the skin during the storage period and the neutralized chitosan foam dressing material 7 are disposed between the back layer and the pressure-sensitive adhesive layer.

The back layer 4 serves to protect the body shape during the wearing period and is formed in a sheet shape of a somewhat larger size than the chitosan foam dressing material 7. The material of the back layer 4 is not limited thereto, but is preferably polyurethane, polyethylene, polyvinylidene chloride (PVDC) or aluminum foil.

The pressure-sensitive adhesive layer (5) is a portion having a pressure-sensitive adhesive to help stick with the skin for a certain period of time. The pressure-sensitive adhesive may be an acrylic pressure sensitive adhesive, a polyisobutylene pressure sensitive adhesive, an A-B-A type copolymer or a silicone pressure sensitive adhesive. In the ABA copolymer, A denotes a thermoplastic polystyrene endblock and B denotes a midblock of polyisoprene, polybutadiene, and poly (ethylene / butylene), and polystyrene-polybutadiene-polystyrene (SBS). , Copolymers of polystyrene-polyisoprene-polystyrene (SIS), polystyrene-poly (ethylene / butylene) -polystyrene (S-EB-S), polystyrene-poly (ethylene / propylene) -polystyrene (S-EP-S) Can be used as a pressure-sensitive adhesive.

The release paper 6, also known as release paper, serves to protect the adhesive area that comes into contact with the skin during storage, and should be easily removable from the wound by the user and should not interact with any component in the formulation. do. The release paper 6 may be made of polyethylene terephthalate (PET), polypropylene, polyvinylchloride (PVC) or polycoated paper. In FIG. 4, the release paper 6 is formed in the form of one sheet having the same size as the back layer 4, or as shown in FIG. 5, in the form of two sheets of half the size of the back layer 4.

The neutralized chitosan foam dressing material 7 is composed of an outer layer, an inner absorbent layer including a large number of pores of 50 to 300 µm, and a wound surface contact layer having a large number of pores of 10 to 50 µm. The thickness is 0.1 to 20 mm. It is preferable. In order to achieve the object of the present invention, the neutralizing chitosan foam dressing material (7) is iii) glycerol, additionally polyethylene glycol (hereinafter referred to as 'PEG') and / or dimethyl sulfoxide (hereinafter referred to as 'DMSO') Freeze drying an acidic aqueous solution of chitosan contained to obtain a chitosan structure on the foam dressing; Ii) neutralizing / washing the chitosan structure with at least 95% pure ethanol, at least 70% ethanol aqueous solution, at least 50% ethanol aqueous solution and water or buffer to completely remove residual acid; And iii) lyophilizing the neutralized chitosan structure again.

Chitosan used in step iii) is a deacetylation of chitin, the viscosity is 2 cps to 800 cps, the degree of deacetylation is used 50 to 99%.

The acidic aqueous solution of chitosan dissolves chitosan at a concentration of 1 to 10% by mass with respect to the acidic aqueous solution. For complete dissolution, it is preferable to dissolve for 12 to 48 hours. The prepared acidic aqueous solution is left to depressurize or incubate for 3 to 24 hours to completely remove air bubbles in the solution, and completely remove impurities and insoluble residues with filter paper or gauze of 1 to 25 μm.

The acidic aqueous solution of chitosan is an example of an organic acid or inorganic acid which can be prepared by dissolving chitosan in an organic or inorganic acid aqueous solution, for example, acetic acid, hydrochloric acid, lactic acid, pyrionic acid, citric acid, acrylic acid, butyric acid, formic acid, glutamic acid, gluconic acid, Glycolic acid, succinic acid, succinic acid, maleic acid, ascorbic acid, tartaric acid, and mixed acids of two or more thereof mixed, and the concentration of the organic acid and inorganic acid aqueous solution is 0.1 to 10% by mass in weight ratio to water.

Glycerol is essentially added to the acidic solution of chitosan, and it is preferable to add 5 to 30% by weight with respect to the acidic aqueous solution, and when added to less than 5% by mass, formation of fine pores and an increase in tensile strength and elongation rate are achieved. It is difficult to expect, and when it exceeds 30% by mass, the concentration of glycerol is too high to form the chitosan foam dressing itself.

In addition, PEG or DMSO may be additionally added. Preferably, 0.5 to 10 mass% of PEG or DMSO is added to the acidic aqueous solution by weight, and the molecular weight of PEG used is preferably between 200 and 20,000. According to the research of the present inventors, when using glycerol, PEG as in the present invention, it is possible to obtain a neutralizing chitosan foam dressing material having excellent mechanical properties in which tensile strength and elongation rate are dramatically increased through hydrogen bonding with chitosan. DMSO also affects the freezing point, resulting in a multi-layered neutralizing chitosan foam dressing with finer pores. More specifically, it is prepared by adding DMSO in an amount of 0.5 to 10 mass% by weight of an acid aqueous solution.

The prepared chitosan acid aqueous solution is placed in a dish of a predetermined shape and size, and freeze-dried to prepare a sponge-like structure in which pores of a predetermined size are formed.

Freeze drying is a method of freezing the material and then drying it by sublimation with gaseous vapor without drying the liquid state in a high vacuum apparatus, so that a much higher quality product can be obtained than a general drying method. As moisture is removed from the dried product, the dried product is characterized by having a light sponge or foam form, and is a drying method to obtain high quality products currently used for drying foods, pharmaceuticals, and microorganisms. In the present invention, the lyophilization is preferably performed by dividing the process of prefreezing and sublimation drying.

In preliminary freezing, the freezing temperature has a great effect on the quality after drying, so careful attention is required for its control. In the present invention, the preliminary freezing at minus 140 ° C to minus 160 ° C using liquid nitrogen is used. Freeze treatment. Sublimation drying is a process of removing the organic solvent present in the chitosan solution. At this time, water is gradually removed to the upper portion of the freezing layer, leaving the chitosan foam dressing material, and the sublimation screen is lowered, and the freezing layer disappears eventually, and the chitosan foam dressing material is removed. Obtained. In freeze-drying, in the present invention, a sponge-like chitosan structure can be prepared by vacuum drying a chitosan solution at a temperature of 10 ° C. to 30 ° C. at a vacuum degree of 10 mmHg or less.

In one preferred embodiment of the present invention, the preliminary freezing in step iii) is carried out in two or more times, and at each preliminary freezing, an additional chitosan acid aqueous solution is added to the preliminary freezing chitosan aqueous solution, and By drying it as a whole, a sponge-like chitosan layered structure can be obtained. At this time, each pre-freezing can be performed by varying the freezing temperature and time, when the pre-freezing temperature is minus 10 ℃ to minus 80 ℃ for 2 to 24 hours, minus 80 ℃ to minus 160 ℃ If performed for 1 to 12 hours. In obtaining a layered sponge by a plurality of preliminary results, the aqueous chitosan solution additionally added in step iii) is the same aqueous solution as the chitosan acid solution previously frozen, or a chitosan solution with different concentrations, or A preliminarily frozen aqueous chitosan acid solution and an acid aqueous solution of the same or different concentration of chitosan with different viscosity and / or deacetylation degrees are used.

In the step of the present invention, an acidic aqueous solution of glycerol-containing chitosan prepared by mixing two or more chitosans having different molecular weight (or viscosity) and / or deacetylation degree may be used. When mixed chitosan with different deacetylation degree is used, 1) Multi-layered neutralizing chitosan foam dressing made of low molecular weight with excellent antimicrobial activity but low mechanical strength can increase mechanical properties while maintaining antimicrobial activity. 2 By using chitosan and chitin with different deacetylation degree together, it has the effect of raising / complementing both advantages (for example, having high solubility and excellent antibacterial property), and 3) multi-layer having desired various physical properties. Structure neutralizing chitosan foam dressing can be obtained. More specifically, within the range of 2 cps to 800 cps viscosity and the deacetylation degree of 50% to 99%, chitosan having a predetermined viscosity and deacetylation degree, and the chitosan and the viscosity and deacetylation degree are different, respectively, An acidic aqueous solution of chitosan may be prepared by mixing one or two or more chitosans having the same viscosity and different degrees of deacetylation, or having the same deacetylation degree and different viscosity.

Since the neutralizing chitosan foam dressing material of the present invention significantly increases the tensile strength and elongation rate, and has uniform micropores, the wound coating material including the same has the effect of preventing leakage of water from the body, absorption of exudates, and invasion of bacteria and infection from the outside. In addition to being excellent, there is an advantage that the flow of air is smooth to help the healing of wounds and the differentiation and growth of cells.

Ii) step of the chitosan foam dressing material manufacturing method used in the present invention, the chitosan structure obtained in step iii) a) 95% or more pure ethanol, b) 70% or more ethanol aqueous solution, c) 50% or more ethanol aqueous solution, And d) neutralizing and washing in turn with water or buffer to completely remove residual acid. The chitosan structure on the foam dressing obtained in step iii) contains the organic acid as it is in the foam dressing. When the basic solution is used to remove it, the overall shrinkage or severe warpage occurs, so that the original form cannot be maintained or the strength is maintained. To solve this problem, the present inventors neutralize and wash the chitosan foam dressing in order of pure ethanol, an aqueous ethanol solution (ie, a mixture of water and ethanol) and water or a buffer to completely remove residual acid. Removed.

Neutralization chitosan form dressing material according to the present invention includes the step iii) freeze-drying the neutralized chitosan structure again freeze-drying as described above. Through this step, a neutralized chitosan structure having a cross section as shown in FIG. 1 and having uniformly distributed micropores having an internal absorption layer as shown in FIG. 2A, a wound surface contact layer as shown in FIG. 2B, and a wound surface contact layer as shown in FIG. 2C. To obtain.

Hereinafter, the configuration and effects of the present invention will be described in more detail with specific examples and comparative examples, but these examples are only intended to more clearly understand the present invention, and are not intended to limit the scope of the present invention.

EXAMPLE

Example 1

Using a 1.2% acetic acid solution containing 10% glycerol, 2% DMSO, and PEG 2% molecular weight 10,000, a viscosity 11 cps (0.5 wt% chitosan solution of 0.5 wt% acetic acid was prepared to obtain a Brookfield viscometer at 20 ° C. 4 w / w% aqueous solution of chitosan with a deacetylation degree of 98%). 60 g of the obtained solution was placed in a plastic dish of 12 × 12 cm and left at room temperature for 24 hours to completely remove air in the solution, and filtered to remove insoluble matters. The solution was preliminarily frozen in a cryogenic freezer at minus 70 ° C. for 24 hours and then sublimed and dried at minus 20 ° C. for 48 hours to obtain a chitosan structure in a foam dressing. The obtained chitosan structure was washed two or more times with 1 L of 95% ethanol, again twice or more with 1 L of 70% ethanol, and washed two times or more with 1 L of 50% ethanol, and then several times with 1 L of distilled water. Washed over. The washed chitosan structure was frozen again in an ultra-low temperature freezer at -70 ° C for 24 hours and then dried at -20 ° C for 24 hours to uniformly distribute micropores of a uniform size. Ash was prepared.

Example 2

The back layer 7 is a polyurethane film, the pressure-sensitive adhesive layer 8 is an acrylic pressure-sensitive adhesive, the release paper 9 is a wound coating material consisting of a polyethylene terephthalate film and chitosan foam dressing prepared in Example 1.

The wound coating material according to the present invention has an advantage of not requiring additional dressing because it has a self-adhesive force capable of easily and effectively fixing chitosan foam dressing material having excellent mechanical properties such as tensile strength and elongation rate, and has a low allergy biocompatible adhesive. No irritation, the back layer regulates air and water vapor permeability, provides waterproofing and blocks bacteria, minimizing the chance of wound infection and cross-infection, promoting wound healing and increasing patient comfort.

Claims (6)

In the wound coating material using the neutralized chitosan foam dressing material, a wound layer comprising a backing layer, a pressure sensitive adhesive layer under the back layer, a release paper under the pressure sensitive adhesive layer, and a neutralized chitosan foam dressing material positioned between the pressure sensitive adhesive layer and the back layer clothing material. According to claim 1, wherein the neutralizing chitosan foam dressing material has a thickness of 0.1 to 20 mm, the structure of the outer layer, an inner absorbent layer containing a large number of pores of 50 ~ 300 ㎛ and a wound having a large number of pores of 10 ~ 50 ㎛ A wound covering comprising a multi-layer structure comprising a surface contact layer. 2. The wound dressing of claim 1, wherein the backing layer is made of polyurethane, polyethylene, polyvinylidene chloride (PVDC) or aluminum foil. The pressure-sensitive adhesive used in the pressure-sensitive adhesive layer is an acrylic pressure-sensitive adhesive, a polyisobutylene pressure-sensitive adhesive, a silicone pressure-sensitive adhesive, polystyrene-polybutadiene-polystyrene (SBS), polystyrene-polyisoprene-polystyrene (SIS), polystyrene-poly A wound coating material comprising a copolymer of (ethylene / butylene) -polystyrene (S-EB-S) or polystyrene-poly (ethylene / propylene) -polystyrene (S-EP-S). 2. The wound dressing of claim 1, wherein the release paper is comprised of polyethylene terephthalate (PET), polypropylene, polyvinylchloride (PVC), or polycoated paper. 2. The wound dressing according to claim 1, wherein the release paper is formed of one sheet having the same size as the rear layer or two sheets of half the size of the rear layer.