WO2018079899A1

WO2018079899A1 - Method for manufacturing dry/wet wound dressing, and wound dressing manufactured thereby

Info

Publication number: WO2018079899A1
Application number: PCT/KR2016/012479
Authority: WO
Inventors: 김태준
Original assignee: 주식회사 유엔헬스케어
Priority date: 2016-10-27
Filing date: 2016-11-01
Publication date: 2018-05-03

Abstract

The present invention provides a method for manufacturing a wound dressing, comprising the steps of: (a) coating a first mixture solution containing an organic acid and 0.01-3 wt% of chitosan so as to form a blood coagulation assisting layer on the upper surface of a fabric layer included in a gauze part; (b) forming a blood coagulation promotion layer by coating a second mixture solution, containing 0.1-20 wt% of kaolin, on the upper surface of the blood coagulation assisting layer in step (a), thereby manufacturing the gauze part comprising the fabric layer having the blood coagulation assisting layer and the blood coagulation promotion layer, which are sequentially stacked thereon; (c) coating an adhesive on one surface so as to manufacture a support part comprising an adhesive layer; and (d) attaching the gauze part, which is manufactured in step (b), to the upper surface of the adhesive layer of the support part, which is manufactured in step (c). According to the present invention, the method for manufacturing a wound dressing forms a blood coagulation assisting layer by coating a first mixture solution containing an organic acid and chitosan on a fabric layer, and forms a blood coagulation promotion layer by coating a second solution, containing kaolin, on the upper surface of the blood coagulation assisting layer, and thus kaolin becomes negatively charged through the pH of the organic acid contained in the blood coagulation assisting layer, and positively charged chitosan and kaolin are bound so as to have sufficient bonding force through an ionic bond, thereby effectively preventing the separation of kaolin from a fabric, and thus a wound dressing exhibiting an excellent hemostatic effect can be manufactured.

Description

Method for manufacturing wet and dry wound dressings and wound dressings produced thereby

The present invention relates to a method for producing a wet and dry wound dressing having both characteristics of a dry dressing and a wet dressing, and a wound dressing produced thereby.

Skin is one of the organs that protects the human body from external stimuli, prevents water loss, and performs important life protection functions such as temperature control and bacterial invasion. Loss of action results in impairment of function, in severe cases affects life.

When a wound occurs, such as a wound or abrasion on the skin, the human body has a property to protect and heal the defects of the skin caused by the wound. In particular, when bleeding occurs in the wound, the human body attempts to defend the defect by inducing hemostasis in order to quickly defend the defect and prevent exposure to bacteria or oxygen.

In general, hemostasis occurs when fibrinogen dispersed in blood reacts with water and thrombin to form fibrin, and the formed fibrin accumulates platelets to form agglomerates, and when the agglomerates harden, contraction It is known to stop the bleeding by forming a blockage.

However, when excessive bleeding occurs, it is difficult to proceed with the above-described hemostasis quickly, so as to quickly heal wounds and minimize secondary side effects, by using appropriate dressing material or applying a hemostatic promoting material. The same wound treatment is essential.

In the past, various studies have been conducted on substances capable of promoting coagulation of blood discharged from wounds to promote hemostasis.

In one example, kaolin is a clay material comprising kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ), which contains alumina and silica in a ratio of about 1: 1 and has an excellent effect on promoting blood coagulation. In addition, as well as excellent dispersibility in water, physiologically inactive, and has the advantage of being inexpensive, attempts have been made to manufacture various products for the purpose of hemostasis. However, the kaolin has a problem that the surface area and the number of substituents are small and the dispersibility for water is high, and thus the binding force is difficult to be introduced when introduced to a support such as fabric.

In order to solve the above problems, sodium alginate (vinyl alcohol), vinyl alcohol (vinyl alcohol) or collagen (collagen), etc. to improve the binding strength between the fabric and kaolin by using a binder, but using the same method In this case, 20 to 50% of a high concentration of kaolin aqueous dispersion should be used to stack the kaolin together with the binder, so that the kaolin solidifies between the fabrics to form agglomerates and is easily released by external force, which makes it difficult to introduce the flexible material. there is a problem.

Therefore, in order to solve the above problems, there is a need for a method of easily introducing kaolin to a flexible fabric.

The present invention has been made to solve the problems of the prior art as described above, it is possible to effectively prevent the falling off of the kaolin from the fabric by maintaining a sufficient bonding force with the fabric, the technical contents of the flexible wound coating material having an excellent hemostatic effect To provide.

In order to achieve the above technical problem, the present invention (a) by applying a first mixed solution containing an organic acid and chitosan in 0.01 to 3% by weight of the blood coagulation auxiliary layer on the upper surface of the fabric layer included in the gauze Forming a; (b) applying a second mixed solution containing kaolin at 0.1 to 20% by weight on the upper surface of the blood coagulation auxiliary layer formed in step (a) to form a blood coagulation facilitating layer, and a blood coagulation auxiliary layer and blood Manufacturing a gauze portion including a fabric layer in which a solidification promoting layer is sequentially laminated; (c) applying a pressure-sensitive adhesive on one surface to prepare a support part including an adhesive layer; And (d) attaching the gauze portion prepared in step (b) to the adhesive layer upper surface of the support portion prepared in step (c).

In addition, the chitosan has an average molecular weight of 10,000 to 1 million Da, characterized in that the deacetylation degree (deacetylation degree) is more than 85%.

In addition, the organic acid is characterized in that it comprises one or more selected from the group consisting of glycolic acid (glycolic acid), ascorbic acid (ascorbic acid) and lactic acid (lactic acid).

The gauze portion may be formed by applying the first mixed solution and the second mixed solution to the fabric layer, respectively, to include the blood coagulation auxiliary layer and the blood coagulation promoting layer at 10 to 70 wt% based on the total weight of the gauze. It is characterized by.

The first mixed solution may contain chitosan in an amount of 0.01 to 3% by weight, and the second mixed solution may contain 0.1 to 20% by weight of kaolin.

In addition, the first mixed solution and the second mixed solution is characterized in that it further comprises one or more selected from the group consisting of fibrinogen (probrinogen), prothrombin (calcium) and calcium (Ca), respectively.

In addition, the present invention is prepared by the method described above, formed on the upper surface of the fabric layer made of fibers, blood coagulation auxiliary layer containing chitosan (chitosan) and organic acid; And a blood coagulation promoting layer formed on an upper surface of the blood coagulation auxiliary layer and including kaolin; And ii) a support part which is adhered to one's skin by applying an adhesive to one surface thereof.

In addition, the gauze portion of the wound covering is characterized in that it comprises 10 to 70% by weight of the blood coagulation auxiliary layer and the coagulation promoting layer based on the total weight of the gauze.

In addition, the blood coagulation auxiliary layer and the coagulation promoting layer of the wound dressing is characterized in that it further comprises one or more selected from the group consisting of fibrinogen (probrinogen), prothrombin (calcium) and calcium (Ca).

In addition, the chitosan of the wound dressing is characterized in that the average molecular weight of 10,000 to 1 million Da, deacetylation degree (deacetylation degree) of 85% or more.

In addition, the organic acid of the wound coating is characterized in that it comprises one or more selected from the group consisting of glycolic acid (glycolic acid), ascorbic acid (ascorbic acid) and lactic acid (lactic acid).

In addition, the blood coagulation auxiliary layer of the wound dressing comprises the chitosan 0.01 to 3% by weight, the blood coagulation promoting layer is characterized in that it comprises 0.1 to 20% by weight of the kaolin.

In addition, the wound coating further comprises a release film attached to the upper surface of the support and the gauze portion.

In the method of manufacturing a wound dressing according to the present invention, the first mixed solution containing organic acid and chitosan is applied to the fabric layer to form a coagulation aid layer, and a second solution containing kaolin is applied to the top surface of the coagulation aid layer. To form a coagulation promoting layer, the kaolin is negatively charged due to the pH of the organic acid contained in the coagulation auxiliary layer, and the chitosan and kaolin, which have a positive charge, are combined to have sufficient binding force through ionic bonds, thereby leaving the kaolin from the fabric. It can be effectively prevented to produce a wound dressing exhibiting an excellent hemostatic effect.

The wound dressing prepared by the above method includes kaolin and chitosan, which simultaneously perform different roles in the hemostatic mechanism, and the chitosan is hydrogelized by absorbing blood or exudate, thereby releasing the bound kaolin to release the inside of the wound. Since it is possible to deliver kaolin deeply until it shows an excellent hemostatic effect, it can exhibit the characteristics of a dry and wet wound dressing having both the characteristics of a dry dressing and a wet dressing.

Furthermore, the wound dressing prepared by the above method is hydrogelized by chitosan absorbing moisture contained in blood or exudate, so that it is easy to remove from the wound.

1 is a process diagram schematically showing a method for producing a wound dressing according to the present invention.

2 is a conceptual diagram showing a continuous manufacturing process for producing a large amount of wound coating according to an embodiment of the present invention.

3 is a conceptual diagram schematically showing a wound covering prepared by the manufacturing method according to the present invention.

Figure 4 is a conceptual diagram showing a gauze fabric layer in which the gauze portion and the blood coagulation auxiliary layer and the blood coagulation facilitating layer introduced into the wound covering prepared by the manufacturing method according to the present invention sequentially laminated.

5 is an actual image of the wound covering manufactured by the method according to the embodiment.

Figure 6 is a light microscope image of a magnified photograph of the fabric layer of the gauze portion prepared by the method according to the embodiment.

The present invention is a simple process of forming a blood coagulation auxiliary layer containing chitosan and organic acids on the upper surface of the fabric layer, and forming a kaolin-containing blood coagulation promoting layer on the upper surface of the blood coagulation auxiliary layer, the kaolin was difficult to laminate on the fabric Not only is introduced to have a sufficient binding force, but also provides a description of a method for producing a wound dressing excellent in hemostatic effects, including chitosan and kaolin simultaneously play a different role in the hemostatic mechanism.

Hereinafter, the present invention will be described in detail.

The present invention, (a) applying a first mixed solution containing an organic acid and chitosan in 0.01 to 3% by weight to form a blood coagulation auxiliary layer on the upper surface of the fabric layer included in the gauze; (b) in the step (a) by applying a second mixed solution containing kaolin at 0.1 to 20% by weight on the upper surface of the blood coagulation auxiliary layer fabric layer in which the blood coagulation auxiliary layer and the coagulation promoting layer is sequentially laminated Manufacturing a gauze comprising a; (c) applying a pressure-sensitive adhesive on one surface to prepare a support part including an adhesive layer; And (d) attaching the gauze portion prepared in step (b) to the upper surface of the adhesive layer prepared in step (c) (see FIG. 1).

In the step (a), it is a step of forming a blood coagulation auxiliary layer on the upper surface of the fabric layer of the gauze by applying a first mixed solution containing an organic acid and chitosan in 0.01 to 3% by weight.

The gauze portion may use a variety of fabrics known in the art, including commonly used fabric fibers. Preferably, the gauze portion may use a flexible and elastic fabric material. The gauze portion may be a representative example of a nonwoven fabric, natural yarns, nylon, rayon, polyester, polypropylene, polyethylene terephthalate, acrylic or ceramic material formed by forming a network structure.

The gauze portion is fixed to the upper surface of the support layer and serves to promote hemostasis and wound healing when introduced into the wound site of the skin, the fabric layer absorbs the exudates from the wound site, and the chitosan absorbs moisture to hydrogel ( Hydrogel) forms a moist environment in the wound area, and hydrogel-formed chitosan forms a coating film on wound areas such as wounds to protect the wound, and prevents the formation of scabs, and excellent hemostatic effect by kaolin Can be achieved.

The chitosan is a positively charged polysaccharide, which binds to the membrane surface of red blood cells with negative charges in the blood to promote blood clot formation, and promotes blood coagulation by inducing aggregation of platelets and ionization of calcium due to mucosal adhesion properties. It is known as a biomaterial that exhibits water solubility, has a molecular structure very similar to that of human tissues, and has excellent human affinity and thus does not cause an immune response.

The chitosan preferably has an average molecular weight of 10,000 to 1 million Da, when the chitosan molecular weight is less than 10,000 Da is easily dissolved in the blood does not promote coagulation, if more than 1 million Da The molecular weight may be too high to reduce the coagulation effect of blood. More preferably, chitosan having an average molecular weight of 20,000 to 200,000 Da can be used.

In addition, the deacetylation degree of chitosan can be used 85% or more, it is preferable to use 90% or more. When the deacetylation degree of the chitosan is less than 85%, the binding force of the negatively charged erythrocytes and the surface of the erythrocyte may be weak, thereby reducing the blood coagulation effect.

The first mixed solution may include chitosan in an amount of 0.01 to 3% by weight. When the chitosan content is less than 0.01% by weight, the lamination amount of kaolin is reduced when the blood coagulation promoting layer is laminated in a step to be described later. If the weight percentage is exceeded, there is a problem that the viscosity is increased and the flexibility is reduced when applied to the wound coating. Preferably, the chitosan may be included in an amount of 0.1 wt% to 1 wt%.

The organic acid may play a role of dissolving chitosan and at the same time inducing kaolin to be described later to have a negative charge, thereby promoting ionic bond between chitosan and kaolin. The organic acid may be a glycolic acid (glycolic acid), ascorbic acid (ascorbic acid), lactic acid (lactic acid) or a mixture thereof.

The first mixed solution may preferably include an organic acid so as to exhibit a pH of 4 to 6, and the first mixed solution may exhibit a pH in such a range to induce negative charge in kaolin to be described later. When the pH of the first mixed solution is less than 4, there is a problem that an excessive charge induction of kaolin by the organic acid proceeds to increase the stacking amount of kaolin, and when the pH exceeds 6, the effect of inducing negative charge by the organic acid is minimal. There is a problem that the stacking amount decreases.

Preferably, the first mixed solution has a pH of 4.5 to 5.5, and the blood coagulation auxiliary layer formed of the first mixed solution may induce kaolin to a negative charge and induce a positive charge with chitosan.

The first mixed solution may include an organic acid in 0.05 to 1% by weight, when the content of the organic acid is less than 0.05% by weight, solubility of chitosan is lowered, and when it exceeds 1% by weight, hydrolysis of chitosan occurs. Can be. Preferably, the organic acid may include 0.5% by weight.

In addition, the first mixed solution may be configured to further include 1 to 20% by weight of glycerin in order to give flexibility to the wound coating, and may preferably include glycerin in a ratio of 5 to 10% by weight. have.

The first mixed solution may be prepared by mixing an organic acid, chitosan and glycerin with water, and stirring the mixture for a sufficient time. The first mixed solution prepared as described above may be applied onto a fabric layer of the gauze portion to form blood. A coagulation aid layer can be formed.

In the step (b), in the step (a) by applying a second mixed solution containing kaolin at 0.1 to 20% by weight on the upper surface of the blood coagulation auxiliary layer, the blood coagulation auxiliary layer and the coagulation promoting layer sequentially A step of manufacturing a gauze including a laminated fabric layer.

The kaolin contained in the second mixed solution may promote blood coagulation through interaction by contacting Factor XII (only Hageman factor) among plasma proteins present in the blood. In addition, it activates Factor XI (plasma thromboplastin precursor, thromboplastin antecedent) or prekallikrein, and plays a role in causing deformation. In particular, Factor XII is involved in activation, kaolin increases the sensitivity of kallikrein, a plasma component of Factor XII, accelerates the rate of activation, thereby promoting blood coagulation, thereby improving the hemostatic effect of the wound.

The second mixed solution may include kaolin in an amount of 0.1 to 20% by weight, and when the content of kaolin in the second mixed solution is less than 0.1% by weight, the amount of kaolin is introduced so that the hemostatic effect of kaolin is insignificant. If it exceeds 20% by weight, the amount of kaolin introduced may be excessive, so that kaolin lumps are formed or the flexibility of the wound coating is poor.

In addition, the second mixed solution may be configured to further include 1 to 20% by weight of glycerin, preferably 5 to 10% by weight in order to impart flexibility to the wound dressing. have.

The second mixed solution as described above may be prepared by mixing kaolin and glycerin with water and stirring for a sufficient time, and the blood coagulation auxiliary layer formed on the fabric layer of the gauze of the second mixed solution prepared as described above. It can be applied to the upper surface of the to form a blood coagulation promoting layer.

By forming a blood coagulation facilitating layer on the blood coagulation auxiliary layer as described above, kaolin is induced to have a negative charge by the organic acid contained in the blood coagulation auxiliary layer, and kaolin which is difficult to be introduced into the fabric by ion-bonding with chitosan having a positive charge. Can be easily stacked to maintain a strong bonding force.

As described above, chitosan and kaolin are coupled through ionic bonds, and thus, agglomeration of kaolin is induced quickly around the chitosan, so that the kaolin is evenly stacked in all directions, and the flexibility of the fabric is maintained to form a gauze portion having flexibility.

The kaolin laminated on the fabric as described above may be evenly applied in all directions and strongly ion-bonded to prevent the kaolin from leaving the fabric through chemical bonding rather than physical bonding to form a flexible wound coating material.

In the present invention, the blood coagulation auxiliary layer and the blood coagulation promoting layer may be configured to include a ratio of 10 to 70% by weight based on the total weight of the gauze portion, the content of the blood coagulation auxiliary layer and blood coagulation promoting layer If the amount is less than 10% by weight, the amount of chitosan and kaolin is insufficient to reduce the hemostatic effect, and when it exceeds 70% by weight, the amount of lamination on the upper surface of the fabric is excessively reduced, thereby reducing the flexibility, which is difficult to apply to the wound. There is.

On the other hand, in the above steps (a) and (b), the first mixed solution and the second mixed solution can be used without limitation as long as it is a coating method of a conventional solution such as dipping and spraying, the first mixed solution and the second It may include a step of heating to increase the solubility in the preparation of the mixed solution.

After applying the first mixed solution and the second mixed solution as described above, a gauze portion in which a blood coagulation auxiliary layer and a blood coagulation facilitating layer are sequentially stacked on the upper surface of the fabric layer may be manufactured by using various conventional drying methods.

In addition, in order to manufacture the first mixed solution and the second mixed solution, an insoluble content and an impurity may be filtered using a mesh filter or the like and then applied.

Furthermore, the coagulation auxiliary layer and the coagulation promoting layer may further include additives such as wound healing accelerators, antibacterial agents, and cell growth factors.

Fibrinogen, prothrombin, calcium (Ca), hyaluronic acid, keratin, collagen, dermatan sulfate, heparin, heparan sulfate, sodium alginate, sodium carboxymethylcellulose, chondroitin sulfate, 3- Aminopropyldihydrogen phosphate, or mixtures thereof may be used.

The antimicrobial agent is gluconate chlorohexidine, acetate chlorohexidine, hydrochloride chlorohexidine, silversulfurazine, povidone iodine, benzalkonium chloride, purazine, iodocaine, hexachlorophene, chloro Tetracycline, neomycin, penicillin, gentamycin, acrinol, silver (Ag) compounds or mixtures thereof can be used.

The cell growth factor may be platelet-derived growth factor (PDGF), transforming growth factor (TGF-β), epidermal cell-derived growth factor (EGF), fibroblast-derived growth factor (FGF), or a mixture thereof. The mixing ratio can be adjusted in various ways.

Preferably, the coagulation auxiliary layer and the coagulation facilitating layer may further include fibrinogen, prothrombin, calcium (Ca), or mixtures thereof.

In the step (c), the adhesive is applied to one surface to prepare a support part including the adhesive layer.

The support may be made of various forms. The support portion is flexible (flexible), the moisture-permeable permeability of the gas, the liquid may be used a material having a waterproof impermeable, such a support portion is polyurethane, polyethylene, silicone resin, natural or synthetic rubber, Synthetic polymers, such as polyglycolic acid, polylactic acid, or these copolymers, can be used, or the film manufactured using natural polymers, such as polyvinyl alcohol, fibrin, and cellulose, etc. can be used. Preferably, the support portion may use a polyurethane film having excellent physical properties such as tensile strength and elongation as well as moisture permeability and waterproofness, and a transparent film may be used to observe a wound state. In addition, the support portion is not limited in size or shape, and can be cut and spread to a predetermined size so as to be convenient to use, or can be directly cut and used by a user according to a use.

In particular, when the support portion is attached to the face, the support portion may cover the opaque color, the blood of the wound and may be formed in flesh color or the like to match the color of the face to prevent the wound from visually appearing. Various shapes may be molded and used, and openings may be formed at regular intervals in the horizontal and vertical directions.

In this step, an adhesive having excellent adhesive strength may be applied to one surface of the support to form a pressure-sensitive adhesive layer to maintain sufficient bonding force with the skin, and the adhesive may be applied to one surface of the support using a conventional method.

In the step (d), the gauze portion prepared in the step (b) is attached to the upper surface of the pressure-sensitive adhesive layer of the support prepared in the step (c).

In this step, a gauze portion having a structure in which a blood coagulation auxiliary layer and a blood coagulation facilitating layer are sequentially stacked on the fabric layer may be attached to the upper surface of the adhesive layer of the support to fix the gauze to form a wound coating material. have.

In addition, in this step, after the wound coating material is manufactured, additionally forming a release film layer on the upper surface of the gauze portion and the support portion to protect the adhesive layer of the gauze portion and the support portion to be configured. Can be.

In the method for producing a wound dressing according to the present invention as described above, by applying a first mixed solution containing an organic acid and chitosan to the fabric layer to form a blood coagulation auxiliary layer, comprising a kaolin on the upper surface of the blood coagulation auxiliary layer The second solution is applied to form a coagulation promoting layer, and the coagulation auxiliary layer and the coagulation promotion layer are sequentially stacked on the upper surface of the fabric layer, and kaolin is negatively charged due to the pH of the organic acid included in the coagulation auxiliary layer. By carrying out the positive and positively charged chitosan and kaolin ion-bonded to maintain a sufficient binding force, the release of kaolin can be effectively prevented to produce a wound coating having excellent hemostatic effect.

Furthermore, according to one embodiment of the present invention, the wound coating material is coated with the first mixed solution and the second mixed solution on the upper surface of the gauze part using a continuous manufacturing process as shown in FIG. And a gauze portion having a structure in which a blood coagulation promoting layer is sequentially stacked, and a gauze portion is fixedly formed on one surface of the support portion to which the pressure-sensitive adhesive is applied to produce a large amount of wound coating material.

To this end, by applying a first mixed solution containing chitosan and organic acid on the upper surface of the gauze fabric layer to form a blood coagulation auxiliary layer (S100); Drying the fabric layer in which the blood coagulation auxiliary layer is formed (S200); Applying a second mixed solution containing kaolin to the upper surface of the blood coagulation auxiliary layer to form a blood coagulation promoting layer (S300); Drying the fabric layer in which the blood coagulation auxiliary layer and the blood coagulation promotion layer are formed (S400); Cutting a gauze portion including the fabric layer (S500); And it is possible to manufacture a large amount of the wound coating material through a continuous production process comprising the step (S600) of fixing the gauze portion to one surface of the support portion to which the adhesive is applied.

In the method of manufacturing a wound dressing according to the present invention as described above, the first mixed solution containing an organic acid and chitosan is applied to the fabric layer to form a blood coagulation auxiliary layer, and an agent comprising kaolin on an upper surface of the blood coagulation auxiliary layer. The solution is applied to form a coagulation promoting layer, and the kaolin is negatively charged due to the pH of the organic acid included in the coagulation auxiliary layer, and the positively charged chitosan and kaolin are combined to have sufficient binding force through ionic bonding. The escape of kaolin can be effectively prevented to produce a wound dressing exhibiting excellent hemostatic effect.

The wound dressing 100 according to the embodiment of the present invention may have a shape and a structure as shown in FIG. 3, and the support 110 and the upper surface of the support 110 coated with the adhesive 111 on one surface thereof. The structure including the fixed-formed gauze portion 120 can be variously adjusted in shape and shape according to the purpose and attachment site.

Gauze portion 120 included in the wound dressing 100 according to an embodiment of the present invention, as shown in Figure 4, the fabric layer 121 made of fibers; A blood coagulation auxiliary layer 123 formed on the top surface of the fabric layer 121 and including chitosan and organic acids; And a blood coagulation promoting layer 125 formed on an upper surface of the blood coagulation auxiliary layer 123 and including kaolin, wherein the fabric layer 121 has a network structure (netwokk sturucture). Has

The support may be made of various forms. The support portion is flexible (flexible), the moisture-permeable permeability of the gas, the liquid may be used a material having a waterproof impermeable, such a support portion is polyurethane, polyethylene, silicone resin, natural or synthetic rubber, Synthetic polymers, such as polyglycolic acid, polylactic acid, or these copolymers, can be used, or the film manufactured using natural polymers, such as polyvinyl alcohol, fibrin, and cellulose, etc. can be used. Preferably, the support portion may use a polyurethane film having excellent physical properties such as tensile strength and elongation as well as moisture permeability and waterproofness, and a transparent film may be used to observe a wound state.

The support portion is not limited in size or shape, and may be cut and spread to a predetermined size for convenience of use, or may be directly cut and used by a user according to a use.

In particular, when the support is attached to the face, the support may cover the opaque color, the blood of the wound and may be formed in flesh color to match the color of the face to prevent the wound from visually appearing.

The support portion may be coated with an adhesive having excellent adhesive force to maintain sufficient bonding force with the skin, and may be used by variously forming the size and shape, and may be used in which openings are formed at regular intervals in the horizontal and vertical directions.

The gauze portion is fixed to the upper surface of the support layer and serves to promote hemostasis and wound healing, the fabric layer absorbs the exudates from the wound site, and chitosan forms a hydrogel to absorb moisture to the wound site. It is possible to create a wet environment, hydrogel-ized chitosan to form a coating film on wounds such as wounds, to protect wounds, to prevent the formation of scabs, and to achieve excellent hemostatic effect by kaolin.

To this end, the gauze portion has a structure comprising a fabric layer, a blood coagulation auxiliary layer, a blood coagulation promoting layer, the gauze portion can be used in a variety of commonly known types of fabric commonly used, including fabric fibers. Preferably, the gauze portion may use a flexible and elastic fabric material. The gauze portion may be a representative example of a material formed by forming a network structure of a fabric fiber such as nonwoven fabric, natural yarn, nylon, rayon, polyester, polypropylene, polyethylene terephthalate, acrylic, or ceramic.

The coagulation auxiliary layer comprises chitosan and organic acid, and the chitosan is a positively charged polysaccharide, which binds to the membrane surface of negatively charged red blood cells in the blood to promote blood clot formation, and platelet aggregation and calcium due to mucoadhesive properties. By inducing the ionization of can play a role in promoting blood clotting.

The chitosan preferably has an average molecular weight of 10,000 to 1 million Da (dalton), when the chitosan molecular weight is less than 10,000 Da is easily dissolved in the blood does not promote coagulation, exceeding 1 million Da If the molecular weight is too high, the coagulation effect of the blood may be reduced. More preferably, chitosan having an average molecular weight of 20,000 to 200,000 Da can be used.

The coagulation auxiliary layer may include chitosan in an amount of 0.01 to 3% by weight, and when the chitosan content is less than 0.01% by weight, the lamination amount of kaolin included in the coagulation promoting layer is lowered and exceeds 3% by weight. In this case, there is a problem that the viscosity is increased, the flexibility is reduced when applied to the wound coating. Preferably, the chitosan may be included in an amount of 0.1 wt% to 1 wt%.

The coagulation auxiliary layer may include an organic acid, and the organic acid may play a role of dissolving chitosan and at the same time, inducing kaolin to be negatively charged, thereby promoting ionic bond between chitosan and kaolin.

The organic acid may be a glycolic acid (glycolic acid), ascorbic acid (ascorbic acid), lactic acid (lactic acid) or a mixture thereof. Preferably, the coagulation auxiliary layer may include an organic acid so as to exhibit a pH of 4 to 6, and may exhibit a pH of the above range to induce negative charge in kaolin to be described later. When the pH of the organic acid is less than 4, there is a problem in that the amount of kaolin stacking is increased due to excessive charge induction of kaolin by the organic acid, and the amount of stacking of kaolin is reduced when the pH is higher than 6, the effect of inducing negative charge by organic acid is minimal. There is a problem. Preferably, the blood coagulation auxiliary layer has a pH of 4.5 to 5.5, and kaolin is induced to a negative charge by the pH in the above range, thereby allowing ionic bonds with chitosan having a positive charge.

In addition, the coagulation auxiliary layer may include an organic acid at 0.05 to 1% by weight, when the content of the organic acid is less than 0.05% by weight, the solubility of chitosan is lowered, and when it exceeds 1% by weight, hydrolysis of chitosan. Can happen. Preferably, the coagulation auxiliary layer may include 0.5% by weight of the organic acid.

The coagulation promoting layer comprises kaolin, and the kaolin may promote blood coagulation through interaction by contacting Factor XII (Hageman factor) among plasma proteins present in the blood. In addition, it activates Factor XI (plasma thromboplastin precursor, thromboplastin antecedent) or prekallikrein, and plays a role in causing deformation. In particular, Factor XII is involved in activation, kaolin increases the sensitivity of kallikrein, a plasma component of Factor XII, accelerates the rate of activation, thereby promoting blood coagulation, thereby improving the hemostatic effect of the wound.

The blood coagulation promoting layer may include the kaolin in an amount of 0.1 to 20% by weight. When the content of kaolin in the blood coagulation promoting layer is less than 0.1% by weight, a small amount of kaolin is introduced so that the hemostatic effect due to the introduction of kaolin is reduced. If it is insignificant, if it exceeds 20% by weight, the amount of kaolin introduced may cause excessive kaolin lumps or poor flexibility of the wound coating material.

In the wound dressing according to the present invention, a blood coagulation auxiliary layer including chitosan and an organic acid is formed on the upper surface of the fabric layer, and a blood coagulation promoting layer including kaolin is formed on the blood coagulation auxiliary layer, thereby providing a blood coagulation auxiliary layer. The included organic acid induces the kaolin to have a negative charge, and ion-bonded with the positively charged chitosan to easily stack the kaolin, which is difficult to introduce into the fabric, to maintain a strong binding force.

As described above, chitosan and kaolin are coupled through ionic bonds, so that aggregation of kaolin is induced rapidly around the chitosan, so that kaolin is evenly laminated in all directions, thereby maintaining the flexibility of the fabric to form a wound coating having flexibility.

In addition, the gauze portion may further include additives such as wound healing accelerators, antibacterial agents, cell growth factors, and the like to promote wound dentition.

The cell growth factor may be platelet-derived growth factor (PDGF), transforming growth factor (TGF-β), epidermal cell-derived growth factor (EGF), fibroblast-derived growth factor (FGF), or a mixture thereof. The mixing ratio can be variously adjusted, and the coagulation auxiliary layer and the coagulation promoting layer preferably include fibrinogen, prothrombin, calcium (Ca), or a mixture thereof.

In addition, the wound dressing may further include a release film attached to the upper surface to protect the support and the gauze. The wound coating material may include a release film to prevent contamination or loss of the support portion and the gauze portion until attached to the user, and the release film may be formed in various materials or shapes.

As described above, the wound dressing containing chitosan and kaolin as an active ingredient is a blood coagulation auxiliary layer containing chitosan and an organic acid, a blood coagulation facilitating layer including kaolin are simultaneously stacked, and the chitosan is hydrogelized. Kaolin is induced to a negative charge by the pH of the organic acid contained, and the kaolin induced by a negative charge is ion-bonded with a chitosan with a positive charge, so that kaolin and chitosan exhibit sufficient binding force on the fabric, while kaolin is in all directions of the fabric. It can be laminated evenly to achieve the effect of maintaining flexibility.

The wound dressing according to the present invention includes kaolin and chitosan which simultaneously perform different roles in the hemostatic mechanism, and the chitosan absorbs blood or exudate, thereby hydrogelizing the kaolin, thereby releasing the supported kaolin, kaolin to the inside of the deep wound. Since it is delivered and exhibits an excellent hemostatic effect, it can exhibit the characteristics of a dry wet wound dressing having both the characteristics of a dry dressing and a wet dressing.

Furthermore, the wound dressing of the present invention can be easily applied to manufacture various products for the purpose of hemostasis when chitosan continuously absorbs blood or exudate and is completely dissolved to facilitate removal from the wound.

In the wound dressing according to the present invention as described above, a blood coagulation auxiliary layer including chitosan and organic acids is formed on the upper surface of the fabric layer, and a blood coagulation promoting layer including kaolin is formed on the upper surface of the blood coagulation auxiliary layer, The organic acid included in the coagulation auxiliary layer induces the kaolin to have a negative charge, and ionically bonds with the chitosan having a positive charge to easily stack the kaolin, which is difficult to be introduced into the fabric, to maintain a strong binding force.

Hereinafter, the present invention will be described in more detail with reference to Examples.

The examples presented are merely illustrative of the invention and are not intended to limit the scope of the invention.

<실시예><Example>

0.01 wt% of chitosan powder having an average molecular weight of 100,000 Daltons (Da) and 90% deacetylation, 0.5 wt% of glycolic acid, and 10 wt% of glycerin for imparting flexibility are mixed with distilled water and stirred at low speed. An aqueous organic acid solution was prepared. The prepared aqueous organic acid solution was filtered using a mesh having a pore size of 500 μm to remove insoluble components and impurities, and degassed and then degassed to remove bubbles formed in the aqueous solution.

An aqueous solution of kaolin was prepared by mixing 1% by weight of kaolin powder and 10% by weight of glycerin for imparting flexibility with distilled water.

The gauze specimen (2.4 × 1.8 cm ² ) was impregnated in the prepared aqueous organic acid solution, and then dried in a vacuum dryer to prepare a gauze specimen in which a blood coagulation auxiliary layer including chitosan and organic acid was formed. Aqueous solution of kaolin was sprayed and dried with a vacuum dryer to prepare a gauze specimen in which a blood coagulation promoting layer was formed.

The prepared gauze specimen was attached to a polyurethane film coated with pressure-sensitive adhesive to prepare a wound coating material having a gauze portion, and the wound wound material thus prepared was photographed and shown in FIG. 5.

In order to confirm the introduction of kaolin to the wound coating prepared by the above method, platinum cyanide, which is a fluorescent material, was coated on the prepared gauze specimen, and the fabric fibers of the gauze portion were observed using an optical microscope. Shown in

Figure 6 (a) is 0.01% by weight of chitosan and 1% by weight of kaolin, Figure 6 (b) is 0.01% by weight of chitosan and 2% by weight of kaolin, Figure 6 (c) is 0.05% by weight of chitosan and 2% by weight of kaolin, Figure 6 (d) is 0.1% by weight of chitosan and 1% by weight of kaolin, Figure 6 (e) is 0.3% by weight of chitosan and 0.5% by weight of kaolin, Figure 6 (f) is 0.3% by weight of chitosan and 1% by weight of kaolin, Figure 6 (g ) Is an optical microscope image of the gauze fiber of the wound coating material prepared with an aqueous solution containing 0.5% by weight of chitosan and 1% by weight of kaolin, and 6% by weight of chitosan and 2% by weight of kaolin.

As shown in Figure 6, the fibers forming the gauze portion of the wound coating is observed by the fluorescent material reacting with the kaolin color development phenomenon is observed on the upper surface of the wound coating material is not agglomerated by the chitosan coated, uniformly well laminated It could be confirmed.

Claims

(a) applying a first mixed solution containing organic acid and chitosan in 0.01 to 3% by weight to form a coagulation auxiliary layer on the upper surface of the fabric layer included in the gauze;

(b) applying a second mixed solution containing kaolin at 0.1 to 20% by weight on the upper surface of the blood coagulation auxiliary layer formed in step (a) to form a blood coagulation facilitating layer, and a blood coagulation auxiliary layer and blood Manufacturing a gauze portion including a fabric layer in which a solidification promoting layer is sequentially laminated;

(c) applying a pressure-sensitive adhesive on one surface to prepare a support part including an adhesive layer; And

(d) a method of manufacturing a wound coating comprising the step of attaching the gauze portion prepared in step (b) to the top surface of the adhesive layer prepared in step (c).
The method of claim 1,

The chitosan has a mean molecular weight of 10,000 to 1 million Da, the deacetylation degree (deacetylation degree) of 85% or more manufacturing method of the wound coating.
The method of claim 1,

The organic acid is a method for producing a wound coating, characterized in that it comprises one or more selected from the group consisting of glycolic acid (glycolic acid), ascorbic acid (ascorbic acid) and lactic acid (lactic acid).
The method of claim 1,

The gauze portion is formed by applying the first mixed solution and the second mixed solution to the fabric layer, respectively, 10 to 70% by weight based on the total weight of the gauze portion to include the blood coagulation auxiliary layer and the coagulation promoting layer. Method for producing wound dressings.
The method of claim 1,

The first mixed solution comprises chitosan in an amount of 0.01 to 3% by weight, and the second mixed solution comprises a kaolin in an amount of 0.1 to 20% by weight.
The method of claim 1,

The first mixed solution and the second mixed solution, respectively, fibrinogen (probrinogen), prothrombin (prothrombin) and calcium (Ca) each of the method for producing a wound coating further comprising at least one selected from the group consisting of.
It is manufactured by the method of any one of Claims 1-6,

A blood coagulation auxiliary layer formed on the upper surface of the fabric layer made of fibers and comprising chitosan and organic acids; And a blood coagulation promoting layer formed on an upper surface of the blood coagulation auxiliary layer and including kaolin; And

ii) a wound is applied to one side of the support portion that can be adhered to the user's skin; wound covering material comprising a.
The method of claim 7, wherein

The gauze portion wound wound coating, characterized in that containing 10 to 70% by weight of the blood coagulation auxiliary layer and the coagulation promoting layer based on the total weight of the gauze.
The method of claim 7, wherein

The coagulation auxiliary layer and the coagulation promoting layer are wound dressings further comprising at least one selected from the group consisting of fibrinogen, prothrombin, and calcium (Ca).
The method of claim 7, wherein

The chitosan has an average molecular weight of 10,000 to 1 million Da, the wound acetalization degree (deacetylation degree) is characterized in that the wound coating.
The method of claim 7, wherein

The organic acid is a wound dressing, characterized in that it comprises one or more selected from the group consisting of glycolic acid (glycolic acid), ascorbic acid (ascorbic acid) and lactic acid (lactic acid).
The method of claim 7, wherein

The coagulation auxiliary layer comprises 0.01 to 3 wt% of the chitosan, and the coagulation promoting layer comprises 0.1 to 20 wt% of the kaolin.
The method of claim 7, wherein

The wound coating material further comprises a release film attached to the support and the upper surface of the gauze.