WO2018079899A1 - Procédé de fabrication d'un pansement sec/humide, et pansement ainsi fabriqué - Google Patents

Procédé de fabrication d'un pansement sec/humide, et pansement ainsi fabriqué Download PDF

Info

Publication number
WO2018079899A1
WO2018079899A1 PCT/KR2016/012479 KR2016012479W WO2018079899A1 WO 2018079899 A1 WO2018079899 A1 WO 2018079899A1 KR 2016012479 W KR2016012479 W KR 2016012479W WO 2018079899 A1 WO2018079899 A1 WO 2018079899A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
kaolin
blood coagulation
chitosan
wound
Prior art date
Application number
PCT/KR2016/012479
Other languages
English (en)
Korean (ko)
Inventor
김태준
Original Assignee
주식회사 유엔헬스케어
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 주식회사 유엔헬스케어 filed Critical 주식회사 유엔헬스케어
Publication of WO2018079899A1 publication Critical patent/WO2018079899A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28—Polysaccharides or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin

Definitions

  • 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.
  • the human body 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.
  • 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.
  • 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.
  • kaolinite Al 2 Si 2 O 5 (OH) 4
  • 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.
  • 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
  • 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.
  • 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.
  • 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).
  • 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%.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • the wound coating further comprises a release film attached to the upper surface of the support and the gauze portion.
  • 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.
  • a coagulation aid 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.
  • 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.
  • FIG. 1 is a process diagram schematically showing a method for producing a wound dressing according to the present invention.
  • FIG. 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.
  • FIG. 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.
  • 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.
  • 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).
  • 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.
  • hydrogel Hydrogel
  • 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.
  • the deacetylation degree of chitosan can be used 85% or more, it is preferable to use 90% or more.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the organic acid may include 0.5% by weight.
  • 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.
  • 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.
  • Factor XII activates Factor XI (plasma thromboplastin precursor, thromboplastin antecedent) or prekallikrein, and plays a role in causing deformation.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an insoluble content and an impurity may be filtered using a mesh filter or the like and then applied.
  • 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 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- ⁇ ), epidermal cell-derived growth factor (EGF), fibroblast-derived growth factor (FGF), or a mixture thereof.
  • PDGF platelet-derived growth factor
  • TGF- ⁇ transforming growth factor
  • EGF epidermal cell-derived growth factor
  • FGF fibroblast-derived growth factor
  • the mixing ratio can be adjusted in various ways.
  • the coagulation auxiliary layer and the coagulation facilitating layer may further include fibrinogen, prothrombin, calcium (Ca), or mixtures thereof.
  • 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.
  • 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 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.
  • the support portion 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • the wound dressing 100 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.
  • 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.
  • 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.
  • the support 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.
  • 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.
  • 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 deacetylation degree of chitosan can be used 85% or more, it is preferable to use 90% or more.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Factor XII Heageman factor
  • it activates Factor XI (plasma thromboplastin precursor, thromboplastin antecedent) or prekallikrein, and plays a role in causing deformation.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the gauze portion may further include additives such as wound healing accelerators, antibacterial agents, cell growth factors, and the like to promote wound dentition.
  • Fibrinogen 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- ⁇ ), epidermal cell-derived growth factor (EGF), fibroblast-derived growth factor (FGF), or a mixture thereof.
  • PDGF platelet-derived growth factor
  • TGF- ⁇ transforming growth factor
  • EGF epidermal cell-derived growth factor
  • FGF fibroblast-derived growth factor
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ⁇ m 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un procédé de fabrication d'un pansement, comprenant les étapes consistant : (a) à revêtir une première solution de mélange contenant un acide organique et 0,01 à 3 % en poids de chitosane de manière à former une couche d'aide à la coagulation sanguine sur la surface supérieure d'une couche de tissu comprise dans une partie gaze; (b) à former une couche favorisant la coagulation sanguine par revêtement d'une seconde solution de mélange, contenant de 0,1 à 20 % en poids de kaolin, sur la surface supérieure de la couche d'aide à la coagulation sanguine de l'étape (a), ce qui permet de fabriquer la partie gaze comprenant la couche de tissu ayant la couche d'aide à la coagulation sanguine et la couche favorisant la coagulation sanguine, qui sont séquentiellement empilées dessus; (c) à revêtir un adhésif sur une surface de façon à fabriquer une partie support comprenant une couche adhésive; et (d) à fixer la partie gaze, qui est fabriquée à l'étape (b), sur la surface supérieure de la couche adhésive de la partie support, qui est fabriquée à l'étape (c). Selon la présente invention, le procédé de fabrication d'un pansement forme une couche d'aide à la coagulation sanguine par revêtement d'une première solution de mélange contenant un acide organique et du chitosane sur une couche de tissu, et forme une couche favorisant la coagulation sanguine par revêtement d'une seconde solution, contenant du kaolin, sur la surface supérieure de la couche d'aide à la coagulation sanguine, et ainsi le kaolin devient chargé négativement par l'intermédiaire du pH de l'acide organique contenu dans la couche d'aide à la coagulation sanguine, et le chitosane et le kaolin chargés positivement sont liés de manière à avoir une force de liaison suffisante par l'intermédiaire d'une liaison ionique, ce qui permet d'empêcher efficacement la séparation du kaolin d'un tissu, ainsi un pansement présentant un excellent effet hémostatique peut être fabriqué.
PCT/KR2016/012479 2016-10-27 2016-11-01 Procédé de fabrication d'un pansement sec/humide, et pansement ainsi fabriqué WO2018079899A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2016-0140926 2016-10-27
KR20160140931 2016-10-27
KR20160140926 2016-10-27
KR10-2016-0140931 2016-10-27

Publications (1)

Publication Number Publication Date
WO2018079899A1 true WO2018079899A1 (fr) 2018-05-03

Family

ID=62025103

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/012479 WO2018079899A1 (fr) 2016-10-27 2016-11-01 Procédé de fabrication d'un pansement sec/humide, et pansement ainsi fabriqué

Country Status (1)

Country Link
WO (1) WO2018079899A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108404193A (zh) * 2018-05-08 2018-08-17 长沙爱扬医药科技有限公司 白及止血绷带产品及其制备方法
CN114748670A (zh) * 2022-04-11 2022-07-15 武汉诺薇生物科技有限公司 一种非织造止血纱布及其制备方法和应用

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4748978A (en) * 1984-09-27 1988-06-07 Kamp Herman F Therapeutic dressing having mineral components
US5836970A (en) * 1996-08-02 1998-11-17 The Kendall Company Hemostatic wound dressing
US20110052665A1 (en) * 2008-04-25 2011-03-03 Med-Trade Products Limited Haemostatic material
JP2012096082A (ja) * 2006-10-30 2012-05-24 Z-Medica Corp クレーベースの止血剤およびその送達のためのデバイス
KR20150027134A (ko) * 2012-06-22 2015-03-11 지-메디카 엘엘씨 지혈 장치

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4748978A (en) * 1984-09-27 1988-06-07 Kamp Herman F Therapeutic dressing having mineral components
US5836970A (en) * 1996-08-02 1998-11-17 The Kendall Company Hemostatic wound dressing
JP2012096082A (ja) * 2006-10-30 2012-05-24 Z-Medica Corp クレーベースの止血剤およびその送達のためのデバイス
US20110052665A1 (en) * 2008-04-25 2011-03-03 Med-Trade Products Limited Haemostatic material
KR20150027134A (ko) * 2012-06-22 2015-03-11 지-메디카 엘엘씨 지혈 장치

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108404193A (zh) * 2018-05-08 2018-08-17 长沙爱扬医药科技有限公司 白及止血绷带产品及其制备方法
CN108404193B (zh) * 2018-05-08 2021-04-16 长沙爱扬医药科技有限公司 白及止血绷带产品及其制备方法
CN114748670A (zh) * 2022-04-11 2022-07-15 武汉诺薇生物科技有限公司 一种非织造止血纱布及其制备方法和应用

Similar Documents

Publication Publication Date Title
CN107802878B (zh) 一种改性明胶/铌酸钾钠复合的电活性抗菌生物敷料及其制备与应用
WO2016209048A1 (fr) Structure de fibre médicale comprenant de la carboxyméthylcellulose de calcium et un composé de chitosan, et son procédé de préparation
WO2013089434A1 (fr) Pansement pour traiter une plaie
WO2018079899A1 (fr) Procédé de fabrication d'un pansement sec/humide, et pansement ainsi fabriqué
WO2018110907A1 (fr) Patch transdermique adhésif
WO2001041776B1 (fr) Pansement a base de miel
CN107626002A (zh) 一种响应型医用凝胶及其制备方法与应用
WO2019088331A1 (fr) Matériau médical produit à l'aide de collagène et procédé de production de celui-ci
WO2019125043A1 (fr) Composition hydrocolloïde et biopatch la comprenant
WO2021167330A1 (fr) Développement de couche dermique à retrait régulé, et fabrication de peau artificielle ayant une performance uniforme à l'aide de ce dernier
WO2018106076A1 (fr) Matériau styptique comprenant une poudre de carboxyméthylcellulose de calcium et une poudre de composé de chitosane soluble dans l'eau, et son procédé de production
WO2018093161A1 (fr) Nouvel agent hémostatique comprenant une protéine adhésive de moule et son procédé de préparation
WO2015099282A1 (fr) Tissu non tissé composite et son procédé de préparation
CN108842302A (zh) 一种柔韧抗菌医用无纺布及其制备方法
US20150182657A1 (en) Active polymer layer made of chitin derivatives, especially for a dressing, and its use
EP0526474A1 (fr) Compositions adhesives
WO2022119322A1 (fr) Composition antioxydante comprenant un nouveau composé
WO2016195152A1 (fr) Procédé de fabrication de film de collagène à l'aide de lumière ultraviolette, film de collagène fabriqué a l'aide de ce dernier, et matériau biologique préparé à l'aide du film de collagène
CN111701069A (zh) 一种创伤辅料及其制备方法
KR100359864B1 (ko) 미세다공성 폴리우레탄 필름이 형성된 창상피복용 드레싱재
KR100564999B1 (ko) 의료용 점착 테이프
WO2017135529A1 (fr) Pansement hémostatique comprenant du kaolin et du chitosane en tant que substances actives
WO2019039858A1 (fr) Composition adhésive, adhésif comprenant celle-ci et procédé de fabrication associé
WO2021040498A1 (fr) Patch cosmétique
WO2017065588A1 (fr) Compresse de type sec

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16920150

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16920150

Country of ref document: EP

Kind code of ref document: A1