WO2017135529A1 - Pansement hémostatique comprenant du kaolin et du chitosane en tant que substances actives - Google Patents

Pansement hémostatique comprenant du kaolin et du chitosane en tant que substances actives Download PDF

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Publication number
WO2017135529A1
WO2017135529A1 PCT/KR2016/008142 KR2016008142W WO2017135529A1 WO 2017135529 A1 WO2017135529 A1 WO 2017135529A1 KR 2016008142 W KR2016008142 W KR 2016008142W WO 2017135529 A1 WO2017135529 A1 WO 2017135529A1
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WO
WIPO (PCT)
Prior art keywords
kaolin
chitosan
solution
weight
fabric
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PCT/KR2016/008142
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English (en)
Korean (ko)
Inventor
김태준
Original Assignee
주식회사 유엔헬스케어
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Publication of WO2017135529A1 publication Critical patent/WO2017135529A1/fr

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    • 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
    • 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
    • A61L15/38—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing enzymes

Definitions

  • the present invention relates to a hemostatic bandage comprising kaolin and chitosan as active ingredients.
  • Blood supplies oxygen and nutrients as it travels through blood vessels, transports waste and processes it, and acts as a hormone transporter or defense against external pathogens and temperature control.
  • the blood is about 4 to 6L in the inside of a person, 20% of the 1L or more is discharged out of the body is known to be dangerous to life.
  • the bleeding from which blood flows out of the body can occur in everyday life, in medical practices such as surgery, or on the battlefield, where appropriate treatments, such as suturing the wound or compressing the bleeding area rapidly It is important.
  • hemostasis induced in the human body reacts with fibrinogen dispersed in the blood to water and thrombin to form fibrin, and the formed fibrin entangles platelets, forming a lump, and agglomerating.
  • fibrinogen dispersed in the blood to water and thrombin to form fibrin
  • fibrin entangles platelets, forming a lump, and agglomerating.
  • Kaolin one of the substances studied for promoting blood coagulation, is a clay material containing mineral kaolinite (Al 2 Si 2 O 5 (OH) 4 ), and the ratio of alumina and silica is about one to one. Consisting of water, excellent dispersibility in water, bioinert as well as inexpensive, and is known to have an excellent effect in promoting coagulation in the blood, using this to manufacture products for the purpose of hemostasis Various studies are underway for this purpose.
  • kaolin has a problem in that the surface area is small, the number of substituents is low, and the dispersibility of water is high, so that the lamination is difficult due to the low binding force when applied to the fabric.
  • sodium alginate, vinyl alcohol, collagen, or the like is used as a binder to improve the binding force between the fabric and kaolin.
  • the present invention is to solve the conventional problems as described above, and to provide a technical content of the hemostatic bandage excellent in hemostatic effect.
  • the present invention provides a blood coagulation auxiliary layer formed by applying a first solution containing chitosan (chitosan) and an organic acid on the upper surface of the fabric; And a blood coagulation promoting layer formed by applying a second solution containing kaolin on the upper surface of the blood coagulation auxiliary layer, wherein the first solution comprises 0.01 to 3 wt% of the chitosan,
  • the second solution provides a hemostatic bandage, characterized in that containing 0.1 to 20% by weight of the kaolin.
  • the hemostatic bandage is formed by applying the first solution and the second solution to the fabric, respectively, so that the blood coagulation auxiliary layer and the coagulation promoting layer comprises a weight of 10 to 70% of the initial total weight of the bandage. It features.
  • the coagulation auxiliary layer and the coagulation promoting layer is characterized in that it further comprises fibrinogen (probrinogen), prothrombin (prothrombin), calcium (Ca) or a mixture thereof.
  • 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 first solution is characterized in that the pH has a range of 4 to 6.
  • the organic acid is characterized in that the glycolic acid (glycolic acid), ascorbic acid (ascorbic acid), lactic acid (lactic acid) or a mixture thereof.
  • the organic acid is characterized in that contained in 0.05 to 1% by weight based on the total weight of the first solution.
  • first solution and the second solution is characterized in that it further comprises 1 to 20% by weight of glycerin (glycerin).
  • the hemostatic bandage according to the present invention is applied to the blood coagulation auxiliary layer formed of the chitosan aqueous solution containing the organic acid, by applying the aqueous solution of kaolin, due to the pH of the organic acid contained in the hydrogelized chitosan, kaolin is induced to have a negative charge, As a result, ionic bonds with chitosan, which are positively charged, have a sufficient binding force between kaolin and chitosan and are evenly laminated in all directions of the fabric, thereby maintaining flexibility.
  • the hemostatic bandage 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 and hydrogelizes, thereby releasing the bound kaolin to the inside of the deep wound. Kaolin is delivered to show good hemostatic effect.
  • hemostatic bandage of the present invention can be easily applied to manufacture hemostatic products for various purposes for hemostasis when chitosan continuously absorbs and completely dissolves blood or exudate and is easily removed from the wound.
  • FIG. 1 is a conceptual diagram showing a hemostatic bandage according to the present invention.
  • FIG. 2 is a conceptual diagram showing an example of a method of manufacturing a hemostatic bandage according to the present invention.
  • FIG. 3 is an actual image showing an example of a hemostatic bandage in the present invention.
  • the hemostatic effect including two active ingredients at the same time to play a different role in the hemostatic mechanism is Provides excellent hemostatic bandages.
  • the hemostatic bandage according to the present invention is formed by applying a second coagulation aid layer comprising kaolin on the upper surface of the blood coagulation auxiliary layer formed by applying a first solution containing chitosan and organic acid on the upper surface of the fabric. It comprises a blood coagulation promoting layer, wherein the first solution comprises the chitosan 0.01 to 3% by weight, the second solution provides a hemostatic bandage, characterized in that containing 0.1 to 20% by weight of the kaolin do.
  • the fabric may utilize various types of fabrics known in the art, and preferably, fabrics having elasticity for compressing wounds may be used, and the fabric may be natural yarn, nylon, rayon, polyester, or polypropylene.
  • a representative example is a woven fabric made of a material such as polyethylene terephthalate, acrylic or ceramic.
  • the hemostatic bandage according to the present invention may form a blood coagulation auxiliary layer by applying a first solution containing chitosan on the upper surface of the fabric.
  • the coagulation auxiliary layer may be formed by applying a first solution containing chitosan to the top surface of the fabric (FIG. 1A).
  • the chitosan has a water solubility, has a molecular structure very similar to that of human tissues, has excellent human affinity, and is known as a biomaterial that does not generate an immune response.
  • chitosan is a positively charged polysaccharide, it binds to the surface of negatively charged red blood cells to promote blood clot formation, and due to its mucoadhesive properties, it promotes blood coagulation by inducing platelet aggregation and calcium ionization. Can be done.
  • the chitosan as described above may preferably use an average molecular weight of 10,000 to 1 million Da, when the chitosan molecular weight is less than 10,000 Da, it is easy to dissolve in the blood does not promote coagulation, exceeding 1 million Da In this case, the coagulation effect of blood may be reduced.
  • the average molecular weight can use 20,000-200,000 Da.
  • the deacetylation degree of chitosan can be used 85% or more, it is preferable to use 90% or more. If the deacetylation degree is less than 85%, the binding force of the negatively charged erythrocytes with the surface may be weak, thereby reducing the blood coagulation effect.
  • chitosan may be included in the first solution in an amount of 0.01 to 3% by weight, preferably 0.1 to 1% by weight.
  • the content of chitosan contained in the first solution is 0.01% by weight or less, the amount of lamination of kaolin is lowered, and when 3% by weight or more, the viscosity may increase to reduce flexibility when applied to hemostatic bandages.
  • the first solution may include an organic acid, and the organic acid may play a role of dissolving chitosan and inducing kaolin to have a negative charge.
  • the first solution may include a pH of 4 to 6, including an organic acid, and preferably include an organic acid to exhibit a pH of 4.5 to 5.5.
  • the organic acid may be glycolic acid, ascorbic acid, lactic acid or a mixture thereof.
  • the organic acid may be included in the first solution in 0.05 to 1% by weight, preferably 0.5% by weight. When the content of the organic acid in the first solution is 0.05% by weight or less, the solubility of the chitosan powder is lowered, and when 1% by weight or more, hydrolysis of chitosan may occur.
  • the first solution may be prepared by heating to increase the solubility of chitosan, in the manufacturing process to filter the first solution with a mesh filter (mesh filter) to remove insoluble matter or impurities, etc. Can be.
  • the first solution prepared as described above may be applied to the fabric by dipping or spraying, and may be configured to be coated on the fabric through vacuum drying after application to form a blood coagulation auxiliary layer containing chitosan.
  • a blood coagulation promoting layer containing kaolin as an active ingredient may be formed on the upper surface of the blood coagulation auxiliary layer containing chitosan as described above.
  • the kaolin may promote the coagulation of blood through the interaction by contacting Factor XII (Hageman factor) among the plasma proteins present in the blood, the kaolin is Factor XII, Factor XI (plasma thromboplastin precursor It activates the substance, thromboplastin antecedent, and prekallikrein, which plays a role in causing deformation.
  • Factor XII is involved in activation, and kaolin increases the sensitivity of kallikrein, a plasma component of Factor XII, significantly accelerating the rate of activation to promote blood coagulation, thereby improving the hemostatic effect of wounds.
  • the second solution containing the kaolin may be coated in the same manner as the method of coating the first solution on the fabric.
  • the kaolin may be included in the second solution in an amount of 0.1 to 20% by weight, and when the second solution contains less than 0.1% by weight of kaolin, the amount of kaolin applied to the fabric is reduced so that the hemostatic effect is reduced. And, if it is included to exceed 20% by weight, the amount of kaolin may be increased, there is a problem that the flexibility is low, preferably, the second solution may contain 1 to 5% by weight of kaolin.
  • the reason why the kaolin may be laminated on the upper surface of the blood coagulation auxiliary layer containing chitosan is because kaolin is induced to a negative charge by the organic acid included in the blood coagulation auxiliary layer, and thus ionically binds to chitosan having a positive charge.
  • the blood coagulation auxiliary layer laminated on the upper surface of the fabric by including the organic acid in the first solution can be configured to have a pH in the above range.
  • the chitosan absorbs moisture and hydrogelizes, and the surrounding pH of the chitosan is 4.5 to 5.5 due to the organic acid.
  • Kaolin is induced to a negative charge and can be ion-bonded with a positively charged chitosan.
  • chitosan and kaolin may be chemically bonded to rapidly induce agglomeration of kaolin around chitosan, and the kaolin may be laminated in all directions to maintain fabric flexibility.
  • the chitosan hydrogelation time in the above process is preferably composed of 5 to 30 seconds, if the hydrogelation faster than 5 seconds kaolin is not aggregated around the chitosan, and if the hydrogelation slower than 30 seconds to the upper surface of the fabric The laminated chitosan falls into the second solution, and the lamination efficiency is lowered.
  • the kaolin When the kaolin is laminated on the fabric in the same manner as described above, the kaolin is evenly applied in all directions, so that the lamination efficiency is excellent, thereby maintaining the flexibility of the fabric to be manufactured, and the ionic bond is a chemical bond, not a physical bond. This results in a strong bond that does not leave the kaolin from the fabric and can be stacked stably.
  • the present invention may be configured to include a blood coagulation auxiliary layer and a blood coagulation facilitating layer having a weight of 10 to 70% of the initial total weight of the bandage by applying and drying the first solution and the second solution to the fabric, respectively.
  • a blood coagulation auxiliary layer and a blood coagulation facilitating layer having a weight of 10 to 70% of the initial total weight of the bandage by applying and drying the first solution and the second solution to the fabric, respectively.
  • first solution and the second solution may further include 1 to 20% by weight of glycerin (glycerin), preferably 5 to 10% by weight in order to give flexibility to the fabric.
  • glycerin glycerin
  • the present invention by applying a first solution containing chitosan (chitosan) and organic acid on the upper surface of the fabric to form a blood coagulation auxiliary layer (S100); And applying a second solution containing kaolin to the upper surface of the blood coagulation auxiliary layer to form a blood coagulation promoting layer (S300).
  • a first solution containing chitosan (chitosan) and organic acid on the upper surface of the fabric to form a blood coagulation auxiliary layer (S100);
  • a second solution containing kaolin to the upper surface of the blood coagulation auxiliary layer to form a blood coagulation promoting layer (S300).
  • each layer after performing the step of forming each layer, it can be configured to go through the step of drying the hemostatic bandage prepared by using a variety of known drying methods (S200, S400), and finally dried by heating By performing the step (S500) to the hemostatic bandage can be prepared.
  • the hemostatic bandage simultaneously containing chitosan and kaolin as an active ingredient was applied by applying an aqueous solution of kaolin to the upper surface of the blood coagulation auxiliary layer formed of an aqueous solution of chitosan containing an organic acid, while chitosan was hydrogelized.
  • the pH of the organic acid induces kaolin to be negatively charged, and the negatively induced kaolin is ionically bonded to the positively charged chitosan, so that the kaolin is evenly laminated in all directions of the fabric, while kaolin and chitosan exhibit sufficient binding force on the fabric. It may have the effect of maintaining flexibility.
  • the hemostatic bandage according to the present invention 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 kaolin that was supported, thereby kaolin to the inside of the deep wound. It is delivered and shows excellent hemostatic effect.
  • hemostatic bandage of the present invention can be easily applied to manufacture hemostatic products for various purposes for hemostasis when chitosan continuously absorbs and completely dissolves blood or exudate and is easily removed from the wound.
  • aqueous solution of organic acid and an aqueous solution of kaolin containing chitosan were prepared and applied to the fabric to prepare a hemostatic bandage.
  • the aqueous organic acid solution containing chitosan contains 0.01 wt% of chitosan powder having an average molecular weight of 100,000 and 90% deacetylation, 0.5 wt% of glycolic acid, and is prepared as an aqueous solution by adding 10 wt% of glycerin to give flexibility. And stirred at low speed.
  • the aqueous solution of the stirred organic acid at low speed was prepared by removing the insolubles and impurities through sieving using a 500 ⁇ m mesh, and degassing after depressurizing to remove bubbles.
  • the aqueous solution of kaolin contains 1% by weight of kaolin powder, in order to give flexibility, 10% by weight of glycerin was added to prepare an aqueous solution.
  • the bandage wound up on a roll is uncoiled and immersed in an organic acid solution containing chitosan along the guide roll (S100), and chitosan is applied to the bandage due to the immersion, and dried using a vacuum dryer. (S200).
  • the dried fabric was put into a conveyor oven and completely dried using heat, thereby preparing a bandage in which a blood coagulation promoting layer and a blood coagulation auxiliary layer were formed (S500).
  • the fibers of the bandages prepared by using an aqueous solution prepared by adjusting the content of chitosan and kaolin were prepared, respectively, and the respective bandages were taken and the image is shown in FIG. It was.
  • 0.01% by weight of chitosan and 2% by weight of kaolin Fig. 3 (b)
  • 0.05% by weight of chitosan and 2% by weight of kaolin Fig. 3 (c)
  • 0.1% by weight of chitosan and 1% by weight of kaolin Fig. 3 ( d)
  • 0.3 wt% chitosan and 0.5 wt% kaolin FIG.

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un pansement hémostatique comprenant une couche d'assistance de coagulation sanguine formée par application d'une première solution comprenant du chitosane et un acide organique sur la surface supérieure d'un tissu; et une couche favorisant la coagulation sanguine formée par application d'une deuxième solution contenant du kaolin sur la surface supérieure de la couche d'assistance de coagulation sanguine, la première solution comprenant de 0,01 à 3 % en poids d'acide organique et de chitosane, et la deuxième solution comprend de 0,1 à 20 % en poids de kaolin. Le pansement hémostatique selon la présente invention peut agglomérer le kaolin autour du chitosane stratifié sur la surface du tissu, de manière à permettre que le kaolin soit stratifié sur le chitosane.
PCT/KR2016/008142 2016-02-05 2016-07-26 Pansement hémostatique comprenant du kaolin et du chitosane en tant que substances actives WO2017135529A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2016-0015069 2016-02-05
KR1020160015069A KR20170093536A (ko) 2016-02-05 2016-02-05 카올린 및 키토산을 유효성분으로 포함하는 지혈 붕대

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WO2017135529A1 true WO2017135529A1 (fr) 2017-08-10

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KR20200126038A (ko) 2019-04-29 2020-11-06 김재홍 유방용 부분 지혈장치

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007515979A (ja) * 2003-06-20 2007-06-21 ジョンソン・アンド・ジョンソン・メディカル・リミテッド 抗酸化性の創傷用包帯材料
US20100292624A1 (en) * 2005-02-15 2010-11-18 Diegelmann Robert F Mineral Technologies (MT) for Acute Hemostasis and for the Treatment of Acute Wounds and Chronic Ulcers
US20140220103A1 (en) * 2011-10-12 2014-08-07 The Trustees Of Columbia University In The City Of New York Hemostatic dressing for arterial bleeding
KR20150027134A (ko) * 2012-06-22 2015-03-11 지-메디카 엘엘씨 지혈 장치
US20150283286A1 (en) * 2011-09-26 2015-10-08 Linda Eastwood Novel hemostatic compositions and dressings for bleeding

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007515979A (ja) * 2003-06-20 2007-06-21 ジョンソン・アンド・ジョンソン・メディカル・リミテッド 抗酸化性の創傷用包帯材料
US20100292624A1 (en) * 2005-02-15 2010-11-18 Diegelmann Robert F Mineral Technologies (MT) for Acute Hemostasis and for the Treatment of Acute Wounds and Chronic Ulcers
US20150283286A1 (en) * 2011-09-26 2015-10-08 Linda Eastwood Novel hemostatic compositions and dressings for bleeding
US20140220103A1 (en) * 2011-10-12 2014-08-07 The Trustees Of Columbia University In The City Of New York Hemostatic dressing for arterial bleeding
KR20150027134A (ko) * 2012-06-22 2015-03-11 지-메디카 엘엘씨 지혈 장치

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