WO2017117995A1 - Colle de fibrine contenant du chitosane et son procédé d'utilisation - Google Patents

Colle de fibrine contenant du chitosane et son procédé d'utilisation Download PDF

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Publication number
WO2017117995A1
WO2017117995A1 PCT/CN2016/092995 CN2016092995W WO2017117995A1 WO 2017117995 A1 WO2017117995 A1 WO 2017117995A1 CN 2016092995 W CN2016092995 W CN 2016092995W WO 2017117995 A1 WO2017117995 A1 WO 2017117995A1
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Prior art keywords
chitosan
solution
lyophilized powder
derivative
content
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Ceased
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PCT/CN2016/092995
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English (en)
Chinese (zh)
Inventor
张俊辉
朱晋辉
万华印
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Guangzhou Municipal Zhongwei Biotechnology Co Ltd
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Guangzhou Municipal Zhongwei Biotechnology Co Ltd
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Publication of WO2017117995A1 publication Critical patent/WO2017117995A1/fr
Anticipated expiration legal-status Critical
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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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/043—Mixtures of macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0015—Medicaments; Biocides
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/08—Polysaccharides
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0052—Mixtures of macromolecular compounds
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0066—Medicaments; Biocides
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254—Enzymes, proenzymes
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding

Definitions

  • the invention relates to the technical fields of biopharmaceuticals, biological products, biological materials and medical instruments, in particular to a protein gel containing chitosan, which can be used for hemostasis, adhesion and sealing in surgery.
  • Rapid and complete hemostasis during surgery is one of the core operations of the basic operation of surgery.
  • various kinds of first-aid such as frequent traffic accidents and accidents, it is also generally faced with problems such as rapid and effective hemostasis, alleviating patient suffering and saving people's lives.
  • the technical problem to be solved by the present invention is to provide a protein gum containing chitosan and a method for using the same, Fast wound healing.
  • the technical solution of the present invention is: a chitosan-containing protein gel comprising a first lyophilized powder and a second lyophilized powder, the components of the first lyophilized powder comprising: fibrin Original, XIII coagulation factor and chitosan or a derivative thereof; components of the second lyophilized powder include: thrombin and chitosan or a derivative thereof.
  • Chitosan has a good hemostatic effect.
  • the hemostasis mechanism is to form red blood cell agglomeration through the combination of polycations carried by chitosan and anion on the surface of erythrocyte membrane, and activate platelet aggregation and activate thrombin to achieve rapid hemostasis.
  • the chitosan when it is in contact with the wound, it can also absorb a large amount of exudate from the wound surface and accelerate hemostasis.
  • Chitosan has the effect of promoting wound healing, often accompanied by low levels of scar formation and good healing appearance. Cellular and molecular studies have shown that this phenomenon is likely to be related to the regulation of collagen synthesis and secretion in the wound by carboxymethyl chitosan.
  • Chitosan can promote fibroblast proliferation, activate macrophages, increase the content of TGF- ⁇ 1 and IL-6, and promote wound healing.
  • the fibrinogen, XIII coagulation factor and thrombin are derived from a mammal.
  • a method for using a chitosan-containing protein gel comprising the following steps:
  • the content of chitosan or its derivative in the first solution is 0.1-20 mg/ml
  • the content of chitosan or its derivative in the second solution is 0.1-20 mg/ml.
  • the content of chitosan or its derivative in the first solution is 0.2 to 10 mg/ml
  • the content of chitosan or its derivative in the second solution is 0.2 to 10 mg/ml.
  • the content of chitosan or its derivative in the first solution is 0.5 to 5 mg/ml
  • the content of chitosan or its derivative in the second solution is 0.5 to 5 mg/ml.
  • the blood coagulation effect of both fibrin and chitosan can be exerted, so that the hemostasis speed is faster, and the wound healing effect after use is better.
  • the human fibrinogen intermediate was dissolved in an appropriate amount of sodium chloride (3 g/L, sodium citrate 1.5 g/L, sodium hydrogencarbonate 0.8 g/L, L-arginine hydrochloride 3.3 g/L).
  • the protein concentration was 4%, and then chitosan was added to 5 g/L to adjust the pH to 7.2. After centrifugation and filtration, the mixture was lyophilized to obtain the first lyophilized powder.
  • the human thrombin intermediate was formulated into 550 IU/ml, glycine 5 g/L, human albumin 2 g/L, chitosan 20 g/L, centrifuged, and lyophilized to obtain a second lyophilized powder.
  • the porcine fibrinogen intermediate was dissolved in the protein with an appropriate amount of sodium chloride (3 g/L, sodium citrate 2 g/L, polysorbate 800.2 g/L, L-arginine hydrochloride 3.3 g/L). The concentration was 3%, and then chitosan was added to 8.5 g/L, and the pH was adjusted to 7.5. After centrifugation and filtration, the mixture was lyophilized to obtain the first lyophilized powder.
  • sodium chloride 3 g/L, sodium citrate 2 g/L, polysorbate 800.2 g/L, L-arginine hydrochloride 3.3 g/L.
  • the concentration was 3%, and then chitosan was added to 8.5 g/L, and the pH was adjusted to 7.5. After centrifugation and filtration, the mixture was lyophilized to obtain the first lyophilized powder.
  • the pig-derived thrombin intermediate was formulated into 550 IU/ml, glycine 5 g/L, human albumin 2 g/L, chitosan 10 g/L, centrifuged, and lyophilized to obtain a second lyophilized powder.
  • the porcine fibrinogen intermediate was dissolved in the protein with an appropriate amount of sodium chloride (2 g/L, sodium citrate 2 g/L, polysorbate 800.2 g/L, L-arginine hydrochloride 3.3 g/L). The concentration was 3.5%, and then hydroxybutyl chitosan was added to 2.5 g/L to adjust the pH to 7.5. After centrifugation and filtration, the mixture was lyophilized to obtain the first lyophilized powder.
  • sodium chloride 2 g/L, sodium citrate 2 g/L, polysorbate 800.2 g/L, L-arginine hydrochloride 3.3 g/L.
  • the concentration was 3.5%, and then hydroxybutyl chitosan was added to 2.5 g/L to adjust the pH to 7.5. After centrifugation and filtration, the mixture was lyophilized to obtain the first lyophilized powder.
  • the pig-derived thrombin intermediate was formulated into 550 IU/ml, glycine 15 g/L, human albumin 2 g/L, chitosan 1 g/L, centrifuged, and lyophilized to obtain a second lyophilized powder.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une colle de fibrine contenant du chitosane et son procédé d'utilisation. La colle de fibrine contenant du chitosane comprend une première poudre lyophilisée et une seconde poudre lyophilisée, les composants de la première poudre lyophilisée comprenant du fibrinogène, du facteur XIII et du chitosane ou des dérivés de celui-ci, et les composants de la seconde poudre lyophilisée comprenant de la thrombine et du chitosane ou des dérivés de celui-ci. Lors de l'utilisation, les deux poudres lyophilisées sont dissoutes dans des solvants, et le mélange de solutions est pulvérisé à la surface d'une plaie afin d'accélérer la cicatrisation. L'ajout de chitosane à la colle de fibrine fait que l'on peut combiner les effets hémostatiques de la fibrine et du chitosane, ce qui accélère l'arrêt du saignement et permet d'obtenir un meilleur effet cicatrisant après utilisation.
PCT/CN2016/092995 2016-01-08 2016-08-03 Colle de fibrine contenant du chitosane et son procédé d'utilisation Ceased WO2017117995A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610010286.0A CN105435299A (zh) 2016-01-08 2016-01-08 一种含有壳聚糖的蛋白胶及其使用方法
CN201610010286.0 2016-01-08

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WO2017117995A1 true WO2017117995A1 (fr) 2017-07-13

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023115427A1 (fr) * 2021-12-23 2023-06-29 Guangzhou Bioseal Biotech Co., Ltd. Thrombine séchée par pulvérisation

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105435299A (zh) * 2016-01-08 2016-03-30 广州市众为生物技术有限公司 一种含有壳聚糖的蛋白胶及其使用方法

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US20020156498A1 (en) * 2000-02-22 2002-10-24 Yoshio Jo Hemostatic soluble cellulose fibers containing coagulating protein for treating wound and process for producing the same
CN1709515A (zh) * 2005-06-28 2005-12-21 吴昌琳 一种稳定的液态复合纤维蛋白封闭剂及其制备和用途
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CN1709515A (zh) * 2005-06-28 2005-12-21 吴昌琳 一种稳定的液态复合纤维蛋白封闭剂及其制备和用途
JP2011092699A (ja) * 2009-09-29 2011-05-12 Chemo-Sero-Therapeutic Research Inst 組織癒着防止剤
CN103191462A (zh) * 2012-01-05 2013-07-10 王伟 医用止血消毒生物敷料
CN105435299A (zh) * 2016-01-08 2016-03-30 广州市众为生物技术有限公司 一种含有壳聚糖的蛋白胶及其使用方法

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YANG, JIAN ET AL.: "The Mechanism of Chitosan Hemostasis and its Application", FOREIGN MEDICAL SCIENCES (BIOMEDICAL ENGINEERING FASCICLE, vol. 24, no. 2, 31 December 2001 (2001-12-31), pages 77 - 80 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023115427A1 (fr) * 2021-12-23 2023-06-29 Guangzhou Bioseal Biotech Co., Ltd. Thrombine séchée par pulvérisation

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