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WO2008117746A1 - 固体状フィブリノゲン製剤 - Google Patents

固体状フィブリノゲン製剤 Download PDF

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Publication number
WO2008117746A1
WO2008117746A1 PCT/JP2008/055254 JP2008055254W WO2008117746A1 WO 2008117746 A1 WO2008117746 A1 WO 2008117746A1 JP 2008055254 W JP2008055254 W JP 2008055254W WO 2008117746 A1 WO2008117746 A1 WO 2008117746A1
Authority
WO
WIPO (PCT)
Prior art keywords
fibrinogen
preparation
salt
amino acid
disclosed
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2008/055254
Other languages
English (en)
French (fr)
Inventor
Shinichi Miyagawa
Tatsuya Araki
Tsutomu Hamuro
Mika Okuda
Hiroshi Kaetsu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chemo Sero Therapeutic Research Institute Kaketsuken
Original Assignee
Chemo Sero Therapeutic Research Institute Kaketsuken
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 Chemo Sero Therapeutic Research Institute Kaketsuken filed Critical Chemo Sero Therapeutic Research Institute Kaketsuken
Priority to US12/532,547 priority Critical patent/US9775884B2/en
Priority to EP08722618.9A priority patent/EP2130549B1/en
Priority to ES08722618.9T priority patent/ES2485901T3/es
Priority to JP2009506319A priority patent/JP5393447B2/ja
Priority to AU2008230476A priority patent/AU2008230476B2/en
Priority to CA2682173A priority patent/CA2682173C/en
Priority to CN2008800169262A priority patent/CN101678086B/zh
Publication of WO2008117746A1 publication Critical patent/WO2008117746A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K38/363—Fibrinogen
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K38/38—Albumins
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/45—Transferases (2)
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4833—Thrombin (3.4.21.5)
    • 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
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • 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
    • 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
    • A61L24/106—Fibrin; Fibrinogen
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/046—Fibrin; Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y203/00—Acyltransferases (2.3)
    • C12Y203/02—Aminoacyltransferases (2.3.2)
    • C12Y203/02013—Protein-glutamine gamma-glutamyltransferase (2.3.2.13), i.e. transglutaminase or factor XIII
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21005—Thrombin (3.4.21.5)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

　溶解性が向上し、短時間で調製され、迅速に臨床現場で使用されうるフィブリノゲン製剤およびそれを用いる組織接着剤を提供する。フィブリノゲンを主成分とし、アルブミン、非イオン性界面活性剤、塩基性アミノ酸またはその塩、および酸性アミノ酸またはその塩および中性アミノ酸またはその塩から選択される少なくとも２種のアミノ酸またはその塩を含有することを特徴とする固体状フィブリノゲン製剤。また、本発明の固体状フィブリノゲン製剤は、その構成成分を医療用基材に固定化することによりフィブリノゲン固定化基材とすることができる。さらに、当該フィブリノゲン固定化基材を、トロンビンを主成分とする成分と組み合わせて、フィブリン接着剤とすることもできる。
PCT/JP2008/055254 2007-03-22 2008-03-21 固体状フィブリノゲン製剤 Ceased WO2008117746A1 (ja)

Priority Applications (7)

Application Number Priority Date Filing Date Title
US12/532,547 US9775884B2 (en) 2007-03-22 2008-03-21 Solid fibrinogen preparation
EP08722618.9A EP2130549B1 (en) 2007-03-22 2008-03-21 Solid fibrinogen preparation
ES08722618.9T ES2485901T3 (es) 2007-03-22 2008-03-21 Preparación sólida de fibrinógeno
JP2009506319A JP5393447B2 (ja) 2007-03-22 2008-03-21 固体状フィブリノゲン製剤
AU2008230476A AU2008230476B2 (en) 2007-03-22 2008-03-21 Solid fibrinogen preparation
CA2682173A CA2682173C (en) 2007-03-22 2008-03-21 Solid fibrinogen preparation
CN2008800169262A CN101678086B (zh) 2007-03-22 2008-03-21 固体纤维蛋白原制剂

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007075380 2007-03-22
JP2007-075380 2007-03-22

Publications (1)

Publication Number Publication Date
WO2008117746A1 true WO2008117746A1 (ja) 2008-10-02

Family

ID=39788481

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/055254 Ceased WO2008117746A1 (ja) 2007-03-22 2008-03-21 固体状フィブリノゲン製剤

Country Status (9)

Country Link
US (1) US9775884B2 (ja)
EP (1) EP2130549B1 (ja)
JP (1) JP5393447B2 (ja)
KR (1) KR20090122279A (ja)
CN (1) CN101678086B (ja)
AU (1) AU2008230476B2 (ja)
CA (1) CA2682173C (ja)
ES (1) ES2485901T3 (ja)
WO (1) WO2008117746A1 (ja)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010061876A1 (ja) * 2008-11-26 2010-06-03 財団法人化学及血清療法研究所 凍結乾燥製剤の包装体の製造方法
WO2010143711A1 (ja) * 2009-06-11 2010-12-16 一般財団法人化学及血清療法研究所 創傷被覆材
KR20150020539A (ko) * 2012-05-14 2015-02-26 데이진 가부시키가이샤 방사선 멸균 내성 단백질 조성물
WO2023017153A1 (en) 2021-08-13 2023-02-16 Biotest Ag Fibrinogen compositions and methods of preparation
US12472237B2 (en) 2021-12-30 2025-11-18 Baxter International Inc. Fibrinogen and thrombin solutions for a fibrin sealant and fibrin sealant kit

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101127127B1 (ko) * 2011-10-27 2012-03-21 주식회사 녹십자 고농도 피브리노겐 용액의 제조 방법 및 이를 이용한 피브린 실란트 제품의 제조방법
EP2797681B1 (en) 2011-12-29 2017-02-01 Omrix Biopharmaceuticals Ltd. Method and device for fast dissolution of solid protein composition
CN108348633B (zh) 2015-11-06 2022-07-08 伊西康公司 压实止血纤维素聚集体
US11413335B2 (en) 2018-02-13 2022-08-16 Guangzhou Bioseal Biotech Co. Ltd Hemostatic compositions and methods of making thereof
CN107754005B (zh) 2016-08-15 2021-06-15 广州倍绣生物技术有限公司 止血组合物及其制造方法
FR3061020B1 (fr) * 2016-12-22 2019-05-17 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Composition de fibrinogene humain
CN111956788A (zh) * 2020-09-22 2020-11-20 上海利康瑞生物工程有限公司 一种猪源纤维蛋白原冻干制剂、制备工艺及其应用

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CA1182444A (en) 1980-08-25 1985-02-12 Heinz Redl Method of accelerating the dissolution of a hard- soluble lyophilized medicament using a magnetic stirrer
JPH047328B2 (ja) * 1982-02-04 1992-02-10 Behringwerke Ag
JPS58185162A (ja) * 1982-04-02 1983-10-28 ドクタ−・ル−ランド・ナハフ・ゲ−エムベ−ハ− 創傷保護材
JPS5980253A (ja) * 1982-10-28 1984-05-09 ユニチカ株式会社 創傷部治療用材料
JPS60204725A (ja) * 1984-03-27 1985-10-16 イムノ・アクチエンゲゼルシャフト 組織接着材の製法
JPS6340546A (ja) 1986-05-19 1988-02-20 ジヨン　ダグラス　マクドナルド　リ−ダ− 光硬化性材料の予備調製器具
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JPH0236872A (ja) 1988-05-31 1990-02-06 Immuno Ag Chem Med Prod 組織接着剤
JPH047328A (ja) 1990-04-25 1992-01-10 Daicel Chem Ind Ltd ポリカーボネートの製造法
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010061876A1 (ja) * 2008-11-26 2010-06-03 財団法人化学及血清療法研究所 凍結乾燥製剤の包装体の製造方法
WO2010143711A1 (ja) * 2009-06-11 2010-12-16 一般財団法人化学及血清療法研究所 創傷被覆材
EP2441477A4 (en) * 2009-06-11 2014-03-26 Chemo Sero Therapeut Res Inst WUNDENABDECKMATERIAL
KR20150020539A (ko) * 2012-05-14 2015-02-26 데이진 가부시키가이샤 방사선 멸균 내성 단백질 조성물
KR102112375B1 (ko) 2012-05-14 2020-05-18 데이진 가부시키가이샤 방사선 멸균 내성 단백질 조성물
WO2023017153A1 (en) 2021-08-13 2023-02-16 Biotest Ag Fibrinogen compositions and methods of preparation
US12472237B2 (en) 2021-12-30 2025-11-18 Baxter International Inc. Fibrinogen and thrombin solutions for a fibrin sealant and fibrin sealant kit

Also Published As

Publication number Publication date
US9775884B2 (en) 2017-10-03
CN101678086B (zh) 2013-07-10
CN101678086A (zh) 2010-03-24
EP2130549A1 (en) 2009-12-09
CA2682173C (en) 2015-10-27
JPWO2008117746A1 (ja) 2010-07-15
US20100119563A1 (en) 2010-05-13
EP2130549B1 (en) 2014-07-16
ES2485901T3 (es) 2014-08-14
EP2130549A4 (en) 2012-04-25
AU2008230476B2 (en) 2012-11-01
KR20090122279A (ko) 2009-11-26
CA2682173A1 (en) 2008-10-02
JP5393447B2 (ja) 2014-01-22
AU2008230476A1 (en) 2008-10-02

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