CN114787185A - 一种凝血因子ⅷ中间品的冻存方法 - Google Patents

一种凝血因子ⅷ中间品的冻存方法 Download PDF

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Publication number
CN114787185A
CN114787185A CN201980102079.XA CN201980102079A CN114787185A CN 114787185 A CN114787185 A CN 114787185A CN 201980102079 A CN201980102079 A CN 201980102079A CN 114787185 A CN114787185 A CN 114787185A
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Prior art keywords
fviii
factor viii
blood coagulation
product
preparation
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CN114787185B (zh
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冉曙光
王强
蒋德席
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Sichuan Yuanda Shuyang Pharmaceutical Co Ltd
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Sichuan Yuanda Shuyang Pharmaceutical Co Ltd
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Water Supply & Treatment (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

本发明公开了一种凝血因子Ⅷ中间品的冻存方法，属于血液制品领域。所述凝血因子Ⅷ中间品取自凝血因子Ⅷ制剂制备过程中原液制备前或超滤浓缩前或超滤浓缩后的FⅧ浓缩液或FⅧ层析洗脱液以及它们的组合或变形。本发明还公开了上述冻存方法在制备凝血因子Ⅷ制剂、减少凝血因子Ⅷ制品杂质析出、提高凝血因子Ⅷ制品长期稳定性等方面的用途。FⅧ中间品经本发明公开的方法冻存处理，可以确保FⅧ活性维持而比活性提升，同时经后续工艺可制成符合中国药典要求的终产品。本发明公开的凝血因子Ⅷ中间品的冻存方法增加了FⅧ生产工艺的灵活性，利于扩大产能、大规模生产FⅧ制剂。

Description

PCT国内申请，说明书已公开。

Claims (10)

  1. PCT国内申请，权利要求书已公开。
CN201980102079.XA 2019-12-30 2019-12-30 一种凝血因子ⅷ中间品的冻存方法 Active CN114787185B (zh)

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CN113563457B (zh) * 2021-08-20 2023-02-24 华兰生物工程股份有限公司 一种同时制备人纤维蛋白原、凝血因子ⅷ和纤溶酶原的方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102228683A (zh) * 2011-06-21 2011-11-02 湖南紫光古汉南岳制药有限公司 冻干人凝血因子ⅷ的制备方法
CN105348382A (zh) * 2015-12-05 2016-02-24 上海洲跃生物科技有限公司 一种高纯人凝血因子viii的制备方法
CN107226859A (zh) * 2017-08-10 2017-10-03 博雅生物制药集团股份有限公司 一种人凝血因子ⅷ的制备方法
CN107880112A (zh) * 2017-12-28 2018-04-06 华兰生物工程股份有限公司 一种人凝血因子viii的制备方法以及人凝血因子viii制品
CN108976297A (zh) * 2018-08-08 2018-12-11 广东双林生物制药有限公司 一种冷沉淀的制备方法及其在人凝血因子ⅷ生产中的应用

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015143696A1 (zh) * 2014-03-28 2015-10-01 成都蓉生药业有限责任公司 一种冷沉淀的制备方法以及用其制备凝血因子ⅷ制剂的方法
CN104231073B (zh) * 2014-09-25 2017-01-25 广东双林生物制药有限公司 一种人凝血因子viii的制备方法
CN105294858A (zh) * 2015-12-05 2016-02-03 上海洲跃生物科技有限公司 一种冻干人凝血因子viii的制备方法
CN107337727A (zh) * 2017-08-03 2017-11-10 国药集团武汉血液制品有限公司 一种血源性人凝血因子ⅷ制备方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102228683A (zh) * 2011-06-21 2011-11-02 湖南紫光古汉南岳制药有限公司 冻干人凝血因子ⅷ的制备方法
CN105348382A (zh) * 2015-12-05 2016-02-24 上海洲跃生物科技有限公司 一种高纯人凝血因子viii的制备方法
CN107226859A (zh) * 2017-08-10 2017-10-03 博雅生物制药集团股份有限公司 一种人凝血因子ⅷ的制备方法
CN107880112A (zh) * 2017-12-28 2018-04-06 华兰生物工程股份有限公司 一种人凝血因子viii的制备方法以及人凝血因子viii制品
CN108976297A (zh) * 2018-08-08 2018-12-11 广东双林生物制药有限公司 一种冷沉淀的制备方法及其在人凝血因子ⅷ生产中的应用

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