CN106139127A - 重组凝血因子ⅷ冻干制剂 - Google Patents
重组凝血因子ⅷ冻干制剂 Download PDFInfo
- Publication number
- CN106139127A CN106139127A CN201610641421.1A CN201610641421A CN106139127A CN 106139127 A CN106139127 A CN 106139127A CN 201610641421 A CN201610641421 A CN 201610641421A CN 106139127 A CN106139127 A CN 106139127A
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- CN
- China
- Prior art keywords
- rdna
- factor viii
- lyophilized formulations
- concentration
- stabilizer
- 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.)
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Classifications
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- 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
- A61K38/37—Factors VIII
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
组分 | 用量 |
重组凝血因子Ⅷ | 1000IU/mL |
组氨酸缓冲液 | 10mM |
蔗糖 | 30mM |
氯化钠 | 300mM |
氯化钙 | 5mM |
甘露醇 | 110mM |
聚山梨酯80 | 0.01wt% |
组分 | 用量 |
重组凝血因子Ⅷ | 1000IU/mL |
组氨酸缓冲液 | 10mM |
蔗糖 | 10mM |
氯化钠 | 300mM |
氯化钙 | 2.5mM |
聚山梨酯80 | 0.01wt% |
组分 | 用量 |
重组凝血因子Ⅷ | 1000IU/mL |
组氨酸缓冲液 | 10mM |
海藻糖 | 10mM |
氯化钠 | 300mM |
氯化钙 | 2.5mM |
聚山梨酯80 | 0.01wt% |
实施例1 | 实施例2 | 实施例3 | |
水分含量(wt%) | 1.8 | 1.1 | 1.3 |
复溶时间(秒) | 11 | 16 | 12 |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201610641421.1A CN106139127B (zh) | 2016-08-05 | 2016-08-05 | 重组凝血因子ⅷ冻干制剂 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201610641421.1A CN106139127B (zh) | 2016-08-05 | 2016-08-05 | 重组凝血因子ⅷ冻干制剂 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN106139127A true CN106139127A (zh) | 2016-11-23 |
CN106139127B CN106139127B (zh) | 2020-04-07 |
Family
ID=57328647
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201610641421.1A Active CN106139127B (zh) | 2016-08-05 | 2016-08-05 | 重组凝血因子ⅷ冻干制剂 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN106139127B (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107467013A (zh) * | 2017-09-20 | 2017-12-15 | 上海贞元诊断用品科技有限公司 | 一种可长期保存的质控品通用血浆基质制备方法 |
CN114642729A (zh) * | 2020-12-21 | 2022-06-21 | 舒泰神(北京)生物制药股份有限公司 | 一种凝血因子x激活剂组合物 |
WO2023246680A1 (en) * | 2022-06-20 | 2023-12-28 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Activators of coagulation factor x and formulations thereof for treating bleeding disorders |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1181974A (zh) * | 1996-07-12 | 1998-05-20 | 美国拜尔公司 | 低糖分、稳定的、不含白蛋的一种重组体凝血因子制剂 |
CN1671410A (zh) * | 2002-06-21 | 2005-09-21 | 诺沃挪第克公司 | 因子ⅶ多肽的稳定化固体组合物 |
CN1917861A (zh) * | 2003-12-19 | 2007-02-21 | 诺和诺德医疗保健公司 | 因子vii多肽的稳定化固体组合物 |
CN101903030A (zh) * | 2007-12-21 | 2010-12-01 | 灵感生物制药学有限公司 | 含海藻糖的稳定化因子ix制剂 |
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 |
CN102295696A (zh) * | 2011-08-16 | 2011-12-28 | 山东泰邦生物制品有限公司 | 由冷沉淀制备凝血因子ⅷ、纤维蛋白原和纤维结合蛋白的方法 |
CN102430116A (zh) * | 2011-08-19 | 2012-05-02 | 上海新兴医药股份有限公司 | 用于人凝血因子ⅷ制剂的干热处理方法及其稳定剂 |
CN103611162A (zh) * | 2013-12-11 | 2014-03-05 | 武汉生物制品研究所有限责任公司 | 人凝血因子ⅷ冻干保护剂及其制备方法 |
CN104231073A (zh) * | 2014-09-25 | 2014-12-24 | 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 |
-
2016
- 2016-08-05 CN CN201610641421.1A patent/CN106139127B/zh active Active
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1181974A (zh) * | 1996-07-12 | 1998-05-20 | 美国拜尔公司 | 低糖分、稳定的、不含白蛋的一种重组体凝血因子制剂 |
CN1671410A (zh) * | 2002-06-21 | 2005-09-21 | 诺沃挪第克公司 | 因子ⅶ多肽的稳定化固体组合物 |
CN1917861A (zh) * | 2003-12-19 | 2007-02-21 | 诺和诺德医疗保健公司 | 因子vii多肽的稳定化固体组合物 |
CN101903030A (zh) * | 2007-12-21 | 2010-12-01 | 灵感生物制药学有限公司 | 含海藻糖的稳定化因子ix制剂 |
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 |
CN102295696A (zh) * | 2011-08-16 | 2011-12-28 | 山东泰邦生物制品有限公司 | 由冷沉淀制备凝血因子ⅷ、纤维蛋白原和纤维结合蛋白的方法 |
CN102430116A (zh) * | 2011-08-19 | 2012-05-02 | 上海新兴医药股份有限公司 | 用于人凝血因子ⅷ制剂的干热处理方法及其稳定剂 |
CN103611162A (zh) * | 2013-12-11 | 2014-03-05 | 武汉生物制品研究所有限责任公司 | 人凝血因子ⅷ冻干保护剂及其制备方法 |
CN104231073A (zh) * | 2014-09-25 | 2014-12-24 | 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 |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107467013A (zh) * | 2017-09-20 | 2017-12-15 | 上海贞元诊断用品科技有限公司 | 一种可长期保存的质控品通用血浆基质制备方法 |
CN114642729A (zh) * | 2020-12-21 | 2022-06-21 | 舒泰神(北京)生物制药股份有限公司 | 一种凝血因子x激活剂组合物 |
CN114642729B (zh) * | 2020-12-21 | 2023-12-15 | 舒泰神(北京)生物制药股份有限公司 | 一种凝血因子x激活剂组合物 |
WO2023246680A1 (en) * | 2022-06-20 | 2023-12-28 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Activators of coagulation factor x and formulations thereof for treating bleeding disorders |
Also Published As
Publication number | Publication date |
---|---|
CN106139127B (zh) | 2020-04-07 |
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Address after: 214092 No. 88 Meiliang West Road, Mashan, Wuxi City, Jiangsu Province Applicant after: Wuxi Yaoming Biotechnology Co., Ltd. Applicant after: SHANGHAI YAOMING BIOTECHNOLOGY CO., LTD. Address before: 214092 No. 88 Meiliang West Road, Mashan, Wuxi City, Jiangsu Province Applicant before: WUXI APPTEC BIOPHARMACEUTICALS CO., LTD. Applicant before: SHANGHAI YAOMING BIOTECHNOLOGY CO., LTD. |
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Effective date of registration: 20211215 Address after: 214092 No. 88 Meiliang West Road, Mashan, Wuxi City, Jiangsu Province Patentee after: Wuxi Yaoming Biotechnology Co.,Ltd. Address before: 214092 No. 88 Meiliang West Road, Mashan, Wuxi City, Jiangsu Province Patentee before: Wuxi Yaoming Biotechnology Co.,Ltd. Patentee before: Shanghai Yaoming Biotechnology Co., Ltd |