CN101439047B - 提高人凝血酶原复合物稳定性fvii得率的工艺方法 - Google Patents
提高人凝血酶原复合物稳定性fvii得率的工艺方法 Download PDFInfo
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- CN101439047B CN101439047B CN2007101147037A CN200710114703A CN101439047B CN 101439047 B CN101439047 B CN 101439047B CN 2007101147037 A CN2007101147037 A CN 2007101147037A CN 200710114703 A CN200710114703 A CN 200710114703A CN 101439047 B CN101439047 B CN 101439047B
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- 238000000034 method Methods 0.000 title claims abstract description 10
- 101000651439 Homo sapiens Prothrombin Proteins 0.000 title description 2
- 229940039715 human prothrombin Drugs 0.000 title description 2
- 238000010521 absorption reaction Methods 0.000 claims abstract description 19
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 13
- 241000700605 Viruses Species 0.000 claims abstract description 11
- 210000002381 plasma Anatomy 0.000 claims abstract description 10
- 238000001914 filtration Methods 0.000 claims abstract description 9
- 238000005352 clarification Methods 0.000 claims abstract description 6
- 238000007710 freezing Methods 0.000 claims abstract description 6
- 230000008014 freezing Effects 0.000 claims abstract description 6
- 238000010828 elution Methods 0.000 claims abstract description 4
- 238000005406 washing Methods 0.000 claims description 12
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 10
- 230000002779 inactivation Effects 0.000 claims description 10
- 239000003480 eluent Substances 0.000 claims description 8
- 238000004519 manufacturing process Methods 0.000 claims description 8
- 230000009849 deactivation Effects 0.000 claims description 6
- 238000010612 desalination reaction Methods 0.000 claims description 6
- 239000002002 slurry Substances 0.000 claims description 6
- 239000001509 sodium citrate Substances 0.000 claims description 6
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 108010094028 Prothrombin Proteins 0.000 claims description 5
- 102100027378 Prothrombin Human genes 0.000 claims description 5
- 229940039716 prothrombin Drugs 0.000 claims description 5
- 239000011780 sodium chloride Substances 0.000 claims description 5
- 239000003381 stabilizer Substances 0.000 claims description 5
- 229920005654 Sephadex Polymers 0.000 claims description 4
- 239000012507 Sephadex™ Substances 0.000 claims description 4
- 239000003292 glue Substances 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 239000006228 supernatant Substances 0.000 claims description 4
- 230000008961 swelling Effects 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 239000008215 water for injection Substances 0.000 claims description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 3
- 230000000249 desinfective effect Effects 0.000 claims description 3
- 238000002347 injection Methods 0.000 claims description 3
- 239000007924 injection Substances 0.000 claims description 3
- 238000002360 preparation method Methods 0.000 claims description 3
- 230000000694 effects Effects 0.000 claims description 2
- 239000010413 mother solution Substances 0.000 claims description 2
- 238000012856 packing Methods 0.000 claims description 2
- 108010064129 Thrombogen Proteins 0.000 abstract 1
- 229960000074 biopharmaceutical Drugs 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 238000012376 hot air sterilization Methods 0.000 abstract 1
- 238000001179 sorption measurement Methods 0.000 description 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Natural products OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 2
- 108090000190 Thrombin Proteins 0.000 description 2
- 229910001424 calcium ion Inorganic materials 0.000 description 2
- 229960004072 thrombin Drugs 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- -1 citric acid radical ion Chemical class 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 238000010668 complexation reaction Methods 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 229940099816 human factor vii Drugs 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Application Number | Priority Date | Filing Date | Title |
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CN2007101147037A CN101439047B (zh) | 2007-11-20 | 2007-11-20 | 提高人凝血酶原复合物稳定性fvii得率的工艺方法 |
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CN2007101147037A CN101439047B (zh) | 2007-11-20 | 2007-11-20 | 提高人凝血酶原复合物稳定性fvii得率的工艺方法 |
Publications (2)
Publication Number | Publication Date |
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CN101439047A CN101439047A (zh) | 2009-05-27 |
CN101439047B true CN101439047B (zh) | 2011-03-23 |
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CN2007101147037A Active CN101439047B (zh) | 2007-11-20 | 2007-11-20 | 提高人凝血酶原复合物稳定性fvii得率的工艺方法 |
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CN (1) | CN101439047B (zh) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102151289B (zh) * | 2011-01-28 | 2013-04-17 | 哈尔滨派斯菲科生物制药股份有限公司 | 一种人凝血酶原复合物的生产方法 |
CN105326859A (zh) * | 2015-11-09 | 2016-02-17 | 上海洲跃生物科技有限公司 | 一种从Cohn血浆组分III中制备人凝血酶原复合物的方法 |
CN106497903B (zh) * | 2016-09-26 | 2018-07-20 | 河北大安制药有限公司 | 一种用于纯化凝血酶原复合物的工艺 |
CN113584006A (zh) * | 2021-08-20 | 2021-11-02 | 华兰生物工程股份有限公司 | 一种冻干人凝血酶原复合物及其制备方法 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1475569A (zh) * | 2002-08-15 | 2004-02-18 | 华兰生物工程股份有限公司 | 冻干人凝血酶原复合物的生产方法 |
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2007
- 2007-11-20 CN CN2007101147037A patent/CN101439047B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1475569A (zh) * | 2002-08-15 | 2004-02-18 | 华兰生物工程股份有限公司 | 冻干人凝血酶原复合物的生产方法 |
Non-Patent Citations (2)
Title |
---|
余蓉等.采用S/D法灭活病毒的新型凝血酶原复合物中试研制的初探.《中国生化药物杂志》.1997,第18卷(第3期),112-115. * |
邱家山等.人凝血酶原复合物分离纯化工艺的研究进展.《生物技术通报》.2006,(第2期),17-24页. * |
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CN101439047A (zh) | 2009-05-27 |
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ASS | Succession or assignment of patent right |
Owner name: ENGINEERING RESEARCH CENTER OF BLOOD PRODUCTS, SHA |
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C41 | Transfer of patent application or patent right or utility model | ||
C53 | Correction of patent for invention or patent application | ||
CB03 | Change of inventor or designer information |
Inventor after: Liu Xinyan Inventor after: Pang Guangli Inventor after: Zhong Lijun Inventor after: Zhang Shunlong Inventor after: Zhang Cuiping Inventor after: Shi Xiumei Inventor after: Guan Changyong Inventor after: Sun Yongchang Inventor before: Liu Xinyan Inventor before: Zhang Shunlong Inventor before: Wu Chuntao Inventor before: Guan Changyong Inventor before: Shi Xiumei Inventor before: Sun Yongchang Inventor before: Du Jiliang |
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COR | Change of bibliographic data |
Free format text: CORRECT: INVENTOR; FROM: LIU XINYAN ZHANG SHUNLONG WU CHUNTAO JIAN CHANGYONG SHI HONGMEI SUN YONGZHANG DU JILIANG TO: LIU XINYAN PANG GUANGLI ZHONG LIJUN ZHANG SHUNLONG ZHANG CUIPING SHI HONGMEI JIAN CHANGYONG SUN YONGZHANG |
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TA01 | Transfer of patent application right |
Effective date of registration: 20101201 Address after: 271000 Tai'an East Road, Shandong, No. 14 Applicant after: Shandong Taibang Biological Product Co., Ltd. Co-applicant after: Shandong Engineering Center for Blood Product Address before: 271000 Tai'an East Road, Shandong, No. 14 Applicant before: Shandong Taibang Biological Product Co., Ltd. |
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C14 | Grant of patent or utility model | ||
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CP02 | Change in the address of a patent holder | ||
CP02 | Change in the address of a patent holder |
Address after: 271000 5666 Longquan Road, hi tech Zone, Tai'an, Shandong Patentee after: SHANDONG TAIBANG BIOLOGICAL PRODUCTS Co.,Ltd. Patentee after: SHANDONG ENGINEERING CENTER FOR BLOOD PRODUCT Address before: 271000 No. 14 East Tiger Hill Road, Shandong, Tai'an Patentee before: SHANDONG TAIBANG BIOLOGICAL PRODUCTS Co.,Ltd. Patentee before: SHANDONG ENGINEERING CENTER FOR BLOOD PRODUCT |