CN101161232A - 静脉注射人乙型肝炎免疫球蛋白制备方法 - Google Patents
静脉注射人乙型肝炎免疫球蛋白制备方法 Download PDFInfo
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- CN101161232A CN101161232A CNA2007101446344A CN200710144634A CN101161232A CN 101161232 A CN101161232 A CN 101161232A CN A2007101446344 A CNA2007101446344 A CN A2007101446344A CN 200710144634 A CN200710144634 A CN 200710144634A CN 101161232 A CN101161232 A CN 101161232A
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- 238000000034 method Methods 0.000 title claims abstract description 36
- 238000010253 intravenous injection Methods 0.000 title claims description 9
- 229940060415 hepatitis b immune globulin Drugs 0.000 title claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 148
- 210000002381 plasma Anatomy 0.000 claims abstract description 28
- 241000700605 Viruses Species 0.000 claims abstract description 25
- 238000006243 chemical reaction Methods 0.000 claims abstract description 24
- 238000001914 filtration Methods 0.000 claims abstract description 16
- 230000002779 inactivation Effects 0.000 claims abstract description 15
- 108060003951 Immunoglobulin Proteins 0.000 claims abstract description 14
- 102000018358 immunoglobulin Human genes 0.000 claims abstract description 14
- 238000004587 chromatography analysis Methods 0.000 claims abstract description 9
- 238000002347 injection Methods 0.000 claims abstract description 8
- 239000007924 injection Substances 0.000 claims abstract description 8
- 238000002844 melting Methods 0.000 claims abstract description 7
- 230000008018 melting Effects 0.000 claims abstract description 7
- 238000012856 packing Methods 0.000 claims abstract description 7
- 238000003825 pressing Methods 0.000 claims description 72
- 102000004169 proteins and genes Human genes 0.000 claims description 60
- 108090000623 proteins and genes Proteins 0.000 claims description 60
- 239000007788 liquid Substances 0.000 claims description 43
- 239000000376 reactant Substances 0.000 claims description 36
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 35
- 238000001556 precipitation Methods 0.000 claims description 30
- 238000003756 stirring Methods 0.000 claims description 30
- 239000000047 product Substances 0.000 claims description 25
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 24
- 239000008215 water for injection Substances 0.000 claims description 23
- 102000011759 adducin Human genes 0.000 claims description 18
- 108010076723 adducin Proteins 0.000 claims description 18
- 230000015572 biosynthetic process Effects 0.000 claims description 18
- 238000001816 cooling Methods 0.000 claims description 18
- 239000002244 precipitate Substances 0.000 claims description 18
- 229910001220 stainless steel Inorganic materials 0.000 claims description 18
- 239000010935 stainless steel Substances 0.000 claims description 18
- 238000003786 synthesis reaction Methods 0.000 claims description 18
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- 238000000108 ultra-filtration Methods 0.000 claims description 13
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 12
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 12
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 12
- 239000008351 acetate buffer Substances 0.000 claims description 12
- 239000012467 final product Substances 0.000 claims description 12
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- 239000008363 phosphate buffer Substances 0.000 claims description 12
- 238000004094 preconcentration Methods 0.000 claims description 12
- 239000000243 solution Substances 0.000 claims description 12
- 239000006228 supernatant Substances 0.000 claims description 12
- 239000012295 chemical reaction liquid Substances 0.000 claims description 11
- 230000001143 conditioned effect Effects 0.000 claims description 11
- 239000012141 concentrate Substances 0.000 claims description 8
- 230000009849 deactivation Effects 0.000 claims description 7
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- 238000003556 assay Methods 0.000 claims description 6
- 239000000872 buffer Substances 0.000 claims description 6
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- 238000000502 dialysis Methods 0.000 claims description 6
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- 239000012530 fluid Substances 0.000 claims description 6
- 238000011010 flushing procedure Methods 0.000 claims description 6
- 239000006166 lysate Substances 0.000 claims description 6
- 238000005259 measurement Methods 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 6
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 6
- 230000003068 static effect Effects 0.000 claims description 6
- 230000001954 sterilising effect Effects 0.000 claims description 6
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- 230000008961 swelling Effects 0.000 claims description 6
- 238000005057 refrigeration Methods 0.000 claims description 3
- 238000010257 thawing Methods 0.000 claims description 3
- 230000001105 regulatory effect Effects 0.000 abstract description 6
- 239000003814 drug Substances 0.000 abstract description 5
- 229940036107 hepatitis b immunoglobulin Drugs 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
- 239000012535 impurity Substances 0.000 abstract description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 238000002360 preparation method Methods 0.000 abstract description 4
- 210000004369 blood Anatomy 0.000 abstract description 3
- 239000008280 blood Substances 0.000 abstract description 3
- 238000007086 side reaction Methods 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 2
- SPSXSWRZQFPVTJ-ZQQKUFEYSA-N hepatitis b vaccine Chemical compound C([C@H](NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](N)CCSC)C(=O)N[C@@H](CC1N=CN=C1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)OC(=O)CNC(=O)CNC(=O)[C@H](C)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@@H](N)CCCNC(N)=N)C1=CC=CC=C1 SPSXSWRZQFPVTJ-ZQQKUFEYSA-N 0.000 abstract description 2
- 229940124736 hepatitis-B vaccine Drugs 0.000 abstract description 2
- 230000000415 inactivating effect Effects 0.000 abstract description 2
- 238000004062 sedimentation Methods 0.000 abstract 2
- 241000700721 Hepatitis B virus Species 0.000 abstract 1
- 230000012447 hatching Effects 0.000 abstract 1
- 239000012528 membrane Substances 0.000 abstract 1
- 208000006454 hepatitis Diseases 0.000 description 4
- 238000007710 freezing Methods 0.000 description 3
- 230000008014 freezing Effects 0.000 description 3
- 238000011084 recovery Methods 0.000 description 3
- 239000010836 blood and blood product Substances 0.000 description 2
- 229940125691 blood product Drugs 0.000 description 2
- 231100000283 hepatitis Toxicity 0.000 description 2
- 208000002672 hepatitis B Diseases 0.000 description 2
- 238000010255 intramuscular injection Methods 0.000 description 2
- 239000007927 intramuscular injection Substances 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 238000012827 research and development Methods 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005192 partition Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
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- Peptides Or Proteins (AREA)
Abstract
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Application Number | Priority Date | Filing Date | Title |
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CNB2007101446344A CN100546651C (zh) | 2007-11-20 | 2007-11-20 | 静脉注射人乙型肝炎免疫球蛋白制备方法 |
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CNB2007101446344A CN100546651C (zh) | 2007-11-20 | 2007-11-20 | 静脉注射人乙型肝炎免疫球蛋白制备方法 |
Publications (2)
Publication Number | Publication Date |
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CN101161232A true CN101161232A (zh) | 2008-04-16 |
CN100546651C CN100546651C (zh) | 2009-10-07 |
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CNB2007101446344A Active CN100546651C (zh) | 2007-11-20 | 2007-11-20 | 静脉注射人乙型肝炎免疫球蛋白制备方法 |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101972479A (zh) * | 2010-11-08 | 2011-02-16 | 江西博雅生物制药股份有限公司 | 一种静注人免疫球蛋白的制备工艺 |
CN102178951A (zh) * | 2011-01-28 | 2011-09-14 | 哈尔滨派斯菲科生物制药股份有限公司 | 一种生产静注人免疫球蛋白的方法 |
CN103980345A (zh) * | 2014-05-07 | 2014-08-13 | 贵州中泰生物科技有限公司 | 一种低多聚体的人免疫球蛋白快速生产工艺 |
CN104231075A (zh) * | 2014-09-02 | 2014-12-24 | 江西博雅生物制药股份有限公司 | 一种乙型肝炎人免疫球蛋白的制备工艺 |
CN111499736A (zh) * | 2020-04-28 | 2020-08-07 | 国药集团武汉血液制品有限公司 | 一种静注covid-19人免疫球蛋白的制备方法 |
-
2007
- 2007-11-20 CN CNB2007101446344A patent/CN100546651C/zh active Active
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101972479A (zh) * | 2010-11-08 | 2011-02-16 | 江西博雅生物制药股份有限公司 | 一种静注人免疫球蛋白的制备工艺 |
CN102178951A (zh) * | 2011-01-28 | 2011-09-14 | 哈尔滨派斯菲科生物制药股份有限公司 | 一种生产静注人免疫球蛋白的方法 |
CN102178951B (zh) * | 2011-01-28 | 2014-03-12 | 哈尔滨派斯菲科生物制药股份有限公司 | 一种生产静注人免疫球蛋白的方法 |
CN103980345A (zh) * | 2014-05-07 | 2014-08-13 | 贵州中泰生物科技有限公司 | 一种低多聚体的人免疫球蛋白快速生产工艺 |
CN104231075A (zh) * | 2014-09-02 | 2014-12-24 | 江西博雅生物制药股份有限公司 | 一种乙型肝炎人免疫球蛋白的制备工艺 |
CN104231075B (zh) * | 2014-09-02 | 2017-03-22 | 江西博雅生物制药股份有限公司 | 一种乙型肝炎人免疫球蛋白的制备工艺 |
CN111499736A (zh) * | 2020-04-28 | 2020-08-07 | 国药集团武汉血液制品有限公司 | 一种静注covid-19人免疫球蛋白的制备方法 |
CN111499736B (zh) * | 2020-04-28 | 2021-04-30 | 国药集团武汉血液制品有限公司 | 一种静注covid-19人免疫球蛋白的制备方法 |
Also Published As
Publication number | Publication date |
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CN100546651C (zh) | 2009-10-07 |
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C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C56 | Change in the name or address of the patentee |
Owner name: HARBIN PAISI FEIKE BIOPHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: HAERBIN SHIHENG BIOENGINEERING MEDICINE STOCK CO., LTD. |
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CP01 | Change in the name or title of a patent holder |
Address after: 150078 No. 640 Airport Road, Daoli District, Heilongjiang, Harbin Patentee after: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Address before: 150078 No. 640 Airport Road, Daoli District, Heilongjiang, Harbin Patentee before: Haerbin Shiheng Bioengineering Medicine Stock Co., Ltd. |
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PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Method of producing intravenous injection human hepatitis b immune globulin Effective date of registration: 20130516 Granted publication date: 20091007 Pledgee: Bank of Hankou Limited by Share Ltd Sales Department Pledgor: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Registration number: 2013990000285 |
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PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20150312 Granted publication date: 20091007 Pledgee: Bank of Hankou Limited by Share Ltd Sales Department Pledgor: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Registration number: 2013990000285 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Method of producing intravenous injection human hepatitis b immune globulin Effective date of registration: 20150313 Granted publication date: 20091007 Pledgee: Bank of Hankou Limited by Share Ltd Sales Department Pledgor: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Registration number: 2015990000191 |
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PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20160413 Granted publication date: 20091007 Pledgee: Bank of Hankou Limited by Share Ltd Sales Department Pledgor: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Registration number: 2015990000191 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Method of producing intravenous injection human hepatitis b immune globulin Effective date of registration: 20160418 Granted publication date: 20091007 Pledgee: Bank of Hankou Limited by Share Ltd Sales Department Pledgor: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Registration number: 2016990000303 |
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PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20180420 Granted publication date: 20091007 Pledgee: Bank of Hankou Limited by Share Ltd Sales Department Pledgor: Harbin Paisi Feike Biological Pharmaceutical Co., Ltd. Registration number: 2016990000303 |
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CP03 | Change of name, title or address | ||
CP03 | Change of name, title or address |
Address after: No.77 Siping Road, Limin Economic Development Zone, Hulan District, Harbin City, Heilongjiang Province Patentee after: Harbin pesfico biopharmaceutical Co.,Ltd. Address before: 150078 No. 640 Airport Road, Daoli District, Heilongjiang, Harbin Patentee before: HARBIN PAISI FEIKE BIOLOGICAL PHARMACEUTICAL Co.,Ltd. |