CN101837119B - 白介素-11半成品溶液的制备方法及其产品 - Google Patents
白介素-11半成品溶液的制备方法及其产品 Download PDFInfo
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- CN101837119B CN101837119B CN2010101764457A CN201010176445A CN101837119B CN 101837119 B CN101837119 B CN 101837119B CN 2010101764457 A CN2010101764457 A CN 2010101764457A CN 201010176445 A CN201010176445 A CN 201010176445A CN 101837119 B CN101837119 B CN 101837119B
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- 239000000047 product Substances 0.000 title claims abstract description 60
- 102000003815 Interleukin-11 Human genes 0.000 title claims abstract description 47
- 108090000177 Interleukin-11 Proteins 0.000 title claims abstract description 47
- 229940074383 interleukin-11 Drugs 0.000 title claims abstract description 45
- 238000000034 method Methods 0.000 title claims abstract description 27
- 239000011265 semifinished product Substances 0.000 title claims abstract description 25
- 239000011259 mixed solution Substances 0.000 claims abstract description 35
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000000243 solution Substances 0.000 claims abstract description 26
- 238000003756 stirring Methods 0.000 claims abstract description 25
- 239000008363 phosphate buffer Substances 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000002253 acid Substances 0.000 claims abstract description 12
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 18
- 238000002360 preparation method Methods 0.000 claims description 18
- 239000004471 Glycine Substances 0.000 claims description 13
- 238000002156 mixing Methods 0.000 claims description 12
- 239000008215 water for injection Substances 0.000 claims description 11
- 239000000843 powder Substances 0.000 claims description 2
- 108090000623 proteins and genes Proteins 0.000 abstract description 13
- 238000002347 injection Methods 0.000 abstract description 11
- 239000007924 injection Substances 0.000 abstract description 11
- 230000010494 opalescence Effects 0.000 abstract description 11
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- 102000004169 proteins and genes Human genes 0.000 abstract description 9
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- 239000003814 drug Substances 0.000 abstract description 2
- 229940079593 drug Drugs 0.000 abstract description 2
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- 230000001502 supplementing effect Effects 0.000 abstract 1
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- 239000007788 liquid Substances 0.000 description 10
- 239000011550 stock solution Substances 0.000 description 10
- 238000012360 testing method Methods 0.000 description 10
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- KDQPSPMLNJTZAL-UHFFFAOYSA-L disodium hydrogenphosphate dihydrate Chemical compound O.O.[Na+].[Na+].OP([O-])([O-])=O KDQPSPMLNJTZAL-UHFFFAOYSA-L 0.000 description 9
- 229910052739 hydrogen Inorganic materials 0.000 description 9
- 239000001257 hydrogen Substances 0.000 description 9
- 239000000546 pharmaceutical excipient Substances 0.000 description 9
- VBJGJHBYWREJQD-UHFFFAOYSA-M sodium;dihydrogen phosphate;dihydrate Chemical class O.O.[Na+].OP(O)([O-])=O VBJGJHBYWREJQD-UHFFFAOYSA-M 0.000 description 9
- 238000005303 weighing Methods 0.000 description 9
- 235000018102 proteins Nutrition 0.000 description 8
- 238000011084 recovery Methods 0.000 description 6
- 101001010568 Homo sapiens Interleukin-11 Proteins 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 5
- 102000049885 human IL11 Human genes 0.000 description 5
- 102000004127 Cytokines Human genes 0.000 description 4
- 108090000695 Cytokines Proteins 0.000 description 4
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- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
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- 210000003995 blood forming stem cell Anatomy 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 230000008034 disappearance Effects 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 229910000397 disodium phosphate Inorganic materials 0.000 description 1
- 235000019800 disodium phosphate Nutrition 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
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- 230000001976 improved effect Effects 0.000 description 1
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- 238000007689 inspection Methods 0.000 description 1
- 239000008176 lyophilized powder Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
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- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
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- 239000003223 protective agent Substances 0.000 description 1
- 238000010188 recombinant method Methods 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000008227 sterile water for injection Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
- 230000001361 thrombopoietic effect Effects 0.000 description 1
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
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Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN2010101764457A CN101837119B (zh) | 2010-05-19 | 2010-05-19 | 白介素-11半成品溶液的制备方法及其产品 |
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Application Number | Priority Date | Filing Date | Title |
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CN2010101764457A CN101837119B (zh) | 2010-05-19 | 2010-05-19 | 白介素-11半成品溶液的制备方法及其产品 |
Publications (2)
Publication Number | Publication Date |
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CN101837119A CN101837119A (zh) | 2010-09-22 |
CN101837119B true CN101837119B (zh) | 2012-07-04 |
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CN2010101764457A Active CN101837119B (zh) | 2010-05-19 | 2010-05-19 | 白介素-11半成品溶液的制备方法及其产品 |
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Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102319206A (zh) * | 2011-09-28 | 2012-01-18 | 厦门特宝生物工程股份有限公司 | 一种稳定的重组人白介素-11水溶液及其制备方法 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JPH0645551B2 (ja) * | 1986-01-07 | 1994-06-15 | 塩野義製薬株式会社 | インタ−ロイキン−2組成物 |
CN1421245A (zh) * | 2001-11-22 | 2003-06-04 | 武汉春天生物工程股份有限公司 | 注射用重组人白介素11制剂及制备工艺 |
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Owner name: EAST CHINA UNIVERSITY OF SCIENCE AND TECHNOLOGY SH Free format text: FORMER OWNER: EAST CHINA UNIVERSITY OF SCIENCE AND TECHNOLOGY Effective date: 20141222 |
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Effective date of registration: 20141222 Address after: 252201 No. 78 donkey hide street, Dong'e County, Shandong Patentee after: SHAN DONG DONG-E E-JIAO Co.,Ltd. Patentee after: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee after: SHANDONG EHUA BIOLOGICAL PHARMACEUTICAL Co.,Ltd. Address before: 252201 No. 78 donkey hide street, Dong'e County, Shandong Patentee before: SHAN DONG DONG-E E-JIAO Co.,Ltd. Patentee before: East China University of Science and Technology |
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Address after: 252201 No. 78 donkey hide street, Dong'e County, Shandong Co-patentee after: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee after: DONG-E E-JIAO Co.,Ltd. Co-patentee after: Huarun Onde Biopharmaceutical Co.,Ltd. Address before: 252201 No. 78 donkey hide street, Dong'e County, Shandong Co-patentee before: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee before: DONG-E E-JIAO Co.,Ltd. Co-patentee before: ANGDE BIOLOGY PHARMACEUTICAL CO.,LTD. Address after: 252201 No. 78 donkey hide street, Dong'e County, Shandong Co-patentee after: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee after: DONG-E E-JIAO Co.,Ltd. Co-patentee after: ANGDE BIOLOGY PHARMACEUTICAL CO.,LTD. Address before: 252201 No. 78 donkey hide street, Dong'e County, Shandong Co-patentee before: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee before: SHAN DONG DONG-E E-JIAO Co.,Ltd. Co-patentee before: SHANDONG EHUA BIOLOGICAL PHARMACEUTICAL Co.,Ltd. |
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Effective date of registration: 20201228 Address after: 200237 No. 130, Meilong Road, Shanghai, Xuhui District Patentee after: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee after: Huarun Onde Biopharmaceutical Co.,Ltd. Address before: 252201 No. 78 donkey hide street, Dong'e County, Shandong Patentee before: Dong-e E-jiao Co.,Ltd. Patentee before: EAST CHINA University OF SCIENCE AND TECHNOLOGY Patentee before: Huarun Onde Biopharmaceutical Co.,Ltd. |
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