| 重组人IL-2的纯化和初步质量监测 |
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| 引用本文： | 田志刚,田彤,孙汭,张捷,张建华,刘杰. 重组人IL-2的纯化和初步质量监测[J]. 中国生化药物杂志, 1994, 0(3) |
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| 作者姓名： | 田志刚 田彤 孙汭 张捷 张建华 刘杰 |
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| 作者单位： | 山东省医科院山东肿瘤生物治疗研究中心!济南250001(田志刚，田彤，孙汭，张捷，张建华)，山东省医科院山 (刘杰) |
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| 摘 要： | 从重组IL-2菌株发酵后包含体中,采用增溶分离、分子筛层析、超滤和反相HPLC等工艺,纯化出具备临床质量要求的IL-2.全套工艺在10d内完成,每周期可获IL-2达200mg(8×10~8CU),产品比活为4×1O~6CU/mg蛋白,回收率为37.5%,产品纯度为99%.产品经家兔热原试验、小鼠安全试验和内毒素测定符合临床要求.根据本实验室规模每周期具备放大5～10倍的能力.
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| 关 键 词： | 重组IL-2 纯化 质控 |
Purification and Quality Control of rIL-2 |
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| Tian Zhigang,Tian Tong,Sun Rui,Zhang Jie,Zhang Jianhua,Liu JieShandong Cancer Biotherapy Center,Shandong Academy of Medical Sciences. Purification and Quality Control of rIL-2[J]. Chinese Journal of Biochemical Pharmaceutics, 1994, 0(3) |
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| Authors: | Tian Zhigang Tian Tong Sun Rui Zhang Jie Zhang Jianhua Liu JieShandong Cancer Biotherapy Center Shandong Academy of Medical Sciences |
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| Affiliation: | Jinan 250001 |
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| Abstract: | Recombinant human interleukin-2 (rIL-2) produced from inclusion bodies in E. coli was purified to apparent homogeneity of clinic-standard by solubilization separation, gel-filtration chromatog-raphy, ultra-filtration, reverse-phase high performance liquid chromatography. The whole process was completed within 10 days, and rIL-2 was obtained about 200 mg (8×108 CU) for each cycle; and the specific activity was about 4× 106 CU/mg pro, yield 37. 5% and purity 99%. The product was examined of rabbit-pyrogen test, mouse safety test and endotoxin test; and the results reached clinic level. This production capacity can be amplified to 5-10 folds. |
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| Keywords: | rIL-2 Purification Quality control |
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