重组人红细胞生成素质量控制体系研究  

A Feasible System for Quality Control of Recombinant Human Erythropoietin

作　　者：周勇[1] 王箐舟[1] 王军志[1] 黄培堂[2] 程雅琴[1] 陈震[1] 沈琦[1] 

机构地区：[1]中国药品生物制品检定所血液制品室,北京100050 [2]军事医学科学院,北京100850

出　　处：《中国生物制品学杂志》2007年第8期586-589,共4页Chinese Journal of Biologicals

摘　　要：目的研究重组人红细胞生成素(rHuEPO)质量控制体系。方法用网织红细胞分析仪测活法测定rHuEPO体内生物学活性。比较不同的等电聚焦电泳条件、蛋白含量测定方法和牛血清白蛋白检测方法。按rHuEPO特点进行其他项目的检测。结果采用全自动网织红细胞计数仪检测rHuEPO体内生物学活性方法简便可靠;电泳时添加尿素可增加区带清晰度和条带清晰度;采用BSAELISA检测牛血清白蛋白含量可准确定量;免疫印迹试验可有效地检测rHuEPO成品质量。结论本研究建立了一套完善的rHuEPO质量控制体系。Objective To optimize the quality control system of recombinant human erythropeietin（rHuEPO）. Methods Determine the in vivo bioactivity of rHuEPO by full-automatic reticulocyte analyzer. Compare the isoelectric focusing（IEF） electrophoretic profiles of rHuEPO under various conditions as well as the determination results of protein and residual bovine serum albumin（BSA） contents by various methods. Identity test and other control tests were performed according to the requirements in Chinese Pharmacopoeia （Volume Ⅲ ,2005 edition）. Results Full-automatic reticulocyte analyzer was simple and reliable for the determination of in vivo bioactivity of rHuEPO. The addition of urea into running gel increased the definiting power of bands on IEF electrophoretic profile. BSA ELISA kit was suitable for accurate quantitative analysis of residual BSA in rHuEPO. Western blot was suitable for identity test on final product of rHuEPO. Conclusion A feasible system for quality control of rHuEPO was developed.

关 键 词：重组人红细胞生成素 质量控制体系 生物学活性 

分 类 号：R392.33[医药卫生—免疫学]