垂直板等电聚焦法测定基因重组人红细胞生成素(rhEPO)各异构体组分含量

Determination of each isomer in Recombinant Human Erythropoietin by vertical slab isoelectric focusing

建立了测定基因重组人红细胞生成素(rhEPO)各异构体组分含量的垂直板等电聚焦方法,该方法经济,测定结果准确、可靠,与《欧洲药典》6.0版规定的毛细管区带电泳法的测定结果基本一致,本法为rhEPO生产过程控制及原液质量控制提供了准确、可行的检测手段。

To establish vertical slab isoelectric focusing（IEF） method for assay the content of the isomer in Recombinant Human Erythropoietin（rhEPO）. This method is economical, and it＇s result is exact and reliable, consistent with the result of Capillary Zone Electrophoresis in European Pharmacopoeia 6.0. This method suited to quality control of product process and bulk assay.