重组人促红细胞生成素在国内外药典中质量标准不同点的对比分析

Comparing and Analysis of the Quality Standards of Recombinant Human Erythropoietin Both in European Pharmacopoeia and Chinese Pharmacopoeia

目的:对比重组人促红细胞生成素在《欧洲药典》(第5版)和《中国药典》(2005年版)中标准的不同点,为国内研发机构对基因重组蛋白产品的研发及国内企业对该产品的进出口提供参考。方法:按2部药典要求,对进口产品或国产产品实样进行部分关键指标的对比分析。结果:2部药典对该产品的标准描述上存在具体内容的区别。结论:在现代药物的研发和生产中,对药品的国际及国内标准要进行综合分析而拟定。

Objective： By comparing the quality standards of recombinant human erythropoietin（rhEPO） both in European Pharmacopoeia（the 5th edition） and Chinese Pharmacopoeia（2005 edition）, some modifying suggestions about the standards of rhEPO to the standards makers were proposed. In addition, it could provide some reference to the genetic recombinant protein development carrying in the R＆D organization and the import and export of rhEPO in China. Methods： The importing samples and domestic samples were analyzed by the means in the two Pharmacopoeia separately. Results： The data shows there are some difference on the standards of rhEPO between the two Pharmacopeias. Conclusion： In the R＆D and production of the modem medicine, the international and domestic standards of the medicines should be analyzed synthetically.