重组人粒细胞刺激因子在《中国药典》和《欧洲药典》中质量标准不同点的对比分析

Comparing and analysis of the quality standards of Recombinant Human Granulocyte Colonystimulating Factor both in Chinese Pharmacopoeia and European Pharmacopoeia

目的对比重组人粒细胞刺激因子(rhG-CSF,Filgrastim)在《中国药典》(2005年版)和《欧洲药典》(6.3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。方法按两部药典要求,对国产产品实样进行部分关键指标的检测分析。结果两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 granulocyte colony-stimulating factor（rhG--CSF, Filgrastim） both in European Pharmacopoeia （the 6.3 edition） and Chinese Pharmacopoeia （2005 edition）, some modifying suggestions about the standards of rhG--CSF 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 rhG--CSF in China. METHODS The domestic samples were analyzed by the means in the two Pharmacopoeia separately. RESULTS The data shows there are some difference on the standards of rhG- CSF between the two Pharmaco- peias. CONCLUSION In the R ＆ D and production of the modern medicine, the international and domestic standards of the medicines should be analyzed synthetically.