摘要
目的对等电聚焦电泳(IEF)分析方法进行优化,以更好地评价重组人红细胞生成素(rHuEPO)产品的质量。方法用优化的IEF方法分析rHuEPO异构体分布,同时参照rHuEPO的体内外生物学活性和唾液酸含量结果,综合评判rHuEPO的质量。结果建立的优化等电聚焦电泳方法分析rHuEPO,图谱清晰,检测结果可靠。结论IEF方法的优化为rHuEPO的质量控制提供了快捷,准确的手段。
Purpose To optimize the condition of isoelectric focusing（IEF）method for Recombinant Human Erythropoietin （rHuEPO） quality control. Methods rHuEPO was assayed by optimized IEF method and the feasibility and reliability were verified by the in vivo and in vitro activity assay and sialic acid content of rHuEPO samples. Results The result of optimized IEF of rHuEPO was clear and correlated well with other quality data. Conclusion The method of optimized IEF of rHuEPO is reliable and feasible for rHuEPO quality control.
出处
《中国生化药物杂志》
CAS
CSCD
2007年第6期397-399,403,共4页
Chinese Journal of Biochemical Pharmaceutics
关键词
重组人红细胞生成素
等电聚焦电泳
生物学活性
Recombinant Human Erythropoietin
isoelectric focusing
biological activity
