关键词: 重组人促红细胞生成素, 体内生物学活性, 剂量组, 小鼠数量

Abstract: Abstract:Objective In vivo biological activity of recombinant human erythropoietin is one of the key indicators of quality control． The aim of this study is to investigate the effect of laboratory mouse number on detection of recombinant human erythropoietin activity in vivo，so as to reduce the retest and false alarm rates，and control the quality risk． Method According to the method described in the Chinese Pharmacopoeia (3)，EPO standard and sample solutions were administrated at low，medium，and high doses respectively to mice by subcutaneous injection． Blood was collected from the orbital venous plexus four days after injection，and be detected． Number of mice in each group was designed as 3，4，6，9，and 12． Ｒesult Ｒetest rate，relative standard deviation， maximum error range，and false alarm rate of the 3 mice group were the highest，no matter what dose of EPO were injected; there were no differences in retest rate，relative standard deviation，and maximum error range between the 4 and 6 mice groups; retest rate，relative standard deviation，maximum error range，and false alarm rate in the 9 and 12 mice groups were the lowest among the experiments． Conclusion The optional number of mice is suggested to be 9 per group in determination of in vivo biological activity of EPO．

Key words: recombinant human erythropoietin, biological activity in vivo, dose group, mice number