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

摘要： 摘要:目的体内生物学活性是重组人促红细胞生成素( Ｒecombinant human erythropoietin，rhuEPO)质量控制的关 键指标之一，通过研究找出实验小鼠数量对rhuEPO 体内活性测定结果的影响，减少检测的复试率和误判率，控制 质量风险。方法根据《中国药典》三部的方法，按低、中、高3 个剂量组，分别于皮下注射人促红细胞生成素 (EPO)标准品和样品溶液，在注射后第4 天从小鼠眼眶后静脉丛采血测定EPO 活性。根据实验设计每剂量组实验 小鼠分别选择为3 只、4 只、6 只、9 只、12 只，通过实验观察每剂量组小鼠数量不同对rhuEPO 内活性测定结果的影 响。结果每剂量组小鼠为3 只的EPO 活性测定复试率、相对标准偏差、最大误差范围和误判率都远高于小鼠数 为4—12 只各组的EPO 活性测定结果;每剂量组小鼠只数为4 只和6 只的实验复试率、相对标准偏差和最大误差 范围相差不大;每剂量组小鼠为9 只和12 只的实验复试率、相对标准偏差、最大误差范围和误判率均低于其他3 个 实验。结论每剂量组小鼠数量越多，EPO 活性测定的相对标准偏差、误差范围和误判率等越低，结合检测成本及 实际可操作性，我们认为每剂量组小鼠数量设为9 只为EPO 生物学活性测定最佳的小鼠使用数量。

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