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目的:对中国药典2010年版三部附录ⅩB重组人促红素(rHuEPO)体内生物学活性测定方法中规定的动物品系进行探讨研究。方法:选用ICR小鼠、BALB/C小鼠作为实验动物,测定19批进口重组人促红素的体内生物学活性,从动物品系、性别的角度进行比较。结果:19批重组人促红素在雌性或雄性ICR小鼠、BALB/C小鼠体内生物学活性之间的差异无统计学意义;每组ICR小鼠的性别为雌雄各半时,体内生物学活性合标示量符合药典规定,但可信限率(FL)超过45%,结果不可靠。结论:ICR小鼠与BALB/C小鼠均可用于重组人促红素体内生物学活性测定,采用单一性别的动物进行试验结果更为可靠。
OBJECTIVE: To investigate the animal strains regulated by the method of determination of the biological activity of rHuEPO in three appendices of three Chinese Pharmacopoeia 2010 edition. Methods: ICR mice and BALB / C mice were selected as experimental animals. The in vivo biological activities of 19 batches of imported recombinant human erythropoiesis were determined and compared in terms of animal strains and sex. Results: There were no significant differences in the biological activity of 19 batches of recombinant human erythropoietin in female or male ICR mice and BALB / C mice. When the sex of each batch of ICR mice was male and female, The amount of active labeled in line with Pharmacopoeia, but the confidence limit (FL) over 45%, the result is not reliable. Conclusion: Both ICR mice and BALB / C mice can be used for the bioassay of recombinant human erythropoiesis. The results of single animal experiment are more reliable.