摘要
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 explore animal species used in bioassay of recombinant human erythropoietin （rHuEPO）in Appendix X B of Chinese Pharmacopoeia Volume Ⅲ （2010 Edition）. Methods： ICR mice and BALB/C micewere selected as the experiment animal, and in vivo biological activities of nineteen batches of rHuEPO were determined and compared in terms of animal species and sex. Results： The results indicated that in vivo biological activi-ties of 19 batches of rHuEPO in BALB/C mice were similar to those in ICR mice of either sex. In groups of ICR mice of half males and half females, the in vivo biological activity was in accordance with the label claim standard-ized in the Chinese Pharmacopoeia;however, the confidence limit rate was high （FL 〉 45% ）, indicating that the result was unreliable. Conclusion ： Both ICR mice and BALB/C mice can be applied for in vivo bioassay of rHuEPO.Results will be more reliable if data are from the group of single sex mice.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第5期779-784,共6页
Chinese Journal of Pharmaceutical Analysis
