摘要
采用多血小鼠法和网织红细胞法，对不同厂家的重组人红细胞生成素进行体内生物学活性测定。认为多血小鼠法灵敏度高，结果准确、客观，重现性符合要求，新申报的重组人红细胞生成素必须采用该法进行测定，但操作复杂，而且需要同位素；网织红细胞法方便、快速，结果可靠，灵敏度、重现性适合常规检验，生产厂家可用该法替代多血小鼠法。
Two bioassay methods were compared to determine the in vivo biological activity of rhEPO preparations produced by different manufacturers. The results suggested that the polycythaemic mice method was sensitive, reliable and reproducible, and the biological activity of newly applied product must be determined by this method, but the usage of radioactive compound and preliminary treatment of animals made it complicated; the reticulocyte counting method was simple and easy, and the sensitivity, reliability and reproducibility were acceptable for routine in vivo bioassay, so it could be used in place of the polycythaemic mice method for manufacturers.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1998年第1期74-76,共3页
Journal of China Pharmaceutical University
