摘要
A simple in vivo bioassay suitable for the routine quality control testing of a new erythropoiesis stimulating protein was developed.Subcutaneous administration of the new erythropoiesis stimulating protein to Balb/c mice in a single dose resulted in a dose-dependent increase in the number of circulating reticulocytes.Within the erythropoiesis stimulating protein dose range of 3.125 to 200 ng per mouse,there is a strong linear relationship between the dose and reticulocyte counts in the treated mice.This linear relationship allows us to determine the biological potency of the testing erythropoiesis stimulating protein preparation relative to a reference standard using parallel line assay.Accuracy,precision,dose variation and blood collection time of this method were analyzed in order to choose doses in the linear range that are suitable for setting up a useful,precise,and economical bioassay.
本文建立了一种新的红细胞生成刺激蛋白体内生物学活性测定方法。将新的红细胞生成刺激蛋白单剂量注射给小鼠后, 小鼠外周血网织红细胞含量随注射剂量增加而升高。在3.125 200 ng/只的剂量范围内, 外周血网织红细胞的含量与注射剂量呈很好地线性关系, 满足量-反应平行线法定量的要求。本文对方法的准确性、精密度、检测范围、采血时间等进行了研究。结果表明, 该方法准确、重现性好, 可用于新的红细胞生成刺激蛋白生物学活性检测。
