摘要
本文通过对网织红百分数法测定rHuEPO体内生物学活性进行研究 ,找出网织红细胞百分数与rHuEPO浓度线性相关的范围。从而确定了用计数网织红细胞百分数的方法测定rHuEPO体内生物学活性。提出在rHuEPO体内生物学活性测定中选择合适的稀释液至关重要。对 ( 3,3)法测定rHuEPO体内生物学活性进行了统计 ,批间CV、批内CV均接近 10 % ,单次实验FL %平均数为 31 2 6% ,并提出鼠间差异是造成FL %较大的主要原因 ;对 ( 3,3)法与 ( 2 ,2 )法测定rHuEPO体内生物学活性进行比较 ,发现 ( 2 ,2 )法较 ( 3,3)法更适合用于rHuEPO生产过程中rHuEPO体内生物学活性的测定。
The counting percentage of reticulocytes method used for measuring rHuEPO in vivo biological activity was investigated.The linearly relative range of the percentage of reticulocytes and the concentration of rHuEPO was found,thus the counting percentage of reticulocytes method for measuring in vivo biological activity of rHuEPO was determined,and it was proposed that the dilution buffer is very important for measuring the biological activity in rHuEPO.The measurement results of rHuEPO in vivo biological activity by (3,3)method was statistical,and it was found the inter assay and intra assay variance are closed to 10%,the mean of FL% is 31 26% for single experiment.It was proposed that the difference between mice is the main reason for the high FL%.The measurement results of rHuEPO in vivo biological activity by (3,3)and (2,2)methods was compared,and it was found that the (2,2)method is better than (3,3)method for measuring the rHuEPO in vivo biological activity during the rHuEPO fabrication.
出处
《生物工程进展》
CSCD
2000年第6期68-73,共6页
Progress in Biotechnology
关键词
网织红细胞
糖蛋白激素
红细胞生成素
rHuEPO in vivo biological activity,Reticulocytes,The percentage of reticulocytes(3,3),Meathod,(2,2)meathod.
