摘要
目的 :用WHO提供的红细胞生成素 (EPO)生物学活性国际标准品 ,测定国外重组人红细胞生成素(rhEPO)产品的体内外生物学活性 ,并比较其差异 ,探讨作为工作标准品的可能性。方法 :网织红法测定rhEPO体内生物学活性 ,ELISA法测定体外生物学活性。结果 :生血素、利血宝的体内生物学活性分别为 1880、2 986IU/瓶 ,体外生物学活性分别为 1867、2 880IU/瓶。结论 :国外rhEPO产品体内、体外生物学活性较一致 ,但与标示量有一定差距 ,需经标定后才能作为EPO产品的体内生物学活性标准。
Purpose: To determine the in vivo/in vitro biological activity for the rhEPO products from abroad by WHO INTERNATIONAL STANDARD for EPO.Methods:The reticulocytes method was used for measuring rhEPO in vivo biological activity, and ELISA was used for measuring rhEPO in vitro biological activity.Results:The counting percentage of reticulocytes method could be used for measuring rhEPO in vivo biological activity.The in vivo biological activity and the in vitro biological activity of Recormon 2 000(1ml)and ESPO injection 3 000(2 ml) were 1 880,1 440 IU/ml and 1 867,1 493 IU/ml,respectively.Conclusion:The in vivo biological activity of the rhEPO products from abroad is equal to the in vitro biological activity about it,but there are some differences with stated content.The calibration is necessary when it is used as working standard.
出处
《中国生化药物杂志》
CAS
CSCD
2000年第4期184-186,共3页
Chinese Journal of Biochemical Pharmaceutics
