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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。
OBJECTIVE: To determine the biological activity of recombinant human erythropoietin (rhEPO) in vitro and in vivo by using the international standards of bioactivity of erythropoietin (EPO) provided by WHO and to compare their differences and to explore the possibility of using as a working standard . Methods: The biological activities of rhEPO were determined by reticulocyte red staining and the biological activity of rhEPO by ELISA. Results: The in vivo biological activity of hematin and reserpine was 1880,2 986 IU / bottle respectively. The in vitro biological activity was 1867,2880 IU / bottle. Conclusion: The biological activity of foreign rhEPO products in vivo and in vitro is consistent, but there is a certain gap with the labeling amount, which needs to be calibrated before being used as the in vivo biological activity standard of EPO products.