重组人红细胞生成素体内外活性检测方法的比较

目的对重组人红细胞生成素 (rhEPO)体内外活性测定结果进行比较 ,说明体内外活性测定对rhEPO质量控制的意义。方法采用59Fe摄入法、网织红细胞法和ELISA法测定rhEPO制品的体内外生物学活性。结果59Fe摄入法和网织红细胞法测定结果一致 ,与rhEPO唾液酸含量具有相关性。当rhEPO唾液酸含量较低时 ,ELISA法与体内活性测定结果有较大差异。结论rhEPO体内外活性测定方法可以相互补充 ,均是保证rhEPO质量不可缺少的质控手段。

Comparison between rhEPO activity assay methods in vivo and in vitro

PurposeThe aim is to demonstrate the necessity of both in vitro and in vivo activity assay methods for quality control of rhEPO products. Methods 59 Fe incorporation and reticulocyte counting methods were used for in vivo assay, ELISA method for in vitro assay.ResultsThere was no difference between the two in viv oassay methods, and the results correlated very well with the sialic acid content of rhEPO. However when the sialic acid content was low, there was great difference between in vivo and in vitro assay results.ConclusionBoth in vitro and in vivo assay methods were necessary for the quality control of rhEPO products.