重组人CTAL4-Ig活性测定参考品的制备及标定

目的　建立用于效价测定的重组人CTAL4 Ig参考品。方法　按WHO标准品有关要求制备参考品 ,分装、冻干后进行检测 ,采用Raji细胞体外活性测定法进行标定。结果　冻干重组人CTAL4 Ig参考品经检测外观、无菌实验合格 ,水分为 2 2 % ,经 10次标定活性值位于 336～ 4 6 3U/支 ,平均值为 4 19U/支 ,10次结果的标准差为36 0 3U/支 ,变异系数为 8 6 1% ,加速热稳定实验表明其生物学活性在 - 2 0℃、4℃和 2 5℃下 12个月保持稳定。结论　该批重组人CTAL4 Ig活性参考品各项指标均符合标准品的要求 ,效价定为 4 0 0AU/支 ,编号为 2 0 0 2 /0 1。

Preparation and Standardization of Bioassay Reference for Recombinant Human CTAL4A-Ig

Objective To establish a bioasscoy reference for recombinant human CTAL4 Ig.Methods Prepare,fill and lyophilize the reference according to WHO requirements for biological standards,and standardize by Raji cell staining assay in vitro.Results The freeze dried recombinant human CTAL4 Ig reference was qualified in inspection of final containers and sterility test,and the residual moisture content in it was 2.2 %.The results of 10 calibration tests proved that its mean bioactivity was 419±36.03 U per container (336 463U per container),and variation coefficient was 8.61%.Thermal stability test proved that the bioactivity of the reference was stable after storage at -20℃,4℃ or 25℃ for 12 months.Conclusion All the quality indexes of this batch(2002/01)of reference met the requirements for biological standard.Its potency was defined as 400AU per container.