重组水蛭素生物学活性检测参考品的制备和标定

目的制备重组水蛭素(Hirudin)生物学活性检测参考品,并标定其生物学活性。方法按照WHO相关规定制备、分装和冻干参考品,经全面检测合格,用TH生色底物法进行体外生物学活性检测。结果外观、无菌试验合格,水分含量为0.8%。经过10次标定,平均生物学活性为12 701 ATU/支,标准差为2 226 ATU/支,变异系数为17.5%。在-20℃、4℃和25℃条件下,生物学活性可以稳定保持9个月。结论该批重组水蛭素各项指标均符合要求,性质稳定,可作为国家参考品,用于重组水蛭素的生物学活性检测。

Preparation and Calibration of Reference for Determination of Biological Activity of Recombinant Hirudin

Objective To prepare the reference for determination of biological activity of recombinant hirudin and calibrate its biological activity.Methods Prepare,dispense and lyophilize the reference according to the related WHO requirements.After the reference was qualified in overall control test,its biological activity in vitro was determined by TH chromogenic-substrate assay.Results The reference was qualified in sterility test and examination on final containers.Its moisture content was 0.8%.The average biological activity of the reference in 10 calibration tests was 12 701 ATU per container,and standard deviation and variation coefficient were 2 226 ATU per container and 17.5% respectively. The biological activity of reference was maintained stably for 9 months at-20℃,4℃ and 25℃.Conclusion All the quality indexes of this batch of recombinant hirudin met the related requirements.The hirudin could be used as a national reference for the determination of biological activity.