第二批人凝血酶国家标准品协作标定

The calibration of the 2 ^( nd) national standard for human thrombin

目的协作标定第二批人凝血酶国家标准品。方法用世界卫生组织首批α 凝血酶国际标准品 (批号 :89/ 5 88)为标准 ,采用纤维蛋白原凝固法标定。并将标准品分别于 2 5℃、37℃、4 5℃保存 6个月 ,进行稳定性考查。结果第二批人凝血酶国家标准品的效价为 12 7IU/支 ,稳定性良好 ,其他项目符合国家标准品要求。结论已成功研制第二批人凝酶国家标准品 ,可以取代首批人凝血酶国家标准品。

PurposeTo calibrate the 2 nd national standard for human thrombin by the collaborative study.MethodsThe potencies of the national standard for human thrombin were assayed against 1 st International Standard for Alpha- thrombin (89/588)by fibrinogen clotting method. Ampoules of thrombin national standard were stored at 25℃、37℃、45℃ for 6 months for accelerated degradation studies.ResultsThe potency of thrombin is 127 IU/ampoule.The results of accelerated degradation studies showed that the preparation is very stable. All the other items met the requirements for national standard of China.ConclusionThe 2 nd national standard for human thrombin was established to replace the 1 st National Standard for human thrombin.