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目的 协作标定第一批人凝血因子Ⅶ浓制剂国家标准品。方法 以 WHO 97/592批人凝血因子Ⅶ浓制剂国际标准品为对照,采用一期法标定我国首批人凝血因子Ⅶ因家标准品,并将标准品分别置4℃、22℃、37℃保存5个月,用加速破坏试验进行稳定性考查。结果 该批标准品效价为16.0IU/支,稳定性良好。其他项目均达到国家标准品要求。结论 已成功研制第一批人凝血因子Ⅶ浓制剂国家标准品。
Objective Cooperate to standardize the first batch of national standards of coagulation factor Ⅶ concentrates. Methods The WHO 97/592 batch of human coagulation factor Ⅶ concentrates international standard as a control, the first phase of the standard method of calibration of the first human factor Ⅶ due to the standard, and the standard were set at 4 ℃, 22 ℃, 37 ℃ Save for 5 months and test for stability with Accelerated Destruction Test. Results The standard batch titer of 16.0IU / support, good stability. Other projects have reached the national standard requirements. Conclusion The first batch of national standards of human coagulation factor Ⅶ concentrates has been successfully developed.