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目的协作标定首批人凝血因子Ⅱ和Ⅹ浓制剂国家标准品。方法用世界卫生组织 98 590批人凝血因子Ⅱ和Ⅹ浓制剂国际标准品 ,采用一期法标定我国首批人凝血因子Ⅱ和Ⅹ浓制剂国家标准品 ,将标准品分别于4℃、2 2℃、37℃保存 5个月 ,进行稳定性考查。结果人凝血因子Ⅱ和Ⅹ国家标准品的效价分别为 1 6 .1IU 支和 1 2 .1IU 支 ,稳定性良好。结论确定了首批人凝血因子Ⅱ和Ⅹ浓制剂的国家标准品
Objective To cooperate to calibrate the first national standards of human coagulation factor Ⅱ and Ⅹ concentrated preparations. Methods The first batch of national standards of human coagulation factor Ⅱ and Ⅹ concentrated preparations was calibrated with the first batch of 98 590 international standard samples of human coagulation factor Ⅱ and Ⅹ concentrated preparations. The standard was respectively separated at 4 ℃, 2 2 ℃, 37 ℃ for 5 months, stability test. Results The titer of human coagulation factor Ⅱ and Ⅹ national standards were 16.1 IU and 12.1 IU, respectively. The stability was good. Conclusions The first national standards of human coagulation factor II and X concentrated formulations were identified