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目的标定第一批人凝血因子Ⅸ浓制剂国家标准品。方法用 ＷＨＯ ９６／８５４批人凝血因子Ⅸ国 际标准品标定我国人凝血因子Ⅸ国家标准品，再用此标准品作对照检测国内生产的冻干人凝血酶原复合物，并分 别将标准品置４℃、３７℃和４５℃保存６个月考查其稳定性。结果各项检测指标均达到国家标准品要求，９．３ＩＵ／支； 检测１４批冻干人凝血酶原复合物ＦⅨ效价，其中１１批达到瓶签标示效价的５０％以上；标准品的稳定性良好。结论 已成功地制定第一批人凝血因子Ⅸ浓制剂国家标准品。
Objective To calibrate the first batch of national standards of coagulation factor IX concentrates. Methods The WHO 96/854 human coagulation factor Ⅸ international standard was used to calibrate our national human coagulation factor Ⅸ national standard, and then the standard was used as a control to test the domestic production of freeze-dried human prothrombin complex. The standard products 4 ℃, 37 ℃ and 45 ℃ for 6 months to check its stability. Results The detection indexes all reached the requirements of national standards, 9.3IU / support; 14 batches of freeze-dried human prothrombin complex FIX titers, of which 11 batches of labeled bottle labeled more than 50% of the potency; standard Good stability. Conclusion The first batch of national standards of human coagulation factor IX concentrates has been successfully formulated.