中国输血杂志2025，Vol.38Issue(3)：415-420,6.DOI:10.13303/j.cjbt.issn.1004-549x.2025.03.017
注射用重组人凝血因子Ⅶa效价检测方法的建立
Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
摘要
Abstract
Objective To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection.Methods By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent(PT reagent),the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup.The logarithm of coagulation time was inversely proportional to the logarithm of hu-man factor Ⅶa potency.Results Under the experimental conditions,the specificity of the methodology was evaluated through spiked recovery,and the recovery rates ranged from 90.0%to 110.0%.Within the range from 0.125 to 1.000 IU/mL,there was a good linear response between the potency and coagulation time of the standard and sample,with correlation coefficients r>0.99.As for the accuracy and repeatability,the recovery rates of various concentrations detected in the stock solution were 101.0%,100.0%and 112.0%,respectively,with RSD values of 2.6%,4.0%and 0.0%,respectively.The recovery rates of various concentrations in finished product testing were 104.0%,94.7%and 112.0%,respectively,with RSD values of 1.9%,2.4%and 0.0%,respectively.As for the intermediate precision,the RSD were 4.5%and 3.7%,respectively.After treated with sample diluent,the sample was tested at room temperature for 6 hours and still ex-hibited relatively stable biological activity.Conclusion This detection method is accurate,stable,easy to operate and highly automated,and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.关键词
注射用重组人凝血因子Ⅶa/凝固法/效价检测Key words
recombinant human coagulation factor Ⅶa/clotting method/detecting of potency分类
临床医学引用本文复制引用
吴蓉,王俪鲆,郎锦烨,朱玥,周静,刘珣,倪静,周顺波,丁亚凌..注射用重组人凝血因子Ⅶa效价检测方法的建立[J].中国输血杂志,2025,38(3):415-420,6.基金项目
药品监管科学全国重点实验室课题(2024SKLDRS0207) （2024SKLDRS0207）
