目的　建立适用于测定人凝血因子Ⅷ（human coagulation factor Ⅷ，FⅧ）中肝素残留量的生色底物法。方法　采用全自动凝血分析仪建立生色底物法（包括动力学法和终点法）测定FⅧ中肝素残留量，并对该方法的专属性、线性、准确度、中间精密度、定量限和检测范围进行验证。采用以上方法对3批FⅧ样品中肝素残留量进行测定。结果　动力学方法和终点法的专属性均良好；当肝素标准溶液浓度在0.000~0.064国际单位(international unit，IU )/mL时，2种方法浓度与吸光度值或其变化速率的对数线性关系良好；加标回收率均值均在75%~120%，重复性相对标准偏差均≤8%，中间精密度相对标准偏差均≤8%。动力学法和终点法的定量限分别为0.007 和0.014 IU/mL，检测范围分别为0.007~0.048 和0.014~0.048 IU/mL。2种方法检测3批样品的肝素残留量均低于定量限。结论　成功建立了FⅧ中肝素残留量检测方法，该法的专属性、线性、准确度、中间精密度均良好。

Objective　To establish a chromogenic substrate method for the determination of residual heparin in human coagulation factor Ⅷ(FⅧ ).Methods　The chromogenic substrate method (including kinetic method and endpoint method) was established using fully automated coagulation analyzer to determine the residual heparin in FⅧ. The method was verified for specificity, linearity, accuracy, intermediate precision, quantification limit and detection range.Heparin residues in three batches of FⅧ samples were measured using the above method.Results　The specificities of the kinetic method and endpoint method were good. In the range of 0.000-0.064 international unit (IU)/mL, the concentration of heparin standard solution for 2 methods showed a good linear relationship with the logarithm of absorbance value or its change rate. The mean values of spiked recoveries were all in the range of 75%-120%. The reproducibility RSDs were all≤8%, and the intermediate precision RSDs were all≤8%. The quantification limit of kinetic method was 0.007 IU/mL, and the detection range was 0.007-0.048 IU/mL.The quantification limit of endpoint method was 0.014 IU/mL, and the detection range was 0.014-0.048 IU/mL.The heparin residues of the 3 batches of samples tested by the 2 methods were below the limit of quantification.Conclusion　The determination method of heparin residue in FⅧ is successfully developed, which has good specificity, linearity, accuracy, repeatability and intermediate precision.