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目的通过对国内5家血液制品厂生产的25个批次的人凝血因子Ⅷ(FⅧ)制品中血管性血友病因子(vWF)的检测和分析,获得国内FⅧ制品中vWF的质量信息,并将国内FⅧ制品中vWF各项指标与用于治疗血管性血友病(vWD)的FⅧ/vWF浓缩物wilate@中vWF各项指标进行比较,为血液制品厂控制和提高FⅧ制品中的vWF的质量提供科学支持。方法采用2种不同方法检测FⅧ制品中vWF活性,分别是瑞斯托霉素辅因子法(vWF∶Rcof)和胶原结合法(vWF∶CBA);采用ELISA法检测FⅧ制品中vWF含量(vWF∶Ag);用全自动凝血仪检测FⅧ制品中FⅧ活性(FⅧ∶C)。
OBJECTIVE To obtain the quality information of vWF in domestic F VIII preparations by detecting and analyzing the vWF in 25 batches of human factor Ⅷ produced by 5 blood products factories in China. The domestic F VIII products in the vWF indicators for the treatment of von Willebrand disease (vWD) F Ⅷ / vWF concentrate wilate @ vWF various indicators for the blood products factory control and improve the F VIII products vWF Quality to provide scientific support. Methods Two different methods were used to detect the vWF activity in FⅧ preparations, including vWF: Rcof and vWF: CBA respectively. The vWF content in FⅧ preparations was detected by ELISA (vWF: Ag). FⅧ activity in F VIII preparations was detected by automatic coagulation analyzer (FⅧ: C).