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欧洲药典新近推荐用胶原结合试验测定因子Ⅷ/von Willebrand因子(FⅧ/vWF)浓制剂的特性,本文就此进行了研究。胶原结合试验最适于减少试剂的变化,便于室间比较。对照第三次WHO国际vWF血浆和因子Ⅷ标准,假设1单位vWF抗原≌1单位胶原结合活性进行标化。研究临床von Willebrand病病人的标本,确立了vWF抗原:Coiagen结合活性<1.4的比率为正常多聚体分布相关,而比率>3.7与丢失高分子量多聚体相关,同时生物活性下降。vWF的胶原结合试验用以监控因子Ⅷ浓制剂生产时vWF生物学活性的改变。对两种常用工业生产方法,即用或者甘氨酸/NaCl沉淀或用TSK DEAE离子交换
The European Pharmacopoeia recently recommended collagen binding assay for the determination of factor Ⅷ / von Willebrand factor (F Ⅷ / vWF) concentrates characteristics, this article was studied. Collagen binding test is best suited to reduce the change of reagents, to facilitate comparison between rooms. In contrast to the third WHO international vWF plasma and factor VIII criteria, one unit vWF antigen ≌ 1 unit collagen-binding activity is assumed to be normalized. Studies of patients with clinical von Willebrand disease confirmed the association of vWF antigen: Coiagen binding activity <1.4 for normal multimeric distribution, whereas a ratio of> 3.7 was associated with the loss of high molecular weight multimers with reduced biological activity. Collagen binding assay of vWF is used to monitor changes in vWF biological activity during production of Factor VIII concentrates. Two common methods of industrial production, precipitation with glycine / NaCl or ion exchange with TSK DEAE