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乙型血友病长期以来威胁病人的生命。多年来凝血酶原复合物(PCC)为该病的主要治疗药物:但因为PCC由大量混合血浆经简单工艺制备而成,制剂中混有未灭活的病毒和大量杂蛋白,因此,该制剂的使用存在一些问题,包括肝炎病毒、艾滋病毒等病毒感染和血栓形成等疾病发生。近几年,由于有效病毒灭活方法的应用和蛋白分离纯化工艺的改进和提高,已开发研制出高纯度、无病毒感染的制剂。本文着重介绍有关因子Ⅸ(FⅨ)的分子生物学特性、PCC的潜在问题,病毒灭活的方法及高纯度制剂的开发前景。
Hemophilia B has long threatened the patient’s life. Prothrombin complex (PCC) has been the mainstay of treatment for many years. However, since PCC is prepared from a large amount of mixed plasma by a simple process with a mixture of inactivated virus and a large amount of hybrid protein, the formulation There are some problems with the use of hepatitis B virus, HIV and other viral infections and thrombosis and other diseases. In recent years, due to the application of effective virus inactivation methods and the improvement and improvement of protein separation and purification processes, preparations with high purity and virus-free infection have been developed. This article focuses on the molecular biology of Factor IX (FIX), the potential problems of PCC, the virus inactivation method, and the development prospects of high purity preparations.