血液制品病毒灭活及去除工艺进展

随着医学科学的进步和大众生活水平的提高,血液制品的安全性愈来愈受到关注。为了提高血液制品的安全性,国家食品药品监督管理局发布的相关指导原则要求生产工艺要具有一定的去除/灭活部分病毒能力,生产过程中应有特定的去除/灭活病毒方法。我们对几种适用于血液制品的病毒灭活方法及病毒去除工艺进行综述,以期对生产及科研提供参考。

Advance in Virus Inactivation and Removal Processes of Blood Products

With the development of medical science and improvement of living conditions for human,the safety of plasma derivatives have been receiving much more attention.In order to ensure the safety of plasma deriva tives,the State Food and Drug Administration issued some guidelines,demanding manufacturing process should has the ability to inactivate and remove virus.Moreover,manufacturing process must include some specific viral in activation and removal procedures.In this article we reviewed several viral inactivation and removal procedures for plasma derivatives,expecting to provide some reference for production and research.