低pH孵放病毒灭活效果回顾性验证评价  

Evaluation of retrospective confirmation on virus inactivation by low pH incubation

作　　者：梁婧[1] 张潇文[1] 李策生[1] 彭良俊[1] 王威[2] 刘思扬[3] 郑宵蓓[1] 刘春杰[1] 张智[1] 

机构地区：[1]武汉生物制品研究所有限责任公司,湖北武汉430207 [2]中国食品药品检定研究院 [3]中国人民解放军艾滋病检测确认实验室

出　　处：《中国输血杂志》2016年第9期915-917,共3页Chinese Journal of Blood Transfusion

摘　　要：目的回顾和评价连续2次低pH病毒灭活工艺验证效果,为静注人免疫球蛋白制品病毒灭活工艺提供进一步技术支持。方法将一定量指示病毒加入IVIG中,在pH4.1±0.3,24±1℃条件下孵放24 d,并在灭活过程中的不同时间节点取样进行残余病毒滴度检测。结果低pH孵放法可有效灭活VSV、Sindbis、HIV指示病毒,3种指示病毒滴度下降均大于4个Logs,符合国药监注[2002]160号文件要求。结论低pH孵放病毒灭活工艺能有效地增加静注人免疫球蛋白的安全性。Objective To investigate and evaluate the results of retrospective confirmation on virus inactivation by low pH incubation in order to provide further technology support for production of human immunogloblin. Methods A certain amount of indicator virus was added to IVIG. The residual titers were detected by titration during the different periods of virus inactivation by low pH incubation （ pH4. 1 ± 0. 3, 24 ± 1 ℃, 24days）. Results The method of low pH incubation can effectively inactivate the three indicator viruses such as VSV, Sindbis and HIV. The capacity of virus inactivation was more than 4 Logs, which fulfilled the requirements of SFDA（2002）. Conclusion The method of low pH incubation can efficiently increase the safety of IVIG.

关 键 词：静注人免疫球蛋白 低pH孵放 病毒灭活 指示病毒 

分 类 号：R457.1[医药卫生—治疗学] R392-33[医药卫生—临床医学]