乙醇工艺对同种异体肌腱病毒灭活效果的研究  

Study on the Effect of Ethanol Process on Virus Inactivation of Allogeneic Tendon

作　　者：段晓杰[1] 王萌 陈丽媛 赵岩[1] 柯林楠[1] 徐丽明[1] 陈亮[1] Duan Xiaojie;Wang Meng;Chen Liyuan;Zhao Yan;Ke Linnan;Xu Liming;Chen Liang(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2021年第5期544-551,共8页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划项目(编号2016YFC11011202);中检院中青年发展研究项目(编号2018C6)。

摘　　要：目的:研究乙醇工艺对同种异体肌腱的病毒灭活效果。方法:选择伪狂犬病毒(PRV)、猪细小病毒(PPV)、牛腹病毒性腹泻病毒(BVDV)和人类免疫缺陷病毒(HIV-1)为指示病毒,将同种异体肌腱(3个批号)分别负载指示病毒后,用75%乙醇浸泡灭活处理;分别在不同时间点取样,用96孔板的细胞病变法和Karber法测定,计算乙醇工艺处理后同种异体肌腱的病毒残留量(LgTCID50/0.1m L)和计算病毒降低量(log)。结果:负载病毒的3个批号样品经过75%乙醇浸泡2 h后,PRV、BVDV和HIV-1滴度降低量分别为≥5.971 logs、≥4.400 logs和≥8.000 logs;病毒灭活动力曲线显示:病毒残留量很快降到最低检出限度值。负载PPV的3个批号样品,经75%乙醇浸泡2 h后,病毒滴度降低量平均为0.850 logs,浸泡延长至24 h后,病毒滴度降低量平均为1.350 logs,病毒灭活动力曲线显示病毒滴度随时间呈缓慢降低趋势。结论:75%乙醇工艺浸泡处理同种异体肌腱2 h,对PRV、BVDV和HIV-1为有效工艺,对PPV无效。Objective: To study the virus inactivation effect of ethanol process on allogeneic tendon. Methods: Pseudorabies virus(PRV), porcine parvovirus(PPV), bovine ventral virus diarrhea virus(BVDV) and human immunodeficiency virus(HIV-1) were selected as indicator viruses. Three batches of allogeneic tendons were spiked with indicator viruses and immersed in 75% ethanol, respectively. Sampling was taken at different time points, and then the virus residual amount(LgTCID50/0.1 mL) and the titer of virus reduction(logs) of the allogeneic tendon which had been treated by ethanol process were calculated by the Cytopatho Genic Effect(CPE) and Karber method. Results: After 2 h immersion in 75% ethanol, the three virus-loaded batches’ virus titer reduction in PRV, BVDV and HIV-1 were ≥5.971 logs, ≥4.400 logs and ≥8.000 logs, respectively;and the curve of virus reduction kinetics showed that the residual viral amount quickly dropped to the minimum detection limit. The average virus reduction titer of the samples spiked with PPV was 0.850 logs and 1.350 logs after 2 hours and 24 hours treatment of ethanol process, respectively. And the curve of virus reduction kinetics showed a slowly downward trend. Conclusion: 75% ethanol process immersion treatment of allogeneic tendons for 2 hours is an effective virus inactivation process for BVDV, PRV and HIV-1, but not for PPV.

关 键 词：同种异体 肌腱 病毒灭活 乙醇 

分 类 号：R955[医药卫生—药学] R187