S/D法对人凝血因子Ⅷ产品中人免疫缺陷病毒灭活效果的研究  

RESEARCH ON INACTIVATION EFFECT OF S/D-TREATMENT ON HUMAN IMMUNODEFICIENCY VIRUS IN A PLASMA-DERIVED FACTOR VIII CONCENTRATE

作　　者：刘思扬[1] 庄道民[1] 董如华[1] 白丽[1] 李韩平[1] 鲍作义[1] 李林[1] 刘永健[1] 王晓林[1] 李天一[1] 李敬云[1] 

机构地区：[1]军事医学科学院微生物流行病研究所病原微生物生物安全国家重点实验室,北京100071

出　　处：《中国消毒学杂志》2012年第8期677-678,681,共3页Chinese Journal of Disinfection

摘　　要：目的研究S/D法对人凝血因子Ⅷ中污染的人免疫缺陷病毒灭活效果。方法采用细胞培养法,对S/D处理人凝血因子Ⅷ灭活HIV的效果进行了检测。结果在常温(25℃)条件下,在污染有HIV的人凝血因子Ⅷ种混入体积分数9%S/D灭活剂,作用60 min,HIV灭活对数值为6.83。重复处理3批人凝血因子Ⅷ制品,对HIV均达到完全灭活,经细胞培养盲传三代,均未出现细胞病变。结论 S/D法能够完全灭活人凝血因子Ⅷ产品中污染的人免疫缺陷病毒,灭活效果可靠。Objective To observe the inactivation effect of solvent-detergent（S/D） methods on a plasma-derived factor VIII concentrate contaminated with human immunodeficiency virus（HIV）.Methods The experiments were carried out by spiking the samples with 9% of the volume with the highest titer available virus culture.The samples were processed under validated conditions（mimicking the industrial process） and the residual infectivity was determined.Results The titration of the virus strains（HIV-1ⅢB） was more than 11.0 log.After 60 minutes of solvent-detergent treatment at normal temperature,the HIV-1 titration declined at least 6.83 log.No cytopathic effect appeared after three-generation passages.Conclusion The S/D method has good inactivation ability on plasma-derived factor VIII concentrate contaminated with human immunodeficiency virus（HIV）.

关 键 词：人凝血因子Ⅷ 人免疫缺陷病毒 S/D处理 灭活效果 

分 类 号：R187.2[医药卫生—流行病学]