静脉注射人免疫球蛋白酸性孵放法灭活艾滋病病毒的效果研究

目的研究静脉注射人免疫球蛋白在生产过程中酸性孵放法灭活艾滋病病毒的效果。方法采用细胞培养法,对含有艾滋病病毒的静脉注射人免疫球蛋酸性孵化法灭活效果进行了实验室检测。结果将含有艾滋病病毒的静脉注射人免疫球蛋白酸度调整为pH4,于21～25℃条件下放置4d,其中艾滋病病毒的滴度(TCID50)由9.50log下降至2.00log以下,下降值达到7.00log以上。相同的样品在pH值7.0条件下放置14d,其中艾滋病病毒滴度仍在3.3log以上;经放置21d,所有样品中艾滋病病毒滴度均在2.0log以下。经过对3批样品重复测定,均未出现细胞病变;经过将样品盲传三代仍未出现细胞病变。结论采用酸性孵放法常温下放置21d,可使静脉注射人免疫球蛋白中艾滋病病毒完全失去活性。

STUDY OF INACTIVATION EFFICACY OF HUMAN IMMUNODEFICIENCY VIRUS BY INCUBATED AT LOW PH VALUE IN INTRAVENOUS-USING HUMAN IMMUNOGLOBULIN

Objective To study the inactivation efficacy of human immunodeficiency virus(HIV)by incubated for 21-day at low pH value during the process of intravenous-using human immunoglobulin.Methods Cell culture method was used to test the inactivation efficacy of intravenous-using human immunoglobulin containing HIV-1 virus incubated at low pH value in laboratory.Results After adjusted pH value of intravenous-using human immunoglobulin containing HIV-1 virus to 4,the specimens were incubated at 21-25℃ for 4 days.The titer of HIV-1 falled from 9.50log to below 2.00 log,the decreased titer was more than 7.00 log.However,the titer of HIV of the same specimens was above 3.3 log after incubated at pH7.0 for 14 days,the titer were below 2.0 log after incubated at pH7.0 for 21 days.CPE was not observed after repeatly tested of 3 batches of specimens,and also no CPE emerged with sequential 3 passages cultured.Conclusion HIV-1 in the intravenous-using human immunoglobulin was completely inactivated by incubated at low pH value for 21 days at the room temperature.