巴氏消毒法对乙型肝炎人免疫球蛋白病毒灭活效果的验证

目的以伪狂犬病病毒(PRV)、Sindbis病毒和HIV-1为模型病毒,验证巴氏消毒法对乙型肝炎人免疫球蛋白(HBIG)的病毒灭活效果。方法将模型病毒按1:9(v/v)的比例加入HBIG样品中,60℃水浴保温10h,测定病毒滴度,观察病毒灭活效果,并以放射免疫法测定病毒灭活前后样品抗HBsAg效价的变化。结果病毒灭活后,PRV滴度下降超过5LgCCID50/0.1ml,Sindbis病毒滴度下降超过6LgPFU/ml,HIV-1滴度下降超过4LgCCID50/0.1ml;3批HBIG样品的抗HBsAg效价分别降低了6.5%、6.0%和5.8%。结论巴氏消毒法可以对HBIG样品中的模型病毒进行有效灭活。目的以伪狂犬病病毒(PRV)、Sindbis病毒和HIV-1为模型病毒,验证巴氏消毒法对乙型肝炎人免疫球蛋白(HBIG)的病毒灭活效果。方法将模型病毒按1:9(v/v)的比例加入HBIG样品中,60℃水浴保温10h,测定病毒滴度,观察病毒灭活效果,并以放射免疫法测定病毒灭活前后样品抗HBsAg效价的变化。结果病毒灭活后,PRV滴度下降超过5LgCCID50/0.1ml,Sindbis病毒滴度下降超过6LgPFU/ml,HIV-1滴度下降超过4LgCCID50/0.1ml;3批HBIG样品的抗HBsAg效价分别降低了6.5%、6.0%和5.8%。结论巴氏消毒法可以对HBIG样品中的模型病毒进行有效灭活。

Verification for Viral Inactivation Effectiveness in Human Hepatitis B Immunoglobulin by Pasteurization

Objective To verify the viral inactivation effectiveness in human hepatitis B immunoglobulin(HBIG)by pasteurization using PRV,Sindbis virus and HIV-1 as indicators.Methods The indicator viruses were added into HBIG samples at a ratio of 1:9(v/v),and the mixtures were heated in 60℃water bath for 10 h then determined for virus titers,based on which the viral inactivation effectiveness was observed,and the antibody titers against HBsAg in samples before and after inactivation were determined by radioimmunoassay.Results After viral inactivation,the titers of PRV,Sindbis virus and HIV-1 decreased by more than 5 LgCCID50/0.1 ml,6 LgPFU/ml and 4 Lg CCID50/0.1 ml,and the antibody titers against HBsAg in 3 batches of HBIG samples decreased by 6.5%,6.0%and 5.8%,respectively.Conclusion Pasteurization is effective for inactivation of indicator viruses in HBIG.