狂犬病人免疫球蛋白低pH孵放工艺的病毒灭活验证  

Verification for virus inactivation in low pH incubation process of human rabies immunoglobulin

作　　者：张航 容新宗 黄琰 梁洪 刘波 李小姣 吴佳君 秦婷婷 ZHANG Hang;RONG Xin-zong;HUANG Yan;LIANG Hong;LIU Bo;LI Xiao-jiao;WU Jia-jun;QIN Ting-ting(Beijing Tiantan Biological Products Co.,Ltd.Chengdu 610041,Sichuan Province,China;不详)

机构地区：[1]北京天坛生物制品股份有限公司,四川成都610041 [2]成都生物制品研究所有限责任公司,四川成都610023 [3]成都蓉生药业有限责任公司,四川成都610041

出　　处：《中国生物制品学杂志》2020年第11期1312-1316,共5页Chinese Journal of Biologicals

摘　　要：目的对狂犬病人免疫球蛋白(human rabies immunoglobulin)低pH孵放生产工艺[pH 3.8~4.4,(24±1)℃,21 d]进行脂包膜病毒灭活验证。方法以伪狂犬病毒(pseudorabies virus,PRV)、水疱性口炎病毒(vesicular stomatitis virus,VSV)、辛德毕斯病毒(sindbis virus,SV)和人免疫缺陷病毒(human immunodeficiency virus,HIV)作为研究病毒,考察低pH孵放对这些脂包膜病毒的灭活能力。同时考察低pH孵放步骤对制品质量的影响。结果在工艺设定的参数范围内,低pH孵放后4种脂包膜病毒的滴度降低均在4.00 Log以上,且3批狂犬病人免疫球蛋白的纯度和分子大小分布保持稳定,抗体效价与灭活前差异均在方法允许的波动范围内。结论低pH孵放工艺能有效地灭活脂包膜病毒,保证了狂犬病人免疫球蛋白制品的质量及安全性。Objective To verify the lipid-enveloped virus inactivation in low pH incubation process[pH 3.8~4.4,(24±1)℃,21 d]of human rabies immunoglobulin.Methods The inactivation efficacy of lipid-enveloped viruses in low pH incubation process was evaluated using pseudorabies virus(PRV),vesicular stomatitis virus(VSV),sindbis virus(SV)and human immunodeficiency virus(HIV)as indicators.The impact on product quality was also be evaluated.Results Within the range of designed process parameters,the titers of four indicator viruses decreased by not less than 4.00 Log after low pH incubation,and the purities and distributions of molecular sizes of three batches of human rabies immunoglobulin remained stable,while the difference of antibody titers before and after inactivation were within the fluctuation range allowed by the method.Conclusion Low pH incubation process may effectively inactivate the lipidenveloped virus and ensure the quality and safety of human rabies immunoglobulin products.

关 键 词：狂犬病人免疫球蛋白 低pH孵放 病毒灭活 

分 类 号：R392-33[医药卫生—免疫学]