静注人免疫球蛋白(pH4)中水痘-带状疱疹病毒中和抗体效价的检测  

Detection of neutralizing antibody titers against varicella-zoster virus in human intravenous immunoglobulin(pH4)

作　　者：袁典 孙珍珠 贾俊婷 汪琳 王蕊 章金刚 张运佳 管利东[2] 马玉媛 YUAN Dian;SUN Zhen-zhu;JIA Jun-ting;WANG Lin;WANG Rui;ZHANG Jin-gang;ZHANG Yun-jia;GUAN Li-dong;MA Yu-yuan(NMPA Key Laboratory for Quality Control of Blood Products,Institute of Health Service and Transfusion Medicine,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100850,China;NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing 100050,China;Shenzhen Weiguang Biologi-cal Products Co.,Ltd.,Shenzhen,Guangdong 518107,China)

机构地区：[1]军事科学院军事医学研究院卫生勤务与血液研究所,国家药品监督管理局血液制品质量控制重点实验室,北京100850 [2]中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京100050 [3]深圳市卫光生物制品股份有限公司,广东深圳518107

出　　处：《军事医学》2022年第1期44-47,共4页Military Medical Sciences

基　　金：重大新药创制国家科技重大专项(2018ZX09J18106-002)。

摘　　要：目的分析国内静注人免疫球蛋白(IVIG)(pH4)制品中水痘-带状疱疹病毒(VZV)中和抗体效价水平,为水痘-带状疱疹人免疫球蛋白(VZIG)的研制提供参考。方法采用微量细胞病变中和试验方法检测国内6家血液制品企业生产的15批IVIG(pH4)制品中VZV中和抗体效价,应用VZV免疫球蛋白国际标准品进行标定。结果15批IVIG(pH4)制品中VZV中和抗体平均效价为3.78 U/ml(效价范围1.95~8.06 U/ml),平均比活为72.72 U/g(比活范围39.01~161.16 U/g),远低于国外上市VZIG产品比活。结论国内IVIG(pH4)制品中VZV中和抗体效价水平较低,需筛选含高效价VZV中和抗体的单采血浆作为原料进行VZIG产品的制备。Objective To measure the levels of neutralizing antibodies against varicella-zoster virus(VZV)in commercial human intravenous immunoglobulin(IVIG)(pH4)preparations manufactured in China in order to provide reference for the development of varicella-zoster immunoglobulin(VZIG). Methods The neutralizing antibody titers against VZV in 15batches of IVIG(pH4)manufactured by six different Chinese blood products manufacturers were determined by the microneutralization assay. The international standard for varicella zoster immunoglobulin was used for standardization. Results The average neutralizing antibody titer against VZV in the 15 batches of IVIG(pH4)products was 3.78 U/ml(ranging from 1.95 to 8.06 U/ml). The average specific activity was 72.72 U/g(ranging from 39.01 to 161.16 U/g),which was far lower than that of commercially available VZIG products abroad. Conclusion The neutralizing antibody titers against VZV in IVIG(pH4)manufactured in China are low. It is necessary to screen for apheresis plasma containing high levels of neutralizing antibodies against VZV as source plasma for VZIG products.

关 键 词：免疫球蛋白类 静脉内 疱疹病毒3型 人 抗体 中和 微量细胞病变中和试验 

分 类 号：R373.11[医药卫生—病原生物学]