重组戊型肝炎疫苗P179抗原蛋白颗粒及二聚体的稳定性分析  

Stability of P179 antigen protein particles and dimer of recombinant hepatitis E vaccine

作　　者：李铮[1] 贾媛[1] 迟祥[1] 宋昊[1] 唐剑光[1] 徐军[1] 陈子杨[1] 张健锋[1] 孟多佳[1] 韩顺子[1] 于爱东[1] 迟春萍[1] 时成波 刘照惠[1] 

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130062 [2]苏州金诺生物技术有限公司,江苏苏州215414

出　　处：《中国生物制品学杂志》2016年第12期1233-1237,共5页Chinese Journal of Biologicals

基　　金：吉林省产业技术研究与开发项目(200903);长春市科技计划项目(11KZ79)

摘　　要：目的分析重组戊型肝炎疫苗P179抗原蛋白颗粒及二聚体在不同条件下的稳定性,为该抗原的纯化工艺及原液储存条件提供参考。方法将重组戊型肝炎疫苗原液置不同温度、不同p H、高盐浓度、高盐低p H条件下及低温长期储存后,通过透射电镜观察P179抗原蛋白颗粒状态,SDS-PAGE分析二聚体含量。结果 HEV抗原在不同温度、不同p H、高盐浓度、高盐低p H条件下,及低温储存不同时间,P179抗原蛋白颗粒维持在20 nm左右,二聚体含量不低于80%;P179抗原低温储存24个月,其蛋白颗粒及二聚体含量均未发生明显改变。结论重组戊型肝炎疫苗P179抗原蛋白颗粒及二聚体稳定性较好。Objective To analyze the stability of P179 antigen protein particles and dimer of recombinant hepatitis E vaccine（r HEV） under various conditions and provide a reference for the purification and storage of the bulk of antigen.Methods Bulk of r HEV antigen was stored at various temperatures and p H values, at high salt concentration, at high salt concentration plus low p H value, and at low temperature, observed for protein particles by transmission electron microscopy, and determined for dimer content by SDS-PAGE. Results After storage at various temperatures and p H values, high salt concentration, high salt concentration plus low p H value and low temperature for various time periods, the sizes the P179 antigen protein particles were maintained at about 20 nm, while the dimer content was not less than 80%.However, after storage at low temperature for 24 months, neither size of antigen protein particles nor dimer content showed significant change. Conclusion Both P179 antigen protein particles and dimer of r HEV showed high stability.

关 键 词：重组戊型肝炎疫苗 P179抗原 蛋白颗粒 二聚体 稳定性 

分 类 号：R378.21[医药卫生—病原生物学] Q789[医药卫生—基础医学]