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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 particles and dimers under different conditions, and to provide a reference for the purification process of the antigen and stock solution storage conditions. Methods After the recombinant hepatitis E vaccine was stored at different temperatures, different pH, high salt, low salt and low pH, and stored at low temperature for a long time, the particle status of P179 antigen was observed by transmission electron microscopy. SDS- PAGE analysis of dimer content. Results At different temperatures, different concentrations of p H, high salt concentration, high salt and low p H, and low temperature storage, the protein particles of P179 maintained at about 20 nm and the dimer content was no less than 80%. P179 Antigenic low temperature storage for 24 months, the protein particles and dimer content did not change significantly. Conclusion The recombinant hepatitis E vaccine P179 antigen particles and dimer stability is good.