冻干甲型肝炎减毒活疫苗的研制  

Preparation of Freeze - dried Live Attenuated Hepatitis A Vaccine

作　　者：刘景晔[1] 李光普[1] 谢宝生[1] 辛 忠[1] 许 明[1] 李育红[1] 孙 姝[1] 王鹏富[1] 万宗举[2] 高佳梅 张华远[2] 

机构地区：[1]长春生物制品研究所,长春130062 [2]中国药品生物制品检定所,北京100050

出　　处：《中国生物制品学杂志》2002年第3期167-170,共4页Chinese Journal of Biologicals

摘　　要：［摘 要］目的 研制冻干甲肝减毒活疫苗，提高疫苗的稳定性，便于保存及运输，保证疫苗的接种效果。方法 采用CA－9冻干保护剂，制备冻干疫苗，疫苗液与保护剂之比为3．5∶1。结果 冻干甲肝减毒活疫苗具有与液体疫苗相同的安全性及免疫原性。在2～8℃保存的有效期较液体疫苗的3～5个月提高到18个月。在室温和37℃保存的稳定性也明显提高。结论 冻干甲肝疫苗的稳定性良好，无需低温保存、冷链运输，便于甲肝疫苗的大规模推广应用。[Abstract] Objective To prepare freeze- dried live attenuated hepatitis A vaccine and study on the stability of it. Methods Live attenuated hepatitis A vaccine was freeze - dried using CA - 9 as protective agent. The ratio of vaccine to protective agent was 3.5: 1. Results The safety and immunogenicity of the freeze - dried vaccine were identical to those of liquid vaccine. Compared with that of liquid vaccine, the validity period of freeze - dried vaccine at 2 - S癈 increased from 3-5 to 18 months. The stability of it at room temperature and 37 癈 were also improved significantly. Conclusion The freeze - dried HA vaccine is stable and needs no storage at low temperature or transport by cold chain. It is suitable for large - scale application.

关 键 词：冻干甲型肝炎减毒活疫苗 研制 冻干甲肝疫苗 稳定性 

分 类 号：R373.21[医药卫生—病原生物学] R512.61[医药卫生—基础医学]