轮状病毒灭活疫苗的稳定性评价  

Stability of inactivated rotavirus vaccine

作　　者：张标[1,2] 佟琳[3] 易山[2] 谢天宏[2] 张光明[2] 李鸿钧[2] 孙茂盛[2] 陈东[1] 

机构地区：[1]广东医学院组织学与胚胎学教研室,湛江524023 [2]中国医学科学院北京协和医学院医学生物学研究所,昆明650118 [3]广东医学院附属医院危重医学科,湛江524001

出　　处：《中国新药杂志》2013年第13期1510-1512,1529,共4页Chinese Journal of New Drugs

基　　金：国家863计划(2006AA02A211);东莞市医疗卫生单位科技计划一般项目(201210515200002);广东医学院科研基金博士启动项目(B2010002)

摘　　要：目的:评价轮状病毒灭活疫苗的稳定性。方法:将4批轮状病毒灭活疫苗在4℃保存12个月或37℃保存4周,在保存的不同时间分别进行外观检查、鉴别试验、pH值和轮状病毒抗原含量测定;同时,免疫Balb/c小鼠,检测保存不同时间轮状病毒灭活疫苗诱发血清中和抗体的水平。结果:轮状病毒灭活疫苗在4℃保存12个月或37℃保存4周,外观检查和鉴别试验未见异常,pH值和轮状病毒抗原含量保持相对稳定,保存不同时间轮状病毒灭活疫苗免疫小鼠血清中和抗体水平与保存前无明显差异。结论:轮状病毒灭活疫苗在4℃保存12个月或37℃保存4周稳定性良好。Objective：To evaluate the stability of inactivated rotavirus vaccine. Methods：Four batches of vaccine were stored at 4 ℃ for 12 months or 37 ℃ for 4 weeks. Appearance inspection,identity test, pH and content of rotavirus antigen determination were carried out after different storage time. Meanwhile, the level of neutralizing antibody induced by inactivated rotavirus vaccine was measured in mice. Results： After storage for 12 months at 4 ℃ or 4 weeks at 37 ℃ , the appearance inspection and identity test did not show abnormal results ; the pH and con- tents of rotavirus antigen kept relative stability;there were no significant differences between the levels of neutrali- zing antibody before storage and those after different storage time at 4 ℃ or 37 ℃. Conclusion ：The inactivated ro- tavirus vaccine has good stability at 4 ℃ for 12 months or 37 ℃ for 4 weeks.

关 键 词：轮状病毒 灭活疫苗 稳定性 中和抗体 

分 类 号：R978.7[医药卫生—药品]