LLR株口服轮状病毒活疫苗在制品稳定性观察

对LLR株口服轮状病毒活疫苗生产中各阶段产物(在制品)放置于-20℃、2～8℃,进行稳定性观察,用细胞微量病变滴定法(CCID50)结合酶联免疫吸附试验(ELISA)检测其病毒感染滴度。结果显示,LLR株口服轮状病毒活疫苗单一收获物-20℃放置18个月,病毒滴度不低于5.50logCCID50/ml,原液-20℃放置18个月,病毒滴度不低于5.50logCCID50/ml。2～8℃存放49d,疫苗原液的病毒滴度不低于5.75logCCID50/ml,疫苗半成品病毒滴度不低于5.50logCCID50/ml。结果表明,LLR株口服轮状病毒活疫苗生产各阶段产物在-20℃及2～8℃存放,其稳定性良好。

Stability observation on in-process products of the live rotavirus vaccine LLR strain

In order to observe the stability of the bulk and final bulk of the live rotavirus vaccine from LLR strain under the conditions of-20℃ and 2～8℃,the virus infect titer was determined by CCID50 and ELISA.The results showed that under the condition of-20℃,the titer of the single harvest vaccine maintained at 5.50 log CCID50/ml for 18 months,and the titer of bulk vaccine maintain at 5.50 log CCID50/ml for 12 months.The titer of the bulk vaccine maintained at 5.75 log CCID50/ml under the condition of 2～8℃ for 49 days,and the titer of the final vaccine maintained at 5.50 log CCID50/ml for 49 days.These results suggested that the live rotavirus vaccine from LLR strain is stable under the conditions of-20℃ and 2～8℃.