LLR株口服轮状病毒活疫苗在制品稳定性观察

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

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。

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℃.