口服Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗(人二倍体细胞)的稳定性观察

摘要

Objective To evaluate the stability of types Ⅰ and Ⅲ oral poliovirus vaccine (human diploid cell) .Methods The vaccine was stored upright and invertedly below - 20 ℃ for 30 months ,at (5 ± 3) ℃ for 15 months ,at (5 ± 3) ℃ (upright) for 28 d after opening ,at (25 ± 2) ℃ for 5 weeks ,at (37 ± 2 ) ℃ for 5 d ,and repeatedly freeze-thawed for 7 times , then the virus titers and other main indicators were observed to evaluate the vaccine stability . Results After vaccine was stored below- 20 ℃ for 30 months ,at (5 ± 3) ℃ for 15 months ,at (5 ± 3) ℃ for 28 d after opening ,at (25 ± 2) ℃for 4 weeks ,at (37 ± 2) ℃ for 4 d ,and freeze-thawed for 6 times ,the total virus titers per 0 .1 ml were≥ 6 .18 lg 50％ cell culture infective dose (CCID50 ) ,type Ⅰ virus titers were ≥ 6 .0 lgCCID50 /0 .1 ml , type Ⅲ virus titers were ≥ 5 .6 lgCCID50 /0 .1 ml ,all meeting standard requirements (total virus ,types Ⅰand Ⅲ virus titers no less than 6 .12 ,6 .0 and 5 .5 lgCCID50 /0 .1 ml ,respectively) .The thermal stability tests showed that the virus titers decreased ≤ 0 .50 lgCCID50 /0 .1 ml when the vaccine was stored at (37 ± 2) ℃ for 2 d ,which met the standard requirement of no more than 0 .50 lgCCID50 /0 .1 ml .Other stability indicators also met the standard requirements .Conclusion Types Ⅰ and Ⅲ oral poliovirus vaccine has good stability under the study conditions .%目的 评价口服 Ⅰ 型 Ⅲ 型脊髓灰质炎减毒活疫苗(人二倍体细胞)的稳定性.方法 将3批疫苗直立和倒立分别于-20℃ 以下存放30个月 、(5±3)℃ 存放15个月 、开瓶后(5±3)℃(直立)存放28 d、(25±2)℃ 存放5周 、(37±2)℃ 存放5 d,另外将疫苗冻融7次,检测病毒滴度及其他疫苗稳定性主要指标.结果 疫苗于-20℃ 以下存放30个月 、(5±3)℃ 存放15个月 、开瓶后(5±3)℃ 存放28 d、(25±2)℃ 存放4周 、(37±2)℃ 存放4 d,以及冻融6次,总病毒滴度 ≥ 每0.1毫升6.18 lg半数细胞培养感染量(50％cell culture infective dose,CCID50)、Ⅰ 型病毒滴度 ≥6.0 lgCCID50/0.1 ml、Ⅲ 型病毒滴度 ≥5.6 lgCCID50/0.1 ml,均符合标准要求(总病毒和 Ⅰ 、Ⅲ 型病毒滴度应分别不低于6.12、6.0、5.5 lgCCID50/0.1 ml).疫苗于(37±2)℃ 放置2 d的热稳定性试验显示,病毒滴度下降≤0.50 lgCCID50/0.1 ml,符合标准要求(不高于0.50 lgCCID50/0.1 ml).其他各项稳定性指标检查也均合格.结论 口服 Ⅰ 型 Ⅲ 型脊髓灰质炎减毒活疫苗在本研究条件下稳定性良好.