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）℃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≥6.18 lg半数细胞培养感染量（50% cell culture infective dose，CCID50）/0.1 ml、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。

 Objective  To evaluate the stability of types Ⅰ and Ⅲ oral poliovirus vaccine (human diploid cel1). Methods  The vaccine was upright and invert stored below －20 ℃for 30 months, at (5±3) ℃for 15 months, at (5±3) ℃for 28 d after opening, at (25±2) ℃for 5 weeks, at (37±2) ℃ for 5 d, and repeated freeze-thaw 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°C 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 repeated freeze-thaw for 6 times, the total virus titers were ≥6.18 lg 50% cell culture infective dose (CCID50) /0.1 ml, type Ⅰ virus titers were ≥6.0 lgCCID50/0.1ml, type Ⅲ virus titers were ≥5.6 lgCCID50/0.1ml, all meeting standard requirements (total virus, types Ⅰ and Ⅲ virus titers no less than 6.12, 6.0 and 5.5 lgCCID50/0.1ml, 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.