25℃与37℃恒温状态下某二价口服脊髓灰质炎减毒疫苗专用热敏标签失效时间研究

Study on the failure time of the vaccine vial monitor used for oral poliovirus vaccine at 25 ℃ and 37 ℃

目的 评价25℃与37℃恒温状态下某口服脊髓灰质炎减毒疫苗（OPV）专用热敏标签的失效时间.方法 样本标签由某公司生产提供,型号QM5D37A,样本份数为160份,从不同批次产品中采用随机数字表法抽样得到;OPV样本疫苗由某国产疫苗企业生产提供,样本份数100份,从不同批次产品采用随机数字表法抽样得到.将160份样本标签平均分配到25℃与37℃水浴恒温箱中,定期测量活性区域颜色值ΔE.当ΔE=40时,活性区域颜色与参照圆圈颜色相同,热敏标签提示失效.采用随机数字表法,将100份OPV样本疫苗平均分配到25℃与37℃水浴恒温箱中,定期测量OPV总病毒滴度与Ⅰ、Ⅲ型病毒滴度.当满足总病毒滴度≤6.12细胞培养半数感染量（CCID50）、Ⅰ型病毒滴度≤6.0 CCID50,Ⅲ型病毒滴度≤5.5 CCID50之一时,样本疫苗失效.采用Origin 8绘制热敏标签ΔE变化拟合曲线图,根据曲线图计算热敏标签失效时间范围,结合疫苗滴度数据判断热敏标签是否存在晚于疫苗失效的情况.结果 25℃下,OPV样本疫苗失效的最早时间为21.0 d,此时,失效的样本疫苗为1份;25℃下,样本标签全部失效的最早时间为12.5 d,小于该温度下OPV失效的最早时间.37℃下,OPV样本疫苗失效的最早时间为4.0 d,此时,失效的样本疫苗为1份;样本标签全部失效的最早时间为3.1 d,小于相同条件下OPV疫苗失效的最短时间.结论 相同温度下样本标签均于疫苗失效前到达终点.37℃下样本标签全部失效的时间与OPV样本疫苗最早失效时间相同;25℃下样本标签全部失效时间早于疫苗最早失效时间.

Objective To evaluate the failure time of vaccine vial monitor （VVM） used for oral poliovirus vaccine （OPV） at 25℃and 37℃. Methods 160 copies of VVM were produced by a company, the model was QM5D37A, samples were taken from different batches by using the method of random number table . 100 bottles of vaccine were produced by a domestic company, and samples were taken from different batches by using the method of random number table. 160 copies of labels were placed in the incubator at 25 ℃ and 37 ℃, which were used to measure the mutative color of the active region. When the values of color were equal to 40, the color of active region was the same with the reference color, and the VVM was failed. 100 bottles of vaccine were placed in the incubator at 25℃and 37℃, which were used to measure the vaccine titer. When total vaccine titer was less than 6.12 CCID50 or vaccine titer of typeⅠwas less than 6.0 CCID50 or vaccine titer of typeⅢwas less than 5.5 CCID50, the vaccine was failed. We drew the graph of mutative color to calculate the failure time range of VVM According to the graph , we can determine that whether the failure time of VVM was later than the time of vaccines by the data of OPV . Results The earliest failure time of OPV was 21 days at 25℃, and the number of samples was one;The earliest Failure time of VVM was 12.5 days at 25℃, and it was less than the earliest failure time of OPV. The earliest failure time of OPV was 4.0 days at 37℃, and the number of samples was one;The earliest Failure time of VVM was 3.1 days at 37℃, and it was equal to the earliest failure time of OPV. Conclusion We could know that the failure time of VVM was always earlier than the failure time of vaccines at the same temperatures . The latest failure time of VVM was equal to the earliest failure time of vaccines at 37℃. All of the failure times of samples were earlier than that of vaccines at 25℃.