Mann G F, Allison L M, Lloyd J S, Tam P, Zuckerman A J, Perkins F T
Rev Infect Dis. 1983 May-Jun;5(3):482-6. doi: 10.1093/clinids/5.3.482.
Accelerated stability tests on lyophilized measles vaccines show two distinct mechanisms of virus inactivation. A rapid initial loss of infectivity occurs only on exposure to temperatures above the ambient temperature. This loss is temperature related and may be attributable to the movement of residual moisture from the virus pellet into the void space of the vial. Subsequent inactivation of virus occurs at all temperatures as a first-order reaction that follows Arrhenius kinetics. Integration of values for these two components allows precise prediction of vaccine stability at any temperature. Analysis of the results obtained for greater than 30 vaccines shows that those which are stable for one week at 37 C have a predicted life of more than one year at 8 C. This simple test is now being applied to the identification of unstable products. The rate of this reaction is closely, if conservatively, matched by a time-temperature color indicator, which may be useful for monitoring vaccine quality.
冻干麻疹疫苗的加速稳定性试验显示出两种不同的病毒灭活机制。仅在暴露于高于环境温度的温度时，才会迅速出现初始感染力丧失。这种丧失与温度相关，可能归因于残余水分从病毒沉淀向小瓶空隙空间的移动。随后，病毒在所有温度下都会发生一级反应失活，该反应遵循阿伦尼乌斯动力学。将这两个成分的值进行整合，可以精确预测疫苗在任何温度下的稳定性。对30多种疫苗所得结果的分析表明，那些在37℃下稳定一周的疫苗在8℃下的预测保质期超过一年。这种简单的试验目前正被用于识别不稳定产品。这种反应的速率与一种时间 - 温度颜色指示剂密切（即使是保守地）匹配，这可能有助于监测疫苗质量。
