通过加速贮存试验估算u-PA产品在不同温度时的贮存寿命

Predicting the stability of lyophilization u-PA at different temperatures by accelerated storage test

通过在 6 0℃、70℃、80℃的加速贮存试验 (MIS)观察了 u- PA冻干产品的热稳定性 ,并对其活性的热降解速度和不同温度时贮存寿命进行了估算。在 3 7℃ ,2 5℃ ,4℃ ,0℃贮存时 ,活性单位损失 5 0 %所需的时间为 1 73 d、2 .78a,70 .8a,1 1 8a:活性单位损失 1 0 %需的时间分别为 2 0 d、1 0 0 d、7.6 4 a、1 1 a。

Using accelerated storage test (MIS) at 60, 70 and 80℃, we had got the rates of thermal degradation (K1), and we could predict that the dried u-PA kept at 37, 25, 4 and 0℃will lost 50% of its activity in 173 days, 2.78 years, 70.8 years and 118 years respectively, or it will lost 10% of its activity in 20 days, 100 days, 7.6 years and 11 years kept at the same temperatures respectively.