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为了便于生产部门建立稳定性预测常规,克服经典恒温法测试点多、实验时间长的缺点.发挥变温加速试验的长处,在不损失精确度的情况下,以较小的工作量完成药物稳定性预测,作到既不需要复杂仪器装置,数据处理也较简便,我们设计了台阶型变温法,即按台阶型曲线变温。在变温过程中,取样观察药物含量随时间的变化,从而按 Arrhenius 指数规律外推室温贮存期。
In order to facilitate the production department to establish the stability prediction routine, to overcome the classic test point of constant temperature method, the long time of the shortcomings of the variable temperature accelerated test to play strengths, without loss of accuracy, with less effort to complete the drug stability Predict, do not need complicated instrument apparatus, data processing is relatively simple, we designed the step-type temperature-changing method, that is, according to the step-type curve of temperature. During the warming process, samples were taken to observe the change of the drug content over time, thus extrapolating the room temperature storage period according to the Arrhenius index rule.