指数程序升温药物稳定性试验

EXPONENTIAL PROGRAMMED FOR DRUG STABILITY EXPERIMENT

介绍了一种新的程序升温（指数程序升温）药物稳定性预测加速试验方法及计算方法。在这一新的程序升温方法中，温度每升高１０℃，升温速率将增大２～４倍：ｄＴ／ｄｔ＝ａ￣（（Ｔ－Ｔ＿０）／１０）·（ｄＴ／ｄｔ）＿０，使药物在高温和低温范围内的降解程度尽可能一致，提高了试验准确度。采用单因素优选法和数值积分法处理试验数据，避免了任何近似处理，使计算结果准确可靠。与线性升温、倒数升温和对数升温加速试验进行了对比，结果表明，指数程序升温法的准确性优于其它３种升温法。

A new programmed heating model(exponential heating model)for drug stabilityexperiment is intreduced.In this heating model,the temperature rising rate dT/dt is increased 2～4times when the temperature increases by every 10℃ to fit most chemical reactions:dT/dt=a·(dT/dt)_0.A comparison of the new heating model and the linear,reciprocal,andlogarithmic heating models is made and discussed.The results indicate that in the new programmedheating experiment,the degradation of drugs can be more uniform within different temperature rangesand the experimental results can be more accurate than those in the linear,reciprocal,or logarithmicheating experiment.A computation method with optimization and numerical integration for the newprogrammed heating experiment is also introduced.In this computation method, there is no need forapproximation.