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用留样观察法测定药物的稳定性,真实可靠,但旷日持久,颇费时间。经典的恒温加速试验法又相当繁复。多种简化法则可供参考。利用温度系数作预测,为其中之一法,对新药预测、制剂研究和养护试验等均可适用。一、基本原理荷兰化学家Van′t Hoff早就发现温度升高10℃,化学反应速度约可增高2～4倍,即K_(T+10)/K_T=r=2～4。式中r就叫温度系数,也有用Q_(10)表示的;K是反应速度常数;T是反应时的绝对温度,在不影响计算的前提下,有时也可用摄氏温度表示。根据推导,可以找出如下关系:
Using sample-like observation of the stability of drug determination, true and reliable, but protracted, quite time-consuming. The classic constant temperature accelerated test method is quite complicated. A variety of simplified rules for reference. Prediction using the temperature coefficient is one of the methods that can be applied to the prediction of new drugs, formulation research and curing tests. First, the basic principle Dutch chemist Van’t Hoff has long been found that the temperature increased by 10 ℃, the chemical reaction rate increased by about 2 to 4 times, that K_ (T +10) / K_T = r = 2 ~ 4. Where r is called the temperature coefficient, but also useful Q_ (10) said; K is the reaction rate constant; T is the absolute temperature of the reaction, without affecting the calculation of the premise, and sometimes can also be expressed in Celsius. According to the deduction, we can find out the following relations: