经典恒温法和多元线性模型预测药物稳定性的空间解析

THREE DIMENSIONAL ANALYSIS OF THE CLASSICAL ISOTHERMAL KINETIC METHOD AND MULTIVARIATE LINEAR MODEL FOR THE STABILITY PREDICTION OF PHARMACEUTICAL PREPARATIONS

应用三维坐标系，以图示方式解析药物稳定性预测法中经典恒温法数据处理的复杂性，提出一个简便的药物稳定性预测方法多元线性模型。此模型是以药物的浓度函数ｌｎ［ｆ（ｃ０）－ｆ（ｃ）］和绝对温度的倒数１／Ｔ为变量，对时间的对数ｌｎ（ｔ）进行多元线性回归，以此计算药物的活化能和室温贮存期。结果表明：多元线性模型可以简化数据处理，明显减少实验工作量和误差。

This paper presents a three dimensional analysis of the complexity of the classical isothermal kinetic method for the stability prediction of pharmaceutical preparations and that of a simpler method multivariate linear model. By plotting the logarithm of time, ln( t ), against the concentration function of drugs, ln[f( c 0 )-f( c )], and the reciprocal of Kelvin temperature, 1/ T , the activation energy and shelf life of drugs can be calculated. An analytical comparison between the classical isothermal kinetic method and this model shows that the latter demands less experimental points and makes data treatment much simpler.