多元线性模型预测药物的稳定性  

A MULTIVARIATE LINEAR MODEL FOR PREDICTING STABILITY OF PHARMACEUTICAL PREPARATIONS

作　　者：乐健[1] 刘文英[1] 杨静化[1] 安登魁[1] 

机构地区：[1]中国药科大学药物分析教研室,中国药科大学数学教研室

出　　处：《药学学报》1996年第11期861-866,共6页Acta Pharmaceutica Sinica

摘　　要：首次提出了预测药物稳定性的多元线性模型。该模型指出，任何满足恒温降解动力学公式和Ａｒｒｈｅｎｉｕｓ公式的药物，都可在３维坐标系中以药物平面形式表示。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，可以计算得到药物的活化能和室温贮存期。应用多元线性模型和经典恒温法对替诺昔康注射液（自制）、抗坏血酸注射液及盐酸丁卡因水溶液的室温贮存期预测的结果表明：两者无显著性差异，而本模型可大大减少实验次数，应用ＳＡＳ软件使数据处理更简便。This paper presents a multivariate linear model for predicting the stability ofpharmaceutical preparations.Any drug,which is fit for isothermal disintegrating kinetic formula andArrhenius formula,can be represented by a drug plane in three-dimensional ccordinates.Predicting thestability of drugs can be accomplished by the following steps:first,the logarithm of the time ln(t)plots against the concentration function of drugs ln[f(c0),-f(c)]and the reciprocal of Kelvintemperature 1/T;second,the regression equation so obtained can be applied to calculate the activationenergy and shelf-life of drugs.The determination of the stability of tenoxicam injection, ascorbic acidinjection and tetracaine hydrochloride solution shows:the results of classical isothermal kinetic methodand those of this model agree with each other satisfactorily.The latter can reduce laboratory workgreatly and using SAS software makes data treatment much simpler.

关 键 词：药物稳定性 多元线性模型 经典恒温法 预测 

分 类 号：R927.11[医药卫生—药学]