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.
出处
《药学学报》
CAS
CSCD
北大核心
1996年第11期861-866,共6页
Acta Pharmaceutica Sinica
关键词
药物稳定性
多元线性模型
经典恒温法
预测
Drug stability
Multivariate linear model
Classical isothermal kinetic method
Tenoxicam
Ascorbic acid
Tetracaine hydrochloride
