经典恒温法和多元线性模型预测阿魏酸钠注射液的有效期

Prediting the expiration date of Sodium ferulate injection by classical isothermal kinetic method and multivariate linear model

目的 研究阿魏酸钠注射液的热降解动力学过程,并预测制得的阿魏酸钠注射液的有效期。方法 采用HPLC法测定含量,采用经典恒温法和多元线性模型两种方法计算药物的有效期,同时比较两种方法的特点。结果 阿魏酸钠注射液的降解动力学过程符合一级动力学过程,用经典恒温法和多元线性模型预测阿魏酸钠注射液的有效期分别为1 . 72、1 . 90年。结论 两种方法预测得到的有效期基本一致,多元线性模型可作为一种简便方法用于注射液的有效期的预测。

OBJECTIVE To investigate the pyrolytic degradation kinetic characteristics of Sodium ferulate injection, and predict the expiration date of the injection. METHODS The HPLC method was used to determine the contents of the sodium ferulate. Classical isothermal kinetic method and multivariate linear model were used to predict the expiration date of the injection, and compared the same time. RESULTS It was found that the pyrolytic degradation kinetics of sodium ferulate injection corresponded with the first-order kinetics. The expiration dates of the injection calculated by two different methods were 1.72 and 1.90 years. CONCLUSION The expiration dates of the injection calculated by two different methods are almost the same. Multivariate linear model can be used for a convenient method to predict the expiration date of the injection.