安乃近的台阶型变温变湿稳定性试验

Stability of Metamizole sodium with stepped humidity and temperature controlled method

目的研究湿度对固体药物稳定性影响的台阶型程序变温变湿法。方法作者以安乃近为模型药物,采用台阶型程序变湿法和台阶型程序变温法进行试验。结果求得了Ea、m、A和t0.9等动力学参数。结论新方法测定结果较好,操作简单,对仪器要求较低。

OBJECTIVE The stability of metamizole sodium, as a solid state model, was investigated by stepped humidity and temperature controlled method. METHODS The stability of drugs which were unstable to both heat and moisture could be studied by a single pair of experiments, one with stepped humidity control and one with stepped temperature control, rather than many standard isothermal studies, each at constant relative humidity. RESULTS The stepped humidity and temperature controlling system used in our experiment was only a normal environmental chamber. CONCLUSION The results indicates that the kinetic parameters obtained are comparable to those from isothermal studies.