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目的建立台阶型变湿变温法对固体药物的稳定性研究方法。方法以哌拉西林钠为模型,采用台阶型变湿变温法研究哌拉西林钠的降解动力学过程。结果得到了哌拉西林钠降解过程的动力学参数A、m及Ea,与经典恒温恒湿法比较,结果一致。结论台阶法可用于哌拉西林钠的降解动力学研究,是否能用于其它固体药物还需进一步研究。
Objective To establish a method to study the stability of solid drugs by the step-down humidification method. Methods Piperacillin sodium was used as a model to study the degradation kinetics of piperacillin sodium by a step-wise humidification-warm-up method. Results The kinetic parameters A, m and Ea of degradation of piperacillin sodium were obtained. The results were in good agreement with those of the classical constant temperature and humidity method. Conclusion The step method can be used to study the degradation kinetics of piperacillin sodium. Whether it can be used in other solid drugs needs further study.