台阶型变湿变温法对固体哌拉西林钠的稳定性研究

Stability Studies on Solid Piperacillin Sodium with Stepped Humidity and Temperature Controlled Method

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 the stepped humidity and temperature controlled method for stability study of solid drugs. METHODS The stepped humidity and temperature controlled method was used to study the degradation kinetics of piperacillin sodium. RESULTS The kinetic parameters of A, m and Ea obtained in the stepped humidity and temperature experi- ments were comparable with those obtained in the experiments at constant humidity and temperature. CONCLUSION The stepped humidity and temperature method was applicable to the stability study of piperacillin sodium. However, applications of the stepped humidity and temperature method to other solid drugs were uncertain.