程序变湿法研究双氯西林钠的稳定性StudiesonStabilityof.PDF

2005 年第 63 卷 化 学 学 报 Vol. 63, 2005 第 6 期, 512～518 ACTA CHIMICA SINICA No. 6, 512～518 ·研究论文· 程序变湿法研究双氯西林钠的稳定性 尹小东 詹先成* 李琳丽 李成容 林 涛 赵 强 何 宁 ( 四川大学华西药学院 成都 610041) 摘要 报道了一种研究固体药物对湿度稳定性的新的实验方法——程序变湿法, 通过一次程序变湿和一次程序变温加 速试验, 得到与湿度和温度有关的药物降解的全部动力学参数; 设计了用电子计算机控制程序变湿和程序变温的装置, 其湿度波动小于±0.5%, 温度波动小于±0.1 ℃; 以双氯西林钠为体系, 采用线性程序变湿和倒数程序变温实验研究 了其稳定性. 结果表明程序变湿和变温加速实验与恒温恒湿对照实验得到的降解动力学参数基本一致. 关键词 药物稳定性; 程序变湿加速; 程序变温加速; 降解动力学; 双氯西林钠 Studies on Stability of Dicloxacillin Sodium with Programmed Humidifying Experiments YIN, Xiao-Dong ZHAN, Xian-Cheng* LI, Lin-Li LI, Cheng-Rong LIN, Tao ZHAO, Qiang HE, Ning (West China School of Pharmacy, Sichuan University, Chengdu 610041) Abstract A drug stability experiment with dicloxacillin sodium in the solid state as a model was investi- gated by programmed humidifying method. A computer-controlled humidifying and heating system was es- tablished. The stability of drugs which were unstable to both heat and moisture could be studied by only one programmed humidifying experiment and one nonisothermal experiment instead of by many conventional classical isothermal experiments at constant relative humidity. In our established system, a pocket computer was used to control a common environmental chamber to obtain programmed humidifying and heating mod- els. This controlling system was found to be quite accurate and reliable. The results from the experiments indi