目的建立青霉素钾的单点测定恒温恒湿稳定性试验方法。方法在恒温和不同湿度及在恒湿和不同温度下进行加速试验,以获得青霉素钾与湿度和温度有关的动力学参数。结果与经典恒温恒湿法相比,单点测定恒温恒湿稳定性试验大大减少了工作量;与程序变湿变温法相比,只需使用普通的恒温恒湿控制装置。结论单点测定恒温恒湿稳定性试验可用于湿度对青霉素钾稳定性研究。
OBJECTIVE To establish the single time point isothermal experiments at constant humidity stability test of penicillin potassium. METHODS Accelerated test were carried out at a set of humidities and a fixed temperature and to obtain the kinetic parameters of Penicillin potassium related to humidity and temperature. RESULTS The proposed experiments saved time, labor and materials compared with classical isothermal experiments at constant humidity; and no specific computer- controlled environmental chamber need to be used in the experiments compared with programmed humidifying and heating experiments. CONCLUSION Single time point isothermal experiments at constant humidity are applicable to the stability study of penicillin potassium.