目的研究固体阿莫西林的降解动力学规律。方法采用HPLC法测定阿莫西林的含量;在恒温恒湿条件下进行加速试验,以获得与温度、湿度相关的动力学参数。结果阿莫西林遵从一级降解动力学规律;速率常数k=Aexp(-Ea/RT)·exp(mHr),指前因子A=(1.28±0.46)×10^19h^-1,活化能Ea=158.0%±1.01%kJ·mol^-1,常数m=6.61%±0.05%。结论采用经典恒温恒湿法能研究温度和湿度对固体阿莫西林稳定性的影响。
OBJECTIVE To perform a kinetic analysis of the degradation of Amoxicillin in the solid phase at different temperatures and relative humidities.METHODS Amoxicillin was incubated in an environmental chamber at different temperatures and relative humidities.After the incubation,the content of Amoxicillin in the presence of its degradation products was measured by HPLC.RESULTS The degradation rate of Amoxicillin obeyed first-order kinetics.The rate constant k could be expressed as:k = Aexp(-Ea /RT)·exp(mHr),where the pre-exponential factor A was(1.28 ±0.37) ×10^19 h^-1.The observed activation energy Ea was 158.0% ± 1.01% kJ·mol^-1 and the constant m was 6.61% ± 0.05%.CONCLUSION The classical isothermal experiments at constant humidity can be used to investigate the stability of Amoxicillin in both moisture and heat.