平面单点测定法研究温度和湿度对阿司匹林稳定性的影响

Influence of moisture and temperature on the stability of Aspirin by the plane single time point isothermal experiment at constant humidity

目的建立一种研究湿度与温度同时影响药物稳定性的新方法。方法以阿司匹林为模型药物,利用均匀优化设计分散原理组合所选的温度与湿度水平,以单测点法在组合点下进行稳定性加速试验,从而获得药物与湿度、温度有关的全部动力学参数。结果所建立的方法与恒温恒湿法和程序变温变湿法得到的降解动力学参数基本一致。与程序变温变湿法相比,其准确度及精密度均高,且只需使用普通的恒温恒湿控制装置;与经典恒温恒湿法比较,能节约时间和样品。结论平面单点测定法可应用于湿度和温度对药物稳定性的研究。

OBJECTIVE To establish a plane single time point isothermal method at constant humidity, and the stability of aspirin against to both moisture and heat was studied. METHODS Uniform design and single time point method were adopted to carry out accelerate tests. Then, the kinetic parameters of drug related to humidity and temperature were obtained. RESULTS The results ob2 tained from the new method, were comparable to those from isothermal experiments at constant humidity and the programmed humidifying and non - isothermal experiments. The proposed experiments saved time, labor and materials compared with classical isothermal experiments at constant humidity; the estimates for the kinetic parameters （Ea,m,A）obtained from the new method were more accurate and precise than those obtained from the programmed humidifying and non - isothermal experiments, and no specific computer - con- trolled environmental chamber need to be used in the new method. CONCLUSION The plane single time point isothermal experiment at constant humidity could be used to study the stability of drug against to humidity and heat.