药物有效期预测及稳定性影响因素实验设计

Experimental design for the prediction of drug validity duration and the investigation of influences on drug stability

目的探索替莫唑胺作为药物稳定性学生实验的可行性,建立预测其水溶液室温有效期的实验方法,并考察pH对稳定性的影响。方法用HPLC法测定替莫唑胺水溶液有效成分含量;用一级反应速率方程及阿雷尼乌斯公式进行计算预测。结果本品水溶液在高温条件下不稳定;同时受pH影响较大,在酸性条件下稳定,在碱性条件下不稳定;室温有效期约为21 d。结论本次实验药物选择合适,实验操作简便,快速准确,适合学生操作,可用于药剂学药物稳定性的实验教学。

Objective To investigate the feasibility of temozolomide replacement of vitamin C and penicillin to evaluate the drug stability for students, experiment; to establish the experimental method to predict the validity duration of temozolomide at room temperature and examine the impact of pH on the validity duration. Methods The concentration of temozolomide was assayed by high performance liquid chromatography （HPLC） ; the rate equation of first order reaction and Arrhenius equation were used to calculate the correlation parameters. Results Temozolomide was stable under the condition of acidic environment , not under the condition of high temperature, or alkaline environment, respectively; the pH value had a great impact on the drug stability; and the validity duration of temozolomide is about 21 days at room temperature. Conclusion The operation was simple and convenient, and temozolomide was suitable as a model drug to evaluate the drug stability for students, experiment.