复方天宁滴丸稳定性考察

目的:考察复方天宁滴丸中阿魏酸的热降解动力学过程.方法:以阿魏酸含量为指标,采用经典恒温加速法和留样观察法考察复方天宁滴丸的有效期,通过HPLC测定阿魏酸含量.结果:阿魏酸的含量变化符合一级动力学过程,预测有效期20.8个月.结论:经典恒温加速法和留样观察法的结果基本一致,经典恒温加速法可快速确定有效期,缩短新药开发周期.

Stability Investigation of Compound Tianning Dripping Pills

Objective: To investigate pyrolytic degradation kinetic characteristics of ferulic acid in compound Tianning dripping pills. Method: With the content of ferulic acid as index,which was determined by HPLC,classic constant temperature acceleration test and sample observation method were adopted for investigating validity period of compound Tianning dripping pills. Result: Content change of ferulic acid was in line with first-order kinetics,validity period of compound Tianning dripping pills was 20.8 months. Conclusion: Results of classic constant temperature acceleration test and sample observation method were basically the same,classic constant temperature acceleration test could quickly determine validity period and shorten development cycle of new drugs.