复方天宁滴丸稳定性考察  

Stability Investigation of Compound Tianning Dripping Pills

作　　者：王友芳[1] 朱善岚[1] 洪清[1] 袁曦[1] 陈庆伟 

机构地区：[1]福建医科大学附属第一医院,福州350005 [2]福州市药品检验所,福州350001

出　　处：《中国实验方剂学杂志》2013年第15期46-48,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：福建省卫生厅青年科学研究课题(2003-2-12)

摘　　要：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。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 firstorder 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.

关 键 词：经典恒温加速法 留样观察法 稳定性 阿魏酸 滴丸 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]