摘要
目的研究天宁滴丸中主要成分阿魏酸的稳定性,并预测有效期。方法采用高效液相色谱法测定阿魏酸含量,采用多元线性模型和经典恒温法研究温度对阿魏酸稳定性的影响,同时比较两种方法,并以长期试验验证。结果天宁滴丸降解动力学过程符合一级动力学过程,用多元线性模型和经典恒温法预测天宁滴丸的有效期分别为21.8,20.8月。结论两种方法预测得到的有效期基本一致,多元线性模型可简化数据处理,作为一种简便方法用于有效期的预测。
OBJECTIVE To study the stability of ferulic acid, the main ingredient of Tianning Drop Pill, and to predict the validity duration. METHODS The HPLC method was used to determine the content of ferulic acid. Multivariate linear model and classical isothermal kinetic method were used to study the influence of temperature on ferulic acid stability. The efficacy of two methods were verified and compared with long term test. RESULTS It was found that the pyrolytic degradation kinetics of Tianning Drop Pill fitted with the first-order kinetics. The expiration dates of Tianning Drop Pill calculated by multiple linear model and classic isothermal accelerated tests were 21.8 months and 20.8 months, respectively. CONCLUSION The expiration dates of Tianning Drop Pill calculated by two different methods are almost the same. Multivariate linear model can be used for a convenient method to predict the expiration date.
出处
《中国现代应用药学》
CAS
CSCD
2013年第4期416-419,共4页
Chinese Journal of Modern Applied Pharmacy
基金
福建省卫生厅青年科学研究课题(2003-2-12)
关键词
天宁滴丸
多元线性模型
经典恒温法
有效期
Tianning Drop Pill
multivariate linear model
classical isothermal kinetic method
expiration date
