| 引用本文: | 洪清,袁曦,王友芳,陈庆伟.多元线性模型和经典恒温法预测天宁滴丸有效期[J].中国现代应用药学,2013,30(4):416-419. |
| HONG Qing,YUAN Xi,WANG Youfang,CHEN Qingwei.Predicting the Expiration Date of Tianning Drop Pill by Multivariate Linear Model and Classical Isothermal Accelerated Tests[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(4):416-419. |
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| 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。 |
| 关键词: 天宁滴丸 多元线性模型 经典恒温法 有效期 |
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| 基金项目:福建省卫生厅青年科学研究课题(2003-2-12) |
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| Predicting the Expiration Date of Tianning Drop Pill by Multivariate Linear Model and Classical Isothermal Accelerated Tests |
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HONG Qing1, YUAN Xi1, WANG Youfang1, CHEN Qingwei2
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1.Department of Pharmacy of the First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, China;2.Fuzhou Institute for Drug Control, Fuzhou 350001, China
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| Abstract: |
| 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. |
| Key words: Tianning Drop Pill multivariate linear model classical isothermal kinetic method expiration date |
