中国药业2016，Vol.25Issue(17)：17-21,5.
Weibull与Logistic模型对常用迟释口服固体制剂药物溶出曲线拟合优度的比较与应用
Fitting Comparison and Application between Weibull and Logistic Model for Drug Dissolution Curves of Oral Solid Preparations with Common Delayed-Release
摘要
Abstract
Objective To investigate and apply the mathematical matching models of drug dissolution curves of oral solid preparations with common delayed-release. Methods 3 kinds and 11 production lots of hard capsules and sugar-coated tablets were selected. The drug dissolution curves of those preparations were monitored with the instrument of fiber-optic in situ dissolution test. Those curves were fitted with the classical Weibull and Logistic models. The fitting“R2”and“F”value were calculated and analyzed. Based on the parameters fitted by Weibull model and 95% confidence interval of parameters, the similarity of drug dissolution curves between the test and referent preparations was discriminated. Results The drug dissolution curves had been shaped in the type of“S”and arc. Overall, the fitted experimental curves with Weibull model was better than those with Logistic model. Of the similar judgment based on the parameters fitted by Weibull model and 95% confidence interval of the parameters, the curve differences of sugar-coated tablets were more significant than of hard capsules, the M preparations of sugar-coated tablets were more significant than N preparations. Conclusion It is suggested that the drug dissolution curves of oral solid preparations with common delayed-release can fitted with Weibull model, the similarity and stability of production technique can be preliminarily judged with fitted model parameters.关键词
Weibull模型/Logistic模型/普通迟释口服固体制剂/药物溶出曲线/拟合优度Key words
Weibull model/Logistic model/oral solid preparations with common delayed-release/drug dissolution curve/goodness of fit分类
化学化工引用本文复制引用
耿东升,陈明,吴晓薇..Weibull与Logistic模型对常用迟释口服固体制剂药物溶出曲线拟合优度的比较与应用[J].中国药业,2016,25(17):17-21,5.基金项目
新疆维吾尔自治区自然科学基金项目，项目编号2013211A119。 （）
