目的：探讨普通迟释口服固体制剂药物溶出曲线的拟合数学模型与应用。方法选择3种11批硬胶囊和糖衣片制剂，采用光纤药物溶出度实时测定仪监测药物溶出曲线，分别运用Weibull与Logistic数学模型拟合，计算并分析其拟合优度( R2)和均方比( F )；依据Weibull模型的拟合参数及其95％的置信区间，判别受试与参照制剂药物溶出曲线的相似程度。结果试验制剂的药物溶出曲线呈现S型和弧型；综合评价，采用Weibull模型拟合更优；依据Weibull模型的拟合参数及其95％的置信区间判别药物溶出曲线的相似度，糖衣片较硬胶囊变异明显，糖衣片M制剂较N制剂变异明显。结论建议采用Weibull模型拟合普通迟释口服固体制剂药物溶出曲线，其拟合参数可以初步判断制剂工艺的相似度和稳定性。%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.
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