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作 者:陈海亭[1] 尹蓉莉[1] 陈金玉[1] 王宝才[1] 党万太[1] 吕懿平[1]
出 处:《中成药》2011年第10期1688-1692,共5页Chinese Traditional Patent Medicine
摘 要:目的应用星点设计-效应面法优化山楂叶总黄酮微孔渗透泵控释片处方。方法以乳糖的用量、致孔剂用量、包衣增重为考察因素,2、6、12 h山楂叶总黄酮的累计释放度为评价指标,采用Design-expert软件对实验数据进行多元线性模型和二次多项式模型拟合,得出最佳数学模型,然后绘制效应图和等高线图,通过重叠等高线图得到最优处方并进行验证。结果二次多项式模型相关系数优于多元线性模型,为最终拟合模型;最佳处方的各时间点累计释放度的实际值和预测值接近,相对偏差绝对值小于5%,且3个验证处方零级释放特性良好。结论通过星点设计-效应面法建立的模型预测性良好,可用于对山楂叶总黄酮微孔渗透泵控释片处方的优化。AIM To optimize the formulations of microporosity osmotic pump tablet of total hawthorn leaf flavonoids by a central composite design-response surface methodology.METHODS The independent variables comprised of the amount of lactose,pore-forming agent and coating weight gain,and the dependent variables involved the cumulative release after 2 h,6 h and 12 h.Design Expert software was used to fit multivariate linear models and quadratic multinomial models for experimental data.Response surface and contour overlay plot were delineated according to best-fit mathematic models and the optimum formulation was selected by contour overlay plot.RESULTS Quadratic multinomial models were better than multivariate linear models.There was close agreement between observed and predicted values for the cumulative release,and bias were all less than 5%.Validation formulations were better to follow zero-order property.CONCLUSION The model established by Design Expert software is better to predict and could be used to optimize the formulations of microporosity osmotic pump tablets of hawthorn leaves flavonoids.
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