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作 者:颜廷旭[1] 杨星钢[1] 高永生[1] 程洁[1] 彭俊杰[1] 潘卫三[1]
出 处:《中国新药杂志》2010年第21期1986-1990,共5页Chinese Journal of New Drugs
摘 要:目的:通过星点设计-效应面法优化四逆散双层渗透泵片处方。方法:以含药层N750用量和NaC l用量、包衣液中PEG 4000用量和包衣增重为考察因素,以药物释放曲线的相关系数和12 h的累积释放量为考察指标,分别用多元线性模型、二次多项式模型和三次多项式模型描述考察指标和任意2个考察因素之间的关系,并绘制了三次多项式模型的效应面和等高线图,通过重叠区域确定优化处方,并通过实验值与预测值比较进行验证。结果:三次多项式为拟合的最佳模型,优化处方考察指标的实验值与预测值非常接近。12 h的累积释放量为97.86%,释放曲线相关系数为0.995 6。结论:采用星点设计-效应面法得到了基于三次多项式模型的四逆散渗透泵片处方优化的模型,实现了该渗透泵片的处方优化。Objective: To optimize the formulation of Sinisan osmotic pump tablets by a central composite design-response surface method.Methods: Independent variables were the N750 and NaCl contents in drug layer,PEG 4000 content in coating solution and weight gain.Dependent variables were percentages of in vitro cumulative releases at 12 h and correlation coefficient of drug release profile.Multilinear,quadratic and third-order quadraric models were used to estimate the relationship between the dependent and the independent variables.The cubic polynomial response surface model and contour map were delineated,the formulation was optimized by determination of the overlap region,and the experimental data were compared with the predicted values.Results: The cubic polynomial was the best fitting model,and the experimental data from optimized formulation were very close to the predictive values of indicators.The ultimate cumulative release was 97.86%,and correlation coefficient of drug release profile was 0.995 6.Conclusion: The central composite design-response surface method based on the cubic polynomial model optimizes the formulation of Sinisan osmotic pump tablets.The optimized formulation displays a complete drug delivery and zero-order release rate.
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