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目的应用星点设计-效应面法优化复方天宁滴丸制备工艺。方法以PEG6000和棕榈山梨坦(司盘40)为联合基质,以药物的质量分数及PEG6000质量分数为自变量,以丸重差异、溶散时限以及一定时间的阿魏酸溶出度为因变量,对试验数据进行多元线性模型和二项式模型拟合,得出最佳数学模型,绘制效应图和等高线图,再根据效应图优选最佳条件。结果二项式模型相关系数优于多元线性模型,复相关系数为0.970,复方天宁滴丸最佳处方为药物质量分数23%,PEG6000质量分数47%,模型的理论预测值与实测值偏差较小,模型具有良好的预测性。结论星点设计-效应面法建立的模型预测性良好,可用于对复方天宁滴丸制备工艺的优化。
OBJECTIVE To optimize the preparation process of compound Tianning dropping pills by the method of apical spot design and response surface method. Methods Taking PEG6000 and palm sorbitan (Span 40) as the joint matrix, drug content and PEG6000 concentration as independent variables, the differences of pill weight, dissolution time and the dissolution rate of ferulic acid for a certain period of time were taken as the dependent variables, The experimental data were multivariate linear model and binomial model fitting, the best mathematical model, draw the effect map and contour map, and then optimize the optimal conditions according to the effect. Results The binomial model correlation coefficient was better than the multivariate linear model, the correlation coefficient was 0.970. The best prescription of compound Tianning dripping pills was 23% of the drug mass and PEG6000 mass fraction of 47%. The deviation between the theoretical predictive value and the measured value Small, the model has good predictability. Conclusion The model established by the star-point design-response surface method has good predictability and can be used to optimize the preparation process of compound Tianning dropping pills.