摘要
目的选用中心复合设计法优化香青兰口腔崩解片处方。方法以PVPP(X1)、MCC(X2)和乳糖(X3)的用量为因变量,以崩解时间(Y)为自变量,分别用两因素相互作用模型(2FI)和三次多项式模型描述因变量和自变量之间的数学关系,绘制等高线图,确定较优处方并进行验证试验。结果优化后的处方为PVPP:38.5 mg,MCC:151.0 mg,乳糖:24.5mg。优化处方制备香青兰口腔崩解片平均崩解时间为30.46 s,预测值和测定值偏差的绝对值均<5%,3次多项式模型比两因素相互作用模型置信度高。结论中心复合设计法优化香青兰口腔崩解片的处方具有良好的预测性。
AIM To optimize the formulation of Greenorchid（Dracocephalum Moldavuca） orally disintegrating tablet by the central composite design（CCD）.METHODS The amount of polyvinylpyrrolidone（PVPP）,microcrystalline cellulose（MCC） and lactose were taken as the independent variables;disintegration time of tablet was taken as the dependent variable.two-factor-design and Cubic polynomial models were used to estimate the relationship between the dependent and independent variables,and contour plots was drawn to select the optimal formulation,and validation.RESULTS The optimized formulation of Greenorchid orally disintegrating tablet was as follows： A 38.5 mg of PVPP,B 151 mg of MCC,and 24.5 mg of lactose.The average disintegration time was 30.46 s,and the absolute value between measured value and predictive value of index fell within 5%.The Cubic polynomial model has higher confidence level than that of the two-factor design.CONCLUSION The CCD-RSM can be applied to optimizing the formulation of Greenorchid orally disintegrating tablet and the Cubic polynomial model has the satisfactory predictive value.
出处
《中成药》
CAS
CSCD
北大核心
2011年第4期603-607,共5页
Chinese Traditional Patent Medicine
基金
国家科技重大专项课题新药创制(2009ZX09103-448)
关键词
香青兰
口腔崩解片
中心复合设计法
Dracocephalum Moldavuca
orally disintegrating tablet
central composite design
