星点设计-效应面法优化复方拜颤停片剂的处方  

Optimization of Prescription of Baichanting Tablets by Central Composite Design-Response Surface Methodology

作　　者：卢芳[1] 井月娥[1] 任燕冬[2] 张淑香[1] 刘树民[3] 

机构地区：[1]黑龙江中医药大学,黑龙江哈尔滨150040 [2]佳木斯医学院,黑龙江佳木斯150400 [3]黑龙江中医药大学药物安全性评价中心,黑龙江哈尔滨150040

出　　处：《中国中医药信息杂志》2016年第7期87-91,共5页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家自然科学基金青年基金(81303249)

摘　　要：目的采用星点设计-效应面优化法优化复方拜颤停片剂的处方。方法分别以微晶纤维素(MCC)、交联羧甲基纤维素钠(c CMC-Na)、微粉硅胶及硬脂酸镁的用量百分比为考察因素,崩解时间及吸湿率为指标,用线性方程和二次多项式描述崩解时间及吸湿率与4个影响因素之间的数学关系,根据最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果崩解时间及吸湿率与4个因素间的关系均不能用线性方程描述,而用二次多项式拟合时,相关系数分别为0.837 9和0.923 1,具有较高的可信度。优选的最佳处方为30.60%MCC、10%c CMC-Na、0.30%微粉硅胶、0.10%硬脂酸镁。最佳处方崩解时限及吸湿率的理论值与预测值偏差均在5%以内。结论所建立的模型预测性良好,应用星点设计-效应面法能够精准地优化复方拜颤停片剂的处方。Objective To optimize the prescription ofBaichanting Tablets by the central composite design-response surface methodology.Methods The doses of MCC, cCMC-Na, SiO2, and magnesium stearate were set as investigation factors; disintegration time and moisture rate were set as indexes. Linear equation quadratic polynomial described mathematic relationship of disintegration time and moisture rate with other four influence factors. Response surface was described according to the optimal mathematic models; the optimal prescription was chosen; predictive analysis was conducted.ResultsThe relationship of disintegration time and moisture rate with other four influence factors could not be described by linear equation. When quadratic polynomial matching was used, correlation coefficients were 0.837 9 and 0.923 1, with relatively high reliability. Optimal prescription contained 30.6%MCC, 10%cCMC-Na, 0.30%SiO2, and 0.10% magnesium stearate. The theoretical value and predicted value deviations of the disintegration time limit and moisture absorption rate were within 5%.Conclusion The predictability of the established model is good. Application of central composite design-response surface methodology can precisely optimize the prescription ofBaichanting Tablets.

关 键 词：拜颤停片 星点设计 效应面法 

分 类 号：R283.5[医药卫生—中药学]