卢芳 井月娥 任燕冬 张淑香 刘树民

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（cCMC-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%cCMC-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。

关键词：拜颤停片；星点设计；效应面法

DOI：10.3969/j.issn.1005-5304.2016.07.022

中图分类号：R283.5 文献标识码：A 文章编号：1005-5304（2016）07-0087-05

Optimization of Prescription of Baichanting Tablets by Central Composite Design-Response Surface Methodology LU Fang1， JING Yue-e1， REN Yan-dong2， ZHANG Shu-xiang1， LIU Shu-min3 （1. Heilongjiang University of Chinese Medicine， Harbin 150040， China； 2. Jiamusi Medical College， Jiamusi 150400， China； 3. Center for Safety Evaluation of Drugs， Heilongjiang University of Chinese Medicine， Harbin 150040， China）

Abstract： Objective To optimize the prescription of Baichanting 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. Results The 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 of Baichanting Tablets.

Key words： Baichanting Tablets； central composite design； response surface methodology

帕金森病（Parkinson's disease，PD），是一种慢性神经系统退行性疾病，其临床症状除震颤、肌肉僵

基金项目：国家自然科学基金青年基金（81303249）

通讯作者：刘树民，E-mail：keji-liu@163.com

直、运动迟缓等运动症状外，通常伴有精神、认知或睡眠障碍等非运动症状。目前对于该病的治疗普遍以多巴胺制剂为主，但只能改善患者的临床症状而不能阻止疾病的进程[1]，且长期服用会出现一系列不良反应。因而开发创新中药保护制剂尤为重要。本课题组选择平肝熄风[2-3]、补益肝肾[4]、补血养肝[5]的3味中药材自组复方并命……