Box-Behnken设计-效应面法优化罗布麻压制包衣脉冲片的处方工艺  

Optimization of Preparation Process of Apocyni Veneti Folium Pulse Compression-Coated Tablets by Box-Behnken Design and Response Surface Methodology

作　　者：吴璐[1] 高文军[1] 黄潇[1] 罗永明[1] 杨华生[1] 

机构地区：[1]江西中医药大学,南昌330004

出　　处：《中国实验方剂学杂志》2014年第3期28-31,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：江西省教育厅科技计划项目(GJJ13602);江西省卫生厅中医药科研计划项目(2011A136);江西中医学院课题(2012ZR012)

摘　　要：目的：研制罗布麻压制包衣脉冲片。方法：采用干法压制包衣法制备罗布麻脉冲片，以释药时滞和7h累积释放率为评价指标，采用Box—Behnken设计试验考察羧甲基淀粉钠-甘露醇、氢化蓖麻油-聚乙二醇6000及包衣重-片芯重对处方工艺的影响，通过二项式方程拟合建立指标与因素之间的函数关系，效应面法优化罗布麻压制包衣脉冲片处方，并对优选处方进行验证。结果：释药时滞和7h累积释放率与考察因素间均可用二项式方程拟合，相关系数分别为0．9798，0．9554。最佳处方为羧甲基淀粉钠-甘露醇（1：1），氢化蓖麻油．聚乙二醇6000（5．38：1），包衣片重-片芯重（1：1），制备的罗布麻压制包衣脉冲片时滞约5h，药物在6～8h内近似零级释放，释药时滞和7h累积释放率实测值与预测值的偏差分别为3．61％，-1．42％。结论：按Box—Behnken设计-效应面法优选处方制备的罗布麻压制包衣脉冲片具有良好的定时脉冲效果。Objective： To prepare Apocyni Veneti Folium pulse compression-coated tablets. Method： Apocyni Veneti Folium pulse tablets were prepared by dry-compression technique with release lag-time and accumulated release rate in 7 h as evaluation indexes, Box-Behnken design was adopted to investigate effects of ratio of CMS-Na to mannitol in core tablet, hydrogenated castor oil to PEG6000 in coating film and coating weight to core weight on prescription process, functional relationship between indexes and factors was established by binomial equation, prescription of Apocyni Veneti Folium pulse compression-coated tablet was optimized by response surface methodology, and optimized prescription for verification. Result： Relationship between indexes （lag-time and accumulated release rate in 7 h） and factors were fitted by binomial equation, regression coefficients of them were O. 979 8 and 0. 955 4, respectively. Optimum prescription was as follows ： CMS-Na to mannitol （ 1 ： 1 ）, hydrogenated castor oil to PEG6000 （5.38：1 ） and coating weight to core weight （1： 1） ; Under these conditions, in vitro lag-time of these prepared tablets was about 5 h, then drug released from these tablets within 6-8 h was found to conform to zero-order kinetics and controlled by bulk erosion mechanism. Bias between observed values and predicted values of lag-time and cumulative release rate in 7 h were 3.61% and - 1.42% , respectively. Conclusion： These prepared Apocyni Veneti Folium pulse compression-coated tablets had an ideal timing pulse release effect.

关 键 词：罗布麻 脉冲片 Box—Behnken设计一效应面法 单因素试验 体外释放度 

分 类 号：R283.6[医药卫生—中药学]