Box-Behnken设计-响应面法用于制备连番止泻包衣微丸的工艺研究  

Preparation of Lianfan Zhixie Coated Pellets by Box-Behnken Design-Response Surface Method

作　　者：黄德浩 何文涛 周嘉纯 叶红斌 胡辉 黄丽 黄源林 宋吉明[2] HUANG Dehao;HE Wentao;ZHOU Jiachun;YE Hongbin;HU Hui;HUANG Li;HUANG Yuanlin;SONG Jiming(Huizhou Jiuhui Pharmaceutical Co.,Ltd.,Huizhou,Guangdong 516007,China;Anhui Uniersity,Hefei,Anhui 230601,China)

机构地区：[1]惠州市九惠制药股份有限公司,广东惠州516007 [2]安徽大学,安徽合肥230601

出　　处：《今日药学》2023年第3期191-195,共5页Pharmacy Today

基　　金：惠州市科技计划项目(2020SC0109009)。

摘　　要：目的优选具有掩味作用的连番止泻包衣微丸的最佳制备工艺。方法通过微丸制备、以及响应面法进行工艺优化,以黄连包合率为指标,确定包衣微丸制备工艺。结果最佳工艺得到的最佳条件为用57.63%EC,20.35%HPMC,15.48%滑石粉作为包衣材料,黄连包合率可达到92.8%,且经过模拟药物在人工唾液中的释放速率,证明包衣微丸在人工唾液中2 min内未释放,5 min仅有少量释放。结论该工艺稳定可行、预测性较好,该工艺研制的包衣微丸质量指标符合要求。OBJECTIVE To optimize the best preparation technology of Lianfan Zhixie coated pellets with taste masking.METHODS The preparation process was optimized by pellet preparation and response surface method,and the coating pellet preparation process was determined with the inclusion rate of Coptis Chinensis as the index.RESULTS The optimum conditions were.57.63%EC,20.35%HPMC and 15.48% tale powder as coating materials,and the inelusion rate of Copis Chinensis was reach 92.8%.And the release rate of drugs in artificial saliva was simulated,it was proved that coated pellets were not released in artificial saliva within 2 minutes and only a small amount was released in 5 minutes.CONCLUSION The process is stable,feasible and predictive,and the quality indexes of coated pellets prepared by this process meet the requirements.

关 键 词：连番止泻包衣微丸 制备工艺 Box-Behnken法 

分 类 号：R283[医药卫生—中药学]