埃索美拉唑镁肠溶微丸的制备  

Preparation of Esomeprazole Magnesium Enteric-coated Pellets

作　　者：张文静[1] 李明丽 樊永庆 薛晓霞 阚淑玲[1] 刘建平[1] 

机构地区：[1]中国药科大学药剂学教研室,南京210009 [2]辰欣药业股份有限公司,山东济宁272000 [3]西藏海思科医药集团股份有限公司,四川成都610000

出　　处：《药学与临床研究》2014年第1期39-42,共4页Pharmaceutical and Clinical Research

摘　　要：目的:采用流化床上药包衣技术制备埃索美拉唑镁肠溶微丸。方法:选择含药层药物浓度、隔离层增重、肠衣层增重为影响因素,以肠溶微丸耐酸力和释放度为评价指标,采用Box-Behnken效应面法优化肠溶微丸处方,并对最优处方进行验证。结果:最优处方为上药浓度19.16%,隔离层增重17.15%,肠衣层增重66.15%,优化处方实测值与预测值相近。结论:该处方工艺可行,重复性良好,质量稳定可靠。Objective： To prepare esomeprazole magnesium enteric-coated pellets by Fluid-bed coatingtechnique. Methods： The drug concentration in drug layer, barrier layer enhanced and enteric layer en-hanced were selected as independent variables. The dependent variables like acid resistivity and cumulativerelease percentage were used for evaluation. Box-Behnken response surface methodology was used to opti-mize the formulation of esomeprazole magnesium enteric-coated pellets. Results： The optimal formulationwas： drug concentration in drug layer was 19.16 %, barrier layer enhanced was 17.15 %, enteric layer en-hanced was 66.15 %. There was little bias between the observed and predicted values. Conclusion： Thismethod is feasible for preparation of esomeprazole magnesium enteric-coated pellets and able to obtaingood repeatability and stable quality.

关 键 词：埃索美拉唑镁 肠溶微丸 Box-Behnken 效应面法 处方优化 

分 类 号：R944.9[医药卫生—药剂学] TQ460.6[医药卫生—药学]