正交试验优化枸橼酸莫沙比利胃漂浮缓释微丸的辅料处方  

Optimization of Excipient Formulation of Mosapride Citrate Gastric Floating Sustained-release Pellets by Orthogonal Test

作　　者：江尚飞[1] 何静[1] 邱妍川[1] 李芝[1] 邢于政[1] 张露[1] JIANG Shangfei;HE Jing;QIU Yanchuan;LI Zhi;XING Yuzheng;ZHANG Lu(College of Pharmacy,Chongqing Medical and Pharmaceutical College,Chongqing 401331,China)

机构地区：[1]重庆医药高等专科学校药学院,重庆401331

出　　处：《中国药房》2018年第24期3369-3371,共3页China Pharmacy

基　　金：重庆市社会民生科技创新专项项目(No.cstc2016shmszx130078)

摘　　要：目的:优化枸橼酸莫沙比利胃漂浮缓释微丸的辅料处方。方法:采用单因素试验考察不同助漂剂、黏合剂、泡腾剂对微丸8 h漂浮率的影响;以十八醇、羟丙基甲基纤维素(HPMC)、碳酸氢钠用量为考察因素,以微丸8 h漂浮率、圆整度和收率的综合评分为指标,设计正交试验法优选辅料处方,并进行验证试验。结果:优化的辅料处方中十八醇、HPMC、碳酸氢钠用量分别为13.0、3.7、3.4 g。验证试验结果显示,按该辅料处方制备的微丸所得综合评分较高,与正交试验结果一致。结论:优化的辅料处方稳定可靠,可用于枸橼酸莫沙比利胃漂浮缓释微丸的制备。OBJECTIVE:To optimize the excipient formulation of Mosapride citrate gastric floating sustained-release pellets.METHODS:Single factor test was used to investigate the effects of different floating assistants,adhesives and effervescent agents on floating rate of pellets within 8 h.The excipient formulation was optimized by orthogonal test with the amount of octadecanol,HPMC and sodium bicarbonate as factors using comprehensive score of 8 h floating rate,roundness and recovery rate as indexes.Validation test was also conducted.RESULTS:The optimal excipient formulation included the weight of octadecanol,HPMC and sodium bicarbonate were 13.0,3.7 g,3.4 g.The results of validation test showed that comprehensive indexes of the pellets prepared by excipient formulation were high,which were consistent with the orthogonal test results.CONCLUSIONS:The optimal excipient formulation is stable and reliable,and is suitable for the preparation of Mosapride citrate gastric floating sustained-release pellets.

关 键 词：正交试验 枸橼酸莫沙比利 胃漂浮缓释微丸 辅料 处方 

分 类 号：R944[医药卫生—药剂学]