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作 者:罗映红[1] 欧志立 徐雄波[1] 张青松[1] 王磊[1] 马宁[1]
机构地区:[1]长沙医学院药学系,长沙410219 [2]湖南炎帝生物工程有限公司,湖南株洲410007
出 处:《中国药房》2014年第21期1964-1966,共3页China Pharmacy
基 金:湖南省科技厅科技计划项目(No.2012SK3104)
摘 要:目的:优化氯波必利生物黏附缓释片的处方和制备工艺。方法:以累积释放度为指标,采用正交设计方法,对制剂辅料羟丙基甲基纤维素(HPMC)、卡波姆、淀粉及乳糖的用量进行考察,确定氯波必利生物黏附缓释片处方。结果:缓释片规格为每片0.1 g,以HPMC和卡波姆为生物黏附和骨架材料,乳糖为稀释剂,淀粉为填充剂和崩解剂,每100片用量分别为5.5、2.2、1.2、2.0g。与氯波必利普通片比较,缓释片具有显著缓释和黏附性能。结论:本制剂制备工艺简单,符合缓释、黏附要求。OBJECTIVE:To optimize the formulation and preparation processes of Clebopride bioadhesive sustained-release tablets.METHODS:Accumulative release rate as index,orthogonal design was adopted to optimize the amount of HPMC,carbomer,starch and glucose to determine the formulation of Clebopride bioadhesive sustained-release tablets.RESULTS:The optimal formulation was as follows:HPMC and carbomer as bioadhesive and skeletal material,lactose as diluent,starch as a filler and a disintegrant,0.1 g each sustained-release tablet.The amounts of above parameters in 100 tablets were 5.5,2.2,1.2 and 2.0 g,respectively.Compared with common tablets,Clebopride sustained-release tablets showed the proporties of sustained release and adhesion.CONCLUSIONS:The technology is simple and meets clinical needs of sustained release and adhesion.
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