雷贝拉唑钠肠溶片的制备及溶出度考察  

Research and Preparation of Rabeprazole Sodium Enteric-Coated Tablets

作　　者：唐建华[1] 叶东[1] 王长斌[1] 赵卉[1] 曹嘉成[1] 

机构地区：[1]江苏奥赛康药业股份有限公司,江苏南京211112

出　　处：《中国药业》2012年第16期57-58,共2页China Pharmaceuticals

摘　　要：目的制备雷贝拉唑钠肠溶片并考察其溶出度。方法应用3因素3水平的正交试验设计进行片心处方筛选,采用高效液相色谱法对肠溶片进行溶出度(释放度)测定。结果所制得的片剂外观洁白,硬度达到40 N以上,30 min内溶出度达到80%以上。结论该工艺条件稳定,用所筛选的处方制备的肠溶片达到设计要求,适于工业化生产。Objective To prepare rabeprazole sodium enteric-coated tablets and to investigate its dissolution.Methods The orthogonal experimental design of three factors and three levels was applied for screening the tablet core prescription.The HPLC method was used to perform the dissolution test of the enteric-coated tablets.Results The prepared tablets had the white appearance,the hardness was more than 40 N and the dissolution reached more than 80%within 30 min.Conclusion The technological condition is stable.The enteric-coated tablets prepared by the screened prescription meet the design requirements and are suitable for industrial production.

关 键 词：雷贝拉唑钠 肠溶片 正交试验 溶出度 高效液相色谱法 

分 类 号：TQ460.6[化学工程—制药化工] R975.6[医药卫生—药品]