雷贝拉唑钠肠溶片处方工艺研究  

Preparation and quality evaluation of Rabeprazole Sodium Enteric - coated Tablets

作　　者：郭增光 郭洪涛 

机构地区：[1]山东新时代药业有限公司,山东临沂273400

出　　处：《药学研究》2013年第6期345-347,共3页Journal of Pharmaceutical Research

摘　　要：目的制备雷贝拉唑钠肠溶片并考察处方工艺与质量。方法根据辅料相容性结果,采用单因素法筛选片芯处方,片芯包肠溶衣后与肠溶胶囊进行体外溶出度的比较。结果所研制的雷贝拉唑钠肠溶片耐酸力、体外溶出度及稳定性均良好,质量符合药典要求。结论优选的雷贝拉唑钠肠溶片处方工艺合理,成品质量稳定。Objective To prepare Rabeprazole Sodium Enteric-coated Tablets and inspect the formulation and quality.Methods According to the results of materials compatibility,the prescription of tablet core was screened by single factor method.The dissolution of enteric-coated tablet core in vitro was compared enteric-coated capsules.Results The acid strength,vitro dissolution and stability of prepared Rabeprazole Sodium Enteric-coated Tablets were good,and the quality met requirements of pharmacopoeia.Conclusion The optimized prescription process of Rabeprazole Sodium Enteric-coated Tablets was reasonable,and the quality was stable.

关 键 词：雷贝拉唑钠 肠溶片 辅料 

分 类 号：R944.4[医药卫生—药剂学]