奥美拉唑镁肠溶微丸片的制备及质量评价  

Preparation and Quality Evaluation of Omeprazole Magnesium Enteric-Coated Pellets-Type Tablets

作　　者：赵佩 程海英 孙晓璐[1] ZHAO Pei;CHENG Haiying;SUN Xiaolu(Medical College,Tianjin Tianshi College,Tianjin 301700,China)

机构地区：[1]天津天狮学院医学院,天津301700

出　　处：《生物化工》2022年第3期40-44,共5页Biological Chemical Engineering

摘　　要：目的:制备一种肠溶微丸片的多单元片剂剂型。方法:采用流化床底喷工艺包衣技术制备奥美拉唑镁肠溶微丸,直接压片法将微丸与一定辅料混合进行压片,然后采用滚转包衣法对片剂包衣。结果:奥美拉唑镁肠溶微丸片含量合格,在pH=1.0盐酸介质中2 h内的累积释放度均小于10%,磷酸盐缓冲液中累积释放度在45 min时高于75%。结论:采用流化床制备的肠溶微丸含药均匀,制得的片剂体外释放符合《中华人民共和国药典》(2020版)要求。Objective:An enteric coated multi-unit tablet formulation was prepared.Methods:Firstly,omeprazole magnesium enteric-coated pellets were fabricated with fluid bed Methods,The pellets were mixed with certain excipients by direct tablet pressing Methods,and then the tablets were coated by rolling coating Methods.Results:The content of magnesium omeprazole enteric-coated pellets tablets is qualified.In addition,drug release in hydrochloric acid(pH=1.0)buffer were less than 10%within 2 hours and more than 75%in phosphate buffer solution during 45 minutes.Conclusion:The enteric coated pellets was prepared by fluidized bed contained uniform drug,drug release of the tablets complies with(2020)requirements.

关 键 词：奥美拉唑镁 肠溶微丸片 制备工艺 缓释制剂 

分 类 号：R975[医药卫生—药品] R944[医药卫生—药学]