埃索美拉唑镁肠溶片的制备  

Preparation of Esomeprazole Magnesium Enteric-coated Tablets

作　　者：张建岭 张菊红 

机构地区：[1]青州市王坟中心卫生院,青州262500 [2]山东省药学科学院,济南250101

出　　处：《北方药学》2015年第11期81-82,99,共3页Journal of North Pharmacy

摘　　要：目的:制备埃索美拉唑镁肠溶片并对自制片进行质量分析。方法:采用流化床包衣法制备埃索美拉唑镁肠溶微丸,然后选用适宜辅料采用直接压片法对微丸压片,并将自制片与市售片进行药物体外药物释放度、耐酸力及稳定性的比较。结果:自制的埃索美拉唑镁肠溶片的各项指标均符合质量标准的要求。结论:优选的埃索美拉唑镁肠溶片的处方工艺合理,重现性好,有效地解决了埃索美拉唑镁的稳定性问题。Objective To prepare Esomeprazole Magnesium Enteric-coated Tablets,and analyse its quality.Methods The enteric-coated Esomeprazole Magnesium pellets were prepared by fluid bed coating technology. The Esomeprazole Magnesium enteric-coated tablets were prepared by direct compression of the enteric-coated pellets and suitable excipients. The self-made tablets compare its drug release in vitro,the resistance to acid and stability with the marketing tablets. Results： All the criteria of the self-made tablets were found to be in line with the quality standard specification. Conclusion The preparation process was simple,feasible and replicable and the problem of Esomeprazole Magnesium′s stability was resolved effectively.

关 键 词：埃索美拉唑镁 肠溶微丸 微丸压片 

分 类 号：R943[医药卫生—药剂学]