摘要
目的:制备埃索美拉唑镁肠溶微丸并对其工艺进行评价。方法:采用流化床包衣法制备埃索美拉唑镁肠溶微丸,按《中国药典》方法对肠溶微丸进行耐酸力和溶出度测定,验证制备工艺的合理性。结果:制备的肠溶微丸在人工胃液中耐酸力良好,人工肠液中溶出迅速而且完全,工艺稳定。结论:该工艺有效地解决了埃索美拉唑镁的稳定性问题且制备工艺简单易行,重现性好,有望应用于工业化生产。
Objective： To develop the esomeprazole magnesium enteric-coated pellets and verify the formulation. Methods： The enteric-coated esomeprazole magnesium pellets were prepared with an air-flow coating method, and then their acid tolerance and dissolution were detected according to the pharmacopoeia to verify the feasibility of the formulation. Results： The prepared pellets were well resistant to acid in the artificial gastric juice and dissolved quickly and completely in the artificial intestinal liquid. Conclusion： This preparation processing, effectively maintaining the stability of esomeprazole magnesium, is simple and feasible with good reproducibility. It may be used in industrial production.
出处
《药学与临床研究》
2012年第1期40-42,70,共4页
Pharmaceutical and Clinical Research
关键词
埃索美拉唑镁
肠溶微丸
流化包衣
Esomeprazole magnesium
Enteric-coated pellets
Air-flow coating method
