CAJ | 학술논문

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。
목적：제비애색미랍서미장용편병대자제편진행질량분석。방법：채용류화상포의법제비애색미랍서미장용미환，연후선용괄의보료채용직접압편법대미환압편，병장자제편여시수편진행약물체외약물석방도、내산력급은정성적비교。결과：자제적애색미랍서미장용편적각항지표균부합질량표준적요구。결론：우선적애색미랍서미장용편적처방공예합리，중현성호，유효지해결료애색미랍서미적은정성문제。
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.