奥美拉唑肠溶微丸片的制备及体外释放度考察

摘要

Objective To study the preparation method of Omcprazole Enteric Pellet Tablets. Methods Extrusion-sphronization technique was introduced to prepare omeprazole pellets,then auxiliary materials were mixed with omeprazole pellets to prepare Omcprazolc Enteric Pellet Tablets. HPMC E50 and Eudragit （R） L30D-55 were used as the coating materials to prepare Omeprazole Enteric PelletrnTablets. Results The abtained data proved that the resistance to acid was good and the dissolution of the pellet tablets was quick in artificial intestinal liquid. Conclusion The Omeprazole Enteric Pellet Tablets prepared by this technique was stable. The preparation procedure is reliable and easy to be operated.%目的 制备一种奥美拉唑肠溶片剂.方法 采用挤出-滚圆法制备奥美拉唑微丸,将奥美拉唑微丸与辅料压片,再对片剂分别用HPMC E50和Eudragit RL30D-55包衣,制成奥美拉唑肠溶片.结果 体外释放度实验显示,制备的奥美拉唑片在酸性介质中2 h稳定性良好,在碱性介质中45 min基本释药完全.结论 用该方法制备奥美拉唑肠溶片,稳定性好,工艺简便,易于操作.