摘要
目的:研制琥乙红霉素缓释片并考察处方工艺对释放度的影响。方法:采用单因素方法考察不同辅料对琥乙红霉素缓释片释放度的影响,并通过正交试验设计,优化处方工艺。结果:优选工艺为:以羟丙甲基纤维素(用量为16%)为缓释骨架材料,乳糖(用量为14%)为填充剂,5%的HPMC(50%乙醇溶液)为黏合剂。释放度研究结果表明,琥乙红霉素缓释片释放度符合规定。结论:筛选优化的制备工艺稳定可控,重复性好。
Objective： To study the formulation and preparation of erythromycin ethylsuccinate sustained-release tablets and their influence on drug release. Method： The release behaviors of erythromycin ethylsueeinate sustained-release tablets were investigated by single factor study. The formulation and preparation procedure were optimized by orthogonal design. Result： HPMC and lactose were se- lected as the excipients of erythromyein ethylsuceinate sustained-release tablets. The results of dissolution in vitro showed that the drug release profile met the requirement. Conclusion： The selected preparation technique is stable and controllable with promising manufac- turing reproducibility.
出处
《中国药师》
CAS
2011年第11期1609-1612,共4页
China Pharmacist
关键词
琥乙红霉素
缓释片
处方工艺
累积释放度
Erythromycin ethylsuccinate
Sustained-release tablets
Formulation and preparation technique
Accumulative release
