依托红霉素片制备工艺优化的研究  

Studies on the optimization process for Erythromycin Estolate Tablets

作　　者：万兴平 

机构地区：[1]福建汇天生物药业有限公司,三明365001

出　　处：《海峡药学》2014年第6期24-25,共2页Strait Pharmaceutical Journal

摘　　要：目的考察依托红霉素片溶出的影响因素,优化处方工艺,提高依托红霉素片的溶出度。方法通过影响因素试验考察优化工艺与原工艺的含量变化;采用正交试验法优选崩解剂的用量,崩解剂的类型、片剂的硬度。结果碳酸氢钠能显著提高依托红霉素片的溶出度。结论优化的工艺质量稳定,重现性良好。OBJECTIVE To study factors that affecting Erythromycin Estolate Tablets dissolution,optimizing formulation process,improving dissolution rate of Erythromycin Estolate Tablets. METHODS Using stress testing（ influence factors test） to study the change of assay between optimizing process and original process. Using orthogonal test to optimize the dosage,type of disintegrating agent,tablets hardness. RESULTS Sodium bicarbonate can improve dissolution rate of Erythromycin Estolate Tablets significantly. CONCLUSION optimized process is steady and has good reproducibility.

关 键 词：正交试验法 依托红霉素片 碳酸氢钠 溶出度 

分 类 号：TQ465[化学工程—制药化工]