阿奇霉素分散片的制备及质量研究  

Preparation and Quality Investigation of Azithromycin Dispersible Tablets

作　　者：陆军[1] 徐伟[2] 刘赛 

机构地区：[1]江苏省药物研究所,南京210009 [2]福建中医学院药学系,福州350003 [3]南京生命能科技开发有限公司,南京210007

出　　处：《江苏药学与临床研究》2004年第5期3-6,共4页Jiangsu Pharmacertical and Clinical Research

摘　　要：目的　制备阿奇霉素分散片。方法　以崩解时间为指标比较不同崩解剂的作用 ,以正交试验设计确定最佳处方 ,并与普通片进行了体外溶出度的比较。结果　崩解剂以交联聚乙烯吡咯烷酮效果最优 ,最佳处方崩解时间为 92 1s,溶出速度远大于普通片 ,其崩解时间、分散均匀度达到中国药典 (2 0 0 0年版二部 )要求 ,稳定性试验表明制剂质量稳定。Objective: To experiment on the preparation of dispersible azithromycin tablets.Methods With the dispersible time as the focus of attention,different disintegrants were compared and orthogonal design was compared with that of the conventional tablets in the market.Results The result showd that its disintegration and uniformity of dispersion reached the standard of Ch.P. 2000,and its quality was stable.Of the four tested disintergrants crospovidone had the best dispersing effect and the dispersible tablets of optimal formulation exhibited a disintegrants crospovidone had the best dispersing effect and the dispersible tablets of optimal formulation exhibited a disintegrating time of 92.1s with a much quicker dissolution speed than that of the conventional tablets.Conclusion The dispersible Agithromycin tablets have a higher dissolution speed than those of conventional tablet.

关 键 词：阿奇霉素 分散片 药品质量 制备工艺 质量检查 

分 类 号：R978.1[医药卫生—药品] R927.1[医药卫生—药学]