文档介绍：进口甘露醇与国产甘露醇在分散片生产中应用的对比唐娜许文东密善武李莉徐琳琳(山东齐都药业有限公司山东淄博 255400 ) 摘要:目的对比进口甘露醇与国产甘露醇对分散片质量的影响, 为分散片的生产选择辅料提供参考。方法将两种甘露醇的部分物理性质进行比较。再以两种甘露醇分别试制罗红霉素分散片为例,通过制粒后颗粒的性质及压片后药片的质量对两种甘露醇的区别进行比较分析。结果两种甘露醇对于罗红霉素分散片颗粒的性质和药片的质量具有很大影响且区别较大。结论进口甘露醇可以直接用于压片技术,成片效果及片剂质量比国产甘露醇好。关键词甘露醇;分散片;应用 Abstract: Objective pare the effec tion of domestic and imported mannitol on dispersible tablets quality , to provide reference on choice of dispersion tablet production excipients . Methods T wo kinds of some physical properties pared with mannitol. In two kinds of mannitol are trial ofR oxithromycin dispersible tablets as an example ,t wo mannitol difference par ed and analysis ed through the granulation and tabletting particulate nature of the quality of tablets . R esults T wo mannitol has a great influence and a larger difference f or Roxithromycin dispersible tablets and the particulate nature of quality of tablets . Conclusions I mported mannitol can be used for directly pressing technology , and the effect of tablet is better than domestic mannitol used for directly pressing technology . Key words: M annitol; D ispersible tablet; A pplication 甘露醇( Mannitol ) ,又称 D- 甘露糖醇,应用于临床上,是良好的利尿剂,肾功能诊断剂,急性肾衰竭治疗的辅助剂,也可用来降低颅内压、眼内压的治疗剂及用作脱水剂。在药物制剂或制剂工艺中,它主要作为稀释剂( 10%--90%W/W )用于片剂处方,某些甘露醇,也可用于直接压片工艺[1 -5] ,如某些进口甘露醇,像 PEARLITOL ? 200 SD 甘露醇。 PEARLITOL ? 200 SD 由特殊颗粒形状的甘露醇组成, 是获专利的稀释型粘合剂, 可用于直接压片。其外观呈结晶粉状,略带甜。是为直接压片特地设计的赋