茶苯海明含片的研制及质量评价  

Preparation and quality control of dimenhydrinate buccal tablets

作　　者：黄智[1] 刘盛业 

机构地区：[1]北京市药品检验所,北京100035 [2]北京益民药业有限公司,北京101300

出　　处：《中国新药杂志》2011年第7期640-643,共4页Chinese Journal of New Drugs

摘　　要：目的:制备口感适宜的茶苯海明含片并进行质量评价。方法:用正交试验筛选茶苯海明复合物的最佳制备条件;辅以甜味剂和矫味剂,湿法制粒制得茶苯海明口含片,采用非模型依赖法比较含片和普通片溶出曲线的相似性。结果:茶苯海明与EudragitE100使用量为1∶1,温度70℃,作用时间12 h时制得复合物口感较好;茶苯海明含片和普通片的溶出度相似(f2=67.29),含片口感外形俱佳,质量可控。结论:一定条件下Eudragit E100能较好遮掩茶苯海明的苦麻味。茶苯海明含片制备工艺可行。Objective： To prepare dimenhydrinate buccal tablets with good taste and evaluate the quality of tablets.Methods： Suitable preparation conditions for dimenhydrinate compound were selected with orthogonal design.By adding sweeteners and flavoring agents,the buccal tablets were prepared by wet granulation compression.Dissolution curve comparability of buccal and ordinary tablets was evaluated by a non-model dependent method.Results： The compound had a good taste when the ratio of dimenhydrinate and Eudragit E100 was 1∶1,temperature was at 70 ℃,and reaction time was 12 h.Dimenhydrinate tablets and buccal tablets had comparability of dissolution curve（f_2=67.29）.The buccal tablets possessed a good taste,appearance and required quality.Conclusion： Eudragit E100 can satisfactorily cover the bitter taste of dimenhydrinate in suitable conditions.The preparation of dimenhydrinate buccal tablets is feasibility.

关 键 词：茶苯海明 含片 研制 正交设计 质量评价 

分 类 号：R944.4[医药卫生—药剂学] R976[医药卫生—药学]