茶苯海明口腔崩解片的研制  

Preparation of dimenhydrinate orally disintegrating tablets

作　　者：张鹏威[1] 陈大为[1] 姚方耀[2] 刘衡[2] 王春龙[2] 苏文琴[3] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]天津药物研究院制剂中心,天津300193 [3]天津中新药业集团有限公司第六中药厂,天津300401

出　　处：《中国药学杂志》2005年第22期1720-1723,共4页Chinese Pharmaceutical Journal

摘　　要：目的制备既可掩盖苦麻味又能快速崩解的茶苯海明口腔崩解片。方法以EudragitE100为包合材料,采用溶剂法制备掩味包合物并对包合物进行差示扫描量热法分析,再采用粉末直接压片法制备口腔崩解片。结果茶苯海明与EudragitE100在1:4重量比以下时制备的掩味包合物形成了固体分散体,以此制得的口腔崩解片在体外崩解时间不超过60s,在0.01mol·L-1盐酸溶液中5min溶出标示量的90%以上。结论该口腔崩解片制备工艺可行,符合用药要求。OBJECTIVE To prepare dimenhydrinate （DMH） orally disintegrating tablets with fast dissolution rate and good taste. METHODS Various ratios of DMH to Eudragit El00 were used to prepare taste masking inclusion complex by solvent method. Differential scanning calorimeter（DSC） was applied to analyse the inclusion comlplex. The tablets were prepared by powder direct compression. RESULTS The tablets disintegrated in no more than 60 seconds and almost tasted no bitter. DSC analysis verified that the drug existed as amorphic state in the inclusion complex. CONCLUSION The orally disintegrating tablets can be used as industrial product and clinical preparation.

关 键 词：茶苯海明 口腔崩解片 掩味 正交设计 

分 类 号：R943.4[医药卫生—药剂学]