苯海拉明口腔溶解膜的制备及溶出度测定  

Preparation and dissolution evaluation of diphenhydramine orally dissolving film

作　　者：王红霞 李雪[1,2] 丁平田 WANG Hongxia;LI Xue;DING Pingtian(School of Pharmacy,Shenyang Pharmaceutical University,Benxi 117004,China;Tianjin Multistar Konwa Pharmaceutical Science and Technology Co.,Ltd.,Tianjin 300384,China)

机构地区：[1]沈阳药科大学药学院,辽宁本溪117004 [2]天津市聚星康华医药科技有限公司,天津300384

出　　处：《中国药剂学杂志》2020年第3期135-146,共12页Chinese Journal of Pharmaceutics

摘　　要：目的:制备苯海拉明口腔溶解膜并建立溶出度测定方法。方法:运用掩味技术制备苯海拉明口腔溶解膜,采用高效液相色谱法进行溶出度测定。结果:采用聚苯乙烯磺酸钠树脂掩味制备苯海拉明口腔溶解膜,以500 mL质量浓度为5 g·L^-1的十二烷基硫酸钠水溶液作为溶出介质,温度为(37±0.5)℃,转速为75 r·min^-1,溶出方法与参比药品溶出行为一致。结论:苯海拉明口腔溶解膜的制备方法简单可行,建立的溶出度测定方法适合苯海拉明口腔溶解膜溶出度的测定。Objective To prepare diphenhydramine orally dissolving film and establish dissolution determination method.Method The taste-dissolving technique was used to prepare diphenhydramine orally dissolving film,and the dissolution rate was determined by HPLC.Result This study used sodium polystyrene sulfonate resin to mask the taste of API to prepare diphenhydramine orally dissolving film.500 mL of sodium dodecyl sulfate aqueous solution(5 g·L^-1)was used as the dissolution medium;the temperature was(37±0.5)℃;the rotation speed was 75 r·min^-1.And the dissolution rate was consistent with the reference drug dissolution behavior.Conclusion The preparation method of diphenhydramine orally dissolving film is simple and feasible,and the established dissolution method is suitable for the determination of the dissolution rate of diphenhydramine orally dissolving film.

关 键 词：苯海拉明 口腔溶解膜 离子交换树脂 溶出度 

分 类 号：R94[医药卫生—药剂学]