不同厂家盐酸多奈哌齐片体外溶出曲线比较  

Dissolution Curves of Donepezil Hydrochloride Tablets by Different Manufacturers

作　　者：罗晓茹[1] 徐江[1] 沈娟[1] 李杉[1] 刘俊[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100166

出　　处：《解放军药学学报》2015年第6期516-517,共2页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的对不同厂家盐酸多奈哌齐片的体外溶出情况进行考察,评价其内在质量。方法采用光纤溶出度实时测定仪(浆法)绘制盐酸多奈哌齐片在不同pH溶出介质中的溶出曲线,转速50 r·min^(-1)、测定波长为271 nm,溶出介质500 ml。结果在水、pH 1.2盐酸、pH 4.0醋酸盐缓冲液和pH 6.8磷酸盐缓冲液中,各厂家盐酸多奈哌齐片的溶出曲线有显著性差异。结论不同厂家生产的盐酸多奈哌齐片的溶出曲线明显不一致,通过进行溶出度检查有助于控制药物质量。Objective To investigate the dissolution of donepezil hydrochloride tablets from different manufacturers and to evaluate their intrinsic quality. Methods The dissolution curves of donepezil hydrochloride tablets in different p H media were determined by the fiber-optic medicine dissolution real time test system. Results The dissolution of donepezil hydrochloride tablets from different manufacturers and in four different pH media（ water,pH1. 2 hydorehlorieaeid,pH 4. 0 acetatebuffer and pH 6. 8 phosphatebuffer） was significantly different. Conclusion The dissolution curves of donepezil hydrochloride tablets from different manufacturers are remarkably different so that dissolution measurement is needed for quality control.

关 键 词：盐酸多奈哌齐片 溶出曲线 溶出介质 

分 类 号：R927.1[医药卫生—药学]