中药生物药剂学分类系统的多成分溶出评价方法在葛根芩连片中的应用  

Application of multicomponent dissolution evaluation method of biopharmaceutics classification system of Chinese materia medica in Gegen Qinlian tablets

作　　者：隗丽[1] 汪国鹏 董玲[1] 唐明敏[1] 张雷[1] 朱美玲[1] 刘洋[1] 

机构地区：[1]北京中医药大学,北京100102 [2]中财瀚熙(北京)生物科技发展有限公司,北京100055

出　　处：《中国中药杂志》2014年第23期4494-4498,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81473362);北京中医药大学创新团队发展计划项目(2011-CXTD-13)

摘　　要：该研究是中药生物药剂学分类系统(biopharmaceutics classification system of Chinese materia medica,CMMBCS)用于中成药评价的实例,重点评估可能影响多成分吸收时序的溶出同步性问题。实验采用HPLC测定复方葛根芩连片中9种成分在不同溶出介质中不同时间点的累积溶出百分率,绘制体外溶出曲线,采用相似因子(f2)和聚类分析进行溶出曲线的相似性比较分析,结果表明在水介质中,峰7和峰8(黄芩苷)所代表的成分与2号参比峰(葛根素)相似性较差,相似因子均为43;在p H 7.4介质中,峰7和峰8(黄芩苷)所代表的成分与2号参比峰(葛根素)相似性较差,相似因子分别为31和45;其他介质中各峰所代表的成分与2号参比峰(葛根素)均相似性较好。该实验表明峰3,4,5和6(小檗碱)所代表的成分与2号参比峰(葛根素)具有完全同步溶出的特性;峰1和峰9所代表的成分与2号参比峰(葛根素)具有基本完全同步溶出的特性;峰7和峰8(黄芩苷)所代表的成分与2号参比峰(葛根素)不具有同步溶出的特性。The study is a paticular embodiment of Chinese patent medicine based on biopharmaceutics classification system of Chinese materia medica （CMMBCS） , focusing on assessment of synchronization issues of dissolution that may affect the timing of the muhicomponent absorption. The accumulative dissolution percentages of nine components in Gengen Qinlian tablets in different dissolu- tion solvents and times were determined by HPLC. The dissolution curve was drew and its similarity was evaluated by similarity factors （f2） and cluster method. Results in this experiment showed that the components that peak 7 and peak 8 （baicalin） represented had poor similarity with the reference peak 2 （puerarin）. Their similarity factors were both 43 in water dissolution media and 31 and 45 in pH 7.4 dissolution media, respectively. Components that peaks represented had better similarity with the reference peak 2 （puerarin） in other medium. It illustrated that components that peak 3,4,5,6 （berberine） represented had fully synchronous dissolution characteristics with the reference peak 2 （puerarin）, components peak 1 and 9 represented had nearly fully synchronous dissolution characteristics with the reference peak 2 （ puerarin）, while components that peak 7 and 8 （baicalin） represented had no synchronous dissolution characteristics with the reference peak 2 （puerarin）.

关 键 词：葛根芩连片 溶出度 相似因子 聚类分析 

分 类 号：R286[医药卫生—中药学]