复方黄连素片质量分析  

Quality analysis of Fufang Huangliansu Tablets

作　　者：林林[1] 林永强[1] 汪冰[1] 郭东晓[1] 臧远芳[1] 徐丽华[1] 

机构地区：[1]山东省食品药品检验所,山东济南250101

出　　处：《药学研究》2013年第3期157-158,164,共3页Journal of Pharmaceutical Research

摘　　要：目的通过对2012年全国药品生产及流通领域复方黄连素片的质量进行考察分析,评价本品的质量现状及存在的问题。方法将法定标准检验与探索性研究相结合。针对法定标准检验项目不全等问题,采用显微观察法进行异性有机物的检查;采用高效液相色谱法进行盐酸药根碱的检查;采用高效液相色谱法进行木香、吴茱萸、白芍中六种指标性成分的含量同时测定;采用近红外光谱扫描法建立近红外光谱库,为快速检验提供依据。结果法定标准检验与探索性研究结果之间存在显著差异。结论探索性研究结果表明法定标准存在较多缺陷,应进一步完善现行质量标准,全面控制产品的质量。Objective To evaluate the current quality situation and problems of Fufang Huangliansu Tablets by testing and analyzing samples collected from drug manufacture and market all over China in 2012. Methods To combine the legal standard with exploratory study. To establish testing methods for heterosexual organic matter by microscopic identification;To inspect jatrorrhizine hydrochloride by HPLC ;To determine the simultaneously six target components in Radix Aucklandiae, Fructus Evodiae Rutaecarpae and Radix Paeoniae Alba by HPLC ;To establish NIR spectrum database as the foundation for instant test. Results There were obvious differences between the results of legal test and exploratory study. Conclusion The results of exploratory study demonstrated that many defects existed in the legal drug specifications, and the quality standard in force should be further improved to control the quality of products.

关 键 词：复方黄连素片 质量分析 法定标准 

分 类 号：R927.1[医药卫生—药学]