紫苏方药物制备物的质量表征及其关联分析  

Quality characteristics and correlation analysis of medicinal preparations from Zisu Fang

作　　者：安琪[1] 唐雪阳[2] 卢广英[2] 温静 梅莹莹 左胜[2] 朱乃亮[2] 王春梅[2] 周永强 张晓雷 王永炎[4] 石任兵[2,5] 

机构地区：[1]首都医科大学中医药学院,北京100069 [2]北京中医药大学中药学院国家中医药管理局中药经典名方有效物质发现重点实验室 [3]上海绿谷制药有限公司 [4]中国中医科学院 [5]北京市教委中药质量控制技术工程中心

出　　处：《北京中医药大学学报》2014年第6期414-419,428,I0006,共8页Journal of Beijing University of Traditional Chinese Medicine

基　　金：十二五国家科技支撑计划项目(No.2012BAI29B06);北京中医药大学创新团队资助项目(No.2011-CXTD-12);北京中医药大学重点学科开放课题(No.2013-2DXKKF-23)

摘　　要：目的确定紫苏方的最佳药物制备物形式,并对如何创制优质药物作出解答。方法运用所建立的HPIC-PDA法,在酸性和碱性系统下测定紫苏方不同药物制备物形式中有效指标性成分黄芩苷、丹酚酸B、迷迭香酸、丹参酮ⅡA、苦参碱和氧化苦参碱的含量。基于有效指标性成分的含量、相对量、含量相对比值以及出膏率和体内外抗菌药效对紫苏方药物制备物的质量进行系统表征,并将质量表征结果进行关联分析。结果紫苏方富集物中6种有效指标性成分的含量(总计53.43%)较其他制备物形式明显提高,约为稀醇提取物的3.2倍,水提取物的3.6倍。出膏率降低至稀醇提取物和水提物的1/3。且成分相对比值更为合理,所组成的药物体系具有最强的体内外抗菌作用。故紫苏方富集物为最佳药物制备物形式。结论基于药物体系基本组成与制备得率,探寻药物成分的最适含量及其相对比值,是创制优质药物的重要途径。Objective To determine the best preparation forms of medicinal in Zisu Fang, and answer the question of how to develop high-quality medicinal. Methods The content of baicalin, salvianolic acid B, rosmarinie acid, tanshinone Ⅱ A, matrine, oxymatrin （ effective index components in different medicinal preparation forms from Zisu Fang ） were detected by using HPLC-PDA under acidic and alkaline systems. The quality of medicinal preparation from Zisu Fang were characterized based on the content, relative quantity, relative ratio of content, yield rate and antibacterial effect in vitro and in vivo, and thecharacterized results were given correlation analysis. Results The content of 6 kinds of effective index component （ totally 53.43% ） in enrichment from Zisu Fang increased significantly, which was 3.2 times higher than in ethanol extract and 3. 6 times higher than in water extract, and the yield rate decreased by one-third of that of ethanol extract and water extract. The relative ratio of components was more reasonable, and medicinal system had higher antibacterial effect in vitro and in vivo. The enrichment was the best preparation form of medicinal in Zisu Fang. Conclusion It is an important way for develop high-quality medicinal to explore the fittest content and relative ratio of medicinal components based on the basic composition of medicinal system and yield rate.

关 键 词：紫苏方 药物体系 质量表征 关联分析 

分 类 号：R284.1[医药卫生—中药学]