赵倩;冯伟红;张启伟;王智民;高慧敏;李春;杨立新;刘晓谦;闫利华;朱晶晶;陈两绵;
ZHAO Qian;FENG Wei-hong;ZHANG Qi-wei;WANG Zhi-min;GAO Hui-min;LI Chun;YANG Li-xin;LIU Xiao-qian;YAN Li-hua;ZHU Jing-jing;CHEN Liang-mian;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences;

• 1:中国中医科学院中药研究所中药质量控制技术国家工程实验室

摘要(Abstract)：

目的:利用一个对照品同步测定栀子金花丸中10种成分的含量,探讨"一测多评"技术在中成药不同类型化合物质量评价中应用的可行性。方法:以栀子金花丸为研究对象,采用高效液相色谱法,以大黄素为内参物,在254 nm检测波长下,建立小檗碱、黄芩苷、汉黄芩苷、黄芩素、芦荟大黄素、汉黄芩素、大黄酸、大黄酚、大黄素甲醚与大黄素间的相对校正因子。采用外标法测定栀子金花丸中大黄素的含量,通过待测成分间的相对校正因子计算栀子金花丸中其他9种成分的含量;并将"一测多评"法的计算值与外标法实测值用相对误差进行评价,以验证"一测多评"法的技术可行性和方法适用性。结果:2种计算结果没有显著性差异,相对误差<5%。结论:"一测多评"的质量评价模式可用于栀子金花丸中3种不同类型化合物的多指标同步质量评价。
Objective: To study the technical feasibility of QAMS to determine different structural types of ingredients in Zhizi Jinhua pill,a Chinese patent medicine.Method: Emodin was chosen as the internal reference substance.The relative correction factors(RCF) of berberine,baicalin,wogonoside,baicalein,aloe-emodin,wogonin,rhein,chrysophanol and physcion to emodin were calculated with the peak areas determined at 254 nm.The ruggedness of these RCFs was validated.The contents of emodin in the samples of Zhizi Jinhua pill were determined by using the external standard method,and the contents of the other nine ingredients were calculated by their RCFs.The contents of these ten ingredients in all samples were also determined by the external standard method.Result: No significant differences were observed between the quantitative results of the two methods.The obtained RCFs were credible.Conclusion: The established QAMS method can be used for quantitative determination of different structural types of multi-compounds in Zhizi Jinhua pill.It can provide reference for the quality control of Chinese patent medicine.

关键词(KeyWords)： “一测多评”法;相对校正因子;生物碱;黄酮;游离蒽醌;栀子金花丸;质量评价
QAMS;relative correction factor(RCF);alkaloids;flavonoids;free anthraquinones;Zhizi Jinhua pill;quality evaluation

Abstract:

Keywords:

基金项目(Foundation): 国家药品标准提高暨2015年版药典科研项目;; 中医药行业科技专业项目(200707009);; 国家“重大新药创制”科技重大专项(2012ZX09103201-009);; 国家科技支撑计划项目(2011BAI03B01);; 国家重点基础研究发展计划(973)项目(2012CB724001);; 国家自然科学基金项目(81274079)

作者(Authors): 赵倩;冯伟红;张启伟;王智民;高慧敏;李春;杨立新;刘晓谦;闫利华;朱晶晶;陈两绵;
ZHAO Qian;FENG Wei-hong;ZHANG Qi-wei;WANG Zhi-min;GAO Hui-min;LI Chun;YANG Li-xin;LIU Xiao-qian;YAN Li-hua;ZHU Jing-jing;CHEN Liang-mian;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences;

参考文献(References)：

• [1]冯伟红,杨菲,王智民,等.一测多评法与外标法测定双黄连制剂中黄酮类成分含量的比较分析[J].中国药学杂志,2012,47(20):1665.
• [2]高慧敏,宋宗华,王智民,等.适合中药特点的质量评价模式——QAMS研究概述[J].中国中药杂志,2012,37(4):405.
• [3]朱晶晶,王智民,张启伟,等.一测多评法同时测定黄芩药材中4种黄酮类成分的含量[J].中国中药杂志,2009,34(24):3229.
• [4]孟江,卢国勇,程轩轩,等.一测多评法同时测定干姜中4种姜酚类成分的含量[J].中国实验方剂学杂志,2012,18(7):77.
• [5]蔡海霞,陈君,李萍.一测多评法测定黄芪中4种异黄酮的含量[J].中国中药杂志,2010,35(20):2712.
• [6]杨菲,王智民,张启伟,等.“一测多评”法测定丹参酚酸类成分的含量[J].中国中药杂志,2011,36(17):2372.
• [7]李倩,刘伟,罗祖良,等.一测多评法测定丹参中丹参酮ⅡA、隐丹参酮、参酮Ⅰ、二氢丹参酮Ⅰ的含量[J].中国中药杂志,2012,37(6):824.
• [8]贺凤成,李守信,赵志全,等.一测多评法测定五味子中4种木脂素类成分的含量[J].药学学报,2012,47(7):930.
• [9]冯伟红,王智民,张启伟,等.一测多评法测定秦皮药材与饮片中香豆素类成分的含量[J].中国中药杂志,2011,36(13):1782.
• [10]王超群,贾秀虹,陈季,等.中药三七“一测多评”质量控制方法的系统研究[J].中国中药杂志,2012,37(22):3438.
• [11]陈静,王淑美,孟江,等.一测多评法测定苦参中5种生物碱的含量[J].中国中药杂志,2013,38(9):1406.
• [12]张锴镔,冯伟红,王智民,等.一测多评法与外标法测定新清宁片中大黄蒽醌类成分含量[J].中国实验方剂学杂志,2012,18(11):61.
• [13]李爱红,陈伟健,胡文军.一测多评法测定银杏叶胶囊中总黄酮醇苷的含量[J].中国药房,2012,23(36):3446.
• [14]李安平,杨锡,丁永辉,等.一测多评HPLC法测定丹参注射液7个水溶性成分含量[J].药物分析杂志,2012,32(9):3.
• [15]傅红,张凯.栀子金花丸的质量研究[J].天津中医药,2008,25(2):165.
• [16]中国药典.一部[S].2010:879.
• [17]刘元媛,卢静华,郭伟英,等.栀子金花丸中黄芩苷的含量测定[J].辽宁医学院学报,2011,32(4):357.
• [18]郭小龙,蔡敏,陈勇,等.液相色谱法同时测定栀子金花丸中栀子苷和盐酸小檗碱的含量[J].湖北大学学报:自然科学版,2007,29(3):283.
• [19]郑峰,徐成志.HPLC法测定栀子金花丸中大黄素和大黄酚的含量[J].安徽医药,2007,1(11):1006.
• [20]杨慧文,王晓可,毋福海.毛细管电泳法测定栀子金花丸中黄芩苷的含量[J].广东药学院学报,2010,26(2):149.
• [21]高晓燕,卢建秋.栀子金花丸中栀子苷,黄芩苷,番泻苷A和番泻苷B的含量测定方法研究[J].中国中药杂志,2009,34(20):2649.
• [22]王龙星,肖红斌,梁鑫淼.等.一种提高色谱指纹谱保留时间重现性的新方法[J].分析化学,2003,3(10):1232.