牛黄消炎片多通道特征图谱分析  

Multichannel Fingerprint and Quality Evaluation of Niuhuang Xiaoyan Tablets

作　　者：汪祺[1] 郑笑为[1] 刘燕[1] 戴忠[1] 姚令文[1] 马双成[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国实验方剂学杂志》2014年第12期47-51,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"专项(2011ZX09307-002-01;2009ZX09308-006)

摘　　要：目的：建立牛黄消炎片多通道特征图谱质量评价方法。方法：采用Agilent SB C_18色谱柱（4．6mm×250mm，5μm），流动相乙腈（A）-1％甲酸（B）梯度洗脱（0～10min，2％A；10～80min，2％～48％A；80～90min，48％～60％A；90～120min，60％A；120～125min，60％～2％A；125～130min，2％A），利用HPLC-DAD-ELSD联用法建立296nm，440nm，ELSD共3个通道的特征图谱，对14家生产企业的牛黄消炎片进行相似度评价。结果：经对照品比对确认了特征图谱中16个色谱峰。与特征图谱比较发现14家生产企业中有3家企业的样品存在问题，验证试验发现样品中含有土大黄苷。结论：建立的牛黄消炎片多通道特征图谱专属性强，方法简便、可靠，可有效控制该产品质量。Objective： To establish a method of multichannel fingerprint analysis for quality evaluation of Niuhuang Xiaoyan tablets. Method： Agilent SB C18 （4.6 mm × 250 mm, 5 μm） column was used with mobile phase of acetonitrile （A） -water containing 0. 1% formic acid （B） for gradient elution （0-10 min, 2%A; 10- 80 min, 2%-48%A; 80-90 min, 48%-60% A; 90-120 min, 60%A; 120-125 rain, 60%-2%A; 125-130 min, 2% A） , fingerprints in three channels of 296 nm, 440 nm and ELSD were established by HPLC-DAD-ELSD spectrometry, samples from 14 enterprises were analyzed for similarity evaluation. Result： Sixteen components in fingerprints were identified by comparing with reference substance. Compared with chromatographic fingerprint of Niuhuang Xiaoyan tablets, three enterprises were different from the standard fingerprint, verification test confirmed these samples containing rhapontin. Conclusion： This established method could rapidly attain identification and quality evaluation of Niuhuang Xiaoyan tablets with strong specificity.

关 键 词：牛黄消炎片 特征图谱 多通道 质量控制 

分 类 号：R284.1[医药卫生—中药学]