牛黄清胃丸中化工染料检查及天然色素成分分析  

Detection of Chemical Dyes and Analysis of Natural Pigment Constituents in Niuhuang Qingwei Pills

作　　者：刘静[1] 刘汇 何轶[1] 戴忠[1] 马双成[1] LIU Jing;LIU Hui;HE Yi;DAI Zhong;MA Shuang-cheng(National institutes for food and drug control,Beijing 100050,China;Institute of Food and Drug,Yanbian Korean Autonomous Prefecture,Yanji 133002,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]延边朝鲜族自治州食品药品检验所,吉林延吉133002

出　　处：《中国现代中药》2020年第1期112-116,共5页Modern Chinese Medicine

摘　　要：目的:建立牛黄清胃丸中化工染料检查方法并对其天然色素成分进行分析。方法:采用HPLC,Phenomenon Luna C18色谱柱,流动相为乙腈-0.05 mol·L^-1醋酸铵(冰醋酸调pH 4.5)梯度洗脱,在490 nm检测波长对处方中黄芩、黄柏等药材可能存在的黄色系化工染料进行检查;此外,以430 nm为检测波长建立了本品天然色素成分指纹图谱。结果:在490 nm检测波长下,18家企业生产的49批牛黄清胃丸样品中均未检出柠檬黄、日落黄、亮黄、金橙Ⅱ和金胺O 5种黄色系化工染料。与此同时,研究建立了本品中天然色素成分HPLC指纹图谱(430 nm),采用Chem pattern软件分析表明,样品与共有模式的相似度为0.68~0.99;确定14个共有峰并鉴定其中9个成分;此外采用主成分分析阐明不同企业产品间差异较大的色素成分。结论:所建立的方法准确、可靠、简便,可用于牛黄清胃丸中化工染料检查及天然色素成分分析,为本品质量控制提供了参考。Objective:To establish methods for detextion of chemical dyes and and analysis of natural pigment constituents in Niuhuang Qingwei Pills.Methods:HPLC method was applied on a Phenomenon Luna C18 column with gradient Acetonitrile-0.05 mol·L^-1 ammonium acetate(pH 4.5 with glacial acetic acid)as eluent.Detection of possible yellow chemical dyes was under visible wavelength at 490 nm.Meanwhile,detection wavelength at 430 nm was selected for fingerprint establishment of natural pigment components.Results:Five kinds of chemical yellow dyes including lemon yellow,sunset yellow,brilliant yellow,golden orangeⅡand auramine O were not detected in all the 49 batches of samples from 18 manufacturers.Additionally,HPLC fingerprint was established under 430 nm for analysis of natural pigment constituents.The result was then analyzed by ChemPattern software.It displayed that the similarities between samples and common pattern were in the range of 0.68-0.99.And 14 common peaks were determined and 9 were identified by comparing with reference standards.Also the principal component analysis demonstrated that the main difference between samples from different manufacturers.Conclusion:The established method was accurate and simple for chemical dye detection and natural pigment components analysis.It also provides scientific basis for its quality control.

关 键 词：牛黄清胃丸 化工染料 天然色素 高效液相色谱 

分 类 号：R944.2[医药卫生—药剂学]