银花痛风颗粒HPLC指纹图谱的建立及6个成分含量测定  

High-performance liquid chromatography fingerprint and determination of six components in Yinhua Gout Granules

作　　者：田欢 翟秉涛 岳宝森 曹向栋 史婉丽 张维英 TIAN Huan;ZHAI Bingtao;YUE Baosen;CAO Xiangdong;SHI Wanli;ZHANG Weiying(Department of Pharmacy,Xi’an Hospital of Traditional Chinese Medicine,Shaanxi Xi’an 710021,China;ZHAO Feng National old medicine worker inheritance studio,Xi’an Hospital of Traditional Chinese Medicine,Shaanxi Xi’an 710021,China;College of pharmacy,Shaanxi University of Chinese Medicine,Shaanxi Xi’an 712046,China;Shaanxi Key Laboratory of Chinese Medicine Fundamentals and New Drugs Research,Shaanxi University of Chinese Medicine,Shaanxi Xi’an 712046,China)

机构地区：[1]西安市中医医院,药剂科,陕西西安710021 [2]西安市中医医院,赵锋全国老药工传承工作室,陕西西安710021 [3]陕西中医药大学,药学院,陕西西安712046 [4]陕西中医药大学,陕西省中药基础与新药研究重点实验室,陕西西安712046

出　　处：《中国医院药学杂志》2025年第5期538-545,共8页Chinese Journal of Hospital Pharmacy

基　　金：陕西省中医药管理局重点科学研究项目(编号:2021-02-22-010);陕西省中药基础与新药研究重点实验室开放项目(编号:KF2201);西安市科技计划项目(编号:23YXYJ0042);国家中医药管理局赵锋全国老药工传承工作室建设项目(编号:国中医药人教函[2024]255号)。

摘　　要：目的:建立银花痛风颗粒的HPLC指纹图谱及6个成分含量测定方法,为其质量控制提供参考。方法:采用Agilent 5 TC-C_(18)(150 mm×4.6 mm,5μm)色谱柱,0.1%甲酸水-乙腈梯度洗脱,检测波长300 nm,流速1.0 mL·min^(-1),柱温30℃,建立10批银花痛风颗粒样品的指纹图谱,并对指纹图谱进行了峰归属和指认,采用SPSS、SIMCA软件进行化学模式识别分析,进一步评价10批银花痛风颗粒间的质量差异,并对指认的化学成分进行含量测定。结果:银花痛风颗粒HPLC指纹图谱标定12个共有峰,指认6个成分,10批样品的指纹图谱相似度大于0.900;通过化学模式识别将10批样品分为两类,其中新绿原酸、绿原酸、阿魏酸、异绿原酸B、洋川芎内酯A、藁本内酯的质量分数在0.3219~2.2142 mg·g^(-1)范围。结论:建立的银花痛风颗粒HPLC指纹图谱方法和6个成分含量测定方法准确可靠,可用于其质量评价。OBJECTIVE To establish the high-performance liquid chromatography(HPLC)fingerprint and determination method of six components of Yinhua Gout Granules(YHG),thus providing reference for its quality control.METHODS A fin⁃gerprint of 10 batches of YHG samples was established using an Agilent 5 TC-C_(18)(150 mm×4.6 mm,5μm)chromatographic column,with a gradient elution of 0.1%formic acid water-acetonitrile as the mobile phase,a detection wavelength of 300 nm,a flow rate of 1.0 mL·min^(-1),and a column temperature of 30℃.Peak assignment and identification were carried out on the finger⁃print chromatograms.Chemical pattern recognition analysis was conducted using SPSS(Statistical Package for the Social Sci⁃ences software)and SIMCA(multivariate data analysis software)to further evaluate the quality differences among the 10 batches of YHG.The content determination of the identified chemical components was also performed.RESULTS The HPLC finger⁃print of YHG was calibrated with a total of 12 common peaks,and 6 components were identified.The similarity of the fingerprint of 10 batches of YHG samples was all greater than 0.900.Through chemical pattern recognition,the 10 batches of YHG samples were divided into two categories,among which the mass fractions of neochlorogenic acid,chlorogenic acid,ferulic acid,isochloro⁃genic acid B,senkyunolide A and ligustilide were in the range of 0.3219—2.2142 mg·g^(-1).CONCLUSION The established HPLC fingerprint method and the content determination method of six components are accurate and reliable for quality evaluation of YHG.

关 键 词：银花痛风颗粒 高效液相色谱 指纹图谱 含量测定 

分 类 号：R286[医药卫生—中药学] R917[医药卫生—中医学]