红药片HPLC特征图谱及多成分含量测定  

HPLC Characteristic Chromatogram and Multi-Component Determination of Hongyao Tablets

作　　者：韩晶 翟宏宇 李丹 戴忠[2] 李雷 朱旭 HAN Jing;ZHAI Hong-yu;LI Dan;DAI Zhong;LI Lei;ZHU Xu(Jilin Institute for Drug Control,Changchun 130033,China;National Institutes for Food and Drug Control,Beijing 100050,China;Jilin Safety Monitoring Center for Drug,Changchun 130062,China)

机构地区：[1]吉林省药品检验研究院,吉林长春130033 [2]中国食品药品检定研究院,北京100050 [3]吉林省药品安全监测中心,吉林长春130062

出　　处：《中国现代中药》2023年第3期604-607,共4页Modern Chinese Medicine

基　　金：2021年国家药品抽检项目(2021Z16)。

摘　　要：目的:建立红药片的高效液相色谱法(HPLC)特征图谱,并对三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd进行含量测定。方法:红药片经80%甲醇超声提取,采用Waters XBridge Shield RP C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.05%磷酸水溶液为流动相进行梯度洗脱,流速为0.8 mL·min^(–1),柱温为30℃,检测波长为203 nm。结果:通过对10个厂家红药片的HPLC特征图谱进行研究,标记并确认了其中9个共有特征峰,分别为阿魏酸、三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd、正丁基苯肽、欧前胡素及异欧前胡素,利用相似度评价软件对各批样品特征图谱进行分析,相似度均在0.90以上。在建立的色谱条件下对其中5个主要成分进行测定,各组分间分离度良好,在各自范围内线性关系良好,回收率为94.70%~98.55%,RSD均小于3.0%。结论:所建立的红药片HPLC特征图谱和定量测定分析方法可全面有效地评价其质量。Objective:To establish an HPLC characteristic chromatogram of Hongyao Tablets and determine five components(notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd).Methods:Hongyao Tablets were extracted by ultrasonication with 80%methanol.The analysis was performed on a Waters XBridge Shield RP C18 column(250 mm×4.6 mm,5μm)with gradient elution of acetonitrile-0.05%phosphoric acid aqueous solution at a flow rate of 0.8 mL·min^(–1).The column temperature was 30℃and the detection wavelength was 203 nm.Results:Through the study of HPLC characteristic chromatograms of samples from 10 manufacturers,9 common characteristic peaks were labeled and identified,which were ferulic acid,notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd,3-n-butylphthalide,imperatorin,and isoimperatorin.A Similarity evaluation software was used to analyze the characteristic chromatograms of each batch of samples,and the similarities were all above 0.90.Five main components were determined under the established chromatographic conditions.The components were well separated with good liner relationship,and the recoveries were 94.70%-98.55%and the RSD was less than 3.0%.Conclusion:The established HPLC characteristic chromatogram and quantitative analysis method provided a comprehensive and effective evaluation approach for the quality control of Hongyao Tablets.

关 键 词：红药片 高效液相色谱法 特征图谱 含量测定 

分 类 号：R286[医药卫生—中药学]