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作 者:朱子聪 边雨 高陆 宋德库 佟志军 ZHU Zicong;BIAN Yu;GAO Lu;SONG Deku;TONG Zhijun(College of Pharmacy,Changchun University of TCM,Changchun 130117,China;Jilin Modern TCM Engineering and Research Center Co.,Ltd.,Changchun 130033,China;Jilin Tianlitai Pharmaceutical Co.,Ltd.,Jilin Baishan 134400,China)
机构地区:[1]长春中医药大学药学院,长春130117 [2]吉林省现代中药工程研究中心有限公司,长春130033 [3]吉林天力泰药业有限公司,吉林白山134400
出 处:《中国药房》2022年第5期586-591,共6页China Pharmacy
基 金:吉林省科技发展计划项目(No.20190304106YY)。
摘 要:目的建立益母草颗粒的高效液相色谱(HPLC)指纹图谱,并对其中盐酸益母草碱、阿魏酸、芦丁、金丝桃苷4个指标成分进行含量测定。方法采用Inertsil^(TM)ODS-3色谱柱,以乙腈(A)-0.1%甲酸溶液(B)为流动相进行梯度洗脱,流速为1.0 mL/min,检测波长为280 nm,柱温为25℃,进样量为5μL。采用《中药色谱指纹图谱相似度评价系统(2012版)》建立10批益母草颗粒的HPLC指纹图谱并分析其相似度,通过与对照品图谱比对进行共有峰指认。使用SPSS 25.0软件和SIMCA 13.0软件进行聚类分析和主成分分析;同时,采用HPLC法测定益母草颗粒中盐酸益母草碱、阿魏酸、芦丁、金丝桃苷4个指标成分的含量。结果建立了10批益母草颗粒的HPLC指纹图谱,共匹配出16个共有峰,并指认出6号峰为盐酸益母草碱、13号峰为阿魏酸、14号峰为芦丁、16号峰为金丝桃苷,10批样品的相似度均大于0.970。通过聚类分析和主成分分析,10批样品均被分为4类,分类结果一致。样品中盐酸益母草碱、阿魏酸、芦丁、金丝桃苷的含量分别为122.10~138.82、9.33~10.45、14.12~18.95、5.87~8.06μg/g。结论建立的益母草颗粒HPLC指纹图谱及4个指标成分含量测定方法简便易行、准确度高、重复性好,可为益母草颗粒的质量评价提供参考。OBJECTIVE To establish HPLC fingerprint of Leonurus japonicus granules,and to determine the contents of 4 index components such as leonurine hydrochloride,ferulic acid,rutin,hyperoside.METHODS The determination was performed on InertsilTM ODS-3 column with mobile phase consisted of acetonitrile(A)-0.1%formic acid solution(B)in the form of gradient elution;the flow rate was 1.0 mL/min,the detection wavelength was 280 nm,the column temperature was 25℃,and the sample size was 5μL.Similarity Evaluation System of Chromatogram Fingerprint of TCM(2012 edition)was used for establishing the HPLC fingerprints of 10 batches of L.japonicus granules and analyzing their similarities.By comparing with HPLC fingerprints of reference substance,the common peaks were identified.SPSS 25.0 and SIMCA 13.0 software were used for cluster analysis and principal component analysis;the above HPLC method was used for the content determination of 4 index components in L.japonicus granules such as leonurine hydrochloride,ferulic acid,rutin,hyperoside.RESULTS HPLC fingerprints of 10 batches of L.japonicus granules were established,and 16 common peaks were matched,and 4 peaks identified were leonurine hydrochloride(peak 6),ferulic acid(peak 13),rutin(peak 14),hyperoside(peak 16);the similarities of 10 batches of samples were all higher than 0.970.The 10 batches of samples could be divided into four categories by cluster analysis and principal component analysis;the classification results were consistent.The contents of leonurine hydrochloride,ferulic acid,rutin and hyperoside were 122.10-138.82μg/g,9.33-10.45μg/g,14.12-18.95μg/g,5.87-8.06μg/g,respectively.CONCLUSIONS Established HPLC fingerprint of L.japonicus granules and the method for the content determination of 4 index components are simple and easy to operate,and have high precision and good repeatability,which provide reference for the quality evaluation of L.japonicus granules.
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