理气舒心片中间体特征图谱研究  

Study on HPLC chromatographic fingerprint of Liqi Shuxin Pian of intermediates

作　　者：展月 徐云 林建梅 王卉玲 徐建 ZHAN Yue;XU Yun;LIN Jian-mei;WANG Hui-ling;XU Jian(Jilin xiuzheng Pharmacetical New Drug Development Co.,Ltd,ChangchunJilin,130103,ChinaJilin;Changbai Mountain Pharmaceutical Group Co.,Ltd.Baishan,Jilin,134000,China)

机构地区：[1]吉林修正药业新药开发有限公司,吉林省中药标准化关键工程技术重点实验室,长春130103 [2]吉林长白山药业集团股份有限公司,白山134300

出　　处：《人参研究》2021年第1期21-25,共5页Ginseng Research

基　　金：吉林省省级医药健康产业发展专项资金项目,项目编号:20180311061YY。

摘　　要：目的建立理气舒心片中间体的HPLC特征图谱分析方法,为全面控制产品质量提供参考依据。方法采用Agilent ZORBAX SB-Phenyl C_(18)色谱柱(250 mm×4.6 mm,5um),以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,流速1.0ml/min;检测波长286nm,柱温35℃,测定10批理气舒心片中间体的特征图谱,建立其共有模式。结果在特征图谱研究中,以柚皮苷为参照峰共确定18个特征峰,指认其中5个化学成分,并归属中间体中10味药材。结论该项研究建立了理气舒心片中间体的特征图谱,方法简便,重现性好,为该品种生产过程质量控制提供了有效方法,为理气舒心片的质量控制方法的提升和完善提供了科学依据和数据支持,可较直观的反映出产品的批间一致性。Objective To establish Liqishuxin Pian of intermediates HPLC feature map analysis method provides reference for the overall control of product quality.Methods performed by HPLC.Thesamples were separated by a Agilent-ZORBAX SB-PHenyl C_(18)(250mm*4.6mm.5μm)column,themobile phase consisted of methol-0.1%phosphoric acid solution in gradient mode at the flow rate of1.0ml·min;the wavelength was set 286nm,and column temperature was maintained at 35℃.Thecharacteristic map of the intermediate of 10 batches of Liqi Shuxin Pian was determined and thecommon pattem was established.Results In the characteristic map study,18 characteristic peakswere determined with naringin as the reference peak,and five chemical components were identified.Conclusion This study established the characteristic map of the intermediate of Liqi Shuxin Pian.The method was simple and reproducibility was good,which provided an effective method for thequality control of the production process of this variety,.and provided scientific basis and data supportfor the improvement and improvement of the quality control method of Liqi Shuxin Pian,which couldreflect the consistency of the products directly between batches.

关 键 词：理气舒心片中间体 特征图谱 柚皮苷 

分 类 号：R286.0[医药卫生—中药学]