理中丸HPLC指纹图谱的建立及9种成分含量测定  

Establishment of HPLC Fingerprints and Content Determination of Nine Components of Lizhong Pills

作　　者：刘晓玲 马海棠 王苗 李运 余磊 邱国玉 程显隆[5] 冯金梁 杨扶德 LIU Xiaoling;MA Haitang;WANG Miao;LI Yun;YU Lei;QIU Guoyu;CHENG Xianlong;FENG Jinliang;YANG Fude(College of Pharmacy,Gansu University of Chinese Medicine,Lanzhou 730000,China;Library,Gansu University of Chinese Medicine,Lanzhou 730000,China;Lanzhou Institute of Food and Drug Inspection and Testing,Lanzhou 730050,China;Gansu Pharmaceutical Group Science and Technology Innovation Research Institute Limited,Lanzhou 730000,China;National Institutes for Food and Drug Control,Beijing 100050,China;Gansu Kangle Pharmaceutical Co.,Ltd.,Lanzhou 730300,China)

机构地区：[1]甘肃中医药大学药学院,兰州730000 [2]甘肃中医药大学图书馆,兰州730000 [3]兰州市食品药品检验检测研究院,兰州730050 [4]甘肃药业集团科技创新研究院有限公司,兰州730000 [5]中国食品药品检定研究院,北京100050 [6]甘肃康乐药业有限责任公司,兰州730300

出　　处：《中国药学杂志》2024年第17期1643-1650,共8页Chinese Pharmaceutical Journal

基　　金：甘肃省药品科研项目资助(2022GSMPA0037);陇原青年创新创业人才项目资助(甘组通字〔2023〕20号);兰州市科技计划项目资助(2022-2-2);科技部国家重点研发计划项目资助(2018YFC1706305);国家自然地区基金项目资助(82160714);甘肃省重点研发计划项目资助(23YFFA0069)。

摘　　要：目的建立理中丸高效液相色谱(HPLC)指纹图谱并测定绿原酸(chlorogenic acid)、甘草苷(liquiritin)、党参炔苷(lobetyolin)、甘草素(liquiritigenin)、甘草酸(glycyrrhetinic acid)、白术内酯Ⅲ(atractylenolideⅢ)、白术内酯Ⅱ(atractylenolideⅡ)、白术内酯Ⅰ(atractylenolideⅠ)和10-姜酚(10-gingero)的含量,为其质量控制提供依据。方法采用Eclipse Plus C18色谱柱,以乙腈体积分数-0.1%磷酸水溶液为流动相,梯度洗脱,流速0.8 mL·min^(-1),检测波长215和254 nm,柱温30℃;通过相似度评价,结合化学模式识别,对21批理中丸指纹图谱进行评价及分析,并对9种指标成分进行定量测定。结果21批理中丸指纹图谱中共标定29个共有峰,各批次的相似度均大于0.9,3个厂家21批样品可聚为3类,组间差异化合物有16个。9种成分在各自线性范围内线性关系良好(r≥0.9987);平均加样回收率95.34%~104.41%,相对标准偏差(RSD)0.95%~2.95%。结论建立的理中丸指纹图谱及多成分定量测定方法简单、准确、重现性较好,可用于理中丸整体质量评价。OBJECTIVE To establish the HPLC fingerprints,determine the contents of chlorogenic acid,liquiritin,lobetyolin,liquiritigenin,glycyrrhetinic acid,atractylenolideⅢ,atractylenolideⅡ,atractylenolideⅠ,10-gingerol in Lizhong Pills,and lay the foundation for its quality control.METHODS A Eclipse Plus C18 column was used with acetonitrile-0.1%aqueous phosphoric acid as the mobile phase in gradient elution at a flow rate of 0.8 mL·min^(-1).The detection wavelengths were set at 215 nm and 254 nm,and the column temperature was maintained at 30℃.Through similarity evaluation,combined with chemical pattern recognition,the fingerprints of 21 batches of Li Zhong Pills were evaluated and analyzed,and 9 index components were quantitatively determined.RESULTS The fingerprints of 21 batches of Lizhong Pills were established,with 29 peaks identified,the similarity of each batch was greater than 0.9,and 21 batches of samples from 3 manufacturers could be clustered into 3 categories,with 16 compounds differing between groups.Nine components showed good linear relationships within their respective linear ranges(r≥0.9987),the average recoveries ranged from 95.34%to 104.41%,and the RSDs ranged from 0.95%to 2.95%.CONCLUSION The fingerprint and quantitative determination method of Lizhong Pills is simple,accurate and reproducible,and can be used for the evaluation of the overall quality of Lizhong Pills.

关 键 词：理中丸 高效液相色谱法 指纹图谱 含量测定 化学模式识别 

分 类 号：R917[医药卫生—药物分析学]