通宣理肺丸HPLC指纹图谱建立及7种成分测定  

Establishment of HPLC fingerprints for Tongxuan Lifei Pills and determination of seven constituents

作　　者：李运 王苗[3] 张国强 邱国玉 石晓峰 戴忠[5] LI Yun;WANG Miao;ZHANG Guo-qiang;QIU Guo-yu;SHI Xiao-feng;DAI Zhong(Lanzhou Municipal Institute for Food and Drug Control/Gansu Pnwincial Engineering Research Center for Monitoring Exogenoim Harmful Residues in Traditional Chinese Medicines,Uinzhou 730000,China;College of Pharmacy,Lanzhou University,Lanzhou 730000,China;College of Pharmacy,,Gansu University of Chinese Medicine,iMnzhou 730000,China;Gansu Proiincial Academy of Medical Science,Linzhou 730050,China;National Institutes for Fond and Drug Control,Beijing 100050,China)

机构地区：[1]兰州市食品药品检验检测研究院/甘肃省种植中药材外源性污染物监测工程研究中心,甘肃兰州730000 [2]兰州大学药学院,甘肃兰州730000 [3]甘肃中医药大学药学院,甘肃兰州730000 [4]甘肃省医学科学研究院,甘肃兰州730000 [5]中国食品药品检定研究院,北京100050

出　　处：《中成药》2021年第10期2630-2636,共7页Chinese Traditional Patent Medicine

基　　金：国家药品标准物质协作研究与标定项目(2020-W0204001);兰州市2019年第一批科技计划项目(2019-1-60)。

摘　　要：目的建立通宣理肺丸(紫苏叶、前胡、桔梗等)HPLC指纹图谱,并测定甘草苷、柚皮苷、橙皮苷、新橙皮苷、黄芩苷、甘草酸、白花前胡甲素含量。方法该药物70%乙醇提取液的分析采用CAPCELL PAK-C_(18)色谱柱(250 mm×4.6 mm, 5μm);流动相水(含0.1%甲酸)-80%乙腈,梯度洗脱;体积流量1.0 mL/min;柱温30℃;检测波长250 nm。结果 31批样品指纹图谱中有39个共有峰,相似度0.16~0.99。7种成分在各自范围内线性关系良好(r≥0.999 7),平均加样回收率93.10%~113.3%,RSD 1.25%~3.86%。结论该方法准确可靠,重复性好,可用于通宣理肺丸的质量控制。AIM To establish the HPLC fingerprints of Tongxuan Lifei Pills(Perillae Folium,Peucedani Radix,Platycodonis Radix,etc.) and to determine the contents of liquiritin, naringin, hesperidin, neo-hesperidin, baicalin, glycyrrhizic acid and praeruptorin A.METHODS The analysis of methanol extract of this drug was performed on a 30 ℃ thermostatic CAPCELL PAK-C_(18) column(250 mm×4.6 mm, 5 μm), with the mobile phase comprising of water(containing 0.1% formic acid)-80% acetonitrile flowing at 1.0 mL/min in a gradient elution manner, and the detection wavelength was set at 250 nm.RESULTS There were thirty-nine common peaks in the fingerprints of thirty-one batches of samples with the similarities of 0.16-0.99. Seven constituents showed good linear relationships within their own ranges(r≥0.999 7),whose average recoveries were 93.10%-113.3% with the RSDs of 1.25%-3.86%.CONCLUSION This accurate, reliable and reproducible method can be used for the quality control of Tongxuan Lifei Pills.

关 键 词：通宣理肺丸 HPLC指纹图谱 化学成分 

分 类 号：R927.2[医药卫生—药学]