芎菊上清丸HPLC特征指纹图谱研究及多成分含量测定  

HPLC Fingerprint and Multi-component Determination of Xiongju Shangqing Pills by HPLC

作　　者：苏强 唐春梅 梁婧 随何欢 杨思芸 唐志立 Su Qiang;Tang Chunmei;Ling Jing;Sui Hehuan;Yang Siyun;Tang Zhili(Key Laboratory of Individualized Drug Therapy in Nanchong,Department of Pharmacy,Second North Sichuan Medicall College/Nanchong Central Hospital,Sichuan Nanchong 637000,China)

机构地区：[1]南充市中心医院/川北医学院第二临床医学院药学部个体化学药物治疗南充市重点实验室,四川南充637000

出　　处：《中国药师》2020年第7期1316-1321,共6页China Pharmacist

基　　金：四川省教育厅科研项目(编号:18ZB0221)。

摘　　要：目的:建立芎菊上清丸的指纹图谱,并进行多成分定量分析,为其质量控制提供参考。方法:采用Agilent SB-C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.05%磷酸水溶液为流动相,梯度洗脱;流速为1.0 ml·min^-1;检测波长为210 nm;柱温为35℃。通过相似度评价结合聚类分析对12批次芎菊上清丸指纹图谱进行质量评价,并对指认的成分进行定量测定研究。结果:在特征指纹图谱中,共标定26个共有峰,通过与对照品比较指认出其中8个化合物,利用相似度软件对12批指纹图谱进行分析,相似度为0.814~0.994。8个化合物在各自范围内线性关系良好,r均大于0.9991;平均加样回收率为98.9%~104.3%,RSD为0.46%~1.05%。通过聚类分析,12批样品聚成三类。结论:所建立的芎菊上清丸HPLC指纹图谱和含量测定方法简便、准确、重复性好、可以用于芎菊上清丸的质量控制。Objective:To establish the HPLC fingerprint and multi-component determination method for Xiongju Shangqing pills to provide reference for the quality evaluation.Methods:The analysis was performed on an Agilent SB-C18 column(250 mm×4.6 mm,5μm),and the mobile phase consisted of acetonitrile-0.05%phosphoric acid with gradient elution at a flow rate of 1.0 ml·min^-1.The detection wavelength was 210 nm and the column temperature was 35℃.Similarity evaluation combined with cluster analysis(CA)was used to evaluate the fingerprints of 12 batches of Xiongju Shangqing pills,and the markers were quantified.Results:The common mode of the HPLC fingerprint showed 26 common peaks,and 8 of which were identified by comparison with the reference substances.The similar degrees of the 12 batches of samples were 0.814-0.994.Eight consitituents showed good linear relationships within their own ranges(r>0.9991).The average recoveries varied from 98.9%to 104.3%with the RSDs of 0.46%-1.05%.All the 12 batches of samples could be classified into three clusters.Conclusion:The established method is simple and accurate with good repeatability,which can be used for the quality control of Xiongju Shangqing pills.

关 键 词：芎菊上清丸 高效液相色谱法 指纹图谱 相似度分析 聚类分析 

分 类 号：TQ460.72[医药卫生—药物分析学]