摘要
目的建立固本增骨胶囊的高效液相色谱(HPLC)指纹图谱和多指标成分的含量测定方法。方法采用HPLC法,色谱条件为Extend-C_(18)色谱柱(250 mm×4.6 mm,5μm),以0.1%甲酸水溶液-乙腈为流动相,梯度洗脱,波长280 nm;柱温30℃;流速1.0 mL·min^(-1),建立固本增骨胶囊HPLC指纹图谱,并对固本增骨胶囊中的松果菊苷、毛蕊异黄酮葡萄糖苷、阿魏酸、毛蕊花糖苷、党参炔苷进行多指标成分含量测定。采用聚类分析、主成分分析、正交偏最小二乘法-判别分析法评价固本增骨胶囊的质量。结果15批固本增骨胶囊样品指纹图谱相似度均>0.991,固本增骨胶囊中松果菊苷、毛蕊异黄酮葡萄糖苷、阿魏酸、毛蕊花糖苷、党参炔苷5个指标性成分的含量分别为0.7845~0.8378、0.7145~0.8261、0.3418~0.3692、0.1113~0.1233、1.9453~2.2407 mg·g^(-1)。化学计量学结果显示,15批固本增骨胶囊样品可分为2类,用以区分各批次样品的质量标志成分峰为15、11、14、13、12、10、6(毛蕊异黄酮葡萄糖苷)、3、4号峰。结论该研究所建立的方法准确可行、稳定性强,可为固本增骨胶囊的质量控制提供参考依据。
Objective To establish an HPLC fingerprint and a multi-component quantitative method for Guben Zenggu Capsules.Methods HPLC was performed using an Extend-C_(18) column(250 mm×4.6 mm,5μm)with a mobile phase of 0.1%formic acid aqueous solution-acetonitrile under gradient elution.The detection wavelength was set at 280 nm,column temperature at 30℃,and flow rate at 1.0 mL·min^(-1).The HPLC fingerprint of Guben Zenggu Capsules was established,and five marker components—echinacoside,calycosin-7-O-β-D-glucoside,ferulic acid,verbascoside,and lobetyolin—were quantitatively analyzed.Quality evaluation of Guben Zenggu Capsules was conducted using clustering analysis,principal component analysis,and orthogonal partial least squares-discriminant analysis.Results The similarity of fingerprints among 15 batches of Guben Zenggu Capsules was>0.991.The contents of the five marker components were as follows:echinacoside(0.7845-0.8378 mg·g^(-1)),calycosin-7-O-β-D-glucoside(0.7145-0.8261 mg·g^(-1)),ferulic acid(0.3418-0.3692 mg·g^(-1)),verbascoside(0.1113-0.1233 mg·g^(-1)),and lobetyolin(1.9453-2.2407 mg·g^(-1)).Chemometric analysis classified the 15 batches into two categories,with peaks 15,11,14,13,12,10,6(calycosin-7-O-β-D-glucoside),3,and 4 identified as quality marker peaks for distinguishing between batches.Conclusion The established method is accurate,feasible,and highly stable,providing a reliable reference for the quality control of Guben Zenggu Capsules.
作者
杨秀娟
李全梅
郭晶晶
海云翔
董万涛
宋敏
YANG Xiujuan;LI Quanmei;GUO Jingjing;HAI Yunxiang;DONG Wantao;SONG Min(Gansu University of Chinese Medicine,Lanzhou 730000 Gansu,China;Affiliated Hospital of Gansu University of Chinese Medicine,Lanzhou 730000 Gansu,China)
出处
《中药新药与临床药理》
北大核心
2025年第10期1748-1756,共9页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家自然科学基金项目(82160755)
甘肃省科技厅重点研发计划-社会发展类项目(21YF5FA017)
甘肃省青年博士支持项目(2025QB-066)
甘肃省中药质量与标准研究重点实验室开放基金项目(ZYZL2024-01)
2024年度甘肃省中医药研究中心专项开放课题(zyzx-2024-zx14)
兰州市城关区人才创新创业项目(2023-rc-7)。
关键词
固本增骨胶囊
指纹图谱
多指标成分测定
化学计量学
质量控制
Guben Zenggu Capsules
fingerprint
multi-component quantitative analysis
chemometrics
quality control
