补肾健骨胶囊高效液相色谱指纹图谱及主成分分析  

High Performance Liquid Chromatography Fingerprint and Principal Component Analysis of Bushen Jiangu Capsule

作　　者：林茂铨 刘爽 黄志军 肖飞 明凯利 黄哲[1] LIN Maoquan;LIU Shuang;HUANG Zhijun;XIAO Fei;MING Kaili;HUANG Zhe(Shenyang Pharmaceutical University,Shenyang 110016,China;Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100044,China;Jianmin Pharmaceutical Group Co.,Ltd.,Wuhan 430052,China)

机构地区：[1]沈阳药科大学,沈阳110016 [2]国家药品监督管理局食品药品审核查验中心,北京100044 [3]健民药业集团股份有限公司,武汉430052

出　　处：《世界中医药》2023年第22期3167-3171,3179,共6页World Chinese Medicine

基　　金：国家重点研发计划“中医药现代化研究”重点专项项目(2017YFC1703000)——茯苓全产业链标准体系构建及产品研发。

摘　　要：目的:建立补肾健骨胶囊的高效液相色谱法(HPLC)指纹图谱,并进行主成分分析。方法:采用HPLC,色谱柱为Thermo-Hypersil GOLD^(TM)-C18(250 mm×4.6 mm×5μm),流动相为乙腈-0.2%磷酸水溶液(梯度洗脱),流速为1.0 mL/min,检测波长为235 nm,柱温为30℃,进样量为10μL。根据15批样品的HPLC检测图谱,采用国家药典委员会《中药色谱指纹图谱相似度评价系统》(2012年版)进行相似度评价和共有峰的确定,并采用Minitab17.0软件进行主成分分析。结果:补肾健骨胶囊指纹图谱共标出13个共有峰,并指认了其中3个共有峰,分别为莫诺苷、马钱苷、淫羊藿苷;15批样品的相似度均大于0.9,各批次样品之间有良好的相似性。经主成分分析,共提取出2个主成分,方差累计贡献率为92.3%,样品中1、2、4、6、8、13号共有峰(特别是13号共有峰)对应成分的含量变化是导致样品质量差异的重要原因。结论:所建HPLC指纹图谱及主成分分析结果可为补肾健骨胶囊的质量评价提供参考。Objective:To establish high performance liquid chromatography(HPLC) fingerprint of Bushen Jiangu Capsule,and to conduct principal component analysis.Methods:The HPLC was performed on a Thermo-Hypersil GOLD~(TM)-C18(250 mm×4.6 mm×5 μm) with mobile phase of acetonitrile-0.2% formic acid solution(gradient elution) at a flow rate of 1.0 mL/min.The detection wavelength was 235 nm,and column temperature was 30 ℃.The simple injection was 10 μL.According to the HPLC fingerprints of 15 batches of samples,the similarity was evaluated and common peaks was determined by the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012).Principal component analysis was conducted using Minitab 17.0.Results:There were 13 common peaks in the HPLC fingerprints and three were identified:morroniside,loganin and icariin.The similarities of the 15 batches of samples were all greater than 0.9,and there was good similarity between them.Through principal component analysis,two principal components were obtained with the accumulative contribution rate of 92.3%.It was indicated that the content change of components corresponding to common peaks 1,2,4,6,8,and 13 in the samples was an important reason for the quality difference of the samples,especially common peak 13.Conclusion:The established HPLC fingerprint and the principal component analysis facilitate the quality evaluation of Bushen Jiangu Capsule.

关 键 词：补肾健骨胶囊 高效液相色谱法 指纹图谱 共有峰 相似度 主成分分析 质量评价 

分 类 号：R285[医药卫生—中药学]