基于指纹图谱和化学计量学的冠心七味片质量控制研究  

Study on quality control of Guanxin Qiwei tablets based on fingerprint and chemometrics

作　　者：刘成东 杨利 陈佳惠 张彭鹏 刘静 张谦 李君 王跃武 LIU Cheng-dong;YANG Li;CHEN Jia-hui;ZHANG Peng-peng;LIU Jing;ZHANG Qian;LI Jun;WANG Yue-wu(School of Pharmacy,Inner Mongolia Medical University,Hohhot 010110,China;Baotou Traditional Chinese Medicine Co.,Ltd.,Baotou 014040,China)

机构地区：[1]内蒙古医科大学药学院,内蒙古呼和浩特010110 [2]包头中药有限公司,内蒙古包头014040

出　　处：《药学学报》2025年第4期1115-1123,共9页Acta Pharmaceutica Sinica

基　　金：内蒙古自治区科技厅,内蒙古自治区科技计划项目(2023YFHH0082);内蒙古自治区蒙医药协同创新中心,国际合作项目(MYYXTGJ202306);内蒙古自治区蒙医药协同创新中心,成果转化培育项目(MYYXTPY202306);内蒙古医科大学“致远”人才计划项目(ZY20242115);内蒙古医科大学面上项目(YKD2024MS015)。

摘　　要：本研究建立了冠心七味片的HPLC指纹图谱与化学计量学结合的多指标含量测定方法,为其质量控制提供科学依据。采用Shim-pack GIST-HP C_(18)色谱柱建立18批冠心七味片的指纹图谱,结合《中药色谱指纹图谱相似度评价系统(2012版)》进行全面分析;采用聚类分析(CA)、主成分分析(PCA)和正交偏最小二乘判别分析(OPLSDA)进行化学计量学研究,并建立HPLC-MS/MS法同时测定9个成分含量。18批冠心七味片指纹图谱共标定了22个共有峰,相似度为0.952~0.998,9个共有峰被指认,分别为1号峰没食子酸、3号峰原儿茶酸、8号峰鞣花酸、9号峰丹酚酸B、12号峰木犀草素、13号峰芹菜素、19号峰去氢二异丁香酚、20号峰隐丹参酮、21号峰丹参酮ⅡA;CA和PCA分析将18批冠心七味片聚为3大类:S1~S4(A厂家)聚为一类,S5~S8(B厂家)聚为一类,S9~S18(C、D厂家)聚为一类,在OPLS-DA分析模式下,以变量权重值(VIP)>1为标准,筛选出了14个质量差异物,其均有不同的显著性差异;9个成分在各自范围内线性关系良好,线性相关系数r均≥0.9990;精密度RSD均<3.00%;稳定性和重复性良好,RSD均<5.00%;平均加样回收率为96.58%~106.28%,RSD为2.68%~6.45%。此方法高效稳定,可用于冠心七味片质量控制。The study aims to establish HPLC fingerprint and multi-index content determination method of Guanxin Qiwei tablets and provide scientific basis for its quality control.The fingerprints of 18 batches of Guanxin Qiwei tablets were established by Shim-pack GGIST HP C_(18)chromatographic column,and analyzed comprehensively in combination with the Similarity Evaluation System of TCM Chromatographic Fingerprint(2012 edition).Cluster analysis(CA),principal component analysis(PCA)and orthogonal partial least squares discriminant analysis(OPLS-DA)were used for stoichiometric study.HPLC-MS/MS method was established for simultaneous determination of 9 components.A total of 22 common peaks were identified in 18 batches of Guanxin Qiwei tablets fingerprint,and the similarity was 0.952-0.998,9 common peaks were identified.They were No.1 gallic acid,No.3 protocatechuic acid,No.8 ellagic acid,No.9 salvianolic acid B,No.12 luteolin,No.13 apigenin,No.19dehydrodiisoeugenol,No.20 cryptotanshinone and No.21 tanshinoneⅡA.CA and PCA analysis grouped 18 batches of Guanxin Qiwei tablets into 3 categories:S1-S4(manufacturer A)was grouped into one category,S5-S8(manufacturer B)was grouped into one category,and S9-S18(manufacturer C and D)was grouped into one category.Under OPLS-DA analysis mode,14 quality differentiators were selected with the variable important projection(VIP)greater than 1 as the standard,and all of them had significant differences.The linear relationship of the 9 components was good in their respective ranges,and the linear correlation coefficient r was greater than or equal to 0.0999.Precision RSDS were all lower than 3.00%.The stability and repeatability were good,RSD lower than 5.00%;The average recoveries were 96.58%-106.28%,RSD was 2.68%-6.45%.This method is efficient and stable,and can be used for quality control of Guanxin Qiwei tablets.

关 键 词：冠心七味片 指纹图谱 化学计量学 方差分析 定量分析 质量控制 

分 类 号：R917[医药卫生—药物分析学]