基于指纹图谱和多成分含量测定的心脉安片质量评价研究  

Quality evaluation of Xinmai'an tablets based on fingerprint and multi-component determination

作　　者：吴双凤 张薇 孙晓波[3] 王德勤[1] 郭海彪[1] 刘晓秋[2] WU Shuangfeng;ZHANG Wei;SUN Xiaobo;WANG Deqin;GUO Haibiao;LIU Xiaoqiu(Hutchison Whampoa Guangzhou Bai Yunshan Chinese Medicine Co.,Ltd.,Guangzhou 510515,China;School of Traditional Chinese Materia Medica,Shenyang Pharmaceutical University,Shenyang 110016,China;Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100193,China)

机构地区：[1]广州白云山和记黄埔中药有限公司,广州510515 [2]沈阳药科大学中药学院,沈阳110016 [3]中国医学科学院北京协和医学院药用植物研究所,北京100193

出　　处：《药学前沿》2025年第3期406-415,共10页China Pharmacist

基　　金：广州市科技计划项目(20212210006)。

摘　　要：目的采用HPLC构建心脉安片的指纹图谱及多种有效成分的含量测定方法。方法构建11批心脉安片的HPLC指纹图谱,同时进行相似度评价,对数据结果进行化学计量学分析,选出心脉安片的差异性化学成分,并测定芍药苷、毛蕊异黄酮葡萄糖苷、丹酚酸B、隐丹参酮、丹参酮Ⅰ和丹参酮ⅡA 6种化学成分的含量。结果11批心脉安片指纹图谱有37个共有峰,指认出芍药苷、毛蕊异黄酮葡萄糖苷、隐丹参酮等19个色谱峰,涵盖复方中人参、丹参、黄芪、赤芍4味药材,相似度均在0.90以上。聚类分析、主成分分析均将11批心脉安片分为2类,S1~S3为一类,S4~S11为一类;正交偏最小二乘法判别分析标记出心脉安片中的18个差异性成分。测定差异较大且含量较高的成分,6种成分分别在4.864~194.600、0.490~19.590、40.330~1613.000、4.980~199.200、1.221~48.880、12.560~502.400μg/mL范围内线性关系良好(r≥0.9999)。3批心脉安片中芍药苷(赤芍)、毛蕊异黄酮葡萄糖苷(黄芪)、丹酚酸B(丹参)、隐丹参酮(丹参)、丹参酮Ⅰ(丹参)和丹参酮ⅡA(丹参)的含量分别为1.63~1.68、0.19、19.18~19.42、1.44~1.46、0.98~1.02、2.21~2.29 mg/g。结论建立的心脉安片HPLC指纹图谱结合化学模式识别法及多种有效成分含量分析方法全面系统稳定可行,为心脉安片整体质量评价及质量标准提高提供了参考。Objective To establish HPLC fingerprint and multi-component determination method of Xinmai'an tablets.Methods The HPLC fingerprints of 11 batches of Xinmai'an tablets were established and the similarity evaluation was conducted.The chemometric analysis was performed on the data to identify the different components of Xinmai'an tablets.The contents of six chemical components,including paeoniflorin,calycosin-7-O-β-D-glucoside,salvianolic acid B,cryptotanshinone,Tanshinone Ⅰ and Tanshinone ⅡA were also determined.Results The HPLC fingerprints of 11 batches of Xinmai'an tablets showed 37 common peaks,among which 19 chromatographic peaks were identified,including paeoniflorin,calycosin-7-O-β-D-glucoside,cryptotanshinone,etc,representing four herbs in the formula:Ginseng radix et rhizoma,Salviae miltiorrhizae radix et rhizoma,Astragali radix,and Paeoniae radix rubra.The similarity indices of 11 batches of Xinmai'an tablets were all above 0.90.The 11 batches of Xinmai'an tablets were divided into two categories by cluster analysis and principal component analysis.S1-S3 were in one group and S4-S11 were in the other group.18 different components in Xinmai'an tablets were screened by orthogonal partial least-squares discrimination analysis.The components with large differences and high concentrations of Xinmai'an tablets were determined.Six components showed a good linear relationship with the peak area in the range of 4.864-194.600,0.490-19.590,40.330-1613.000,4.980-199.200,1.221-48.880 and 12.560-502.400μg/mL(r≥0.9999),respectively.The contents of paeoniflorin(Paeoniae radix rubra),calycosin-7-O-β-D-glucoside(Astragali radix),salvianolic acid B(Salviae miltiorrhizae radix et rhizoma),cryptotanshinone(Salviae miltiorrhizae radix et rhizoma),tanshinone Ⅰ(Salviae miltiorrhizae radix et rhizoma),and tanshinone ⅡA(Salviae miltiorrhizae radix et rhizoma)were 1.63-1.68,0.19,19.18-19.42,1.44-1.46,0.98-1.02 and 2.212.29 mg/g in 3 batches of Xinmai'an tablets,respectively.Conclusion The established HPLC fingerprint

关 键 词：心脉安片 高效液相色谱 指纹图谱 化学计量学 含量测定 芍药苷 毛蕊异黄酮葡萄糖苷 丹酚酸B 隐丹参酮 丹参酮Ⅰ 丹参酮ⅡA 

分 类 号：R286.0[医药卫生—中药学]