基于HPLC指纹图谱和一测多评法的复方南板蓝根颗粒质量评价  

Quality Evaluation of Fufang Nanbanlangen Keli Based on HPLC Characteristic Fingerprint and Quantitative Analysis of Multi-components with Single Marker

作　　者：刘主洁 毕福钧[1] 林彤[1] LIU Zhu-jie;BI Fu-jun;LIN Tong(NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,国家药监局中成药质量评价重点实验室,广东广州510160

出　　处：《分析测试学报》2024年第11期1835-1842,共8页Journal of Instrumental Analysis

基　　金：2021年广东省科技创新战略专项(20212210005)。

摘　　要：采用高效液相色谱法(HPLC)对复方南板蓝根颗粒进行指纹图谱研究和相似度评价,并结合主成分分析(PCA)、正交偏最小二乘判别分析(OPLS-DA)进行统计学研究。在此基础上,以秦皮乙素为内参物,计算单咖啡酰酒石酸和菊苣酸的相对校正因子,并利用外标法(ESM)验证一测多评法(QAMS)的可靠性。10批复方南板蓝根颗粒的指纹图谱中共确定13个共有峰,相似度为0.942~0.996。PCA、OPLS-DA模式识别结果均表明,不同厂家样品间的成分存在一定差异。QAMS与ESM检测数据表明,两种算法的差异不大。所建立的指纹图谱结合统计学分析和一测多评法评价模式经济可靠、准确可行,可用于完善复方南板蓝根颗粒的质量标准监控。The analysis was achieved by high-performance liquid chromatography(HPLC)and similarity of fingerprints evaluation.Additionally,principal component analysis(PCA)and orthogonal partial least squares discriminate analysis(OPLS-DA)were employed to explorate the overall data and differential compounds of Fufang Nanbanlangen Keli.At the same time,taking aesculetin as the internal standard,relative correction factors of caftaric acid and chicoric acid were calculated to establish the multi-components by single marker(QAMS)method.The correctness and practicability of this study was assessed by contrasting the data with external standard method(ESM).13 common chromatographic peaks were signed in fingerprints with 10 batches of Fufang Nanbanlangen Keli,and the similarities of each batch were 0.942-0.996.The PCA and OPLS-DA study showed that there were certain varies from different manufacturers.Compared with ESM data,the data of QAMS method were not significantly different.The established fingerprint combined with QAMS method are econimic and reliable,which can provide references and systematic studies for the comprehensive supervisory control of Fufang Nanbanlangen Keli.

关 键 词：复方南板蓝根颗粒 指纹图谱 一测多评 秦皮乙素 高效液相色谱 

分 类 号：O657.7[理学—分析化学] R284.1[理学—化学]