清脑降压片多组分定量控制及综合质量评价模型构建  

Construction of Multi-Component Quantitative Control and Comprehensive Quality Evaluation Model of Qingnao Jiangya Tablets(清脑降压片)

作　　者：马丹凤[1] 李静[1] 张传香[1] 李志平 MA Danfeng;LI Jing;ZHANG Chuanxiang;LI Zhiping(Hunan Children's Hospital,Changsha Hunan 410007,China;School of Pharmacy,Hunan University of Chinese Medicine,Changsha Hunan 410208,China)

机构地区：[1]湖南省儿童医院,湖南长沙410007 [2]湖南中医药大学药学院,湖南长沙410208

出　　处：《中医药导报》2024年第4期50-56,66,共8页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：湖南省中医药科研计划项目(2021072)。

摘　　要：目的:建立清脑降压片一测多评测定方法,同时测定其中11种成分含量,并构建其OPLS-DA、EM-TOPSIS法综合质量评价模型。方法:以Agilent Extend C_(18)柱为色谱柱,乙腈-0.1%甲酸为流动相,同时测定18批清脑降压片中β-蜕皮甾酮、异钩藤碱、钩藤碱、黄芩苷、汉黄芩苷、红镰霉素-6-O-β-龙胆二糖苷、决明子苷C、橙黄决明素、丹参素、丹酚酸B、丹参酮ⅡA的含量,采用主成分分析(PCA)法和正交偏最小二乘法-判别分析(OPLS-DA)其整体质量进行综合评价。结果:11种成分分别在各自范围内线性关系良好(r≥0.999),精密度、重复性、稳定性、准确度良好(RSD<2.0%)。以汉黄芩苷为参照物,β-蜕皮甾酮、异钩藤碱、钩藤碱、黄芩苷、红镰霉素-6-O-β-龙胆二糖苷、决明子苷C、橙黄决明素、丹参素、丹酚酸B、丹参酮ⅡA的平均相对校正因子分别为1.648 9、0.925 7、1.434 6、1.299 1、0.751 6、0.836 9、1.129 5、1.573 0、0.788 5和1.256 9;ESM法与QAMS法测定结果比较,差异无统计学意义(P>0.05)。PCA结果显示不同批次清脑降压片质量存在差异;OPLS-DA筛选出黄芩苷、汉黄芩苷、丹酚酸B、红镰霉素-6-O-β-龙胆二糖苷和β-蜕皮甾酮等5种引起清脑降压片质量差异的主要因素。结论:所建立的方法对清脑降压片的质量控制和整体评价具有重要意义。Objective:To establish a quality evaluation method for Qingnao Jiangya tablets by quantitative analysis of multi-components with a single-marker(QAMS),to determine the contents of 11 components at the same time,and to construct the comprehensive quality evaluation model of OPLS-DA and EM-TOPSIS.Methods:HPLC was used with Agilent Extend C_(18) column as the chromatographic column and acetonitrile-0.1%formic acid as the mobile phase.The contents of β-ecdysterone,isorhynchophylline,rhynchophylline,baicalin,wogonosid,rubrofusarin-6-O-beta-D-gentiobioside,cassiaside C,aurantio-obtusin,danshensu,salvianolic acid B and tanshinone ⅡA in 18 batches of Qingnao Jiangya tablets were determined.Principal component analysis(PCA)and orthogonal partial least squares discriminant analysis(OPLS-DA)method were used for comprehensive quality evaluation.Results:The 11 components showed good linear relationships within their respective ranges(r≥0.999),and their precision,repeatability,stability and accuracy were good(RSD<2.0%).Then wogonosid was chosen as internal reference for calculation the correction factors for the other ten components.The average relative correction factors of β-ecdysterone,isorhynchophylline,rhynchophylline,baicalin,rubrofusarin-6--beta-D-gentiobioside,cassiaside C,aurantio-obtusin,danshensu,salvianolic acid B and tanshinone ⅡA were respectively 1.6489,0.9257,1.4346,1.2991,0.7516,0.8369,1.1295,1.5730,0.7885 and 1.2569.There was no significant difference between the data analyzed by ESM and the data obtained from QAMS method(P>0.05).The PCA results showed that there were some differences in the quality of different batches of Qingnao Jiangya tablets.The OPLS-DA showed that baicalin,wogonosid,salvianolic acid B,rubrofusarin-6-O-beta-D-gentiobioside and β-ecdysterone were the main factors to distinguish Qingnao Jiangya tablets.Conclusion:The established method is of great significance for quality control and overall evaluation of Qingnao Jiangya tablets..

关 键 词：清脑降压片 一测多评法 主成分分析 正交偏最小二乘法-判别分析 质量评价 

分 类 号：R284.1[医药卫生—中药学]