摘要
目的:建立一测多评法(QAMS)多指标定量联合化学计量学、熵权优劣解距离(EW-TOPSIS)法评价山楂内消丸质量的方法。方法:采用Agilent Extend C_(18)色谱柱,以乙腈-0.2%磷酸水溶液为流动相,以橙皮苷为内参物建立与其他成分的相对校正因子,采用QAMS同时测定12批山楂内消丸中牡荆素葡萄糖苷、牡荆素鼠李糖苷、金丝桃苷、柚皮芸香苷、橙皮苷、3,5,6,7,8,3',4'-七甲氧基黄酮、橘红素、莪术二酮、莪术醇、香附烯酮、圆柚酮和α-香附酮的含量,与外标法检测结果进行比对,再对QAMS含量数据进行化学计量学分析和EW-TOPSIS法分析。结果:定量检测方法学验证均符合《中华人民共和国药典》2020年版要求。以橙皮苷为内参物,各成分的相对校正因子分别为0.7344、0.5914、0.9538、0.8047、0.6852、1.1046、1.3291、1.2000、0.6396、1.4862、0.8426(RSD均小于2.0%),QAMS与外标法测定结果接近。通过化学计量学分析,12批样品聚为3类,同一厂家的聚为一类,并确立了牡荆素鼠李糖苷、莪术二酮、橙皮苷、柚皮芸香苷和香附烯酮为差异性质量标志物;EW-TOPSIS法结果显示,12批山楂内消丸的欧氏贴近度(Ci)值为0.1637~0.7450,EW-TOPSIS法能够有效评价不同批次样品的质量。结论:建立的12个指标成分定量方法可用于山楂内消丸内在质量控制,化学计量学及EW-TOPSIS法可用于其质量评价。
Objective:To establish a method for evaluating the quality of Shanzha Neixiao Pills using QAMS multi-index quantitation combined with chemometrics and the entropy weight-TOPSIS(EW-TOPSIS)method.Methods:An Agilent Extend C_(18) column was used with acetonitrile-0.2%phosphoric acid aqueous solution as the mobile phase,and hesperidin was used as the internal reference to establish relative correction factors for other components.The QAMS method was used to simultaneously determine the contents of vitexin-4'-O-glucoside,rhamnosylvitexin,hyperoside,narirutin,hesperidin,3,5,6,7,8,3',4'-heptamethoxyflavone,tangeretin,curdione,curcumol,cyperenone,nootkatone,andα-cyperone in 12 batches of Shanzha Neixiao Pills,and the results were compared with those obtained by the external standard method(ESM).The QAMS data were then analyzed using chemometric analysis and the EW-TOPSIS method.Results:The validation of the quantitative detection methods met the requirements of the 2020 edition of the Chinese Pharmacopoeia.The QAMS results showed that the relative correction factors for each component were 0.7344,0.5914,0.9538,0.8047,0.6852,1.1046,1.3291,1.2000,0.6396,1.4862,and 0.8426(RSD<2.0%).The results obtained by QAMS were close to those obtained by the ESM.Chemometric analysis grouped the 12 batches of samples into three categories,with samples from the same manufacturer clustering into one group,and rhamnosylvitexin,curdione,hesperidin,narirutin,and cyperenone were identified as differential quality markers.The EW-TOPSIS results showed that the Euclidean proximity(Ci)values of the 12 batches of Shanzha Neixiao Pills ranged from 0.1637 to 0.7450,the EW-TOPSIS method could effectively evaluate the quality of different batches of samples.Conclusion:The established quantitative method for 12 index components can be used for the internal quality control of Shanzha Neixiao Pills,and chemometrics and the EW-TOPSIS method can be applied to effectively evaluate their quality.
作者
纪康康
李志明
冯金鹰
JI Kangkang;LI Zhiming;FENG Jinying(Department of Pharmacy,Shandong Provincial Third Hospital,Jinan 250000,China;School of Pharmacy,Shandong University of Traditional Chinese Medicine,Jinan 250355,China)
出处
《中国现代中药》
2025年第1期152-160,共9页
Modern Chinese Medicine
基金
山东省卫生健康委员会中医药科技项目(M-2023200)。
作者简介
通信作者:冯金鹰,主管药师,研究方向:中药新制剂新技术,Tel:0531-81656252,E-mail:blgcge@163.com。
