一测多评法同时测定蒙药孟根·沃斯-18丸中10种化学成分  

Simultaneous determination of ten chemical components in Menggen Vos-18 pills by method of quantitative analysis of multi-components by single marker

作　　者：苏都那布其 荷叶 莫日根 郝俊生 海金 王秀兰[1,2] SU Duna-buqi;HE Ye;MO Ri-gen;HAO Jun-sheng;HAI Jin;WANG Xiu-lan(College of Mongolian Medicine and Pharmacy,Inner Mongolia University for Nationalities,Tongliao 028000,China;Inner Mongolia Institute of Mongolian Medicine Engineering Technology,Tongliao 028000,China;Tongliao Market Inspection Center,Tongliao 028000,China)

机构地区：[1]内蒙古民族大学蒙医药学院,通辽028000 [2]内蒙古蒙医药工程技术研究院,通辽028000 [3]通辽市市场检验检测中心,通辽028000

出　　处：《中国新药杂志》2025年第4期419-425,共7页Chinese Journal of New Drugs

基　　金：内蒙古自治区科技成果转化专项资金资助项目(2021CG0025);内蒙古自治区药品监督管理局药品安全监管科研项目(NMYJ-KJ-202308);中国民族医药学会科研项目(2023MY049-12)。

摘　　要：目的:建立HPLC一测多评法(quantitative analysis of multi-components by single marker,QAMS)同时测定蒙药孟根·沃斯-18丸中没食子酸、表儿茶素、鞣花酸、杨梅素、肉桂酸、丁香酚、橙黄决明素、甘松新酮、α-细辛脑和大黄酚等10种成分,并验证该方法在蒙药孟根·沃斯-18丸质量分析中应用的可行性。方法:采用Agilent Eclipse Plus C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.2%磷酸溶液(B),梯度洗脱(0~60 min,5%A→25%A,波长210 nm;60~80 min,25%A→36%A,波长280 nm;80~145 min,36%A→75%A,波长250 nm),流速为1.0 mL·min^(-1);柱温为40℃。以鞣花酸为内参物,建立与其他9种待测成分的相对校正因子(f_(s/i)),采用f_(s/i)计算各成分的质量分数,同时用外标法(external standard method,ESM)测定,比较2种方法测定结果,评价QAMS在蒙药孟根·沃斯-18丸中应用的准确性。结果:蒙药孟根·沃斯-18丸中没食子酸、表儿茶素、杨梅素、肉桂酸、丁香酚、橙黄决明素、甘松新酮、α-细辛脑和大黄酚9种成分的fs/i重现性良好,分别为0.2422,0.2315,0.3199,0.2565,1.9699,1.2089,1.2602,0.5605和1.2132,QAMS,ESM所得结果接近。结论:该方法简便、稳定、重复性良好,可用于孟根·沃斯-18丸的质量控制。Objective:To establish an HPLC method for simultaneous determination of 10 components(gallic acid,epicatechin,ellagic acid,myricetin,cinnamic acid,eugenol,hesperidin,alpha-asarol and chrysophanol)in a Mongolian medicine,Menggen Vos-18 pills,and verify the feasibility of applying this method in its quality analysis.Methods:The chromatography was performed on Agilent Eclipse Plus C_(18)column(250 mm×4.6 mm,5μm)with mobile phase consisting of acetonitrile(A)-0.2%phosphoric acid solution(B)and gradient elution(0~60 min,5%A→25%A,wavelength 210 nm;60~80 min,25%A→36%A,wavelength 280 nm;80~145 min,36%A→75%A,wavelength 254 nm),and the flow rate was 1.0 mL·min^(-1).The column temperature was 40℃.Relative correction factors(f_(s/i))were established with ellagic acid as the internal reference,the mass fractions of each component were calculated by relative correction factor,and the results were determined by external standard method.The accuracy of the application of quantitative analysis of multi-components by single marker(QAMS)method in Menggen Vos-18 pills was evaluated.Results:The f_(s/i)reproducibility of gallic acid,epicatechin,myricetin,cinnamic acid,eugenol,hesperidin,manpinone,alpha-asarol and chrysophenol in Menggen Vos-18 pills was good.They were 0.2422,0.2315,0.3199,0.2565,1.9699,1.2089,1.2602,0.5605 and 1.2132,respectively.The results obtained by QAMS method and external standard method were close to each other.Conclusion:The method is simple,stable and reproducible,and can be used for the quality control of Mengen Vos-18 pills.

关 键 词：孟根·沃斯-18丸 相对校正因子 一测多评法 没食子酸 表儿茶素 鞣花酸 杨梅素 肉桂酸 丁香酚 橙黄决明素 甘松新酮 Α-细辛脑 大黄酚 

分 类 号：R927[医药卫生—药学]