基于一测多评法同时定量测定人参女金丸中9个主要成分  

Quantitative Study on Simultaneous Determination of Nine Components in Renshen Nüjin Pills Based on QAMS

作　　者：冯桂玲 刘莹娟[1] 李文献[3] 孙智蔚[4] 钞俊红 高利敏 阮耀[4] FENG Gui-ling;LIU Ying-juan;LI Wen-xian;SUN Zhi-wei;CHAO Jun-hong;GAO Li-min;RUAN Yao(School of Life Science and Technology,Nanyang Normal University,Nanyang 473001,China;The Second Affiliated Hospital of Nanyang Medical College ,Nanyang473001,China;Nanyang Medical College,Naayang 473001,China;Hospital of Nanyang Normal University,Nanyang 473001,China)

机构地区：[1]南阳师范学院生命科学与技术学院,河南南阳473001 [2]南阳师范学院校医院,河南南阳473001 [3]南阳医学高等专科学校第二附属医院,河南南阳473001 [4]南阳医学高等专科学校,河南南阳473001

出　　处：《中国药学杂志》2018年第23期2047-2053,共7页Chinese Pharmaceutical Journal

摘　　要：目的建立一测多评法同时测定人参女金丸中洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、藁本内酯、氧化芍药苷、芍药内酯苷、芍药苷、苯甲酰芍药苷和α-香附酮的含量,为其质量标准的研究提供依据。方法采用Agilent Zorbax SB C18色谱柱(4. 6 mm×250 mm,5μm);以甲醇-乙腈(2∶1)与0. 1%磷酸溶液为流动相,梯度洗脱;流速为0. 9 m L·min-1;柱温30℃;检测波长分别为:280、230和242 nm;以芍药苷为内参物,建立人参女金丸中洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、藁本内酯、氧化芍药苷、芍药内酯苷、苯甲酰芍药苷和α-香附酮与该成分的相对校正因子,通过一测多评法与外标法结果的比较,验证所建立方法的准确性和可行性。结果洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、藁本内酯、氧化芍药苷、芍药内酯苷、芍药苷、苯甲酰芍药苷和α-香附酮在一定范围内浓度与峰面积呈良好的线性关系;精密度、稳定性、重现性等均符合方法学要求;平均加样回收率分别为97. 38%、98. 16%、98. 84%、99. 63%、97. 04%、99. 14%、100. 04%、96. 93%和98. 48%,RSD分别为1. 38%、1. 18%、0. 97%、0. 86%、1. 68%、1. 30%、0. 57%、1. 32%和1. 19%;一测多评法所得结果与外标法结果无显著差异。结论一测多评法可以用于人参女金丸中9个成分的含量测定及质量控制。OBJECTIVE To establish a quantitative analysis of multi-components by single-marker (QAMS)method for simultaneous determination of senkyunolide H,senkyunolide I,senkyunolide A,ligustilide,oxypaeoniflorin,albiflorin,paeoniflorin,benzoylpaeoniflorin and α-cyperone in Renshen Ntijin pills,in order to provide basis for studying its quality standards.METHODS The analysis of the methanol extract of Renshen Ntijin pills was performed on Agilent Zorbax SB C18 column (4.6mm × 250mm,5μm), with mobile phase composed of methanol-acetonitrile (2:1)-0.1% phosphoric acid solution at a flow rate of 0.9mL·min^-1 in gradient elution mode.The column temperature was maintained at 30℃,and the detection wavelengths were set at 280,230 and 242nm.Paeoniflorin was selected as the internal standard,and the relative correlation factors (RCF)of senkyunolide H,senkyunolide I,senkyunolide A,ligustilide,oxypaeoniflorin,albiflorin,paeoniflorin,benzoylpaeoniflorin and α-cyperone were determined by HPLC.The accuracy and feasibility of the method were validated by comparing the results of QAMS method and external standard method. RESULTS The standard curves of senkyunolide H,senkyunolide I,senkyunolide A,ligustilide,oxypaeoniflorin,albiflorin,paeoniflorin,benzoylpaeoniflorin and α-cyperone had good linear relationship in the ranges of the tested concentrations.The precision,stability and repeatability complied with the requirements of methodology.The recoveries were 97.38%,98.16%,98.84%,99.63%, 97.04%,99.14%,100.04%,96.93%and 98.48%,RSDs were 1.38%,1.18%,0.97%,0.86%,1.68%,1.30%,0.57%, 1.32% and 1.19%,respectively.No significant differences were observed in the determination results by QAMS method and external standard method.CONCLUSION The QAMS method can be used for the content determination and quality control of the nine components in Renshen Nüjin pills.

关 键 词：人参女金丸 洋川芎内酯H 洋川芎内酯I 洋川芎内酯A 菜本内酯 氧化芍药苷 芍药内酯苷 芍药苷 苯甲酰芍药苷 α-香附酮 一测多评法 

分 类 号：R917[医药卫生—药物分析学]