基于有效基准特征图谱质量表征的卷丹饮片质量评价研究  

Study on quality evaluation of Lilium Lancifolium based on quality criterion of effective benchmark specific chromatogram

作　　者：范圆圆 李林福[2] 李亚琪 黄玉娟 高园园 舒一崧 孔静 潘锋 孙仁弟 黄广伟 姜艳艳 石任兵 FAN Yuanyuan;LI Linfu;LI Yaqi;HUANG Yujuan;GAO Yuanyuan;SHU Yisong;KONG Jing;PAN Feng;SUN Rendi;HUANG Guangwei;JIANG Yanyan;SHI Renbing(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学中药学院国家中医药管理局中药经典名方有效物质发现重点研究室,102488 [2]赣南医学院药学院 [3]上海绿谷生命园医药有限公司 [4]北京市教委中药质量控制技术工程中心

出　　处：《环球中医药》2021年第5期767-776,共10页Global Traditional Chinese Medicine

基　　金：国家“十二五”科技支撑计划(2012BAI29B06);北京市教委共建科研基地建设项目;北京中医药大学重点学科开放课题(2013-2DXKKF-23)。

摘　　要：目的建立基于卷丹有效基准特征图谱的质量表征模式、方法与质量评价应用,以精准、有效地评价卷丹饮片质量。方法以确定具有降血糖作用的卷丹饮片(实验样品编号S16)为饮片基准,以代表性成分王百合苷C及其含量为质量表征基准点,采用HPLC-PDA建立卷丹有效基准特征图谱。基于王百合苷C对照品模拟基准点的有效基准特征图谱质量表征信息作为评价卷丹饮片质量标尺,并对其准确性进行佐证及质量评价应用与验证。结果以卷丹饮片(S16)为基准,以代表性成分王百合苷C为质量表征基准点(保留时间:16.200分钟、检测溶液浓度:0.0774 mg/mL),通过制备王百合苷C对照品溶液模拟质量表征基准点,对卷丹有效基准饮片进行质量表征。以模拟基准点的基准信息得到卷丹有效基准特征图谱质量表征信息为:特征峰数目、相对保留时间、相对峰面积及5个代表性成分(王百合苷C、王百合苷A、王百合苷E、王百合苷B及卷丹皂苷[(25R)-3β,17α-二羟基-5α-螺甾烷-6-酮-3-O-α-L-鼠李糖基-(1→2)-β-D-葡萄糖苷]的相对含量,其中涵盖了卷丹降血糖药效架构中的两类主要化学类型:酚类和甾体皂苷类。采用课题组前期构建的中药饮片质量评价模式及新建的质量基准标尺对15批卷丹饮片的质量进行评价得出:饮片S7,S11,S10,S12,S5,S13和S4质量较优;通过换算系数计算得到的5个代表性成分的含量与实际测定值基本一致。结论建立的基于有效基准特征图谱的卷丹质量表征模式、方法能够整体、准确地对卷丹饮片进行质量表征,且可以有效、精准、便捷地评价卷丹饮片质量。Objective To establish the quality criterion model,method and the application of quality evaluation based on the effective benchmark specific chromatogram of Lilium Lancifolium,so as to evaluate the quality of decoction pieces of Lilium Lancifolium accurately and effectively.Methods Taking the decoction pieces of Lilium lancifolium(S16)with the hypoglycemic effect as the standard,taking the representative component regaloside C and its content as the reference point for quality criterion,using HPLC-PDA to establish effective benchmark specific chromatogram of Lilium Lancifolium.Simulating quality criterion information of effective benchmark specific chromatogram based on regaloside C reference substance,which was used as a quality standard to evaluate the decoction pieces of Lilium Lancifolium.The accuracy was confirmed and its quality evaluation were applied and verified.Results Taking the Lilium Lancifolium decoction piece(S16)as the reference point and the representative component of regaloside C as the quality characterization reference point(retention time was 16.200 minutes,concentration of detection solution was 0.0774 mg/mL),the quality criterion of effective reference decoction pieces of Lilium Lancifolium were performed,by preparing of regaloside C reference solution to simulate quality characterization reference point.Based on the reference information of simulated reference points,the quality characterization information of the effective reference characteristic spectrum was obtained,including the number of characteristic peaks,relative retention time,relative peak area and the contents of five representative components(regaloside C,regaloside A,regaloside E,regaloside B and lililancifoloside(25R-3β,17α-2 hydroxy-5α-spirostan-6-ketone-3-α-L-rhamnosyl-(1→2)-β-D-glucoside).It covers the two main chemical types in the pharmacodynamic framework for hypoglycemia:phenols and steroidal saponins.The quality evaluation model of Chinese herbal medicine decoction pieces established by the research group i

关 键 词：卷丹 王百合苷C 有效基准特征图谱 质量表征 质量评价 质量标尺 

分 类 号：R285.5[医药卫生—中药学]