基于HPLC-QAMS法对清热通淋丸中7种成分的质量控制研究  

Quality control research of seven components in Qingre Tonglin pills based on HPLC-QAMS

作　　者：刘德军[1] 贺玲 樊苗苗 陶弘武[4] 王艳荣 LIU De-jun;HE Ling;FAN Miao-miao;TAO Hong-wu;WANG Yan-rong(Department of Preparation Center,the Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110003,China;Shenyang Hongqi Pharmaceutical Co.,Ltd,Shenyang 110179,China;Liaoyang Drug Inspection Institute,Liaoyang 111000,China;The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine&Liaoning Province Chinese Medicine Research Institute,Shenyang 110034,China)

机构地区：[1]辽宁中医药大学附属第三医院制剂中心,辽宁沈阳110003 [2]沈阳红旗制药有限公司,辽宁沈阳110179 [3]辽阳市药品检验所,辽宁辽阳111000 [4]辽宁中医药大学附属第二医院&辽宁省中医药研究院,辽宁沈阳110034

出　　处：《实用药物与临床》2020年第11期1022-1028,共7页Practical Pharmacy and Clinical Remedies

基　　金：辽宁省科技厅公益基金(20170019)。

摘　　要：目的建立高效液相一测多评法(HPLC-QAMS)同时测定清热通淋丸中三叶豆紫檀苷、苦参醇I、苦参酮、槐属二氢黄酮G、6′-羟基爵床脂素B、6′-羟基爵床脂素A和爵床脂素B的含量。方法采用高效液相色谱法,以Agilent Zorbax SB-C18柱(250 mm×4.6 mm,5μm)为色谱柱,流动相为乙腈-水,梯度洗脱,流速为1.0 ml/min,柱温为30℃。以苦参酮为内参物,建立其他6个成分的相对校正因子,计算含量。结果三叶豆紫檀苷、苦参醇Ⅰ、苦参酮、槐属二氢黄酮G、6′-羟基爵床脂素B、6′-羟基爵床脂素A和爵床脂素B的质量浓度分别在0.91~22.75μg/ml(r=0.999 5)、1.89~47.25μg/ml (r=0.999 3)、5.67~141.75μg/ml (r=0.999 7)、1.29~32.25μg/ml (r=0.999 5)、1.48~37.00μg/ml (r=0.999 6)、2.56~64.00μg/ml (r=0.999 4)、4.09~102.25μg/ml (r=0.999 8)范围内线性关系良好,平均加样回收率(RSD)分别为97.99%(1.42%)、98.44%(0.85%)、99.47%(0.92%)、96.98%(1.21%)、99.50%(0.74%)、100.00%(1.04%)和98.39%(1.32%),建立的高效液相一测多评法用于测定清热通淋丸中7种指标性成分的含量,一测多评法所得结果与外标法无明显差异。结论所建立的HPLC-QAMS法结果准确,可用于清热通淋丸的质量控制。Objective To develop an HPLC-QAMS method for the determination of trifolirhizin,kushenol I,kurarinone,sophoraflavanone G,6′-hydroxy justicidin B,6′-hydroxy justicidin A and justicidin B in Qingre Tonglin pills.Methods An HPLC method was applied with Agilent Zorbax SB-C18(250 mm×4.6 mm,5 μm) as column;the mobile phase was acetonitrile-water,the flow rate was 1.0 ml/min,the column temperature was 30 ℃.Using kurarinone as an internal standard,the relative correction factors of the other six constituents were calculated,after which the content determination was made.Results Trifolirhizin,kushenol Ⅰ,kurarinone,sophoraflavanone G,6′-hydroxy justicidin B,6′-hydroxy justicidin A and justicidin B showed good linear relationships within the ranges of 0.91~22.75 μg/ml(r=0.999 5),1.89~47.25 μg/ml(r=0.999 3),5.67~141.75 μg/ml(r=0.999 7),1.29~32.25 μg/ml(r=0.999 5),1.48~37.00 μg/ml(r=0.999 6),2.56~64.00 μg/ml(r=0.999 4) and 4.09~102.25 μg/ml(r=0.999 8),whose average recoveries(RSDs) were 97.99%(1.42%),98.44%(0.85%),99.47%(0.92%),96.98%(1.21%),99.50%(0.74%),100.00%(1.04%) and 98.39%(1.32%),respectively.The established HPLC-QAMS method was used to determine the contents of the seven index components in Qingre Tonglin pills.The results obtained by QAMS had no obvious difference from those obtained by external standard method.Conclusion The established HPLC-QAMS method is accurate which can be used for the quality control of Qingre Tonglin pills.

关 键 词：一测多评法 清热通淋丸 三叶豆紫檀苷 苦参醇Ⅰ 苦参酮 槐属二氢黄酮G 6′-羟基爵床脂素B 6′-羟基爵床脂素A 爵床脂素B 

分 类 号：R286.0[医药卫生—中药学]