基于HPLC-QAMS法的复方苦参肠炎康片中10种成分质量控制研究  

Quality control research of 10 components in Fufang Kushen Changyankang Tablets based on HPLC-QAMS

作　　者：刘琼 何宇鸿 刘璐群 张韦深 曹颖男 汪雪兰 LIU Qiong;HE Yuhong;LIU Luqun;ZHANG Weishen;CAO Yingnan;WANG Xuelan(Experimental Research Center,Guangzhou Xinhua University,Guangzhou 510520,China)

机构地区：[1]广州新华学院医学实验中心,广东广州510520

出　　处：《沈阳药科大学学报》2022年第4期393-404,共12页Journal of Shenyang Pharmaceutical University

基　　金：广东高校省级重点平台和重大科研项目成果(2019KTSCX230、2017KTSCX214、2016GXJK213);广州市创新环境建设计划(201806020107);中山大学新华学院教学质量与教学改革工程项目(2019J044、2019HHJG012、2018J026)。

摘　　要：目的建立高效液相一测多评法同时测定复方苦参肠炎康片中大车前苷、毛蕊花糖苷、异毛蕊花糖苷、木通苯乙醇苷B、黄芩苷、黄芩素、汉黄芩素、苦参醇Ⅰ、苦参酮和槐属二氢黄酮G的含量。方法采用Agilent Zorbax SB C_(18)色谱柱(250 mm×4.6 mm,5μm),柱温30℃。乙腈-体积分数0.1%甲酸溶液为流动相梯度洗脱,体积流量1.0 mL·min^(-1)。检测波长分别为330 nm(大车前苷、毛蕊花糖苷、异毛蕊花糖苷、木通苯乙醇苷B)、280 nm(黄芩苷、黄芩素、汉黄芩素)和295 nm(苦参醇Ⅰ、苦参酮和槐属二氢黄酮G)。以黄芩苷为内参物,建立其他9种成分的相对校正因子,计算各成分含量。结果大车前苷、毛蕊花糖苷、异毛蕊花糖苷、木通苯乙醇苷B、黄芩苷、黄芩素、汉黄芩素、苦参醇Ⅰ、苦参酮和槐属二氢黄酮G分别在2.110~84.40 mg·L^(-1)(r=0.9994)、7.730~309.2 mg·L^(-1)(r=0.9998)、1.570~62.80 mg·L^(-1)(r=0.9996)、0.4300~17.20 mg·L^(-1)(r=0.9993)、24.64~985.6 mg·L^(-1)(r=0.9997)、3.460~138.4 mg·L^(-1)(r=0.9994)、1.230~49.20 mg·L^(-1)(r=0.9993)、3.709~151.6 mg·L^(-1)(r=0.9999)、14.53~581.2 mg·L^(-1)(r=0.9994)和5.410~216.4 mg·L^(-1)(r=0.9991)范围内线性关系良好。平均加样回收率(RSD)分别为98.42%(1.5%)、100.1%(0.82%)、97.92%(1.1%)、96.87%(1.2%)、100.1%(0.62%)、98.90%(0.81%)、97.96%(1.3%)、99.19%(0.90%)、99.58%(0.57%)和99.01%(1.4%)。复方苦参肠炎康片中大车前苷、毛蕊花糖苷、异毛蕊花糖苷、木通苯乙醇苷B、黄芩苷、黄芩素、汉黄芩素、苦参醇Ⅰ、苦参酮和槐属二氢黄酮G含量一测多评法计算结果与外标法实测值无明显差异。结论所建立的一测多评法可作为复方苦参肠炎康片多指标成分质量控制方法。Objective To develop an high performance liquid chromatography-quantitative analysis of multi-components by single marke(HPLC-QAMS)method for simultaneous determination of plantamajoside,verbascoside,isoacteoside,calceolarioside B,baicalin,baicalein,wogonin,kushenol I,kurarinone and sophoraflavanone G in Fufang Kushen Changyankang Tablets.Methods The chromatographic separation was carried out on Agilent Zorbax SB C_(18)(250 mm×4.6 mm,5μm)column with a mobile phase consisting of acetonitrile-0.1%formic acid solution in a gradient mode at a flow rate of 1.0 mL·min^(-1) and the column temperature was set at 30℃.The detection wavelength was set at 330 nm for plantamajoside,verbascoside,isoacteoside and calceolarioside B,280 nm for baicalin,baicalein and wogonin,and 295 nm for kushenol I,kurarinone and sophoraflavanone G.Baicalin was used as an internal standard,the relative correction factors(RCF)of the other nine constituents were calculated,and the content of each component was determined.Results Plantamajoside,verbascoside,isoacteoside,calceolarioside B,baicalin,baicalein,wogonin,kushenol I,kurarinone and sophoraflavanone G showed good linear relationships within the ranges of 2.110-84.40 mg·L^(-1)(r=0.9994),7.730-309.2 mg·L^(-1)(r=0.9998),1.570-62.80 mg·L^(-1)(r=0.9996),0.4300-17.20 mg·L^(-1)(r=0.9993),24.64-985.6 mg·L^(-1)(r=0.9997),3.460-138.4 mg·L^(-1)(r=0.9994),1.230-49.20 mg·L^(-1)(r=0.9993),3.790-151.6 mg·L^(-1)(r=0.9999),14.53-581.2 mg·L^(-1)(r=0.9994)and 5.410-216.4 mg·L^(-1)(r=0.9991),whose average recoveries(RSDs)were 98.42%(1.5%),100.1%(0.82%),97.92%(1.1%),96.87%(1.2%),100.1%(0.62%),98.90%(0.81%),97.96%(1.3%),99.19%(0.90%),99.58%(0.57%)and 99.01%(1.4%),respectively.There was no significant difference between the calculation values by HPLC-QAMS method and measured values by external standard method(ESM)of plantamajoside,verbascoside,isoacteoside,calceolarioside B,baicalin,baicalein,wogonin,kushenol I,kurarinone and sophoraflavanone G in Fufang Kushen Changyankang Tablets.Conclusion The es

关 键 词：复方苦参肠炎康片 大车前苷 毛蕊花糖苷 异毛蕊花糖苷 木通苯乙醇苷B 黄芩苷 黄芩素 汉黄芩素 苦参醇Ⅰ 苦参酮 槐属二氢黄酮G 

分 类 号：R917[医药卫生—药物分析学]