一测多评法同时测定祛痰止咳颗粒中7种成分的含量  

Simultaneous determination of seven components in Qutan Zhike granules by QAMS

作　　者：陈家仪[1] 栗建明[1] 顾利红[1] 侯惠婵[1] 李镜友 CHEN Jia-yi;LI Jian-ming;GU Li-hong;HOU Hui-chan;LI Jing-you(NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Guangzhou Institute for Drug Control,Guangzhou 510160,China;Guangzhou Huacheng Pharmaceutical Company Limited,Guangzhou 510555,China)

机构地区：[1]广州市药品检验所,国家药品监督管理局中成药质量评价重点实验室,广东广州510160 [2]广州花城药业有限公司,广东广州510555

出　　处：《药学学报》2022年第11期3405-3410,共6页Acta Pharmaceutica Sinica

基　　金：国家药典委员会2021年国家药品标准提高(2021Z031)。

摘　　要：建立同时测定祛痰止咳颗粒中芹菜素-7-葡萄糖醛酸、槲皮苷、芫根苷、木犀草素、芹菜素、羟基芫花素、芫花素7种成分含量的一测多评法。采用Agilent EC-C18(150 mm×4.6 mm,4μm)色谱柱,以甲醇-0.15%磷酸(梯度洗脱)为流动相,检测波长为338 nm,以芹菜素为内参物,分别建立6种成分的相对校正因子,并采用两点校正法结合相对保留时间法对各成分进行色谱峰定位。分别按一测多评法和外标法检测7种成分的含量,并进行比较。上述6种成分的相对校正因子分别为芹菜素-7-葡萄糖醛酸1.7628、槲皮苷2.3104、芫根苷1.8984、木犀草素1.2828、羟基芫花素1.1913、芫花素1.0669,在不同色谱条件下其相对校正因子的RSD均小于3%。采用两点校正法结合相对保留时间法能准确定位各成分色谱峰,预测保留时间与实际保留时间非常接近。10批样品一测多评计算结果与外标法测定结果之间的相对误差在-5%~5%。一测多评法操作简便,经济实用,结果准确,可应用于祛痰止咳颗粒中7个成分的含量测定。We have established a quantitative analysis of multi-components by single marker method(QAMS)for the simultaneous determination of apigenin-7-glucuronide,quercitrin,yuankanin,luteolin,apigenin,hydroxygenkwanin,and genkwanin in Qutan Zhike Granules.The chromatographic column used was an Agilent EC-C18(150 mm×4.6 mm,4μm),the mobile phase was methanol-0.15% phosphoric acid solution(gradient elution),and the detection wavelength was 338 nm.Apigenin was chosen as the internal reference standard,the relative correction factors for the six components were determined by multi-point correction method and included apigenin-7-glucuronide,quercitrin,yuankanin,luteolin,hydroxygenkwanin and genkwanin.According to the two-point correction method combined with the relative retention time correction of the components to be tested,the peak location was determined.The contents of these seven compounds in 10 batches of Qutan Zhike Granules samples were determined with relative correction factors,and the relative error(RE)was used to compare the results to that of the external standard using the External Standard Method to verify the accuracy of QAMS.The relative correction factors for apigenin-7-glucuronide,quercitrin,yuankanin,luteolin,hydroxygenkwanin and genkwanin were 1.7628,2.3104,1.8984,1.2828,1.1913 and 1.0669,respectively.RSDs of the relative correction factors were all lower than 3%.The peaks for each constituent were accurately located by the two-point correction method combined with relative retention time correction,and the predicted retention time was close to the actual retention time.The relative error of the contents by QAMS and determined by ESM in 10 batches of Qutan Zhike Granules were between -5% and 5%.This content determination method can be used for the simultaneous determination of seven components in Qutan Zhike Granules.

关 键 词：祛痰止咳颗粒 相对校正因子 一测多评 外标法 两点校正法 

分 类 号：R917[医药卫生—药物分析学]