一测多评法在肺宁口服液品质评价中的应用  

Application of quantitative analysis of multi-components by singlemarker method in quality evaluation of feining oral liquid

作　　者：徐云 于艳辉 牟荣 王宝成 苏小红 肖俊美 徐建 XU Yun;YU Yan-hui;MU Rong;WANG Bao-cheng;SU Xiao-hong;XIAO Jun-mei;XU Jian(Jilin xiuzheng Pharmaceutical New Drug Development Co.,Ltd.,key engineering technology laboratory of standardization of traditional Chinese medicine,Changchun,Jilin,130103,China;Jilin Provincial Center for drug evaluation,Changchun,130000,China;Tongyao Pharmaceutical Group Co.,Ltd.,Tonghua,134000,China)

机构地区：[1]吉林修正药业新药开发有限公司,吉林省中药标准化关键工程技术重点实验室,长春130103 [2]吉林省药品审评中心,长春130000 [3]通药制药集团股份有限公司,通化134000

出　　处：《人参研究》2020年第6期38-41,共4页Ginseng Research

基　　金：吉林省科技厅项目,项目编号:YYZX201810。

摘　　要：目的建立一种同时测定肺宁口服液中新绿原酸、绿原酸、隐绿原酸含量的一测多评方法。方法采用高效液相色谱法色谱柱,乙腈-0.2%甲酸水溶液为流动相,梯度洗脱,流速0.8ml/min,柱温为35℃。结果以绿原酸为参照物,测定新绿原酸、隐绿原酸的相对校正因子分别为f绿/新=1.268、f绿/隐=1.220;并采用一测多评法(QAMS)与外标法同时测定11批样品进行对比研究,外标法与一测多评法测得的新绿原酸P值为0.893,隐绿原酸的P值为0.926,P>0.05,说明两种方法之间无显著性差异。进一步验证一测多评法用于新绿原酸、绿原酸、隐绿原酸的测定结果的准确性。结论将一测多评法应用于产品的品质评价中,方法简便、准确、可行,也为其他肺宁制剂的品质评价方法建立提供依据。Objective To establish a method for simultaneous determination of neochlorogenic acid,chlorogenic acid and cryptochlorogenic acid in feining oral liquid.Method High-performance Liquid Chromatography,C18 column,acetonitrile-0.2%formic acid solution as mobile phase,gradient elution,the flow rate was 0.8 ml/min,the column temperature was 35℃.Results The relative correction factors of chlorogenic acid and cryptochlorogenic acid were1.268 and 1.220,respectively,and 11 samples were determined simultaneously by the quantitative analysis of multi-components by single marker(QAMS)and external standard method,the P values of neochlorogenic acid and cryptochlorogenic acid were 0.893 and 0.926,P>0.05,which showed that there was no significant difference between the two methods.The accuracy of the multi-evaluation method for the determination of neochlorogenic acid,chlorogenic acid and cryptochlorogenic acid was further verified.Conclusion The method is simple,accurate and feasible,and can be used to evaluate the quality of other feining preparations.

关 键 词：一测多评 品质评价 肺宁 含量测定 

分 类 号：R286.0[医药卫生—中药学]