摘要
目的:建立HPLC指纹图谱和多指标成分含量测定的方法,同时采用聚类分析(CA)及主成分分析(PCA)等化学计量学方法对其进行质量评价研究。方法:利用中药色谱指纹图谱相似度评价系统(2012.A版)建立金叶败毒颗粒HPLC指纹图谱并进行相似度评价,共标定22个共有峰,通过对照品比对指认8个共有峰,分别为绿原酸、咖啡酸、木犀草苷、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸、槲皮素、菊苣酸、靛玉红,并同时测定8个共有峰的含量。基于8个成分含量测定结果,采用CA、PCA及正交偏最小二乘判别分析(OPLS-DA)等化学计量学方法对15批金叶败毒颗粒进行质量评价。结果:15批金叶败毒颗粒的HPLC指纹图谱相似度均>0.98,8个共有峰含量测定结果分别为2.456~2.123、1.635~1.401、0.966~0.828、0.654~0.518、0.469~0.278、0.789~0.605、1.362~0.903、0.551~0.433 mg·g^(-1),线性关系良好(r≥0.9994),平均回收率分别为99.3%、98.3%、98.6%、98.9%、98.3%、98.6%、98.8%、99.1%,RSD均≤2.0%;该方法的精密度、稳定性、重复性均较好。CA和PCA结果表明15批样品按生产年份分为3类。通过OPLS-DA分析得出区分各类样品的强特征峰为菊苣酸、绿原酸和咖啡酸。结论:该方法准确可靠,可用于金叶败毒颗粒的质量控制和综合评价。
Objective:To establish an HPLC characteristic chromatogram of Jinye Baidu granules and determine the active principle ingredients.Meanwhile,chemometrics methods such as cluster analysis(CA) and principal component analysis(PCA) were used for comprehensive evaluation of Jinye Baidu granules.Methods:The fingerprint of Jinye Baidu granules was established by HPLC.Twenty-two common peaks were confirmed and eight of them were identified as chlorogenic acid,caffeic acid,luteolin-7-O-glucoside,3,5-O-dicaffeoylquinic acid,4,5-dicaffeoylquinic acid,quercetin,chicoric acid,and indirabin by comparison with referencesubstances,and their contents in samples were simultaneously determined.The chemometrics methods such as CA,PCA and orthogonal partial least squares discriminant analysis(OPLS-DA) were used to evaluate the quality of 15 batches of Jinye Baidu granules based on the results of fingerprint and content determination.Results:The similarity of 15 batches of Jinye Baidu granules were all above 0.98.The contents of the above mentioned eight components in 15 batches of Jinye Baidu granules were 2.456-2.123,1.635-1.401,0.966-0.828,0.654-0.518,0.469-0.278,0.789-0.605,1.362-0.903,0.551-0.433 mg·g^(-1),respectively.The linearity was good(r≥0.999 4) and the average recoveries were 99.3%,98.3%,98.6%,98.9%,98.3%,98.6%,98.8% and 99.1%,respectively with RSDs less than 2.0%.Precision,stability and reproducibility of the method were satisfactory.CA and PCA showed that 15 batches of Jinye Baidu granules were clearly divided into three categories,significant characteristic peaks for discrimination of different samples were chicoric acid,chlorogenic acid and caffeic acid.Conclusion:The method is accurate and reliable,and it can be used to control and comprehensively evaluate the quality of Jinye Baidu granules.
作者
苏若
阮健
李桂女
SU Ruo;RUAN Jian;LI Gui-nü(The Second Affiliated Hospital of Hainan Medical University,The Department of Pharmacy,Haikou 570102,China;Yantai Center for Food and Drug Control and Test,Yantai 264670,China;The First Affiliated Hospital of Hainan Medical University,The Department of Pharmacy,Haikou 570100,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2022年第8期1381-1390,共10页
Chinese Journal of Pharmaceutical Analysis
