基于HPLC-QAMS法多指标成分定量控制及化学计量学的复方止咳胶囊质量控制研究  

Research on quality control of Fufang Zhike capsules based on quantitative control and stoichiometry of HPLC-QAMS method

作　　者：王连兰 黄灿 郑晓敏 WANG Lian-lan;HUANG Can;ZHENG Xiao-min(Center for Research and Development,Jimin Health Management Co.,Ltd,Taizhou 318020,China;Zhejiang University School of Medicine,Hangzhou 310011,China)

机构地区：[1]济民健康管理股份有限公司研发中心,浙江台州318020 [2]浙江大学医学院,浙江杭州310011

出　　处：《中国药物应用与监测》2023年第1期10-14,共5页Chinese Journal of Drug Application and Monitoring

基　　金：浙江省医药卫生科研基金项目(2017KY320)。

摘　　要：目的:建立高效液相色谱一测多评(HPLC-QAMS)法同时检测复方止咳胶囊中10种成分的含量,并结合化学计量学方法构建其质量控制体系。方法:采用高效液相色谱法同时检测复方止咳胶囊中去芹糖桔梗皂苷E、桔梗皂苷E、桔梗皂苷D、连翘酯苷B、连翘酯苷A、连翘苷、牛蒡子苷元、桑皮苷A、桑辛素M和二氢桑色素;采用化学计量学方法挖掘不同批次产品间对质量控制具有显著贡献的主要成分。结果:10种成分分别在各自范围内线性关系良好(r>0.999);平均加样回收率在96.91%~100.11%之间(RSD<1.80%);QAMS法与外标法(ESM)结果无差异;挖掘出连翘苷、桔梗皂苷D、连翘酯苷A、去芹糖桔梗皂苷E和桑皮苷A是影响其产品质量的差异性标志物。结论:本研究所建立的方法及化学计量学模式专属性强,可用于复方止咳胶囊的质量控制和综合评价。Objective:To establish a high-performance liquid chromatography-quantitative analysis of multi-components by a single marker(HPLC-QAMS)method to simultaneously detect the content of 10 components in Fufang Zhike capsules,and the quality control system was constructed with stoichiometric method.Methods:The content of celery-free platycodon saponin E,platycodon saponin E,platycodon saponin D,forsythoside B,forsythoside A,forsythin,arctigenin,mulberroside A,moracin M,and dihydromorin in Fufang Zhike capsules were detected by HPLC.And the main components from different batches which had significant contribution to the quality control were analyzed based on stoichiometric method.Results:10 components all showed good linear relationship in their respective range(r>0.999).The average recovery rate was 96.91%–100.11%(RSD<1.80%).There was no significant differences between the results of QAMS method and external standard method(ESM).Forsythin,platycodon saponin D,forsythoside A,celeryfree platycodon saponin E and mulberroside A were the differential markers for the quality of Fufang Zhike capsules.Conclusion:The established method and stoichiometric model were specific and suitable for the quality control and comprehensive evaluation of Fufang Zhike capsules.

关 键 词：复方止咳胶囊 高效液相色谱一测多评法 偏最小二乘法-判别分析 化学计量学 综合质量评价 

分 类 号：R917[医药卫生—药物分析学] R285.5[医药卫生—药学]