芪蓉润肠口服液HPLC-QAMS多指标成分定量控制联合化学计量学的综合质量评价研究  

Comprehensive quality evaluation of Qirong Runchang oral liquid based on HPLC-QAMS quantitative control of multi-components and chemometrics analysis

作　　者：冯晓川[1] 徐延昭[2] 张静[1] 张蕊[1] Xiao-Chuan FENG;Yan-Zhao XU;Jing ZHANG;Rui ZHANG(Department of Chinese Pharmacy,Beijing Jishuitan Hospital,Beijing 100035,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]北京积水潭医院中药房,北京100035 [2]中国食品药品检定研究院,北京100050

出　　处：《药物流行病学杂志》2023年第4期404-416,共13页Chinese Journal of Pharmacoepidemiology

基　　金：北京市中医管理局第二批中药骨干人才培养项目(京中医科字[2018]213号)。

摘　　要：目的建立高效液相色谱一测多评法(HPLC-QAMS)多指标成分定量控制与化学计量学相结合的芪蓉润肠口服液综合质量评价方法。方法以毛蕊花糖苷为内参物,建立其与其他9种成分的相对校正因子,采用外标法和HPLC-QAMS法计算各成分含量并对检验结果进行对比,验证所建立的HPLC-QAMS法准确性和可行性,再运用化学计量学方法对HPLC-QAMS法检测结果进行聚类分析、主成分分析和偏最小二乘法-判别分析,建立芪蓉润肠口服液综合质量评价方法。结果芪蓉润肠口服液中10种定量控制指标成分线性关系良好(r>0.9990);平均加样回收率在96.92%~100.11%之间(RSD<2.0%);两种方法所测得各成分含量差异无统计学意义(P>0.05);聚类分析结果显示12批样品聚成3类;主成分分析和偏最小二乘法-判别分析显示松果菊苷、毛蕊异黄酮葡萄糖苷、白术内酯Ⅲ、管花苷A和毛蕊花糖苷是影响不同批次芪蓉润肠口服液样品差异性的主要标记物。结论所建立的HPLC-QAMS多指标成分定量控制联合化学计量的综合质量评价方法结果准确、重复性和稳定性好,可用于芪蓉润肠口服液的质量控制。Objective To establish a comprehensive quality evaluation method of Qirong Runchang oral liquid based on HPLC-QAMS quantitative control of multi-components and chemometrics analysis.Methods Verbascoside as the internal reference substance,the relative correction factor with other nine components was established.The contents of each component were calculated by external standard method and HPLC-QAMS method,and the test results were compared to verify the accuracy and feasibility of the established HPLC-QAMS method.The cluster analysis,principal component analysis and partial least squares-discriminant analysis of HPLC-QAMS test results were performed by chemometrics methods to establish the comprehensive quality evaluation method of Qirong Runchang oral liquid.Results There was a good linear relationship among the 10 quantitative control components in Qirong Runchang oral liquid(r>0.9990).The average recovery was 96.92%-100.11%(RSD<2.0%).There was no significant difference in the content between the two methods(P>0.05).The 12 batches of samples could be clustered into three categories by cluster analysis.The principal component analysis and partial least squares-discriminant analysis show that echinacoside,calycosin-7-O-β-D-glucopyranoside,atracylenolideⅢ,tubuloside A and verbascoside were the main markers affecting the difference of samples from different batches of Qirong Runchang oral liquid.Conclusion The comprehensive quality evaluation method of HPLC-QAMS quantitative control of multi-components combined with chemometrics is accurate,repeatability and stability,which can be used for the quality control of Qirong Runchang oral liquid.

关 键 词：高效液相色谱一测多评法 芪蓉润肠口服液 相对校正因子 综合质量评价 化学计量学 多指标成分 定量控制 

分 类 号：R286.0[医药卫生—中药学]