摘要
目的:建立高效液相色谱一测多评(HPLC-QAMS)技术联合化学计量学评价脂必泰胶囊质量的方法。方法:采用HPLC法,以泽泻醇A为内参物,通过外标法建立其与牡荆素葡萄糖苷、牡荆素鼠李糖苷、齐墩果酸、熊果酸、白术内酯Ⅲ、白术内酯Ⅰ、24-乙酰泽泻醇A、23-乙酰泽泻醇B的相对校正因子(f),利用建立的f计算对应的8个成分含量,比较实测值与计算值间的差异。采用化学计量学分析含量数据,评价其质量。结果:泽泻醇A与牡荆素葡萄糖苷、牡荆素鼠李糖苷、齐墩果酸、熊果酸、白术内酯Ⅲ、白术内酯Ⅰ、24-乙酰泽泻醇A、23-乙酰泽泻醇B的f值分别为1.0440、0.6331、0.8610、0.6917、1.2248、1.3727、1.5161和0.7682,同时重复性良好。13批脂必泰胶囊中9种成分经QAMS法与外标法测定,结果差异不明显。主成分分析结果显示13批样品聚为3类;脂必泰胶囊的主要质量差异因子为牡荆素鼠李糖苷、熊果酸、白术内酯Ⅲ、白术内酯Ⅰ和23-乙酰泽泻醇B。结论:所建立的方法可用于脂必泰胶囊质量的综合评价。
Objective:To establish a method for the quality evaluation of zhibitai capsules by high performance liquid chromatography-quantitative analysis of multi-components by single marker(HPLC-QAMS)combined with chemometrics.Methods:HPLC method was used to establish the relative correction factors(f)of alisol A with vitexin-4″-O-glucoside,rhamnosylvitexin,oleanolic acid,ursolic acid,atractylenolideⅢ,atracylenolideⅠ,alisol A 24-acetate and 23-acetate alisol B by external standard method with alisol A as the internal reference.The established f was used to calculate the contents of the corresponding eight components,and the differences between the measured values and the calculated values were compared.The content data were analyzed by chemometrics to evaluate its quality.Results:The f values of alisol A with vitexin-4″-O-glucoside,rhamnosylvitexin,oleanolic acid,ursolic acid,atractylenolideⅢ,atracylenolideⅠ,alisol A 24-acetate and 23-acetate alisol B were 1.0440,0.6331,0.8610,0.6917,1.2248,1.3727,1.5161 and 0.7682,respectively,and the repeatability was good.Nine components in 13 batches of zhibitai capsules were determined by QAMS method and external standard method,and the results were not significantly different.The results of principal component analysis showed that 13 batches of samples were clustered into 3 categories.The main quality difference factors of zhibitai capsule were rhamnosylvitexin,ursolic acid,atractylenolide III,atracylenolide I and 23-acetyl alisol B.Conclusion:The established method can be used for the comprehensive evaluation of the quality of zhibitai capsules.
作者
余万冰
张单丽
关素珍
王海燕
YU Wanbing;ZHANG Danli;GUAN Suzhen;WANG Haiyan(Department of Traditional Chinese Medicine Pharmacy,Nanyang Central Hospital,Nanyang 473000,China;School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China)
出处
《中国药品标准》
CAS
2024年第6期545-554,共10页
Drug Standards of China
基金
河南省高等学校重点科研指导计划项目(20B460010)。