Optimization of Quality Standards for Polygalae Radix Based on Characteristic Chromatograms and QAMS for Xanthones
10.13422/j.cnki.syfjx.20260166
- VernacularTitle:基于特征图谱及𠮿酮类成分一测多评的远志质量标准优化
- Author:
Humin XIE
1
;
Xiaoqing CUI
1
;
Weihong FENG
1
;
Yu LU
2
;
Xiaoqian LIU
1
;
Xiaoli SUN
2
;
Yanrong LI
3
;
Zhimin WANG
1
;
Chun LI
1
Author Information
1. National Engineering Laboratory for Quality Control Technology of Chinese Materia Medica， Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. School of Biomedicine，Beijing City University，Beijing 100094，China
3. Yulin No.5 Hospital，Yulin 719000，China
- Publication Type:Journal Article
- Keywords:
Polygalae Radix;
quality standards;
high performance liquid chromatography（HPLC）;
quantification;
characteristic chromatograms;
quantitative analysis of multi-components by single marker（QAMS）;
xanthones
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(9):196-204
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo address the limitations of the current quality standard for Polygalae Radix（PR）， which relies on a single component for quality assessment and struggles to holistically control its intrinsic quality， by constructing a comprehensive quality evaluation system integrating "macro-characterization of chemical profile， synchronous quantification of multiple index components， and quantitative analysis of multi-components by single marker（QAMS） for key component groups". This study aims to facilitate the scientific revision of the quality standard for PR. MethodsHigh performance liquid chromatography（HPLC） characteristic chromatograms were established for 11 batches of PR medicinal materials（YZ）， 10 batches of PR decoction pieces（YP）， and 10 batches of licorice-processed PR decoction pieces（ZYZ）， followed by similarity evaluation and identification of common peaks. HPLC-QAMS was developed for xanthones（sibiricaxanthone B， polygalaxanthone Ⅺ， polygalaxanthone Ⅲ） in the characteristic chromatograms. Simultaneously， the external standard method（ESM） was used to determine the contents of the corresponding xanthones and 3，6'-disinapoyl sucrose in YZ， YP， and ZYZ， followed by multivariate statistical analysis and Spearman correlation analysis. ResultsThe similarity between the characteristic chromatograms of 31 batches of PR samples and the reference chromatogram was>0.9. A total of 13 common peaks were identified， and 10 of these peaks were characterized through reference standard comparison. The successfully constructed QAMS method showed that the relative correction factors（RCFs） of sibiricaxanthone B and polygalaxanthone Ⅺ to polygalaxanthone Ⅲ were 0.76 and 0.88， and their relative retention times（RRTs） were 0.85 and 0.97， respectively. The results calculated by the QAMS method showed no significant difference from those obtained by the ESM. According to the limit standard for polygalaxanthone Ⅲ in the 2020 edition of the Pharmacopoeia of the People's Republic of China（hereinafter referred to as the Chinese Pharmacopoeia）， the pass rate of 31 batches of samples was only 19.35%. Multivariate statistical analysis indicated certain compositional differences between different batches of YZ and YP， as well as between YP and ZYZ， with 3，6'-disinapoyl sucrose identified as the main differentiating component. Furthermore， correlation analysis revealed that the content of polygalaxanthone Ⅲ was positively correlated with the contents of sibiricaxanthone B and polygalaxanthone Ⅺ， but showed no association with the content of 3，6'-disinapoyl sucrose. ConclusionIt is recommended that the content limit for polygalaxanthone Ⅲ in YZ，YP and ZYZ be revised to not less than 0.07%， or the total content of polygalaxanthone Ⅲ， sibiricaxanthone B and polygalaxanthone Ⅺ be not less than 0.18%. The newly established triple quality control model of "holistic control via characteristic chromatograms， precise quantification of oligosaccharide esters， and efficient detection of xanthones by QAMS" provides a systematic and precise solution for quality evaluation of PR and similar Chinese herbal medicines.
