Li Yan, Fu Kang-Ning, Wang Shuai, Yang Li, Wang Zheng-Tao, Wang Rui, Shi Yan-Hong
School of Pharmacy, Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
the MOE Key Laboratory of Standardization of Chinese Medicines, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
Zhongguo Zhong Yao Za Zhi. 2024 Dec;49(24):6699-6712. doi: 10.19540/j.cnki.cjcmm.20240910.201.
This study aims to establish a quality grading standard that combines the conventional quality evaluation based on morphological characteristics of traditional Chinese medicine with the modern quality evaluation. Based on the existing standards and market circulation of Isatidis Radix, the diameter and color of Isatidis Radix decoction pieces were selected as the appearance traits for preliminary grading. The effects of internal quality indexes such as moisture, total ash, acid-insoluble ash, ethanol-soluble extractives, and 9 water-soluble components on different grades of decoction pieces were comprehensively compared, and the key grading indexes were determined by t-test. The relevance between appearance traits and the internal quality indexes was investigated by multi-dimensional statistical analyses such as correlation analysis, principal component analysis(PCA), orthogonal partial least squares-discriminant analysis(OPLS-DA), and hierarchical cluster analysis(HCA). Furthermore, the fluorescent substrate was employed to investigate the inhibitory effects of different grades of Isatidis Radix decoction pieces on the neuraminidase of influenza virus. The rationality of the selected grading index components was verified by network pharmacology. The results showed that the diameter of decoction pieces had significantly positive correlations with other index components except moisture. Considering the existing commodity specifications, grading standards, and actual market circulation of Isatidis Radix, the quality grading standard of Isatidis Radix decoction pieces was developed with diameter as the appearance trait and(R,S)-goitrin as the limit index component of being qualified. On this basis, the content of ethanol-soluble extractives, total sinigrin, and total nucleoside were selected for quality grading. The in vitro enzyme activity evaluation showed that the first grade of Isatidis Radix decoction pieces had stronger inhibitory effect on the neuraminidase of influenza virus, and the network pharmacology results showed that the selected index components for quality grading had significant correlations with influenza. This study established a quality grading standard combining appearance traits and internal quality indexes, which provides a scientific basis for improving the existing grading standards and the price and quality of Isatidis Radix decoction pieces.
本研究旨在建立一种将基于中药形态特征的传统质量评价与现代质量评价相结合的质量分级标准。基于板蓝根的现有标准和市场流通情况，选取板蓝根饮片的直径和颜色作为外观性状进行初步分级。综合比较水分、总灰分、酸不溶性灰分、醇溶性浸出物和9种水溶性成分等内在质量指标对不同等级饮片的影响，通过t检验确定关键分级指标。采用相关性分析、主成分分析（PCA）、正交偏最小二乘法判别分析（OPLS - DA）和层次聚类分析（HCA）等多维统计分析方法研究外观性状与内在质量指标之间的相关性。此外，采用荧光底物研究不同等级板蓝根饮片对流感病毒神经氨酸酶的抑制作用。通过网络药理学验证所选分级指标成分的合理性。结果表明，饮片直径与除水分外的其他指标成分呈显著正相关。综合考虑板蓝根的现有商品规格、分级标准及实际市场流通情况，制定了以直径为外观性状、（R，S）-异硫氰酸烯丙酯为合格限指标成分的板蓝根饮片质量分级标准。在此基础上，选取醇溶性浸出物、总芥子苷和总核苷含量进行质量分级。体外酶活性评价表明，一级板蓝根饮片对流感病毒神经氨酸酶的抑制作用较强，网络药理学结果表明所选质量分级指标成分与流感具有显著相关性。本研究建立了外观性状与内在质量指标相结合的质量分级标准，为完善现有分级标准及提高板蓝根饮片价格和质量提供了科学依据。
