Quality Evaluation and Suggestions on Pharmacopoeia Standard of Eucommiae Folium
10.13422/j.cnki.syfjx.20220157
- VernacularTitle:杜仲叶质量评价和药典标准建议
- Author:
Ping WANG
1
;
Shaojia LIANG
2
;
Wenwen ZHANG
3
;
Weihong FENG
3
;
Hong YI
3
;
Chun LI
3
;
Fengqian GUO
3
;
Qin SI
3
;
Dejing FU
3
;
Man GONG
1
;
Zhengtao WANG
4
;
Hongchu ZHENG
2
;
Xiaoqian LIU
3
;
Zhimin WANG
1
Author Information
1. Henan University of Chinese Medicine，Zhengzhou 450008，China
2. Yanling DU Renkang Biotechnology Co. Ltd.，Xuchang 461000，China
3. Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences，Beijing 100700，China
4. Institute of Traditional Chinese Medicine（TCM），Shanghai University of TCM，Shanghai 201203，China
- Publication Type:Journal Article
- Keywords:
Eucommiae Folium;
quantitative analysis multi-components by single marker method （QAMS）;
aucubin;
geniposidic acid;
chlorogenic acid;
relative correction factor;
quality standard
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(2):10-17
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish a quantitative analysis multi-components by single marker method （QAMS） for five main components （aucubin， geniposidic acid， chlorogenic acid， asperuloside and rutin） in Eucommiae Folium， to verify its feasibility and applicability in the determination of Eucommiae Folium， so as to provide a scientific basis for the development of quality standard of this herb. MethodHigh performance liquid chromatography was performed on a Welch Boltmatetm™ C18 column （4.6 mm×100 mm， 2.7 μm） with methanol （A）-0.2% phosphoric acid aqueous solution （B） as the mobile phase for gradient elution （0-8 min， 3%A； 8-10 min， 3%-11%A； 10-26 min， 11%A； 26-27 min， 11%-25%A； 27-60 min， 25%-32%A）， the column temperature was set at 30 ℃， the flow rate was 0.6 mL·min-1， the detection wavelengths were at 210 nm and 254 nm. Chlorogenic acid was used as an internal reference to establish the relative correction factors （f） between it and the other four components， and the contents of the five components in 14 batches of Eucommiae Folium were determined by QAMS and external standard method （ESM）， respectively. ResultThe f values of chlorogenic acid to aucubin， geniposidic acid， asperuloside and rutin were 3.13， 1.45， 2.64 and 0.56， respectively. Repeatability was good under different experimental conditions， relative standard deviation （RSD） was <5.0%. The contents of aucubin， geniposidic acid， chlorogenic acid， asperuloside and rutin in 14 batches of Eucommiae Folium were 1.340-28.975， 0.252-36.086， 10.016-27.443， 1.396-8.646， 0.533-1.766 mg·g-1， respectively. There were no significant difference between content results of QAMS and that of ESM （RSD<5.0%）. ConclusionQAMS established with chlorogenic acid as the internal reference can be used to determine the contents of five components in Eucommiae Folium， and this method is simple and accurate. After comprehensive evaluation， the quality standard of Eucommiae Folium in subsequent editions of Chinese Pharmacopoeia is suggested that three main active components， chlorogenic acid， aucubin and geniposidic acid， are selected as quality markers， and their content limits are recommended not less than 1.5%， 1.0% and 1.0%， respectively. This quality standard draft can avoid the potential quality risk due to poor specificity and low content limit of the index component （chlorogenic acid） in the previous editions of Chinese Pharmacopoeia.
