Research on quality marker (Q-Marker) of Chinese materia medica: Quality evaluation and quality standards of Rhizoma Corydalis

ZHANG Tie-jun1 XU Jun1 HAN Yan-qi1 ZHANG Hong-bing2 GONG Su-xiao1 LIU Chang-xiao3

(1.Modern Research Department of Chinese Materia Medica, Tianjin Institute of Pharmaceutical Research, Tianjin, China 300193)
(2.Tianjin University of Traditional Chinese Medicine, Tianjin, China 300193)
(3.Center for New Drug Evaluation and Research, Tianjin Institute of Pharmaceutical Research, Tianjin, China 300193)

【Abstract】Rhizoma Corydalis was taken as an example for demonstration research based on the concept of quality markers (Q-Markers), confirmed standards and research modes were proposed by the author. The chemical constituents of were identified using high performance liquid chromatography/electrospray ionization quadruple time-of-flight mass spectrometry (HPLC/ESI-Q-TOF MS). The source and specificity of chemical constituents were confirmed by analyzing biosynthetic pathway and component specificity. The major effective components were clarified through efficacy, drug property, pharmacokinetic studies, and correlation analysis of chemical constituents. The Q-markers were determined by integrating all the results of the studies. At last, seven alkaloidal compounds including tetrahydropalmatine, corydaline, coptisine, palmatine, dehydrocorydaline, tetrahydrojatrorrhizine, and protopine have been selected as Q-markers and quality control methods of multi-components assaying and fingerprint have been established.

【Keywords】 Rhizoma Corydalis; quality markers; biosynthesis pathway; specificity; drug efficacy; quality control;


【Funds】 Key Program of the National Natural Science Foundation of China (81430096)

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This Article



Vol 47, No. 09, Pages 1458-1467

May 2016


Article Outline


  • 1 Principle of determining Q-Markers of Chinese materia medica and its significance for quality control
  • 2 Discovery and determination of Q-Markers of Rhizoma Corydalis
  • 3 Establishment of quality standard of Rhizoma Corydalis
  • 4 Conclusion and discussions
  • References