ABSTRACT
The quality control of traditional Chinese medicine provides the premise of its modernization and globalization. Currently, the dual quality control based on chemical benchmark and effect benchmark has been recognized domestically and internationally. Research efforts have lead to establishment of a series of effective quality control methods based on chemical components, medicinal properties, microscopic characteristics, material constituents and pharmacodynamic targets. In the study of quality control based on chemical benchmarks, fruitful results on fingerprints, DNA barcodes, and quality markers have been achieved. However, due to a variety of factors, such as growth period, origin, growth environment and preparation process of traditional Chinese medicine, the quality control of traditional Chinese medicine based on chemical benchmarks remains difficult to fully reflect the quality of traditional Chinese medicine. At present, there is still a dispute on how to accurately reflect the quality of traditional Chinese medicines based on chemical benchmarks. For example, the index components selected in the Chinese medicine quality standards are difficult to totally reflect all the components of Chinese medicine, and the relevance between the index components versus therapeutic effect is not yet clear. In view of the complex signal network by cascade reaction and crosstalk of multi-signaling pathways within an organism, and the coordinated regulation of multi-components and multi-targets of traditional Chinese medicine, there may be different components regulating the same signal network or situations where the amount of certain chemical components within a range is not sufficient to cause a change in the signal network. Therefore, the quality control of traditional Chinese medicine based on the effect benchmark may be a useful supplement to the quality standard of traditional Chinese medicine. This paper proposes a Q-biomarker research strategy based on the effect benchmark in order to provide a methodological reference for the quality control research of traditional Chinese medicine.
ABSTRACT
Quality marker (Q-marker) is one of the new directions in the research of quality control of Chinese materia medica. The Q-marker can be either quality chemomarker (Q-chemomarker) or quality biomarker (Q-biomarker). The establishment of a good Q-biomarker can improve the linkage of Chinese medicine quality control methods and standards with clinical safety and effectiveness, at the same time considering the operability of quality control. At present, the FDA of China and the United States have adopted biological evaluation methods as an important part of quality control of Chinese medicines and botanicals medicines. Many companies and researchers are also actively exploring and developing methods for the evaluation of quality of Chinese materia medica. This paper further enlarges and expands the methods and indicators of biological evaluation of Chinese materia medica, and summarizes and analyzes relevant research examples from the perspective of Q-biomarker. We hope that it would promote the richness and development of the theoretical system of Chinese medicine quality markers, so as to provide a reference to solve the practical problems for the quality control and evaluation of Chinese materia medica.