Research strategy for quality-biomarkers of traditional Chinese medicine based on effect benchmarks / 药学学报

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.