Abstract
Safety, efficacy and quality control are the three key elements in the modernization and internationalization of traditional Chinese medicines (TCM). In this paper, we summarize and discuss the issues on the quality control and the research and development of evidence-based TCM. Establishing analytical methodologies and expanding the application of chemical markers are crucial for the quality control of TCM. Apart from the well-known organonepic technique for TCM au-thentication, various advanced analytical methodologies including DNA sequencing, and hyphenated chromatographic meth-ods have been used for the quantitative and qualitative analysis of the raw materials and products. As for new drug develop-ment, we focused on those TCMs that show promising effects on specific diseases or syndromes, including cardiovascular diseases, diabetes, irritable bowel syndrome, depression and menopausal syndrome. The strategies used for new drug devel-opment were either extensive evidence-based investigation of traditional formulas that are based on traditional Chinese medi-cal theory, or lead compound discovery through high throughput screening. Both clinical trials of randomized, double-blind and placebo-controlled studies, and pharmacological and toxicological studies with molecular, celluar, organ and animal mod-els were conducted. Factors which hinder the progress of quality control and new drug development are also addressed and discussed. In this review, 74 references published by the authors and collaborators over the past three years, were cited.
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