Xuan Zeng1, Yuying Zheng1, Yuling Liu1, Weiwei Su2. 1. Guangdong Engineering & Technology Research Center for Quality and Efficacy Reevaluation of Post-Market Traditional Chinese Medicine, Guangdong Provincial Key Laboratory of Plant Resources, School of Life Sciences, Sun Yat-sen University, 510275, Guangzhou, People's Republic of China. 2. Guangdong Engineering & Technology Research Center for Quality and Efficacy Reevaluation of Post-Market Traditional Chinese Medicine, Guangdong Provincial Key Laboratory of Plant Resources, School of Life Sciences, Sun Yat-sen University, 510275, Guangzhou, People's Republic of China. Electronic address: lsssww@126.com.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Fufang Danshen Tablet (FDT) is a traditional Chinese medicine (TCM) formula composed of three Chinese medicinal materials comprising Salviae Miltiorrhizar Radix et Rhizoma (Dan-Shen in Chinese), Notoginseng Radix et Rhizoma (San-Qi), and Borneolum Syntheticum (Bing-Pian). It has been documented to exert significant effects in promoting blood circulation and removing blood stasis, and become a frequently used formula in the treatment of cardiovascular and cerebrovascular diseases. AIM OF THE REVIEW: To systematically analyze and summarize the research findings concerning the chemical composition, quality control, pharmacokinetics, pharmacological properties, clinical applications, and toxicity of FDT, so as to point out some typical problems and provides opinions for future study. MATERIALS AND METHODS: Literatures involving FDT were collected from online scientific databases including China National Knowledge Infrastructure, WanFang Data, PubMed, Science Direct, Scopus, Web of Science, Springer Link, SciFinder, and Google Scholar up to March 2021. All eligible studies are analyzed and summarized in this review. RESULTS: This review summarizes reported results concerning the post-marketing quality and efficacy of FDT. Some problems are pointed out for FDT. Hereon we propose several directions for future study: (a) improvement of quality control based on exact overall chemical profiles, entire production process monitoring, and biopotency-associated multi-index content determination method; (b) clarification of functional mechanisms focused on pharmacokinetic profiles in human, interplay with gut microbiota, and integration of multi-omics technologies; (c) reconfirmation of clinical effectiveness and safety from large-scale clinical studies based on evidence-based medicine. CONCLUSIONS: FDT is a typical TCM formula in treating cardiovascular and cerebrovascular diseases, but there are also some troubles. Future studies should focus on the improvement of quality control, the clarification of functional mechanisms, as well as the reconfirmation of clinical effectiveness and safety.
ETHNOPHARMACOLOGICAL RELEVANCE: Fufang Danshen Tablet (FDT) is a traditional Chinese medicine (TCM) formula composed of three Chinese medicinal materials comprising Salviae Miltiorrhizar Radix et Rhizoma (Dan-Shen in Chinese), Notoginseng Radix et Rhizoma (San-Qi), and Borneolum Syntheticum (Bing-Pian). It has been documented to exert significant effects in promoting blood circulation and removing blood stasis, and become a frequently used formula in the treatment of cardiovascular and cerebrovascular diseases. AIM OF THE REVIEW: To systematically analyze and summarize the research findings concerning the chemical composition, quality control, pharmacokinetics, pharmacological properties, clinical applications, and toxicity of FDT, so as to point out some typical problems and provides opinions for future study. MATERIALS AND METHODS: Literatures involving FDT were collected from online scientific databases including China National Knowledge Infrastructure, WanFang Data, PubMed, Science Direct, Scopus, Web of Science, Springer Link, SciFinder, and Google Scholar up to March 2021. All eligible studies are analyzed and summarized in this review. RESULTS: This review summarizes reported results concerning the post-marketing quality and efficacy of FDT. Some problems are pointed out for FDT. Hereon we propose several directions for future study: (a) improvement of quality control based on exact overall chemical profiles, entire production process monitoring, and biopotency-associated multi-index content determination method; (b) clarification of functional mechanisms focused on pharmacokinetic profiles in human, interplay with gut microbiota, and integration of multi-omics technologies; (c) reconfirmation of clinical effectiveness and safety from large-scale clinical studies based on evidence-based medicine. CONCLUSIONS: FDT is a typical TCM formula in treating cardiovascular and cerebrovascular diseases, but there are also some troubles. Future studies should focus on the improvement of quality control, the clarification of functional mechanisms, as well as the reconfirmation of clinical effectiveness and safety.