Challenges in research and development of Traditional Chinese Medicines

Abstract

Abstract: In this review, the author analyzed the challenges in modern research and development of Traditional Chinese Medicine (TCM) products.Chinese traditional and herb drugs have gained interest from the international medical, biomedical and pharmaceutical institutions as potential source of valuable medicinal agents.For the researches and development of TCMs, the first challenge is to evaluate the efficacy, pharmacological properties, action mechanism and active chemical constituents. The second one is to summarize the issues for developing safety research methodologies, to improve the quality and enhance the value of research in TCM and to provide appropriate evaluation methods to facilitate the regulation and registration of TCM products, and the third is to study drug metabolism and pharmacokinetics, and the fourth is to apply new “-omics” techniques and tools in new revolution in drug discovery-development and to impact on modern research of TCM products.This interest is needed to apply modern research on the development and exploration of the promising medical potential resources of Chinese traditional and herbal drugs, especially from medicinal plants.

Key words: Traditional Chinese Medicine, challenge, research, development, efficacy, safety, new technique

LIU Chang-xiao, SI Duan-yun, XIE Hai-tang. Challenges in research and development of Traditional Chinese Medicines[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2007, 12(10): 1122-1129.

References

1 Di Masi JA, Paquette C.The economics of follow-on drug research and development trends in entry rates and the timing of development[J].Pharmacoeconomics, 2004;22:1-14.
2 Mrnh LH, Zhang JS, Ding J.Salvicine, a novel DNA topoisomerase II inhibitor, exerting its effects by trapping enzyme-DNA cleavage complexes[J].Biochem Pharmacol, 2001;62: 733-741.
3 Meng LH, Zhang JS, Ding J.DNA topoisomerase II as the primary cellular target for salvicine in Saccharomyces cerevisiae [J].Acta Pharmacol, 2001;22:741-746.
4 Qing C, Zhang JS, Ding J, et al. Cytotoxicity of salvicine, a novel diterpenoid quinine[J].Acta Pharmacol Sin, 1999;20: 297-302.
5 Zhang JS, Ding J, Tang Q, et al. Snthesis and antitumor activity of novel diterpenequinone salvicine and the analogs[J]. Bioorg Med Chem Lett, 1999;9:27311-2736.
6 Qing C, Jing C, Zhang JS, et al. Induction of apoptosis in human leukemia K-562 and gastric cancenoma SGC-7901 cells by salvicine, a novel anticancer compound[J].Anticancer Drugs, 2001;12:51-56.
7 Meng LH, Ding J.Induction of bulk and c-mys P2 promoterspecific DNA damage by an anti-topoisomerase II against salvicine is an early event leading to apoptosis in HL-60 cells [J].Federation of European Biochermical Societies Letter, 2001;501:59-64.
8 Liu CX, Xiao PG.Recalling the research and development of new drugs from traditional Chinese medicine[J].Asian J Drug Metab Pharmacokinet, 2002;2:136-156.
9 Zhu DY, Tang XC, Lin C, et al. Huperzine, a derivative, their preparation and their Use[P].US Ptent 5929084 07/27/1999.
10 Zhu DY, Tang XC, Lin C, et al. Huperzine, a derivative, their preparation and their Use [P]. Chinese Patent 95196884X, 0510/2000.
11 Anonymous, ZT-1, a new treatmint for Alzheimer' s disease [EB OL].http://www.debiopharm.com.2004.
12 Xu RS, Zhao WM.New drug research on basis of active compounds in traditional Chinese medicines[J].Chin J Natur Med, 2005;3:322-327.
13 Li C, Du FF, Chen Y, et al. A sensitive method for the determination of the novel chloliesterase inhibitor ZT-1 and its active metabolite huperzine A in rat blood suing liquid chromatography/tandem mass spectrometry[J].Rapid CommunMass Spectr, 2004;18:651-656
14 Wei GL, Xiao SH, Lu R, et al. Pharmacokinetics of ZT-1 in experimental animals[J].Drug Metabolism Reviews, 2006;37 (s2):329.
15 Wei GL, Xiao SH, Lu R, et al. Simultaneous determination of ZT-1 and its metabolite huperzine A in plasma by high-performance liquid chromatography with ultraviolet detection[J].J Chromatogar B, 2006;830:120-125.
16 Bhushan Patwardhan B.Ethnopharmacology and drug discovery [J].J Ethnopharmacol, 2005;100:50-52.
17 Wanger H.Trends and challenges in phytomedicine:Research in the New Millennium[A].In:Handbook of Medicinal Plants [M].New York:The Haworth Medical Press Inc, 2005:3-30.
18 Anonymous.WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine[S].World Health Organization, Geneva, Switzerland, 2000:74.
19 Cordell GA, ColvardMD.Some thoughts on the future of ethnopharmacology[J].J Ethnopharmacol, 2005;100:5-14.
20 Chow MSS, Yin OQP, Zuo Z, et al. Application of pharmacokinetics in the modernization of traditional Chinese medicine key issues and challenges[J].Asian J Drug Metab Pharmacokine, 2004;3:89-92.
21 Liu CX.Different and hot-points of studies on traditional Chinese medicines[J].Acta Pharm Sin, 2005;40:395-401.
22 Liu CX.The understanding drug metabolism and pharmacokinetics of traditional Chinese medicines[J].Asian J Drug Metab Pharmacokinet, 2005;5:25-36.
23 Fiehn O.Metabolomics-the link between genotypes and phenotypes[J].PlantMol Biol, 2002;48:155-171.
24 Fiehn O, Kopka J, Dormann P, et al. Metabolite profiling for plant functional genomics[J].Nat Biotechnol, 2000;18:1157-1161.
25 Verpoorte R, Choi YH, Kim HK.Ethnopharmacology and systems biology:A perfect holistic match[J].J Ethnopharmacol, 2005;100:53-56.
26 Liu CX.Application of metabonomics in drug discovery and development[A].In:He FC, ed.Post-gene-time:Drug Diascovery (Ed He FC) [M].Beijing:Military Medical Science Press, 2004:17-20.
27 Liu CX.Significance of metabonomics in modern research of Chinese traditional and herbal drugs[J].Zhong Cao Yao, 2004;35:601-605.
28 Wu XJ, Lin YP, Song NN, et al. Application of principal component analysis for data process in metabonomic studies[J]. Asian J Drug Metab Pharmacokinet, 2005;5:287-294.

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