TCM-based new drug discovery and development in China

WU Wan-Ying; HOU Jin-Jun; LONG Hua-Li; YANG Wen-Zhi; LIANG Jian; GUO De-An

Volume 12 Issue 4

Apr. 2014

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Article Navigation > Chinese Journal of Natural Medicines > 2014 > 12(4): 241-250

Citation:

TCM-based new drug discovery and development in China

Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China

Corresponding author:
Received Date: 13-Feb.-2014

Fund Project: This project was supported by the Twelfth Five-Year National Science and Technology Major Project(No.201409304-307-301).

Abstract

Over the past 30 years,China has significantly improved the drug development environment by establishing a series of policies for the regulation of new drug approval.The regulatory system for new drug evaluation and registration in China was gradually developed in accordance with international standards.The approval and registration of TCM in China became as strict as those of chemical drugs and biological products.In this review,TCM-based new drug discovery and development are introduced according to the TCM classification of nine categories.
- China,
- China Food and Drug Administration(CFDA),
- Traditional Chinese Medicine,
- Regulatory classification,
- Drug discovery,
- Drug development

References

[1]	Xue T,Roy R.Studying traditional Chinese medicine[J].Science,2003,300(5620):740-741.
[2]	State Council of the PRC.Drug Administrative Law[Z].Beijing,China,1985.
[3]	Ministry of Health of the PRC.Provisions for New Drug Approval[Z].Beijing,China,1985.
[4]	Deng RL,Kaitin K.The regulation and approval of new drugs in China[J].Drug Info,2004,(37):29-39.
[5]	SFDA.Provisions for Drug Registration[Z].(No.2).Beijing,China,1999.
[6]	Fan TP,Deal G,Koo HL,et al.Future development of global regulations of Chinese herbal products[J].J Ethnopharmacol,2012,140(3):568-586.
[7]	SFDA.Provisions for Drug Registration[Z].(No.28).Beijing,China,2007.
[8]	Miller LH SX.Artemisinin:discovery from the Chinese herbal garden[J].Cell,2011,146(6):855-859.
[9]	Pharmacopoeia of the People's Republic of China English edition(2010)[S].Vol.I.2010:1884.
[10]	Liu JM,Ni MY,Fan JF,et al.Artemisinin structures and reactions[J].Acta Chim Sin,1979,37:129-143.
[11]	Lin AJ,Klayman DL,Milhous WK.Antimalarial activity of new water-soluble dihydroartemisinin derivatives[J].J Med Chem,1987,30(11):2147-2150.
[12]	Deng RX.New progress in studies on antimalarial drugs in recent years in China[J].Chinese J Pharm,1989,20(8):372-375.
[13]	Bai DL.Traditional Chinese medicines and new drug development[J].Pure Appl Chem,1993,65(6):1103-1112.
[14]	Sun HD ML,Hu X C,et al.Ai-Ling I treated 32 cases of acute promyelocytic leukemia[J].Chin J Integr Tradit West Med,1992,12(3):170-171.
[15]	Chen GQ,Zhu J,Shi XG,et al.In vitro studies on cellular and molecular mechanisms of arsenic trioxide(As2O3) in the treatment of acute promyelocytic leukemia:As2O3 induces NB4 cell apoptosis with downregulation of Bcl-2 expression and modulation of PML-RAR alpha/PML proteins[J].Blood,1996,88(3):1052-1061.
[16]	Mervis J.Ancient remedy performs new tricks[J].Science,1996,273(2):578.
[17]	Liu G.From Schisandra research to the discovery of benzene diester[J].Acta Chim Sin,1983,18(9):714-720.
[18]	Anufriev VP,Malinovskaya GV,Denisenko VA,et al.Synthesis of ginsenoside Rg3,a minor constituent of Ginseng radix[J].Carbohydr Res,1997,304(2):179-182.
[19]	SunY,Lin H,Zhu YZ,et al.A randomized,prospective,multi-centre clinical trial of NP regimen(vinorelbine+cisplatin) plus Gensing Rg3 in the treatment of advanced non-small cell lung cancer patients[J].Chin J Lung Cancer,2006,9(3):254-258.
[20]	Liu J,Sun L,Zhao Y,et al.Clinical phase II study on immu noimprovement of patients with breast cancer treated by shenyi capsule[J].Chin J Clin Oncol,2000,27(7):534-536.
[21]	Sucher NJ.The application of Chinese medicine to novel drug discovery[J].Expert Opin Drug Discov,2013,8(1):21-34.
[22]	Guo LY,Li CY.Cordyceps kyushuensis new to China[J].Mycosystema,2000,19(02):296.
[23]	Li A.Establishment of Quality Standard and Fingerprint Chromatograph of Ipomoea batatas(L.) Lam.Simon No.1[D].Central South University.2010.
[24]	Ju FX.Pharmaceutical Research of Capsule of Mangjishi[D].Jilin University.2012.
[25]	Chen ZA,Liu GY,Hu SY.Studies on cultivation of Paecilomyces cicadae and its pharmacological function[J].Acta Mycologica Sin,1993,12(2):138-144.
[26]	Liu CJ.Niu R.Method for preparing confervoide oil and medicine containing thereof[P].Chinese patent CN200310104187 Year Needed.
[27]	Zhao CF,Liu JP,Li PY.Studies on the Fructus Panax Quinquefolii for medicinal use[J].Lishenzhen Med Mater Med Res,2007,18(1):115-116.
[28]	Liu JZ,Li GY,Zhang B,et al.The effect of haishengsu on Lewis lung cancer[J].Shandong Med J,2009,49(07):30-31.
[29]	Zhou YH.Analysis on application for registration of active fractions in Chinese materia medica during 2004-2007[J].Chin Tradit Herb Drugs,2009,40(8):1177-1181.
[30]	SFDA.Supplement of Provision for Traditional Chinese Medicine Registration[Z].Beijing,China,2008.

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通讯作者: 陈斌, bchen63@163.com

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沈阳化工大学材料科学与工程学院沈阳 110142

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TCM-based new drug discovery and development in China

Corresponding author:

1. Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China

Received Date: 2014-02-13

Fund Project: This project was supported by the Twelfth Five-Year National Science and Technology Major Project(No.201409304-307-301).

Abstract: Over the past 30 years,China has significantly improved the drug development environment by establishing a series of policies for the regulation of new drug approval.The regulatory system for new drug evaluation and registration in China was gradually developed in accordance with international standards.The approval and registration of TCM in China became as strict as those of chemical drugs and biological products.In this review,TCM-based new drug discovery and development are introduced according to the TCM classification of nine categories.

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Reference (30)

[1]	Xue T,Roy R.Studying traditional Chinese medicine[J].Science,2003,300(5620):740-741.
[2]	State Council of the PRC.Drug Administrative Law[Z].Beijing,China,1985.
[3]	Ministry of Health of the PRC.Provisions for New Drug Approval[Z].Beijing,China,1985.
[4]	Deng RL,Kaitin K.The regulation and approval of new drugs in China[J].Drug Info,2004,(37):29-39.
[5]	SFDA.Provisions for Drug Registration[Z].(No.2).Beijing,China,1999.
[6]	Fan TP,Deal G,Koo HL,et al.Future development of global regulations of Chinese herbal products[J].J Ethnopharmacol,2012,140(3):568-586.
[7]	SFDA.Provisions for Drug Registration[Z].(No.28).Beijing,China,2007.
[8]	Miller LH SX.Artemisinin:discovery from the Chinese herbal garden[J].Cell,2011,146(6):855-859.
[9]	Pharmacopoeia of the People's Republic of China English edition(2010)[S].Vol.I.2010:1884.
[10]	Liu JM,Ni MY,Fan JF,et al.Artemisinin structures and reactions[J].Acta Chim Sin,1979,37:129-143.
[11]	Lin AJ,Klayman DL,Milhous WK.Antimalarial activity of new water-soluble dihydroartemisinin derivatives[J].J Med Chem,1987,30(11):2147-2150.
[12]	Deng RX.New progress in studies on antimalarial drugs in recent years in China[J].Chinese J Pharm,1989,20(8):372-375.
[13]	Bai DL.Traditional Chinese medicines and new drug development[J].Pure Appl Chem,1993,65(6):1103-1112.
[14]	Sun HD ML,Hu X C,et al.Ai-Ling I treated 32 cases of acute promyelocytic leukemia[J].Chin J Integr Tradit West Med,1992,12(3):170-171.
[15]	Chen GQ,Zhu J,Shi XG,et al.In vitro studies on cellular and molecular mechanisms of arsenic trioxide(As2O3) in the treatment of acute promyelocytic leukemia:As2O3 induces NB4 cell apoptosis with downregulation of Bcl-2 expression and modulation of PML-RAR alpha/PML proteins[J].Blood,1996,88(3):1052-1061.
[16]	Mervis J.Ancient remedy performs new tricks[J].Science,1996,273(2):578.
[17]	Liu G.From Schisandra research to the discovery of benzene diester[J].Acta Chim Sin,1983,18(9):714-720.
[18]	Anufriev VP,Malinovskaya GV,Denisenko VA,et al.Synthesis of ginsenoside Rg3,a minor constituent of Ginseng radix[J].Carbohydr Res,1997,304(2):179-182.
[19]	SunY,Lin H,Zhu YZ,et al.A randomized,prospective,multi-centre clinical trial of NP regimen(vinorelbine+cisplatin) plus Gensing Rg3 in the treatment of advanced non-small cell lung cancer patients[J].Chin J Lung Cancer,2006,9(3):254-258.
[20]	Liu J,Sun L,Zhao Y,et al.Clinical phase II study on immu noimprovement of patients with breast cancer treated by shenyi capsule[J].Chin J Clin Oncol,2000,27(7):534-536.
[21]	Sucher NJ.The application of Chinese medicine to novel drug discovery[J].Expert Opin Drug Discov,2013,8(1):21-34.
[22]	Guo LY,Li CY.Cordyceps kyushuensis new to China[J].Mycosystema,2000,19(02):296.
[23]	Li A.Establishment of Quality Standard and Fingerprint Chromatograph of Ipomoea batatas(L.) Lam.Simon No.1[D].Central South University.2010.
[24]	Ju FX.Pharmaceutical Research of Capsule of Mangjishi[D].Jilin University.2012.
[25]	Chen ZA,Liu GY,Hu SY.Studies on cultivation of Paecilomyces cicadae and its pharmacological function[J].Acta Mycologica Sin,1993,12(2):138-144.
[26]	Liu CJ.Niu R.Method for preparing confervoide oil and medicine containing thereof[P].Chinese patent CN200310104187 Year Needed.
[27]	Zhao CF,Liu JP,Li PY.Studies on the Fructus Panax Quinquefolii for medicinal use[J].Lishenzhen Med Mater Med Res,2007,18(1):115-116.
[28]	Liu JZ,Li GY,Zhang B,et al.The effect of haishengsu on Lewis lung cancer[J].Shandong Med J,2009,49(07):30-31.
[29]	Zhou YH.Analysis on application for registration of active fractions in Chinese materia medica during 2004-2007[J].Chin Tradit Herb Drugs,2009,40(8):1177-1181.
[30]	SFDA.Supplement of Provision for Traditional Chinese Medicine Registration[Z].Beijing,China,2008.

TCM-based new drug discovery and development in China

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通讯作者: 陈斌, bchen63@163.com

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