An important role of pharmacokinetics of traditional Chinese medicine in the new drug development in TCM

Abstract

Abstract: Although the pharmacokinetic study of traditional Chinese medicine (TCM) plays a limited role in promoting the registration of new drugs of TCM, it plays an important role in reforming the Chinese medicine formulations, elucidating the material basis of Chinese medicine, designing the dose regimens for clinical treatment and promo ting the internationalization of Chinese medicine.This review summarized the recent advances and illustrated with examples how the pharmacokinetics of TCM can promote the research and development of Chinese medicine.

Key words: Traditional Chinese medicine, Pharmacokinetics, New drug

CLC Number:

R969

ZHONG Jie, WANG Hai-nan, MA Yue-ming. An important role of pharmacokinetics of traditional Chinese medicine in the new drug development in TCM[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(3): 241-246.

References

[1] 刘昌孝. 中药药代动力学研究的难点和热点[J].药学学报, 2005, 40(5):395-401.
[2] 中国国家食品药品监督管理局.药品注册管理办法[S].[2007-07-10].药品注册管理办法[S].[2007-07-10] http://www.sda.gov.cn/WS01/CL0053/24529.html
[3] 李攻戍,张毅,翁维良.中药新药Ⅰ期临床试验设计的几个问题[J].中药新药与临床药理,2005,16(2):79-81.
[4] 韩玲. 多成分中药药物代谢动力学研究的现状及思考[J].中国中药杂志, 2008, 33(21):2442-2448.
[5] 郝琨, 柳晓泉, 王广基.藤黄酸在大鼠体内的药代动力学[J].中国药科大学学报, 2005, 36(4):338-341
[6] 郝琨, 柳晓泉, 王广基.犬血浆中藤黄酸HPLC 测定及其药代动力学[J].中国天然药物, 2005, 3(5):312-315.
[7] 邓远辉, 曾星, 冯怡, 等.单次静滴人参皂苷-Rd 注射液在中国健康志愿者的药代动力学及耐受性[J].中国临床药理学杂志, 2009, 25(2):116-119.
[8] 黄芳华, 笪红远, 张陆勇.中药一类新药的特殊毒理、药代动力学技术问题的讨论[J].中国新药杂志,2002, 11(12):906-908.
[9] Zhang Y, Akao T, Nakamura N, et al. Extremely low bio availability of magnesium litho spermate B, an active component from Salvia miltiorrhiza, in rat[J].Planta Med, 2004, 70(2):138-142.
[10] Li X, Yu C, Lu Y, et al. Pharmacokinetics, tissue distribution, metabolism, and excretion of depside salts from Salvia miltiorrhiza in rats[J].Drug Me tab Dispos, 2007, 35(2):234.
[11] Li XC, Yu C, Sun WK, et al. Pharmacokinetics of magnesium lithospermate B after intravenous administ ration in beagle dogs[J].Acta Pharmacol Sin,2004, 25(11):1402-1407.
[12] 高蕊,张颖,王书臣, 等.丹参酚酸盐在健康志愿者的药代动力学和药效学研究[J].中国临床药理学与治疗学, 2004, 9(11):1209-1212.
[13] 韩旻, 傅韶, 方晓玲.三七总皂苷油包水微乳的处方筛选及体内外评价[J].药学学报, 2007, 42(7):780-786.
[14] U.S.Fo od and Drug Administ ratio n. Guidance for industry:botanical drug products[S].[2004]www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm106136.pdf
[15] 周华. 美国第一个植物药VeregenTM 简介及其对中药研发的启示[J].中药新药与临床药理, 2008, 19(4):326-328.
[16] 唐健元, 张磊, 杜晓曦.国外上市植物药评价简介和对我国中药新药临床研究现状的思考[J].中药药理与临床, 2007, 23(5):222-227
[17] Liu H, Yang J, Du F, et al. Absorptio n and disposition n of ginsenosides after oral administration of Panax notoginseng ex tract to rats[J].Drug Metab Dispos, 2009, 37(12):2290-2298.