中草药新药多成分药代动力学评价的研究进展  

Research progress on current pharmacokinetic evaluation of Chinese herbal medicines

作　　者：黎国富[1,2] 赵浩如[1] 杨劲[2] 

机构地区：[1]中国药科大学中药制剂教研室,江苏南京210009 [2]中国药科大学药物代谢动力学重点实验室,江苏南京210009

出　　处：《中国中药杂志》2011年第5期644-649,共6页China Journal of Chinese Materia Medica

基　　金：国家科技支撑计划项目(2006BAI21B00)

摘　　要：植物药在国外上市前必须经历药代动力学、生物利用度等一系列严格的科学研究以确证其安全性和有效性。美国FDA颁布了《植物药指导原则》以辅助申请者开发植物药,这对中草药新药研发也有极其重要的借鉴意义。该文对与FDA理念相一致的中草药药代动力学评价方法进行了综述和讨论,主要包括中草药中"药代动力学标记物"(PK markers)的鉴定、矩量法整合的多组分药代动力学研究、生物药剂学药物处置分类系统、群体药代动力学-药效动力学在中药-化药相互作用中的研究。In order to prove safety and efficacy,herbal medicines must undergo the rigorous scientific researches such as pharmacokinetic and bioavailability,before they are put on the market in the foreign countries.Botanical Drug Products promulgated by the US FDA could guide industry sponsors to develop herbal drugs,which was also an important reference for investigating Chinese herbal medicines.This paper reviews and discusses novel approaches for how to assess systemic exposure and pharmacokinetic of Chinese herbal medicines,which were in line with FDA guidance.This mainly focus on identifying pharmacokinetic markers of botanical products,integral pharmacokinetic study of multiple components,Biopharmaceutics drug disposition classification system,and population pharmacokinetic-pharmacodynamic study in herb-drug interaction.

关 键 词：中草药药代动力学 矩量法 药代动力学标记物 生物药剂学体内处置分类系统 中草药-化学药相互作用 

分 类 号：R285[医药卫生—中药学]