第四章 药品体内药学特性评价指南  

Chapter 4 Guideline for the Evaluation of Drug Pharmaceutical Properties in vivo

作　　者：孙雯娟[1] 张波[1,2] SUN Wenjuan;ZHANG Bo(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Capital Medical University,Beijing 100730,China;State Key Laboratory of Complex Severe and Rare Diseases,National Rare Disease Medical Quality Control Center,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Capital Medical University,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院药剂科,北京100730 [2]中国医学科学院北京协和医学院北京协和医院疑难重症及罕见病全国重点实验室国家罕见病医疗质量控制中心,北京100730

出　　处：《临床药物治疗杂志》2024年第S1期27-31,69,共6页Clinical Medication Journal

摘　　要：本章介绍了药品体内药学特性的评价要点,包括药动学和药效学2个方面,药动学主要是阐明药物体内的吸收、分布、代谢和排泄环节中的变化过程及规律;药效学主要是阐述药物在生物体内药物作用部位的浓度与药理作用或不良反应的关系。临床上根据药物在体内作用的特征和参数并结合患者生理、病理等因素的影响,制定和调整给药方案,从而安全、有效、合理地使用药物。药物体内药学特性的其他作用还包括:对药物相互作用的影响,与特殊人群用药的关系,对新药研发、药物制剂改进、生物利用度和生物等效性研究方面起到关键作用。This chapter introduces the key points for evaluating the pharmaceutical properties of drugs in vivo,including pharmacokinetics and pharmacodynamics.Pharmacokinetics mainly explains the changes and laws in the absorption,distribution,metabolism,and excretion of drugs in the body,while pharmacodynamics refers to the relationship between the concentration of drugs at the site of action and pharmacological effects or adverse reactions in vivo.In clinical practice,based on the characteristics and parameters of drug action in the body,combined with the influence of patient physiology,pathology,and other factors,medication regimens are formulated and adjusted to ensure safe,effective,and rational use of drugs.Other effects of the pharmaceutical properties of drugs in vivo include their impact on drug interactions,their relationship with medication in special populations,and their critical role in new drug development,drug formulation improvement,bioavailability and bioequivalence research.

关 键 词：体内药学特性 药动学 药效学 

分 类 号：R95[医药卫生—药学]