生物技术药物药代动力学研究进展

Progress on pharmacokinetics of biotechnology drugs

生物技术药物作为现代药物研发热点而备受关注,它具有和传统小分子药物截然不同的理化性质,因此其药动学呈现出独特性和复杂性。阐述生物技术药物的概念;总结4种主要的生物技术药物分析方法;进一步综述生物技术药物在体内吸收、分布、代谢和排泄的药动学特点;最后以生物技术药物主流之一的单克隆抗体药物为代表,通过相关数据对比单克隆抗体药物与传统小分子药物在药动学方面的差异。以期为充分了解生物技术药物的药动学特征以及形成机制、研发和筛选新型生物技术药物提供强有力的支持,同时为药物安全性评价和临床用药提供重要参考。

Biotechnology drugs have attracted increasing attention as a hot topic in research and development of new drugs.The pharmacokinetics of biotechnology drugs shows uniqueness and complexity due to the different physical and chemical properties from those of small molecule drugs.In this paper,the concept of biotechnology drugs was described and four main analytical methods for biotechnology drugs were summarized,the absorption,distribution,metabolism and excretion of biotechnology drugs in vivo were reviewed and the differences in pharmacokinetics between monoclonal antibody drugs,one of the mainstreams of biotechnology drugs,and small molecule drugs were compared.This review was intended to provides a deep and fully understanding for the pharmacokinetic characteristics and mechanisms of biotechnology drugs,which can serve as a supporting reference for the new biotechnology drug screening,R&D,safety evaluation and clinical use of drugs.