基于PBL的体内药物分析实验教学与实践

Teaching and Practice of Drug Analysis Experiment in Vivo Based on PBL

随着临床药理学、药动学、生物药剂学及临床治疗药物浓度监测、药物代谢组学等研究领域的迅猛发展,采用现代分析技术,对体内不同体液和组织中的药物进行定性定量分析,从分子、细胞水平来研究探索药物的体内动力学过程、药效学和毒理学机制,在探求科学用药规律与安全、有效合理用药及在新药筛选、保障人类健康方面具有重要意义。在新药研究过程中,按照国家新药注册审批有关规定,须进行动物和人体体内药代动力学、毒代动力学研究;在新药一致性评价中须进行生物等效性研究;为保证临床用药安全有效,还要进行治疗药物监测研究等。

With the rapid development of clinical pharmacology,pharmacokinetics,biopharmacy,clinical therapeutic drug concentration monitoring,drug metabonomics and other research fields,and by using modern analytical technology,the drugs in different body fluids and tissues in vivo were qualitatively and quantitatively analyzed,and the in vivo kinetic process,pharmacokinetics and toxicological mechanism of the drugs were studied and explored at the molecular and cell levels.It is of great significance in exploring the law and safety of scientific drug use,effective,rational drug use and screening of new drugs to ensure human health.In the process of new drug research,in accordance with the relevant provisions of the national registration and examination and approval of new drugs,it is necessary to carry out pharmacokinetics in animals and human bodies.In order to ensure the safety and effectiveness of clinical drug use,it is necessary to carry out therapeutic drug monitoring research in order to ensure the safety and effectiveness of clinical drug use.