纳米药物制剂体内分析方法及药动学研究进展和问题策略分析  

Research progress and problem strategy analysis of in vivo analysis methods and pharmacokinetics of nanopharmaceutical preparations

作　　者：仲曼 胡慧慧 缪明星[2] 何华[3] 郝琨 ZHONG Man;HU Huihui;MIAO Mingxing;HE Hua;HAO Kun(Key Laboratory of Drug Metabolism&Pharmacokinetics,Institute of Pharmaceutical Sciences,China Pharmaceutical University,Nanjing 210009,China;Center of National Pharmaceutical Experimental Teaching Demonstration,China Pharmaceutic University,Nanjing 210009,China;Center of Drug Metabolism and Pharmacokinetics,China Pharmaceutical University,Nanjing 211100,China)

机构地区：[1]中国药科大学药物科学研究院药物代谢动力学重点实验室,江苏南京210009 [2]中国药科大学国家药学实验示范中心,江苏南京210009 [3]中国药科大学药物代谢和药代动力学研究中心,江苏南京211100

出　　处：《药物评价研究》2022年第7期1413-1425,共13页Drug Evaluation Research

基　　金：国家自然科学基金资助项目(81973391)。

摘　　要：近年来随着纳米技术的不断发展,纳米药物制剂在改善药物递送、提高生物利用度方面显示出独特优势,已成为临床新药开发研究的热点,为诸多疾病尤其是恶性肿瘤的治疗提供了新思路。然而,由于对纳米药物制剂的体内过程了解不够全面,导致纳米药物制剂的临床转化率极低,严重制约了纳米药物制剂的发展。基于纳米药物制剂良好的应用前景及目前药动学研究中存在的关键问题,调研了国内外的相关文献,首先介绍了常见的具有不同纳米载体类型的纳米药物制剂的种类,对纳米药物制剂体内药物浓度分析测定的方法进行归纳总结,最后分析纳米载体的理化性质对纳米药物制剂体内药动学行为的影响,旨在为纳米药物制剂的体内过程研究提供参考,以获取更为全面的体内药动学数据,提高药物的临床转化率。同时针对目前纳米药物制剂的载体研究、体内浓度定量分析方法以及药动学研究中存在的问题进行讨论,以期为纳米药物制剂的研究与开发利用提供方向。In recent years,with the continuous development of nanotechnology,nanomedicine preparation have shown unique advantages in improving drug delivery and bioavailability,and have become the focus of clinical new drug development and research.It provides a new idea for the treatment of many diseases,especially tumors.However,due to many problems in preclinical research,especially the lack of comprehensive understanding of the in vivo process of nanomedicine preparation,the clinical conversion rate of drugs is very low,which seriously restricts the development of nanomedicine preparation.Based on the good application prospect of nanomedicine preparation and the key problems existing in the current preclinical research,after investigating the relevant literature at home and abroad,this paper introduces the common types of nano-drug preparations and related drugs.Then the methods for the analysis and determination of drug concentration in vivo of nano-drug preparations were summarized.Finally,the effects of the physical and chemical properties of nano-carriers on the pharmacokinetic behavior of nanomedicine preparation in vivo were analyzed,in order to provide reference for the study of the in vivo process of nanomedicine preparation,in order to obtain more comprehensive pharmacokinetic data in vivo and improve the clinical conversion rate of drugs.At the same time,this paper discusses and reflects on the problems existing in the carrier research,in vivo concentration quantitative analysis and pharmacokinetic research of nanomedicine preparation,in order to provide a direction for the preclinical research,development and utilization of nanomedicine.

关 键 词：纳米药物 体内药物分析 药动学 恶性肿瘤 纳米载体 

分 类 号：R969.1[医药卫生—药理学] R944[医药卫生—药学]