近年來隨著納米技術(shù)的不斷發(fā)展，納米藥物制劑在改善藥物遞送、提高生物利用度方面顯示出獨特優(yōu)勢，已成為臨床新藥開發(fā)研究的熱點，為諸多疾病尤其是惡性腫瘤的治療提供了新思路。然而，由于對納米藥物制劑的體內(nèi)過程了解不夠全面，導(dǎo)致納米藥物制劑的臨床轉(zhuǎn)化率極低，嚴重制約了納米藥物制劑的發(fā)展。基于納米藥物制劑良好的應(yīng)用前景及目前藥動學研究中存在的關(guān)鍵問題，調(diào)研了國內(nèi)外的相關(guān)文獻，首先介紹了常見的具有不同納米載體類型的納米藥物制劑的種類，對納米藥物制劑體內(nèi)藥物濃度分析測定的方法進行歸納總結(jié)，最后分析納米載體的理化性質(zhì)對納米藥物制劑體內(nèi)藥動學行為的影響，旨在為納米藥物制劑的體內(nèi)過程研究提供參考，以獲取更為全面的體內(nèi)藥動學數(shù)據(jù)，提高藥物的臨床轉(zhuǎn)化率。同時針對目前納米藥物制劑的載體研究、體內(nèi)濃度定量分析方法以及藥動學研究中存在的問題進行討論，以期為納米藥物制劑的研究與開發(fā)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.

國家自然科學基金資助項目（81973391）