纳米药物毒性效应机制和安全性评价

The mechanism of toxic effect and safety evaluation of nanomedicines

目的随着纳米技术在医学领域的应用,纳米药物和纳米材料的安全性问题越来越受到人们的关注。纳米药物毒性效应机制和安全性评价研究对加速纳米药物临床转化进程,确保纳米药物临床应用的安全有效具有一定的参考价值。方法对纳米药物特殊的理化性质影响纳米药物安全性的内在机制、纳米药物安全性评价的方法框架和具体的检测手段进行了综述。结果与结论纳米药物与生物系统的相互作用是纳米药物对机体造成毒性效应的主要原因,这种相互作用又主要取决于纳米粒的理化性质,包括粒径、形态、可变形性、表面性质、生物可降解性和生物相容性等。由于纳米药物复杂的结构组成和特殊的理化性质,传统药物的安全性评价方法并不完全适用于纳米药物,需要采取基于级联检测的毒理学评价方案并对特殊的理化性质进行充分表征。

Objective With the application of nanotechnology in the medicine,the security issues of nanomedicines and nanocarriers are of increasing concern.The mechanism of toxic effect and safety evaluation of nanomedicines have reference value for accelerating the process of clinical translation of nanomedicines,and ensuring the safety and effectiveness of nanomedicines in clinical applications.Methods To review the intrinsic mechanism that the special physicochemical properties of nanomedicines affect the safety of nanomedicines,the methodological framework of the safety evaluation towards nanomedicines and the specific detection means.Results&Conclusion The interaction between nanomedicines and biological systems is the main mechanism by which nanomedicines cause toxic effects on the organism.And this interaction depends on the physicochemical properties of nanoparticles in turn,including particle size,morphology,deformability,surface properties,biodegradability and biocompatibility.Due to the complex structural composition and special physicochemical properties of nanomedicines,the safety evaluation methods of traditional drugs are not completely applicable to nanomedicines.It is necessary to adopt the toxicological evaluation protocols based on cascading tests and adequate characterization of specific physicochemical properties.