Biological Safety Analysis of Nanoparticles: Exploring Toxicity, Mechanisms, and Safety Factors for Pharmaceuticals.

Background: With the rapid advancement of nanotechnology, nanoparticles (NPs) have been widely applied in fields such as drug delivery, medical imaging, and disease therapy, owing to their unique physicochemical and biological properties. However, as NPs become increasingly prevalent in industrial production and daily life, the frequency and routes of human exposure have significantly increased, making the safety issues arising from their interactions with biological systems a major focus of public health concern. Methods: This review systematically retrieved relevant literature from databases including PubMed and Web of Science over the past 15 years, focusing on toxicological studies of NPs at the organ and system levels. Results: It summarizes the key mechanisms of nanotoxicity and the critical factors influencing safety evaluation. The findings indicate that NPs toxicity primarily targets the liver, kidneys, nervous system, and immune system. Oxidative stress, inflammatory responses, and DNA damage represent the major common mechanisms of nanotoxicity, while physicochemical properties such as particle size, surface charge, and protein corona formation are the core factors affecting safety. Conclusion: Based on these findings, this review analyzes the limitations of existing research in the context of the current research landscape, aiming to provide theoretical support for the safe application of NPs and to offer a reference for the establishment of a systematic nanotoxicity safety evaluation framework.