随着医药科技的飞速发展，新药研发与上市进程日益加速，药物安全性评价的科学性与准确性愈发凸显其关键地位。系统梳理2013—2025年不同药物安全性评价技术的研究进展，重点聚焦实验新技术、计算机辅助技术与数据库，以及非哺乳类模式动物在该领域的创新应用。其中，类器官、微流控芯片、代谢流分析、质谱成像、转基因技术等实验新技术，通过构建高度仿生的研究平台，从多维度探究并验证毒性发生的分子及细胞机制，不仅显著提升了药物评价的精准度，还降低了对动物实验的依赖；定量结构-活性关系建模、实时无标记细胞分析、高内涵细胞影像分析及人工智能预测模型等技术，有效提高了药物评价效率与早期毒性预测能力；线虫、斑马鱼等非哺乳类模式动物因繁殖迅速、成本低廉、胚胎透明等独特优势，在严格遵循3R原则的基础上得到广泛应用。这些技术的协同发展，共同推动药物安全性评价向更高效、更符合伦理的方向迈进，为保障药物的安全性与有效性奠定了坚实基础。

With the rapid development of medical science and technology, the process of new drug research and development is accelerating, and the scientificity and accuracy of drug safety evaluation have become increasingly crucial. This article systematically reviews the research progress of different drug safety evaluation technologies from 2013 to 2025, focusing on experimental new technologies, computer-aided technologies and databases, as well as innovative applications of non-mammalian model animals in this field. Among them, experimental new technologies such as organoids, microfluidic chips, metabolic flow analysis, mass spectrometry imaging and transgenic technology, by constructing highly biologically similar research platforms, explore and verify the molecular and cellular mechanisms of toxicity occurrence from multiple dimensions, not only significantly improving the accuracy of drug evaluation, but also reducing the reliance on animal experiments; quantitative structure-activity relationship modeling, real-time unlabeled cell analysis, high-content cell imaging analysis and artificial intelligence prediction models, effectively improve the efficiency of drug evaluation and the ability to predict early toxicity; nematodes, zebrafish, etc., non-mammalian model animals, due to their unique advantages such as rapid reproduction, low cost, and transparent embryos, have been widely used on the basis of strictly following the 3R principles. The collaborative development of these technologies jointly promote drug safety evaluation towards a more efficient and more ethical direction, laying a solid foundation for ensuring the safety and reliability of drugs.

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国家自然科学基金委员会青年科学基金项目（82204938）；河南省医学科技攻关计划联合共建项目（LHGJ20240427）