随着中药注射剂在临床上应用的日益广泛，其不良反应成为中药安全评价研究的热点和难点之一，日渐引起重视。中药注射剂常导致Ⅰ型过敏反应及类过敏反应，近年来针对这2种过敏反应已经开发出多种细胞、类过敏反应动物模型、Ⅰ型过敏反应动物模型以及酶联免疫吸附（ELISA）法、高通量筛选分离方法、虚拟技术筛选等。通过综述近年来中药注射剂致敏实验模型及检测方法原理、适用性及局限性，以期为建立新型过敏原筛选方法、寻找中药注射剂过敏原和研究潜在致敏机制提供更多参考。

With the increasing application of traditional Chinese medicine (TCM) injection in clinic, the adverse reactions have become one of the hot spots and difficulties in the study of TCM safety evaluation, and has increasingly attracted people's attention. TCM injections often cause type I allergic reaction and anaphylactoid reactions. In recent years, a variety of cells, animal models of anaphylactoid reaction, animal models of type Ⅰ anaphylactoid reaction, and ELISA, a variety of high-throughput screening and isolation methods, and virtual technology screening have been developed for these two kinds of allergic reactions.In this paper, the principles, applicability and limitations of experimental models and detection methods for sensitization of traditional Chinese medicine injections in recent years are reviewed, in order to provide more references for establishing new screening methods for allergens, finding allergens for TCM injections, and studying potential sensitization mechanisms.

R285.5；R943

山西省科技合作交流专项项目（202104041101032）；中国辐射防护研究院自主科研项目（YP21010202）