目的 对《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》（以下简称《医保目录》）“中成药部分”中含毒性饮片的中成药进行归纳分析，为其安全应用与监管提供参考。方法 以《中国药典》2020年版中标注“大毒、有毒、小毒”的中药饮片为基准，对《医保目录》“中成药部分”含上述毒性饮片的中成药展开归纳梳理，整理该目录中相关品种并分析其特点。结果 1 336个中成药中含毒性饮片的有470种，涉及68种毒性中药饮片，其中大毒、有毒和小毒饮片分别为8、36和24种，含2种及以上毒性饮片的中成药157种，占33.40%，功效涉及9个大类、35个亚类，以内科用药为主，多为化痰止咳平喘剂、祛湿剂和祛瘀剂，口服为主要给药途径，73个儿童用中成药中明确剂量的有55种，区分年龄段的有45种。结论 《医保目录》中成药涉及毒性饮片种类较多、功效广泛，部分儿童用药说明书剂量不明确，故建议开展毒性分级研究、规范药品说明书、加强合理用药和监管以保障用药安全。

Objective To summarize and analyze the traditional Chinese patent medicines containing toxic Chinese medicine decoction pieces in the "Chinese Patent Medicine Section" of the "National Basic Medical Insurance, Employment Injury Insurance and Maternity Insurance Medicines List (2024 Edition)" (hereinafter referred to as the "Medical Insurance List"), providing references for their safe application and supervision. Methods Taking the toxic Chinese medicine decoction pieces marked as "extremely toxic, toxic, slightly toxic" in the 2020 edition of the "Chinese Pharmacopoeia" as the benchmark, the traditional Chinese patent medicines containing the above-mentioned toxic Chinese medicine decoction pieces in the "Chinese Patent Medicine Section" of the "Medical Insurance List " were sorted out and analyzed. The related varieties in the list were sorted out and their characteristics were analyzed. Results Among the 1 336 traditional Chinese patent medicines, 470 contained toxic Chinese medicine decoction pieces, involving 68 kinds of toxic Chinese medicine decoction pieces, among which extremely toxic, toxic, and slightly toxic herbal slices were 8, 36, and 24 kinds respectively. There were 157 kinds of traditional Chinese patent medicines containing two or more Chinese medicine decoction pieces, accounting for 33.40%. The functions involved 9 major categories and 35 subcategories, mainly internal medicine, mostly expectorant, antitussive and anti-asthmatic agents, dampness-removing agent and blood stasis removers. Oral administration was the main route of administration. Among the 73 traditional Chinese patent medicines for children, 55 had clear dosages and 45 were differentiated by age groups. Conclusion The traditional Chinese patent medicines in the "Medical Insurance List" involve a wide variety of Chinese medicine decoction pieces and have extensive functions. The dosages of some children's medicines are not clear. Therefore, it is suggested to conduct toxicity grading research, standardize the drug instructions, strengthen rational drug use and supervision to ensure drug safety.

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江苏省研究型医院学会精益化用药-石药专项科研基金项目（JY202131）；江苏省药学会-正大天晴医院药学科研基金项目（Q202204）；江苏省中药骨干人才高级研修项目；南京市中医药青年人才培养计划项目（ZYQ20019）