目的 對《國家基本醫(yī)療保險、工傷保險和生育保險藥品目錄（2024年）》（以下簡稱《醫(yī)保目錄》）“中成藥部分”中含毒性飲片的中成藥進行歸納分析，為其安全應(yīng)用與監(jiān)管提供參考。方法 以《中國藥典》2020年版中標注“大毒、有毒、小毒”的中藥飲片為基準，對《醫(yī)保目錄》“中成藥部分”含上述毒性飲片的中成藥展開歸納梳理，整理該目錄中相關(guān)品種并分析其特點。結(jié)果 1 336個中成藥中含毒性飲片的有470種，涉及68種毒性中藥飲片，其中大毒、有毒和小毒飲片分別為8、36和24種，含2種及以上毒性飲片的中成藥157種，占33.40%，功效涉及9個大類、35個亞類，以內(nèi)科用藥為主，多為化痰止咳平喘劑、祛濕劑和祛瘀劑，口服為主要給藥途徑，73個兒童用中成藥中明確劑量的有55種，區(qū)分年齡段的有45種。結(jié)論 《醫(yī)保目錄》中成藥涉及毒性飲片種類較多、功效廣泛，部分兒童用藥說明書劑量不明確，故建議開展毒性分級研究、規(guī)范藥品說明書、加強合理用藥和監(jiān)管以保障用藥安全。

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.

R283.6

江蘇省研究型醫(yī)院學(xué)會精益化用藥-石藥專項科研基金項目（JY202131）；江蘇省藥學(xué)會-正大天晴醫(yī)院藥學(xué)科研基金項目（Q202204）；江蘇省中藥骨干人才高級研修項目；南京市中醫(yī)藥青年人才培養(yǎng)計劃項目（ZYQ20019）