| 刘青,郑红梅,康琪,张志强,梁雪兰,蒋永忠.《医疗用毒性药品管理办法》中毒性中药与现行药品标准的横向比对研究[J].中国药事,2023,(11):1225-1235 |
| 《医疗用毒性药品管理办法》中毒性中药与现行药品标准的横向比对研究 |
| Horizontal Comparison Study on Toxic TCM and Current Drug Standards in the "Management Measures for Medical Toxic Drugs" |
| 投稿时间：2023-06-28 |
| DOI：10.16153/j.1002-7777.2023.11.002 |
| 中文关键词: 毒性中药 分类 名称 毒性 功效与主治 用法用量 横向比对 |
| 英文关键词: toxic TCM classification name toxicity efficacy and indications usage and dosage horizontal comparison |
| 基金项目:基于“大毒治大病”对27味“大毒”中药的基础研究（编号 22ZRYB07、TD-2022-8） |
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| 中文摘要: |
| 目的：分析《医疗用毒性药品管理办法》中27味毒性中药名称、毒性、功效与主治、用法用量， 为27味毒性中药临床应用和研究提供参考。方法：查阅2020年版《中国药典》、各省及直辖市《中药饮片炮制规范》、药智数据及文献资料，进行横向比对。结果：收载在2020年版《中国药典》品种有19 味，未收载在2020年版《中国药典》品种有8味；在这27味毒性中药中，部分毒性中药名称和《中国药典》不一致；13味标注“大毒”，14味标注“有毒”；内服和外用功效主治不同的有15味；未标明剂量的有4味；使用频次均为0的有7味。结论：《医疗用毒性药品管理办法》中部分毒性中药的名称需要和 2020年版《中国药典》统一，“有毒”毒性标定有待商榷，对27味毒性中药除应加强严格管理外，同时还应注意其用法与用量，加大使用频次均为0的毒性中药的研究。 |
| 英文摘要: |
| Objective: To analyze the names, toxicity, efficacy and indications, usage and dosage of 27 toxic TCMs in the "Management Measures for Medical Toxic Drugs" and provide references for the clinical application and research of 27 toxic TCMs. Methods: Data were acquired and compared from the 2020 edition of the Chinese Pharmacopoeia, the provincial and municipal standards for the preparation of TCM pieces, medical intelligence data and literature. Results: Nineteen drugs were included in the 2020 edition of the Chinese Pharmacopoeia, while 8 drugs were not included in the 2020 edition of the Chinese Pharmacopoeia. Among these 27 toxic TCMs, some of them have inconsistent names compared to Chinese Pharmacopoeia. 13 drugs labeled as "highly toxic", and 14 drugs labeled as "toxic". There are 15 drugs with different therapeutic effects for internal or external use. 4 drugs don’t label the dosage and 7 drugs show no usage frequency. Conclusion: The names of some toxic TCM in the "Management Measures for Medical Toxic Drugs" need to be unified with the 2020 edition of the Chinese Pharmacopoeia. The label of "toxic" remains to be discussed. In addition to strengthening management of 27 toxic TCM, attention should be paid to their usage and dosage, and research on toxic TCM with zero frequency of use should be increased. |
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