文章摘要
大麻二酚类药物在我国面临的问题与探讨
Problems and Discussion on Cannabidiol-based Pharmaceuticals in China
投稿时间:2023-11-05  修订日期:2024-03-22
DOI:
中文关键词: 大麻二酚  四氢大麻酚  成瘾性  工业大麻  种植
英文关键词: cannabidiol  delta-9-tetrahydrocannabinol  addiction  hemp  planting
基金项目:
作者单位邮编
刘晓敏* 首都医科大学附属北京世纪坛医院 100038
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中文摘要:
      目的:为大麻二酚类药物研发、生产、上市提供可行性监管途径的理论参考,从而促进此类药品在国内的研发和应用。方法:通过梳理《麻醉药品和精神药品管理条例》、《关于麻醉药品和精神药品实验研究管理规定的通知》,以及云南、黑龙江两省的地方规定,结合大麻二酚成瘾性和医疗价值,探讨工业大麻种植、大麻二酚类药物实验研究立项和生产中存在的监管问题,并提出针对性建议。结果与结论:大麻二酚类药物不具有成瘾性,在神经精神疾病中具有重要临床价值。目前监管法规对大麻二酚类药物实验研究立项存在一定的限制和空白。建议细化梳理相关法规规章和规范性文件,促进大麻二酚类药物在国内的研发和临床应用,助力神经精神疾病的临床治疗。
英文摘要:
      Objective: To provide reference for the research and development, production, and marketing of Cannabidiol-based pharmaceuticals, and to provide feasible regulatory channels for regulatory authorities, in order to promote the research and application of such pharmaceuticals in China. Method: By reviewing the "Regulations on the Administration of Anesthetic Drugs and Psychotropic Substances", the "Notice on the Administration of Experimental Research on Anesthetic Drugs and Psychotropic Substances", and local regulations in Yunnan and Heilongjiang provinces, combined with the addiction and medical value of cannabinoid, this study explores the regulatory issues in industrial cannabis cultivation, experimental research projects and production of cannabinoid drugs, and proposes targeted suggestions. Results and Conclusion: Cannabinoid drugs have important clinical value in neuropsychiatric disorders and are not addictive. There are certain limitations and gaps in the current regulatory regulations regarding the cultivation of industrial cannabis and the establishment of experimental research projects for cannabinoid drugs. It is recommended to promote the formulation and revision of relevant regulations, rules and normative documents. Thus, promoting the research and clinical application of cannabinoid drugs in China, and promoting the clinical treatment of neurological and psychiatric diseases.
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