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

目的:大麻二酚是大麻植物中存在的一种大麻素类物质。欧美国家已经批准其用于癫痫的治疗。在我国,大麻二酚作为四氢大麻酚的同分异构体,按照第一类精神药品进行监管,尚未有此类药品上市。本研究旨在探讨大麻二酚类药物研发、生产、上市过程中存在的监管问题,提出可行性监管途径,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。工业大麻种植监管存在一定的空白。建议在借鉴国内已有经验的基础上,平衡好药品的可及性和滥用风险,有计划、有步骤地推动大麻二酚类药物的发展,促进其在国内的研发和临床应用,助力神经精神疾病的临床治疗。

Objective:Cannabidiol is one kind of cannabinoids present in cannabis plants.European and American countries have approved its use for the treatment of epilepsy.In China,cannabidiol,as an isomer of tetrahydrocannabinol,is regulated as a first class psychotropic drug and has not yet been marketed.The aim of this study is to explore regulatory issues in the development,production,and marketing of cannabidiol drugs,propose feasible regulatory approaches,and promote the research and application of such drugs in China.Methods:By reviewing the"Regulations on the Administration of Anesthetic Drugs and Psychotropic Drugs"and the"Notice on the Administration of Experimental Research on Anesthetic Drugs and Psychotropic Drugs",as well as local regulations in Yunnan and Heilongjiang provinces,combined with the addiction and medical value of cannabinoid,this study explored the regulatory issues in hemp cultivation,experimental research projects and production of cannabinoid drugs,and proposed targeted suggestions.Results and Conclusion:Cannabinoid drugs have important clinical value in neuropsychiatric disorders and are not addictive.At present,regulatory regulations have certain limitations on the approval of experimental research projects for cannabidiol drugs.There is a certain gap in the supervision of hemp cultivation.It is recommended to balance the accessibility and risk of drug abuse based on the existing experience in China,and promote the development of cannabidiol drugs in a planned and systematic manner,promote their research and clinical application in China,and assist in the clinical treatment of neurological and psychiatric disorders.