含成瘾物质中药的检测方法及科学监管对策  

Detection Methods and Scientific Regulatory Countermeasures of Traditional Chinese Medicine Containing Addictive Substances

作　　者：严倩茹 邬伟魁 宋伟 Yan Qianru;Wu Weikui;Song Wei(Meizhou Institute for Food and Drug Control,Meizhou 514071,China;Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]梅州市食品药品监督检验所,梅州514071 [2]武汉大学人民医院,武汉430060

出　　处：《中国药事》2023年第3期264-275,共12页Chinese Pharmaceutical Affairs

基　　金：广东省药品监督管理局科技创新项目(编号2021TDB09)。

摘　　要：目的:了解含成瘾物质中药及其检测方法,为其监管提供参考。方法:检索2018-2022年国内外文献,对含成瘾物质(罂粟壳、吗啡、可待因、四氢大麻酚、咖啡因等)中药及其检测方法进行梳理,分析含成瘾物质中药监管面临的挑战。结果与结论:药物成瘾是一种慢性疾病,涉及一系列的个体、医疗、社会及经济问题。部分中药含成瘾物质,当前人们对其认识不足、管理不到位,科学管控成瘾风险迫在眉睫。相关药品监管政策的变革亟需成瘾物质分析技术的支持,检测方法在药品安全领域意义重大,成为当前研究热点。建议加强研发、生产、经营和使用环节的监管,建立严谨的质量标准,精准有效管控风险,为中药安全检测、临床合理用药以及科学监管提供参考。Objective: To understand traditional Chinese medicines(TCM) containing addictive substances and their detection methods, to provide references for drug supervision. Methods: TCM containing addictive substances(papaveris pericarpium, morphine, codeine, tetrahydrocannabinols, caf feine, etc.) and their detection methods were retrieved by searching domestic and foreign literatures from 2018 to 2022. The current challenges of scientifi c supervision of TCM containing addictive substances were analyzed. Results and Conclusion: Drug addiction is a chronic disease involving a range of individual, medical, social and economic problems. Some TCM contains addictive substances. At present, people have insu ffi cient understanding of them and their management is not in place. It is imminent to scientifi cally control the risk of addiction. The reform of relevant drug regulatory policies urgently needs the support of analytical techniques for addictive substances. The detection methods have great signifi cance in the fi eld of drug safety and have become a current research hotspot. In this paper, it is suggested to strengthen the supervision of R&D, production, management and use, establish strict quality standards, and accurately and ef fectively control risks, in order to provide references for safe detection, clinical rational drug use and scientifi c supervision of TCM.

关 键 词：中药 成瘾物质 检测方法 科学监管 大麻素 四氢大麻酚 罂粟壳 吗啡 

分 类 号：R95[医药卫生—药学]