复方甘草口服溶液的应用现状及思考  

Management of compound glycyrrhiza oral solution and recommendations

作　　者：曹颖 周虎子威 朱兰 王胜锋[1] CAO Ying;ZHOU Huziwei;ZHU Lan;WANG Shengfeng(Peking University School of Public Health,Key Laboratory of Epidemiology of Major Diseases(Peking University),Beijing 100191,China;Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China)

机构地区：[1]北京大学公共卫生学院,重大疾病流行病学教育部重点实验室(北京大学),北京100191 [2]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076

出　　处：《中国药物警戒》2024年第5期529-534,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82173616)。

摘　　要：目的 梳理复方甘草口服溶液监管现状并提出建议。方法 检索中国知网、万方数据、维普网、美国食品药品监督管理局、我国国家药品监督管理局及省级药品监督管理局网站有关文件,对纳入文献进行汇总和分析。结果 当前我国复方甘草口服溶液存在生产制备过程部分不稳定、含量测定标准相对不全面、说明书记载相对不全、药品不良反应临床表现多样等状况。结论 建议参考国内外对类似药物的监管办法优化对复方甘草口服溶液的监管措施;企业规范销售对象与流程;加强医务人员培训、开展科普活动。Objective To investigate the current management level of compound glycyrrhiza oral solution,and to offer recommendations for improvement.Methods Related literature was retrieved from CNKI,Wanfang,VIP,the website of the FDA of the United States,and the official websites of NMPA and provincial drug regulatory agencies of China before being summarized and analyzed.Results There were some problems with this solution,such as unstable preparation processes,incomplete standards for content determination,ambiguous instructions,and complicated ADRs during the use of compound glycyrrhiza oral solution in China.Conclusion It is recommended that ways to regulate similar drugs at home and abroad be referred to to optimize the regulations of CGOS,the targets of marketing and processes be standardized for enterprises,health care providers be better trained and related knowledge be made more accessible.

关 键 词：复方甘草口服溶液 阿片类物质 药物成瘾 药物滥用 药物安全 监管措施 

分 类 号：R974[医药卫生—药品] R954[医药卫生—药学]