中成药中非法添加化学药物的现状分析及对策  

Current situation analysis and countermeasures of illegal addition of chemical drugs in proprietary Chinese medicine

作　　者：张金月 杨一荻 曲范娜 笔雪艳[1,2] ZHANG Jinyue;YANG Yidi;QU Fanna;BI Xueyan(Heilongjiang University of Chinese Medicine,Harbin 150040,China;NMPA Key Laboratory of Quality Research and Evaluation of Traditional Chinese Medicines,Heilongjiang Provincial Key Laboratory of Quality Research and Evaluation of Traditional Chinese Medicines,Heilongjiang Institute for Drug Control,Harbin 150088,China)

机构地区：[1]黑龙江中医药大学,黑龙江哈尔滨150040 [2]黑龙江省药品检验研究院,国家药品监督管理局中药质量研究与评价重点实验室,黑龙江省中药质量研究与评价重点实验室,黑龙江哈尔滨150088

出　　处：《药学研究》2025年第4期384-393,共10页Journal of Pharmaceutical Research

基　　金：国家药品监督管理局药品监管科学体系建设重点项目(No.RS2024Z006)。

摘　　要：中成药在疾病治疗上具有安全、治本之优势,但往往作用缓和,起效相对较慢。近年来,不法分子向中成药中非法添加化学药物不正当牟利,患者在不知情的情况下服用此类药物会发生诸多安全隐患。因此,本文对目前中成药中非法添加化学药物的方式、特点、类别、代表成分、检测技术等进行归纳分析,并提出应对策略和建议,为药品监督管理部门科学监管提供参考依据,以期助力中成药不断规范化发展。Proprietary Chinese medicine has the advantages of safety and root cure in the treatment of diseases,but the effect is usually mild and the effect is relatively slow.In recent years,criminals have illegally added chemical drugs to proprietary Chinese medicines for improper profit,and many safety risks will occur when patients take such drugs without their knowledge.Therefore,this paper summarized and analyzed the methods,characteristics,categories,representative ingredients and detection techniques of illegal chemical drugs in proprietary Chinese medicines,and proposed countermeasures and suggestions to provide reference for scientific supervision by drug supervision and administration departments,in order to help the continuous standardized development of proprietary Chinese medicines.

关 键 词：中成药 非法添加 科学监管 质量安全 高分辨质谱 

分 类 号：R286[医药卫生—中药学]