摘要
目的:探讨对含有杂质的中药饮片依法认定假劣药的标准,讨论如何结合具体案情、质量风险等对处罚措施进行综合裁量,确保患者用药安全。方法:汇总国家药品监管部门颁布的相关法规及标准、有关省份的炮制规范及相关规定,查阅相关文献,并结合笔者参与某个假劣药认定的专家会议切身体会,针对相关问题展开讨论,提出建议。结果:中药饮片的杂质超标原因比较复杂,导致的结果不尽相同,有的可能不影响安全性、有效性,有的则可能危害人体。我国关于中药饮片含有杂质案件的假药/劣药认定和处罚存在一定的模糊地带,各省的执行情况也不统一。结论:在严格查处生产、销售假药/劣药定性的基础上,规范适用条款的认定,严重的情形应当视为生产销售假药;对从轻处罚的情形实施涉案中药饮片召回;对生产销售的中药材实行分级管理;亟需确立杂质占比超过标准多少被认定为假劣药的处罚标准;并尽快制定全国统一中药饮片的炮制规范。
Objective:To explore the criteria for identifying counterfeit and substandard drugs in accordance with the law for Chinese herbal pieces containing impurities,and to discuss how to implement comprehensive discretionary penalties based on specific cases,quality risks,and other factors to ensure the safety of patients' medication.Methods:Summarize the relevant regulations and standards issued by the national drug regulatory authorities,as well as the processing norms and relevant regulations of the relevant provinces,consult the literature,and combine the author's participation in the expert meeting of a counterfeit and substandard drug identification,discuss the relevant issues and make recommendations.Results:The phenomenon of impurities exceeding the standard in Chinese herbal pieces is common.The reasons are complicated,and it leads to dif ferent results.Some of the excessive impurities may not affect the safety and effectiveness,and some may endanger the human body.For all that there is a certain vague zone in the identification and punishment of counterfeit/substandard drugs in the case of Chinese herbal pieces containing impurities in China,and the implementation of the provinces is not uniform.Conclusion:On the basis of strict investigation and punishment of the production and sale of counterfeit drugs/substandard drugs,the identification of applicable provisions should be standardized.And serious cases should be regarded as production and sale of counterfeit drugs.In the case of light punishment,the recall of Chinese herbal pieces involved can be implemented.Hierarchical management can be used in the production and sales of Chinese medicinal materials.It is urgent to establish a penalty standard for determining the proportion of impurities exceeding the standard as counterfeit or inferior drugs.And the national processing standards of Chinese herbal pieces should be established as soon as possible.
作者
张志国
印遇龙
吴萍
蒯梦妮
杨磊
黄治
Zhang Zhiguo;Yin Yulong;Wu Ping;Kuai Mengni;Yang Lei;Huang Zhi(The First Afiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410007,China;Institute of Subtropical Agriculture,Chinese Academy of Sciences,Changsha 410125,China;The First People's Hospital of Changde,Changde 415700,China;Hunan Jiaoyang Law Firm,Changsha 410031,China)
出处
《中国药事》
2023年第12期1362-1368,共7页
Chinese Pharmaceutical Affairs
基金
全国名老中医药专家张志国传承工作室建设项目(编号国中医药人教发【2016】42号)
国家自然科学基金项目(编号81804075)
湖南省自然科学基金科药联合项目(编号2021JJ80021)
湖南省中医药管理局一般课题项目(编号B2023136)。
关键词
中药饮片
药品标准
杂质
假药
劣药
处罚标准
Chinese herbal pieces
pharmaceutical standards
impurities
counterfeit drugs
substandard drugs
punishment standards
