中药材及饮片质量问题与流通一线监管能力提升对策OA
Quality Problems of Traditional Chinese Medicinal Materials and Decoction Pieces and Countermeasures for Improving the Frontline Supervision Capability of Circulation
目的 探讨中药材及饮片市场存在的质量问题与药品流通一线监管存在的不足,阐述提升中药材及饮片流通一线监管快速鉴别能力的对策.方法 利用市场调查、文献检索和收集各级药品监管部门公开信息,梳理并分析我国中药材及饮片市场常见质量问题与药品流通一线监管存在的不足,阐述提升药品流通一线监管能力的有效举措.结果 我国中药材及饮片市场存在以其他品种冒充正品、相似品种混用、掺入非药用部位或杂质等问题,而流通一线监管存在检查重"文件"轻"质量"、监管人员缺乏快速鉴别技能、质量标准繁杂而不统一、监管人力资源不能满足市场监管需要等短板.对此,应当在药品流通一线监管中采取加强中药传统经验鉴别技能培训,推广中药快速检测技术应用,开展中药数智化服务监管等措施,提升相应机构及人员的监管能力.结论 树立科学监管理念、加强一线监管人员队伍建设、提升一线监管执法装备水平、借助专业力量和鼓励先进技术的应用,是解决当前中药材及饮片市场监管难题的有效途径.
Objective To investigate the quality issues existing in the market of traditional Chinese medicinal materials and decoction pieces,as well as the deficiencies in the frontline supervision of drug circulation,and elaborate on the countermeasures to improve the rapid identification ability of frontline supervision in the circulation of traditional Chinese medicinal materials and decoction pieces.Methods Market surveys,literature retrieval,and public information from drug regulatory authorities at all levels were used to systematically review and analyze the common quality problems in the market of traditional Chinese medicinal materials and decoction pieces in China,as well as the deficiencies in frontline supervision of drug circulation.The effective measures to improve the frontline supervision capabilities of drug circulation were elaborated.Results The market of Chinese medicinal materials and decoction pieces in China faced problems such as other varieties being passed off as genuine products,similar varieties being mixed,and non-medicinal parts or impurities being added.Meanwhile,shortcomings including an emphasis on ″documents″ over ″quality″ in inspections,a lack of rapid identification skills among supervisory personnel,complex and inconsistent quality standards,and insufficient regulatory manpower to meet market supervision needs to be still exhibited in the frontline of supervision of circulation.In response,measures such as strengthening training of traditional empirical identification skills of traditional Chinese medicine,promoting the application of rapid detection technology for traditional Chinese medicine,and implementing digital intelligence service supervision for traditional Chinese medicine should be adopted in frontline supervision of drug circulation to enhance the regulatory capabilities of relevant institutions and personnel.Conclusion Establishing a scientific supervision concept,strengthening the construction of frontline supervision personnel,improving the level of frontline supervision and law enforcement equipment,leveraging professional forces,and encouraging the application of advanced technologies are effective ways to solve the current regulatory challenges in the market of Chinese medicinal materials and decoction pieces.
计周正;葛蓉;林锦锋
广东省药品检验所,广东 广州 510663广东省药品检验所,广东 广州 510663广东省药品检验所,广东 广州 510663
医药卫生
中药材中药饮片药品流通监管能力科学监管
Chinese medicinal materialsChinese decoction piecesdrug circulationsupervision capacityscientific supervision
《中国药业》 2026 (8)
28-33,6
广东省药品监督管理局科技创新项目[2022YDZ03].
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