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产地趁鲜切制药材质量控制现状分析

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目的 为企业参与趁鲜切制药材产地加工、采购趁鲜切制药材及其监管提供参考。方法 检索我国及各省/区/市药品监督管理局出台的产地趁鲜切制相关政策,以及维普、中国知网、PubMed数据库2010年1月至2024年4月与产地趁鲜切制相关的文献,对比各省/区/市相关政策,分析存在的主要问题,并提出对策。结果 全国已有25个省/区/市出台产地趁鲜切制相关政策,趁鲜切制品种总计共212个;当前药材产地趁鲜切制存在的主要问题包括硬件条件差,包装不规范,加工方法盲目、随意、不可控及掺杂使假等。结论 当前我国产地趁鲜切制药材质量存在不足。建议通过选择道地产区药材、强化供应商质量管理体系评估、加强对外合作、向上游延伸管理体系、建立全产业链质量追溯体系、严格按标准验收药材等方法加以改进。
Current Status of Quality Control of Fresh-Cut Medicinal Materials at Producing Areas
Objective To provide a reference for enterprises to participate in the processing of fresh-cut medicinal materials at the producing areas,purchase the fresh-cut medicinal materials and the pharmaceutical regulation.Methods The policies on fresh-cut processing at producing areas introduced by the National Medical Products Administration and drug regulatory administrations of Chinese provinces/autonomous regions/municipalities were searched,as well as the relevant literature in VIP,CNKI and PubMed databases from January 2010 to April 2024.The relevant policies in each province/autonomous region/municipality were compared,the main problems were analyzed,and the countermeasures were proposed.Results A total of 25 provinces/autonomous regions/municipalities nationwide had introduced the policies related to fresh-cut processing,involving 212 varieties.The main problems in the current fresh-cut processing at producing areas included poor hardware facilities,non-standard packaging,blind,arbitrary and uncontrollable processing,adulteration and counterfeiting.Conclusion Currently,there are deficiencies in the quality of fresh-cut medicinal materials at producing areas in China.Suggestions for improvement include selecting genuine regional drugs,strengthening quality management system evaluation of suppliers,enhancing external cooperation,extending management systems upstream,establishing a whole-industry-chain quality traceability system,and strictly inspecting medicinal materials according to standards.

producing areafresh-cut processingChinese medicinal materialquality control

于宗斌、潘宏春

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重庆太极实业<集团>股份有限公司,重庆 408000

重庆中药饮片厂有限公司,重庆 408000

产地 趁鲜切制 中药材 质量控制

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(24)