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基于2023-2025年上海中药饮片质量抽检状况分析的监管策略OA

Research on the Supervision Strategy Based on the Analysis of the Quality Status of Chinese Herbal Pieces in Shanghai Sampling Inspection from 2023 to 2025

中文摘要英文摘要

目的 通过对2023-2025年上海市中药饮片抽检数据进行分析,梳理当前中药饮片质量现状、主要不合格项目及风险点,为提升中药饮片质量监管效能提供科学依据和政策建议.方法 检索2023-2025年在上海阳光医药采购网公示的中药饮片抽检数据,结合不合格品种的分布及特征进行统计分析.结果 抽检数据显示,中药饮片总体合格率较高,但部分品种在性状、水分、含量测定、鉴别等方面仍存在较高风险.结论 上海市中药饮片质量整体向好,但在源头污染、工艺控制、标准执行等方面仍存有隐患.建议从源头上强化对中药质量的管控,注重中药饮片的加工管理,建立统一规范,并通过多方协作加强监管,以形成科学而系统的中药饮片质量监督体系.

Objective To outline the current quality status of Chinese herbal pieces,identify major non-compliance issues and risk points,and provide scientific evidence and policy recommendations for improving the quality supervision efficiency of Chinese herbal pieces by analyzing the quality status of Chinese herbal pieces in Shanghai sampling inspection from 2023 to 2025.Methods Sampling inspection data of Chinese herbal pieces publicly disclosed by the Shanghai Pharmaceutical Procurement Center from 2023 to 2025 were retrieved and statistically analyzed based on the distribution and characteristics of non-compliant varieties.Results The sampling inspection data indicated that the overall qualification rate of Chinese herbal pieces was high.However,certain varieties still exhibited elevated risks in aspects such as characteristics,moisture content,content determination,and identification.Conclusion The overall quality of Chinese herbal pieces in Shanghai is improving,but risks remain in areas such as source contamination,process control,and standard implementation.Recommendations include strengthening source control of herbal material quality,emphasizing the processing management of Chinese herbal pieces,unifying standards,and enhancing multi-stakeholder intelligent supervision to build a scientific and systematic quality supervision system for Chinese herbal pieces.

顾晓玲;邱彦;陆涛;白雪松

上海市浦东新区人民医院药剂科,上海 201299上海市浦东新区人民医院药剂科,上海 201299上海市浦东新区人民医院药剂科,上海 201299上海市浦东新区人民医院药剂科,上海 201299

医药卫生

中药饮片抽检状况监管策略上海

Chinese herbal piecessampling inspectionsupervision strategyShanghai

《光明中医》 2026 (12)

23-27,5

上海市浦东新区卫生健康委员会学科建设项目(No.PWZbr2022-13)浦东新区卫生健康委员会优秀青年医学人才培养计划(No.PWRq2024-44)上海市浦东新区"国家中医药传承创新发展试验区"建设基金:《清宫医案》中代茶饮及膏药方配伍组方特色研究(No.PDZY-2025-0512)

10.70976/j.issn.1003-8914.2026.12.005

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