| 郗昊,王翀,程显隆,王巨才,孙婷,朱炯,胡增峣.基于问卷调研的中药材质量监测机制优化探索[J].中国药事,2024,38(3):279-291 |
| 基于问卷调研的中药材质量监测机制优化探索 |
| Optimization of the Mechanism in Chinese Medicinal Herbs Quality SurveillanceBased on Questionnaire Survey |
| 投稿时间：2023-10-23 |
| DOI：10.16153/j.1002-7777.2024.03.006 |
| 中文关键词: 国家药品抽检协作网络 在线问卷调研 中药材质量监测 |
| 英文关键词: national drug sampling and testing collaboration network online questionnaire surveys Chinesemedicinal herbs quality surveillance |
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| 摘要点击次数: 651 |
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| 中文摘要: |
| 目的：为进一步优化完善中药材质量监测机制，探索建立国家与省级中药材质量监测统筹模式提供参考。方法：基于国家药品抽检协作网络，在国家药品抽检信息系统内，采用在线问卷调研的方式，面向国家药品抽检承检机构以及省级药品监督管理部门征集意见建议。结果：共有46家承检机构与32家药品监督管理部门作答问卷，汇总分析显示，中药材质量监测逐步建立相互衔接、各有侧重的国家与省级协作体系，适当扩大监测品种范围，对药材市场与种植基地、饮片和中成药生产企业重点监测，建立风险分级管理制度，并与国家药品抽检协同发布监测结果。结论：中药材质量监测应当基于国家药品抽检协作网络，进一步优化品种遴选流程与范围，围绕药品生产企业、药材市场与种植基地，完善风险处置机制。 |
| 英文摘要: |
| Objective: To provide references for further optimizing and improving the mechanism in Chinesemedicinal herbs quality surveillance and explore a establishment for the national and provincial Chinesemedicinal herbs quality surveillance. Methods: Based on the National Drug Sampling and Testing CooperationNetwork, the method of online questionnaire surveys was conducted in the National Drug Sampling and TestingInformation System to collect opinions and suggestions from national drug sampling inspection institutions andprovincial drug supervision and administration departments. Results: A total of 46 quality inspection agenciesand 32 drug supervision and administration departments responded to the questionnaire. The summary analysisshowed that the Chinese medicinal herbs quality surveillance gradually established a coordinated national andprovincial cooperation system with diff erent focuses, expanded the scope of surveillance varieties appropriately,emphasized the surveillance on the market and planting base of Chinese medicinal herbs, decoction pieces and traditional Chinese patent medicines production enterprises, established a risk classifi cation management system,and released monitoring results in coordination with Nnational Drug Sampling and Testing Program. Conclusion:The Chinese Medicinal Herbs Quality Surveillance should be based on the National Drug Sampling and TestingCollaboration Network, further optimize the variety selection process and scope , and improve the risk disposalmechanism around drug manufacturers, market of chinese medicinal herbs, and planting bases. |
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