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 Surveillance Based on Questionnaire Survey

作　　者：郗昊 王翀[1] 程显隆[1] 王巨才[3] 孙婷 朱炯[1] 胡增峣 Xi Hao;Wang Chong;Cheng Xianlong;Wang Jvcai;Sun Ting;Zhu Jiong;Hu Zengyao(National Institute of Food and Drug Control,Beijing 102629,China;National Medical Products Administration,Beijing 100037,China;Hainan Institute For Drug Control,Haikou 570216;Hebei Institute of Drug and Medical Device Inspection,Shi Jiazhuang 050200,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药品监督管理局,北京100037 [3]海南省药品检验所,海口570216 [4]河北省药品医疗器械检验研究院,石家庄050200

出　　处：《中国药事》2024年第3期279-291,共13页Chinese Pharmaceutical Affairs

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。Objective:To provide references for further optimizing and improving the mechanism in Chinese medicinal herbs quality surveillance and explore a establishment for the national and provincial Chinese medicinal herbs quality surveillance.Methods:Based on the National Drug Sampling and Testing Cooperation Network,the method of online questionnaire surveys was conducted in the National Drug Sampling and Testing Information System to collect opinions and suggestions from national drug sampling inspection institutions and provincial drug supervision and administration departments.Results:A total of 46 quality inspection agencies and 32 drug supervision and administration departments responded to the questionnaire.The summary analysis showed that the Chinese medicinal herbs quality surveillance gradually established a coordinated national and provincial 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 Testing Collaboration Network,further optimize the variety selection process and scope,and improve the risk disposal mechanism around drug manufacturers,market of chinese medicinal herbs,and planting bases.

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 

分 类 号：R95[医药卫生—药学]