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2013-2016年我国中药材及饮片质量状况及相关问题探讨
引用本文:张萍,李明华,石岩,刘薇,魏锋,马双成. 2013-2016年我国中药材及饮片质量状况及相关问题探讨[J]. 中国药事, 2018, 32(4): 438-444
作者姓名:张萍  李明华  石岩  刘薇  魏锋  马双成
作者单位:中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050
摘    要:目的:分析近几年来我国中药材及饮片质量总体状况。方法:针对2013-2016年全国中药材及饮片的专项抽验、监督抽验及评价性抽验等工作,结合各省市药品监管部门的监督检查和抽验工作,对近几年来发现的中药材及饮片的质量情况进行了汇总与分析。结果:几年来经过国家食品药品监督管理总局和地方药品监管部门的大力监管,中药材及饮片的质量有所好转,但总体情况仍不容乐观。本文针对存在的问题进行了分析与探讨,并提出了相关建议和意见。结论:为相关部门制定监管策略提供大数据支持,进而有针对性地提高和完善药品标准,并有序、稳妥推进药品质量监管工作。

关 键 词:中药材  饮片  质量状况  相关问题  意见和建议
收稿时间:2017-02-23

Discussion on Quality Status and Related Problems of Chinese Medicinal Materials and Decoction Pieces from 2013 to 2016 in China
Zhang Ping,Li Minghu,Shi Yan,Liu Wei,Wei Feng and Ma Shuangcheng. Discussion on Quality Status and Related Problems of Chinese Medicinal Materials and Decoction Pieces from 2013 to 2016 in China[J]. Chinese Pharmaceutical Affairs, 2018, 32(4): 438-444
Authors:Zhang Ping  Li Minghu  Shi Yan  Liu Wei  Wei Feng  Ma Shuangcheng
Affiliation:National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:Objective: To analyze the general quality of Chinese medicinal materials and decoction pieces in recent years in China. Methods: The quality status of Chinese medicinal materials and decoction pieces in recent years was summarized and analyzed based on the data of national special sampling inspection, supervision sampling inspection, as well as evaluation sampling inspection of Chinese medicinal materials and decoction piece and combined with the supervision inspection and sampling inspection of provincial and municipal drug administration from 2013 to 2016. Results: The quality of Chinese medicinal materials and decoction pieces has been improved year by year due to the joint supervision of China Food and Drug Administration and local drug administration, but the overall quality is still not optimistic. We analyzed and discussed the problems of Chinese medicinal materials and decoction pieces and put forward relevant suggestions and comments. Conclusion: The paper provided big data support for relevant regulatory departments to draft regulatory policies, to improve standards for Chinese medicinal materials and decoction pieces, and to smoothly and orderly promote the supervision of drug quality.
Keywords:Chinese medicinal material  decoction piece  quality status  related problem  suggestions and comments
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