文章摘要
李明华,刘薇,程显隆,张萍,魏锋,马双成.我国中药红花的质量问题和监管策略[J].中国药事,2018,32(9):1217-1219
我国中药红花的质量问题和监管策略
On Quality Problems and Supervision Strategies of Traditional Chinese Medicine Carthami Flos
投稿时间:2017-07-04  
DOI:10.16153/j.1002-7777.2018.09.010
中文关键词: 红花  中药材  饮片  质量问题  染色
英文关键词: Carthami flos  TCM crud drugs  prepared slices  quality problem  dye
基金项目:国家科技重大专项"中药安全检测技术及标准平台"课题(编号2014ZX09304307-02)
作者单位E-mail
李明华 中国食品药品检定研究院, 北京 100050  
刘薇 中国食品药品检定研究院, 北京 100050  
程显隆 中国食品药品检定研究院, 北京 100050  
张萍 中国食品药品检定研究院, 北京 100050  
魏锋 中国食品药品检定研究院, 北京 100050 weifeng@nifdc.org.cn 
马双成 中国食品药品检定研究院, 北京 100050 masc@nifdc.org.cn 
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中文摘要:
      目的:通过检验和监管工作中发现的问题,对当前红花市场质量状况进行分析,为红花的质量监管及临床用药提供建议。方法:在全国范围内进行抽样检查,依据红花现行标准对抽验样品进行检验。统计分析检验数据及其存在的质量问题。结果:检验发现部分样品有染色现象。结论:染色的目的是掩盖药材的质量问题;非法加入的色素和染料,特别是一些化工合成染料的安全性风险较高,染色行为严重危害公众用药质量和安全。提升红花药材及饮片的质量,需要注重源头治理和可追溯体系建设,加强生产、流通、使用领域的监管,保障公众用药安全和有效。
英文摘要:
      Objective: To analyze the quality of crude drugs and prepared slices of traditional Chinese medicine (TCM) carthami flos based on the problems found during supervision and inspection, and to provide suggestions for the quality supervision and clinical medication.Methods: The samples which were obtained from national wide sample testing were tested according to the current standards of carthami flos. The test data and the quality problems were analyzed.Results: Some samples were illegally dyed.Conclusion: The purpose of dyeing is to cover the quality problems of the TCM crude drugs and prepared slices. The safety risk of illegal addition of pigments and dyes, especially some chemical synthetic dyes is high. The behavior of illegal dyeing seriously affects quality and safety of medication. In order to improve the quality of crude drugs and prepared slices of TCM carthami flos and ensure quality and safety of medication, the government should focus on source control and traceability system construction and pay more attention to the supervision of production, distribution and use.
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