| 高妍,伊辛,过立农,唐琳娜,芦进财,刘杰,马双成,郑健,昝珂.全国肉苁蓉饮片专项抽验情况分析与研究[J].中国药事,2019,33(6):679-685 |
| 全国肉苁蓉饮片专项抽验情况分析与研究 |
| Analysis and Research on National Special Sampling Inspection of Cistanches Herba Decoction Pieces |
| 投稿时间：2019-03-07 |
| DOI：10.16153/j.1002-7777.2019.06.012 |
| 中文关键词: 肉苁蓉 中药饮片 专项抽验 质量分析 沙苁蓉 混伪品 |
| 英文关键词: Cistanches Herba decoction pieces of Chinese herbal medicines special sampling inspection quality analysis Cistanche sinensis adulterant |
| 基金项目:国家科技重大专项（编号2018ZX09735-006）；中医药行业科研专项“中药饮片质量保障系统研究（一）”（编号201507002） |
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| 中文摘要: |
| 目的：通过全国中药材饮片专项抽验工作，了解肉苁蓉饮片市场整体质量现状及存在的问题，为相关部门实施监管措施提供技术支持和依据，完善肉苁蓉检验标准，保障公众用药安全。方法：从全国30个省级行政区抽取肉苁蓉饮片样品，按照《中华人民共和国药典》2015年版一部肉苁蓉项下规定开展检验工作，出具检验报告，分析检验数据以评价肉苁蓉饮片市场情况。针对检验中发现的问题，采用实地调研、生药学鉴定等技术开展探索性研究。结果与结论：本次抽验的肉苁蓉样品共计171批次，按现行质量标准检验合格159批，不合格12批，均为【性状】不合格，经探索性研究鉴定不合格样品为伪品沙苁蓉片或掺有沙苁蓉片的肉苁蓉饮片样品。 |
| 英文摘要: |
| Objective:To analyze the overall quality status and the related quality problems of Cistanches Herba decoction pieces in the market through national special sampling inspection of decoction pieces of Chinese herbal medicines in order to provide technical support and references for relevant departments to formulate and implement regulatory measures, improve testing standards and ensure the safety of drug use. Methods:According to the current statutory standard of Cistanches Herba stipulated in Chinese Pharmacopoeia (2015 edition), the quality inspection and data analysis were carried out to evaluate the quality of Cistanches Herba decoction pieces in the market, which were sampled and inspected from 30 provincial administrative regions in China. Moreover, techniques such as on-site investigation and pharmacognosy identification were used in exploratory study to solve the problems found in quality inspection. Results and Conclusion:A total of 171 batches of Cistanches Herba piece samples collected nationwide were tested, among which 159 batches were qualified whereas 12 batches were unqualified (labeled as unqualified traits) according to the current quality standards. In exploratory research, the unqualified samples were identified as fake Cistanche sinensis or Cistanches Herba decoction pieces with adulterated Cistanche sinensis. |
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