文章摘要
李耀磊,金红宇,王丹丹,赵萌,高晓明,项新华,马双成.金银花中镉元素残留量测定能力验证研究[J].中国药事,2019,33(5):568-574
金银花中镉元素残留量测定能力验证研究
Study on Proficiency Testing of Determination Cadmium Residues in Honeysuckle
投稿时间:2018-10-18  
DOI:10.16153/j.1002-7777.2019.05.011
中文关键词: 能力验证  金银花    电感耦合等离子体质谱法  原子吸收法  微波消解  指定值
英文关键词: proficiency testing  honeysuckle  cadmium  ICP-MS  AAS  microwave digestion  assigned value
基金项目:国家十二五"重大新药创制"课题"中药质量安全检测和风险控制技术平台"(2014ZX09304307-002)
作者单位E-mail
李耀磊 中国食品药品检定研究院, 北京 100050  
金红宇 中国食品药品检定研究院, 北京 100050 jhyu@nifdc.org.cn 
王丹丹 中国食品药品检定研究院, 北京 100050  
赵萌 中国食品药品检定研究院, 北京 100050  
高晓明 中国食品药品检定研究院, 北京 100050  
项新华 中国食品药品检定研究院, 北京 100050  
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:评价参与能力验证实验室的镉元素残留量测定能力,提高残留检测质量水平。方法:根据CNAS相关文件要求,对制备的能力验证用金银花样品进行均匀性和稳定性检验,以参加实验室检测结果的中位值为指定值,采用实验室的检测结果与指定值的百分相对差(D)对能力验证结果进行统计分析,评价标准:|D|≤ 16%,评价结果为"满意";|D|>16%,评价结果为"不满意"。结果:在252家参加实验室中,有249家实验室按要求提交有效数据,满意率为94.4%,不满意率为5.6%。结论:大多数参加实验室对标准的执行能力和质量保障体系均比较良好。根据收集到的信息,对于产生偏离的原因,从总体上对共性问题进行技术分析,并给出相关的技术建议,有助于提升参加实验室的检验能力。
英文摘要:
      Objective:To evaluate the capacity of laboratories participated in the proficiency testing of determination Cadmium residues and improve the quality of residual testing. Methods:According to the requirements of CNAS related documents, the homogeneity and stability of the prepared honeysuckle samples for proficiency testing were evaluated. The median value of the test results of the laboratories participated in the proficiency testing was used as assigned value. Statistical analysis was carried out on the results of the proficiency testing using the relative difference between the test results of the laboratory and the assigned values (D). Evaluation criteria:if|D| ≤ D|t, the result was satisfactory; if|D|>16%, the result was unsatisfactory. Results:Of the 252 laboratories participated in the proficiency testing, 249 submitted valid data as required, with a satisfaction rate of 94.4% and an unsatisfactory rate of 5.6%. Conclusion:Most laboratories participated in the proficiency testing have a good performance and quality assurance system. According to the information collected, a technical analysis in general was carried out to find out the reasons for the deviation, hence relevant technical suggestions were given to help improve the testing ability of the laboratories.
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