金银花中镉元素残留量测定能力验证研究
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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。
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
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
引文
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[2]ISO/IEC 17043:2010能力验证提供者认可准则[S]2010:3.
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[10]ISO 13528:2015实验室间比对能力验证用统计方法[S].2015:8.5.
[11]CNAS-G03:2006能力验证样品均匀性和稳定性评价指南[S].2015:4.
[12]桑国卫.中国药品检验操作规范[M].北京:中国医药科技出版社,2010.
[13]左甜甜,李耀磊,金红宇,等.ICP-MS法测定18种动物药中重金属及有害元素的残留量及初步风险分析[J].药物分析杂志,2017,37(2):237-242.
[14]左甜甜,李耀磊,陈沛,等.西洋参、山楂、枸杞子中重金属及有害元素残留量测定及初步风险评估[J].药物分析杂志,2016,36(11):2016-2021.
[2]ISO/IEC 17043:2010能力验证提供者认可准则[S]2010:3.
[3]王桂安,梁春穗,黄琼,等.广东省居民主要膳食镉暴露风险的初步评估[J].中国食品卫生杂志,2012,24(4):353-357.
[4]滕葳,柳琪,李倩,等.重金属污染对农产品的危害与风险评估[M].北京:化学工业出版社,1996.
[5]Jarup L,Akesson A.Current Status of Cadmium as an Environmental Health Problem[J].Toxicol Appl Pharm,2009,238(3):201-208.
[6]Satarug S,Garrett SH,Sens MA,et al.Cadmium,Environmental Exposure,and Health Outcomes[J].Cien Saude Colet,2011,16(5):2587-2602.
[7]中国药典:一部[S].2015.
[8]CNAS-GL40能力验证的选择核查与利用指南[S].2015:4.4.
[9]CNAS-GL02能力验证结果的统计处理和能力评价指南[S].2015:4.4.
[10]ISO 13528:2015实验室间比对能力验证用统计方法[S].2015:8.5.
[11]CNAS-G03:2006能力验证样品均匀性和稳定性评价指南[S].2015:4.
[12]桑国卫.中国药品检验操作规范[M].北京:中国医药科技出版社,2010.
[13]左甜甜,李耀磊,金红宇,等.ICP-MS法测定18种动物药中重金属及有害元素的残留量及初步风险分析[J].药物分析杂志,2017,37(2):237-242.
[14]左甜甜,李耀磊,陈沛,等.西洋参、山楂、枸杞子中重金属及有害元素残留量测定及初步风险评估[J].药物分析杂志,2016,36(11):2016-2021.