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化妆品中地塞米松检测能力验证研究
引用本文:高家敏,李红霞,项新华,曹进,丁宏.化妆品中地塞米松检测能力验证研究[J].中国药事,2017,31(9):1017-1020.
作者姓名:高家敏  李红霞  项新华  曹进  丁宏
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
摘    要:目的:设计组织化妆品中地塞米松测定能力验证项目,评价实验室检测化妆品中地塞米松的技术能力和水平,促进各参加实验室对该类测试项目检测能力的提高。方法:通过实施能力验证计划,获得各参加实验室化妆品中地塞米松含量的测定结果,对结果进行稳健统计分析,通过Z比分数评价实验室检测能力。结果:样品通过分析,在P<0.05显著水平,制备的300瓶样品均匀性符合要求且在整个计划周期内保持稳定,满足能力验证计划要求。40家参加能力验证的实验室中39家结果为满意结果,满意率为97.5%。结论:多数参加实验室检测能力评价为满意,表明化妆品中地塞米松检测水平总体良好。实验操作误差是造成个别实验室结果离群的主要原因。

关 键 词:实验室质量管理  能力验证  地塞米松  糖皮质激素  化妆品  液相色谱-串联质谱法  水平测试
收稿时间:2017/5/9 0:00:00

Proficiency Testing of Determination of Dexamethasone in Cosmetics
Gao Jiamin,Li Hongxi,Xiang Xinhu,Cao Jin and Ding Hong.Proficiency Testing of Determination of Dexamethasone in Cosmetics[J].Chinese Pharmaceutical Affairs,2017,31(9):1017-1020.
Authors:Gao Jiamin  Li Hongxi  Xiang Xinhu  Cao Jin and Ding Hong
Institution: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 design and organize the proficiency testing program (PTP) for determination of dexamethasone in cosmetics so as to assess the proficiency and level of the laboratories and to improve the proficiency of participant laboratories. Methods:Results of the content of dexamethasone in cosmetics of the participant laboratories were obtained through PTP and analyzed by robust statistics. The proficiency of the participant laboratories was evaluated by Z score. Results:All 300 bottles of prepared samples were homogeneous and stable in the whole program period at significant level of P<0.05, which met the requirement of PTP. 39 laboratories among the 40 laboratories participating in the proficiency testing had satisfactory results, with a satisfaction rate of 97.5%. Conclusion:The majority of participant laboratories passed the proficiency testing with satisfactory results, indicating that the detection capability for determination of dexamethasone in cosmetics was generally good. The main reason for the outlier results found in few laboratories was due to experimental operation error.
Keywords:laboratory quality management  proficiency testing  dexamethasone  glucocoticoid  cosmetics  liquid chromatography-tandem mass spectrometry  level testing
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