铜绿假单胞菌能力验证样品的研制及应用研究  

Research on Preparation and Application of Pseudomonas Aeruginosa Capability Verification Samples

作　　者：余文[1] 安琳 陈怡文 任秀[1] 骆海朋[1] 刘娜[1] 崔生辉[1] Yu Wen;An Lin;Chen Yiwen;Ren Xiu;Luo Haipeng;Liu Na;Cui Shenghui(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2020年第7期806-811,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:研制符合能力验证要求的铜绿假单胞菌质控样品,并将该质控样品用于铜绿假单胞菌的能力验证。方法:通过对冻干工艺和冻干保护剂的研究,研制出均一性、储藏稳定性和运输稳定性均符合要求的能力验证样品。本次能力验证样品为2瓶以粉底膏为基质的铜绿假单胞菌样品,通过产生随机数字的方式对样品进行编码,然后随机分配给参试实验室。结果:铜绿假单胞菌的质控样品的均一性、储藏和运输稳定性均符合能力验证中质控样品的要求;全国65家实验室中62家结果评定为满意,满意率为95.38%。3家不满意的实验室中2家为省级检验机构,1家为地市级检验机构。省级检验机构的满意率为94.28%,地市级检验机构的满意率为95.65%。结论:研制的铜绿假单胞菌质控考核样品可以满足能力验证的需求,本次能力验证真实地反映了参试单位的检测水平。Objective:To develop the quality control samples of Pseudomonas aeruginosa that conform to proficiency tests and to apply the quality control samples to the proficiency test of Pseudomonas aeruginosa.Methods:By studying the lyophilization process and the lyophilization protectant,the samples which meet the requirements of homogeneity,storage and transportation stability have been developed.The proficiency test samples consisted of 2 bottles of Pseudomonas aeruginosa based on foundation paste,which were randomly assigned to the participating laboratories.Results:The homogeneity,storage and transportation stability of the quality control samples of Pseudomonas aeruginosa met the requirements of proficiency tests.62 out of the 65 laboratories rated the result as satisfaction.The satisfactory rate is 95.38%.2 of 3 unsatisfactory laboratories are provincial-level,and one is municipal-level.The satisfactory rate of provincial-level and municipal-level laboratories was 94.28%and 95.65%respectively.Conclusion:The quality control test samples of Pseudomonas aeruginosa can meet the requirements of proficiency tests.This proficiency test truly reflects the testing level of the participating laboratories.

关 键 词：化妆品 能力验证 铜绿假单胞菌 

分 类 号：R95[医药卫生—药学]