摘要
目的:评价参与能力验证(proficiency testing,PT)实验室的黄曲霉毒素残留量检测能力,促进药品行业残留检测质量水平的提高。方法:制备黄曲霉毒素B;残留量测定能力验证用远志样品,根据中国合格评定认可委员会(CNAS)相关文件要求,对其均匀性和稳定性进行检验,并按照项目计划发放样品;以参加实验室检测结果的中位值为指定值,依据Horwitz方程计算能力评定标准差,采用Z比分对能力验证结果进行统计分析,评价标准:|Z|≤2%,评价结果为"满意";2<|Z|<3,评价结果为"可疑";|Z|≥3,评价结果为"不满意"。结果:参加能力验证计划实验室共69家,均按项目要求提交有效数据,满意率为100%。结论:参加黄曲霉毒素残留量检测的实验室对标准的执行能力和质量保障体系整体较好。深入分析收集的原始数据及实验报告,对黄曲霉毒素检测时存在的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 which participated in the proficiency testing for aflatoxins residue determination and improve the quality of residual testing.Methods:Polygalae radixsamples for proficiency testing of aflatoxin B;residues were prepared,their uniformity and stability were tested according to the requirements of CNAS related documents,then the samples were distributed according to the project plan.Taking the median value of the laboratory test results as the specified value,the standard deviation of the ability assessment was calculated according to the Horwitz equation,and theZscore was used to perform statistical analysis of the proficiency test results.The evaluation standard was set as follows:|Z|≤2%,the evaluation result was‘satisfactory’;2<|Z|<3,the evaluation result was‘suspicious’;|Z|≥3,the evaluation result was‘unsatisfactory’.Results:A total of 69 laboratories participating in the proficiency testing program submitted valid data according to project requirements,and the satisfaction rate was 100%.Conclusion:The laboratories participating in the detection of aflatoxin residues have relatively good overall implementation capabilities and quality assurance systems.In-depth analysis of the collected raw data and experimental reports,technical analysis of common problems existing in the detection of aflatoxin,and relevant technical suggestions are helpful to improve the testing capabilities of participating laboratories.
作者
李耀磊
李海亮
昝珂
王丹丹
项新华
金红宇
马双成
LI Yao-lei;LI Hai-liang;ZAN Ke;WANG Dan-dan;XIANG Xin-hua;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第4期337-342,共6页
Chinese Journal of New Drugs
基金
国家“重大新药创制”科技重大专项资助项目(2018ZX09303-024,2018ZX09735-006)。
关键词
能力验证
远志
黄曲霉毒素B
HPLC法
光化学衍生法
碘衍生法
指定值
proficiency testing
Polygalae radix
aflatoxin B1
HPLC
photochemical derivatization
iodine derivatization
assigned value
