目的 研究并建立甲基安非他明检测试剂盒国家参考品。方法 通过检测阈值确定、原料筛选、参考品组成的确定、参考品配制等步骤制备甲基安非他明检测试剂盒国家参考品,并采用经方法学验证的液质联用含量测定法对样品盘进行标定及稳定性考察。结果 建立的甲基安非他明检测试剂盒国家参考品包括阳性参考品1份,阴性参考品12份,最低检测限参考品3份,重复性参考品1份。结论 建立甲基安非他明检测试剂盒国家参考品,该参考品的准确性和稳定性均可以满足作为参考品的要求。该参考品通过了5家检测试剂盒生产企业的协作标定。为甲基安非他明检测试剂盒的质量控制建立统一的标准物质,有助于规范我国毒品类试剂盒的研制和生产过程的规范。
Abstract
OBJECTIVE To establish the reference panel of methamphetamine(MET) Kits. METHODS After determining the cut-off value of MET kits, selecting the raw material, and determining the component of reference material, MET kits reference material was prepared. The reference material was characterized by verified LC-MS method, and also tested for the stability. RESULTS The national reference material of MET kits consists of one positive sample, 12 negative samples, three LOD samples, and one repeatability sample. This reference material passed the co-characterization of five companies. CONCLUSION The developed national reference material of MET kits meets the corresponding requirement. The establishment of the national reference material of MET kits may help regulate the development and production process of the drug kits.
关键词
甲基安非他明检测试剂盒 /
国家参考品 /
液质联用
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Key words
methamphetamine kits /
national reference panel /
LC-MS
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中图分类号：
R917
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参考文献
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脚注
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基金
中国食品药品检定研究院中青年发展研究基金资助项目(2013NA5)
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