国家药品对照品有机氯农药混合对照品溶液的研制与不确定度评定  

Preparation and uncertainty evaluation on national drug reference substance of organochlorine pesticide mixed reference solution

作　　者：乔菲[1] 金红宇[1] 孙磊[1] 马双成[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2018年第2期347-353,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：国家十二五"重大新药创制"专项课题:中药质量安全检测和风险控制技术平台;课题编号:014ZX09304-307;子课题3:标准物质研制及痕量分析质量保证体系

摘　　要：目的:制备适用于中国药典2015年版农药残留量测定法的农药标准物质。方法:以药典通则2341中规定的22种农药为研究对象,以农药标准物质为原料,用容量法制备,采用气相色谱-电子捕获检测法(GC-ECD法)进行均匀性和稳定性检验,协作标定进行定值,并对量值的不确定度进行评估。结果:22种农药的质量浓度范围为9.9~10.5μg·mL^(-1),相对扩展不确定度为2.8%~8.4%。结论:有机氯农药混合对照品溶液符合国家药品对照品的技术要求,可为药品检验、科学研究等方面的测量和研究工作提供技术支撑和量值溯源保障。Objective：To prepare pesticide reference substance for the determination of pesticide residues following Chinese Pharmacopoeia（ChP）of 2015 edition.Method：22 kinds of pesticides described in the general rules 2341 of ChP were selected as the research objects.With the reference materials as raw material,mixed reference solution of organochlorine pesticide was prepared by volumetric method.After the homogeneity and stability tested by the gas chromatograph with configuring electron capture detector（GC-ECD）,collaborative calibration was used to set the value and the uncertainty of the fixed value was evaluated.Results：The mass concentration of 22 pesticides ranged from 9.9 to 10.5 μg·m L^-1,and the relative expanded uncertainty was 2.8%-8.4%.Conclusion：Mixed reference solution of organochlorine pesticide met the technical requirements of the national reference substance,and provided technical support for the measurement and research work in the field of drug control and scientific research.

关 键 词：有机氯农药 混合对照品 农药残留量 均匀性测定 稳定性 协作标定 不确定度 

分 类 号：R917[医药卫生—药物分析学]