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在 ISO/CD 指南 80 框架下生产磺胺甲噁唑质控材料。

Producing a sulfamethazine quality control material under the framework of ISO/CD Guide 80.

机构信息

Ministério da Agricultura, Pecuária e Abastecimento - MAPA Laboratório Nacional Agropecuário de Minas Gerais - LANAGRO/MG, Av. Rômulo Joviano, s/n° Cx. Postal 35, 50 CEP.: 33600-000 Pedro Leopoldo/Minas Gerais, Brazil.

出版信息

Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2012;29(4):571-6. doi: 10.1080/19440049.2011.641162. Epub 2012 Jan 13.

DOI:10.1080/19440049.2011.641162
PMID:22243444
Abstract

The increasing use of antimicrobial agents such as sulfonamides by the pig industry is of concern, since residues in both pork and its by-products, when derived from animals treated improperly, can endanger human health. The aim of this study was to establish the production conditions and to evaluate the homogeneity and the stability of sulfamethazine in porcine liver quality control material, produced 'in-house' for use in ring tests of the laboratory network of residues and contaminants of the Ministry of Agriculture, Livestock and Food Supply, Brazil. In the process of preparing the material, a FOSS blender was used, where the samples were ground to obtain a homogeneous mass, which was packed in polypropylene bottles. The material resulting from this process of homogenisation was sampled and analysed by LC/MS/MS. The analytical results were statistically evaluated by one-way ANOVA. According to statistical evaluation, the material produced was considered homogeneous, with 95% confidence. Stability tests were performed with the bottles stored under the specified storage conditions. They were randomly selected and analysed in duplicate by the same analytical method as the homogeneity study. The analytical results were statistically evaluated by the procedures for a stability check described in ISO 13528:2005, indicating that the material was unstable under the conditions of storage.

摘要

养猪业对抗菌剂(如磺胺类药物)的使用不断增加引起了人们的关注,因为如果动物处理不当,猪肉及其副产品中的残留药物会危害人类健康。本研究旨在为巴西农业部残留和污染物实验室网络的内部环测试建立生产条件,并评估磺胺甲恶唑在猪肝脏质控材料中的均一性和稳定性。在制备材料的过程中,使用了 FOSS 混合器,将样品粉碎以获得均匀的质量,并将其包装在聚丙烯瓶中。通过 LC/MS/MS 对来自这一均化过程的材料进行采样和分析。采用单因素方差分析对分析结果进行统计学评估。根据统计学评估,所生产的材料具有 95%置信度的均匀性。采用规定的储存条件对储存的瓶子进行稳定性测试。按照与均一性研究相同的分析方法,随机选择并进行双份分析。采用 ISO 13528:2005 中描述的稳定性检查程序对分析结果进行统计学评估,表明在储存条件下,该材料不稳定。

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