磺胺间甲氧嘧啶钠注射液含量测定的能力比对结果分析

Result Analysis of Laboratory Capacity Comparison for Content Determination of Sulfamonomethoxine Sodium Injection

关键词:  磺胺间甲氧嘧啶钠注射液含量测定  能力比对  永停滴定法  Z比分数

Key words:  content  determination of  Sulfamethoxine Sodium  Injection, capacity  comparison, dead-stop  titration, Z-score

摘要:

为加强兽药检验检测机构能力建设,进一步提升检测技术水平,组织开展了全国省级兽药检验机构磺胺间甲氧嘧啶钠注射液含量测定的能力比对。依据《中国兽药典》2020年版一部附录0701电位滴定法与永停滴定法以及中国合格评定国家认可委员会(CNAS)规定的程序进行本次能力比对。分别采用单因子方差分析法和Ss≤0.3σ准则对测试样品进行均匀性检验,采用t检验方法和σ准则对样品进行稳定性考察,采用Z比分数评价各参加实验室的测试结果。参加本次能力比对的36家兽药检测实验室中,33家结果为满意,满意率91.7%。

Abstract:

In order to strengthen the capacity-building of veterinary drug inspection and testing institutions and further improve the level of detection technology, veterinary drug testing and other relevant institutions were organized to carry the capacity comparison of content determination of Sulfamethoxine Sodium Injection. According to appendix 0701 potentiometry and dead-stop titration of the Chinese Veterinary Pharmacopoeia (2020 edition) and the procedures stipulated by China National Accreditation Service for Conformity Assessment (CNAS), this comparison was carried out. The homogeneity of the samples were tested by one-way ANOVA and Ss≤0.3σ criteria, respectively, and the stability of the samples were examined by t-test andσ criteria which met the requirements. The Z-score was used to evaluate the test results of each participating laboratory. Among the 36 veterinary drug testing laboratories that participated in the capacity comparison, 33 were satisfied with the results, with a satisfaction rate of 91.7%.