药品中金黄色葡萄球菌的定性检测和质量控制

Qualitative detection and quality control of staphylococcus aureus in medicines

目的:通过参加中国食品药品检定研究院组织的药品中金黄色葡萄球菌检测能力验证,提升实验室药品中金黄色葡萄球菌的检测能力。方法:参照作业指导书及《中国药典》四部对3份样品进行检验,利用血浆凝固酶实验及全自动生化鉴定仪进行菌种鉴定。结果:第1,3份未检出金黄色葡萄球菌,第2份样品检出。结论:本实验室能力验证结果满意,认证了实验室检测能力。

Objective:To improve the detection and calibration ability of staphylococcus aureus level for laboratory drugs through proficiency testing.Methods:Based on the work instruction and Chinese pharmacopoeia in volume four,three groups of samples were tested accordingly,where the staphylococcus aureus were identified through plasma coagulase test and automatic biochemical analyzer.Results:No staphylococcus aureus was detected in the sample 1 and 3,but in the sample 2.Conclusion:Satisfactory results are obtained through the laboratory’s ability verification,which certifies the drug testing ability of the laboratory.