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药品中需氧菌总数计数能力验证的结果与分析

Analysis of proficiency testing results of total aerobic microbial count in drugs

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目的 通过能力验证提高药品微生物实验室的管理能力和药品微生物检验检测的技术水平,确保实验室检验结果的准确性和可靠性.方法 根据《NIFDC-PT-340药品中需氧菌总数计数能力验证作业指导书》及《中国药典》2020版四部通则 1105非无菌产品微生物限度检查:微生物计数法进行检验.结果 样品QA03400543的计数结果为 34000 cfu·mL-1,QA03400717的计数结果为 38000 cfu·mL-1,样品QA03400447的计数结果小于1 cfu·mL-1.获得能力验证满意评价.结论 实验室完全具备药品中需氧菌总数计数的检验能力.
Objective Through the proficiency testing to improve the laboratory management and technical level of microbiological testing of drugs,ensure the accuracy and reliability of laboratory testing results.Methods The test was conducted according to the Operation Instruction for Verification of the Total Counting Ability of Aerobic Bacteria in NIFDC-PT-340 Drugs and the Microbiological Limit Test of non-sterile Products:Microbiological counting method in the fourth General Rule 1105 of Chinese Pharmacopoeia 2020 Edition.Results he experimental results show that the counting result of the sample QA03400543 is 34000 cfu·mL-1,the counting result of the QA03400717 is 38000 cfu·mL-1 and the counting result of the sample QA03400447 is less than 1 cfu·mL-1.Achieved satisfactory evaluation of the proficiency testing.Conclusion The laboratory has the ability of drugs total aerobic bacteria microbial count.

proficiency testingmicrobial limit testtotal aerobic microbial count

高土玲、何荣强、符天晓、夏体泽

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海南省检验检测研究院三亚分所,三亚 572000

能力验证 微生物限度检查 需氧菌总数

2024

实验室检验
中国检验检测学会

实验室检验

ISSN:2097-261X
年,卷(期):2024.2(3)
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