摘要
采用人工加菌方式建立药品微生物检验的不确定度评定方法。依据《中国药典》2020版通则1105中非无菌产品微生物限度检查微生物计数法,对药品辅料玉米淀粉进行人工加菌后,分析在检验过程中引入的不确定度,并建立数学模型对不确定度进行评定。样品的扩展不确定度U=0.046(以对数结果计算,置信区间P=95%,k=2)。样品进行人工污染已知菌株的方式建立的不确定度评定方法及结论,可为微生物实验室药品检验内部质量控制提供依据和参考。
Establish an uncertainty assessment method for drug microbiological testing using artificial addition of bacteria.According to the microbial count method in the microbial limit test of non-sterile products in the general rule 1105 of Chinese Pharmacopoeia 2020,after the drug adjuvant corn starch was artificially added with bacteria,analyze the uncertainty introduced during the inspection process,and establish a mathematical model to evaluate the uncertainty.The combined uncertainty of sample was 0.046(calculated as a logarithmic result,confidence interval P=95%,k=2).The evaluation method and conclusion of uncertainty established by the method of artificially contaminating samples with known strains can provide basis and reference for the internal quality control of microbiology laboratory drug testing.
作者
杨亚宗
于波
YANG Yazong;YU Bo(Being Union Pharmaceutical Factory limited company,Beijing,102600,China)
出处
《质量安全与检验检测》
2024年第5期74-78,共5页
QUALITY SAFETY INSPECTION AND TESTING
关键词
药品微生物
菌落总数
不确定度
Drug microorganisms
Total number of colonies
Uncertainty
作者简介
第一作者:杨亚宗,E-mail:yangyazong123@126.com。
