药品抽验中检出鲍曼不动杆菌案例的风险评估回顾和策略探讨  

Review and discussion on risk assessment of cases with Acinetobacter baumannii detected in national drug sampling

作　　者：顾珉 沈海英 顾炳仁 邢以文 GU Min;SHEN Haiying;GU Bingren;XING Yiwen(Suzhou Institute for Drug Control,Suzhou 215104,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215104

出　　处：《中国药品标准》2020年第6期487-493,共7页Drug Standards of China

摘　　要：药品微生物污染是引起药品安全性问题的重大风险因素,然而药品微生物实验室当前面临的普遍现实是应急反应能力慢、鉴定水平能力不足、对检出的具有潜在危害性的微生物评估手段应对不够,本文通过对2018年度国家药品抽样检验中检出鲍曼不动杆菌的案例回顾,依据《中国药典》进行潜在危害性的微生物的风险评估,从而为药品微生物检测实验室进行有关风险评估提供参考。Microbial contamination of drugs is a major risk factor that causes drug safety problems.However,the current situation of drug microbiological laboratories is that the emergency response is slow,the microbial identification ability is insufficient,and the assessment measures of potential pathogenic microorganisms are not enough.In this article cases with Acinetobacter baumannii detected in the national drug sampling in 2018 are reviewed and the risk assessment of potential pathogenic microorganisms is made according to the Chinese Pharmacopoeia.That provides a reference for the risk assessment of drug microbial test laboratory.

关 键 词：潜在危害性的微生物 微生物鉴定 风险评估 

分 类 号：R921.2[医药卫生—药学]