感冒清热颗粒微生物限度检查及质量分析  

Microbial limit test and quality analysis for Ganmao Qingre granules

作　　者：牛萌萌 姬俊 王立云 王尊文 NIU Mengmeng;JI Jun;WANG Liyun;WANG Zunwen(Qingdao Institute for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Traditional Marine Chinese Medicine,Qingdao 266071,China;Qingdao Women and Children′s Hospital,Qingdao 266034,China)

机构地区：[1]青岛市食品药品检验研究院,国家药监局海洋中药质量研究与评价重点实验室,山东青岛266071 [2]青岛市妇女儿童医院,山东青岛266034

出　　处：《中国药品标准》2023年第5期525-528,共4页Drug Standards of China

基　　金：国家药品评价性抽验品种。

摘　　要：目的:考察55家生产企业220批次的感冒清热颗粒的微生物污染情况。方法:依据《中国药典》2015年版和2020年版对感冒清热颗粒进行微生物限度方法适用性试验,按建立的方法进行微生物限度检查,并对结果进行分析。结果:所有批次的感冒清热颗粒的微生物限度检验结果均符合规定,在控制菌检验中分离出其他污染菌,经鉴定分别为鲍曼不动杆菌复合物、阪崎肠杆菌属、非脱羧勒克菌、气味沙雷菌、泛菌属。结论:220批感冒清热颗粒微生物限度的合格率为100%,其中10个厂家共18批次的感冒清热颗粒在控制菌检查中检出其他条件致病菌,可能存在微生物污染的潜在危害。Objective:To investigate the microbial contamination in 220 batchesof Ganmao Qingre granules from 55 manufacturers.Methods:To establish a method for microbial limit test applied to Ganmao Qingre granules according to the Chinese Pharmacopoeia 2015 and 2020.Results:All the results of microbial limits met the requirements.In the control bacteria test,some contaminant bacteria were separated and identified as Acinetobacter baumannii complex,Cronobacter sakazakii group,Leclercia adecarboxylata,Serratia odorifera and Pantoea species.Conclusions:All Ganmao Qingre granules were fully qualified in microbial limit test,in which 18 batches of samples from 10 manufacturers were found to have opportunistic pathogens,indicating the potential risk of microbial contamination.

关 键 词：感冒清热颗粒 微生物限度检查 微生物鉴定 微生物污染 

分 类 号：R921.2[医药卫生—药学]