消炎止咳片微生物限度考察及问题菌株鉴定  

Investigation on Microbial Limit Inspection for Anti-inflammatory Cough Tablets and Method Study on Identification of Suspected Strains

作　　者：张翠所 高燕霞 

机构地区：[1]河北省药品检验研究院,石家庄050011

出　　处：《中国药事》2015年第5期522-527,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:通过建立消炎止咳片微生物限度检查方法,考察来源于20家生产企业、分布于31个省级行政单位、145家供样单位提供的208批样品微生物污染状况,并对发现的问题菌株进一步鉴定,为标准的修订提供参考。方法:采用5种阳性对照菌测定菌落回收率,对控制菌检查添加阳性对照菌的方式进行常规法的验证。同时对消炎止咳片按照现行药典进行微生物限度检查,并对检出菌株进行鉴定。结果:在208批样品检查中,微生物限度结果均在标准限度内,并有6批次检出与大肠埃希菌不易区分的非脱羧勒克菌(Leclercia adecarboxylata)。结论:消炎止咳片的微生物污染情况基本能被接受,建议其它被认可的菌种鉴定技术,可以作为标准收载的大肠埃希菌鉴定方法的补充。Objective： By establishing the method for microbial limit inspection for anti-inflammatory cough tables, to investigate the microbial contamination conditions of the 208 batches of samples from the 20 manufacturers, as well as 145 business units distributed in 31 provincial administrative units across the county, and to further identify the suspected strains so as to provide a reference for the revision of the standard. Methods： The colony recovery was determined by using five kinds of positive control strains, and the control bacteria were checked by adding the positive control bacteria with the conventional method. Meanwhile, the microbial limit inspection of the anti-inflammatory cough tables was carried out in accordance with the current Pharmacopoeia, and the detected strains were indentified. Results： In 208 batches of samples during inspection, the results were within the standard limit, and Leclercia adecarboxylata which was not easy to be distinguished from Escherichia coli was detected in 6 batches. Conclusion： The microbial contamination condition of anti-inflammatory cough tablets can be accepted basically, and it is suggested that other recognized species identification technology be used as the supplementary of the standard method of Escherichia coli.

关 键 词：微生物限度 非脱羧勒克菌 大肠埃希菌 

分 类 号：R921.2[医药卫生—药学]