口腔溃疡糊剂微生物检查方法学研究  

Methodological study on microbial detection of stomatic ulcer paste

作　　者：王铁战 李莉娜 李冬梅 李建民 张翠所 WANG Tie-zhan;LI Li-na;LI Dong-mei;LI Jian-min;ZHANG Cui-suo(Hebei Pharmaceutical Professional Inspector Corps,Shijiazhuang,Hebei 050002,China)

机构地区：[1]河北省药品职业化检查员总队,河北石家庄050002 [2]河北一品制药股份有限公司 [3]河北省药物警戒中心 [4]河北省药品医疗器械检验研究院

出　　处：《中国卫生检验杂志》2023年第11期1281-1284,共4页Chinese Journal of Health Laboratory Technology

基　　金：河北省市场监督管理局科技计划项目(2020ZC50)。

摘　　要：目的建立口腔溃疡糊剂微生物限度及控制菌检查方法。方法采用常规法、稀释法和薄膜过滤法对口腔溃疡糊剂进行微生物限度和控制菌检查的方法学研究。结果口腔溃疡糊剂的微生物限度检查,霉菌和酵母菌总数检查可采用常规法,需氧菌总数采用薄膜过滤法,用pH7.0氯化钠-蛋白胨缓冲液冲洗滤膜至少500 ml/膜;控制菌检查,大肠埃希菌和铜绿假单孢菌检查可采用常规法,金黄色葡萄球菌检查需用培养基稀释法(600 ml)。结论口腔溃疡糊剂对金黄色葡萄球菌有较强的抑制作用,微生物项目检查要进行方法适用性验证,避免出现假阴性结果,保证检验结果的准确性。Objective This paper aims to establish a detection method for microbial limit and bacteria control in stomatic ulcer paste.Methods Routine method,diluting method and membrane filtration method were employed to conduct the methodology study of microbial limit and control bacteria in stomatic ulcer paste.Results For microbial limit detection in stomatic ulcer paste,a routine method is competent for the detection of total count of yeasts and molds,and total aerobic microbial count required the membrane filtration method,with the filter membrane washed with pH7.0 sodium chloride-peptone buffer solution not≥500 ml/membrane.For control bacteria detection,a routine method is competent for the detection of Escherichia coli and Pseudomonas aeruginosa;the detection of Staphylococcus aureus requires a medium dilution method(600 ml).Conclu⁃sion Stomatic ulcer paste showed a strong inhibitory effect on Staphylococcus aureus,and the applicability of the method should be verified to avoid false negative results and ensure the accuracy of the results.

关 键 词：口腔溃疡糊剂 微生物限度 控制菌 薄膜过滤法 稀释法 

分 类 号：R446.5[医药卫生—诊断学]