阿奇霉素干混悬剂微生物限度检查方法选择原则  

The principles for selection of microbial limit test methods of Azithromycin for suspension

作　　者：闵红 张秉华 闫博 刘宇 戴涌 MIN Hong;ZHANG Binghua;YAN Bo;LIU Yu;DAI Yong(Shaanxi Institute for Food and Drug Control,Shaanxi,Xi’an 710065,China;Suide County market supervision and law enforcement brigade,Shaanxi,Suide 718099,China)

机构地区：[1]陕西省食品药品检验研究院,陕西西安710065 [2]陕西省绥德县市场监管综合执法大队,陕西绥德718099

出　　处：《中国医药科学》2024年第3期79-82,90,共5页China Medicine And Pharmacy

基　　金：陕西省重点研发计划项目(2023-YBSF-461)。

摘　　要：目的 比较阿奇霉素干混悬剂不同微生物检验方法的优势与劣势,并提出方法选择原则。方法 采用常规法、中和法、稀释结合中和法以及薄膜过滤结合中和法等13种方法对阿奇霉素干混悬剂进行微生物限度方法适用性研究。结果 可采用稀释结合中和法(1:500供试液1 ml平均倾注5个皿)或稀释结合薄膜过滤结合中和法(1:100供试液,冲500 ml/膜)进行需氧菌总数计数。结论 从仪器耗材成本、操作便利性、污染风险角度,阿奇霉素干混悬剂检验应首选稀释结合中和法;从检验灵敏度方面应首选稀释、薄膜过滤结合中和法。Objective In order to compare the advantages and disadvantages of different test methods of Azithromycin for suspension,and propose principles for the selection of microbial limit test methods.Methods A total of 13 kinds of methods including routine method,neutralization method,dilution combined with neutralization methods,membrane filtration combined with neutralization methods etc.were adopted for microbial limit methodology of Azithromycin for suspension.Results The dilution combined with neutralization method(1ml of 1 ∶ 500 test liquid was poured into 5 dishes) and dilution,membrane filtration combined with neutralization method(1 ∶ 100 test liquid,rinsed 500 ml/film) could be used to count the total aerobic microbial.Conclusion The dilution combined with neutralization method should be the first choice for azithromycin dry suspension,from the aspect of the cost of instruments and consumables,convenience of operation and pollution risk.The dilution,membrane filtration combined with neutralization method should be the first choice from the aspect of the sensitivity.

关 键 词：阿奇霉素干混悬剂 微生物限度 方法适用性 选择原则 

分 类 号：R927.1[医药卫生—药学]