不同辅料硝酸咪康唑乳膏微生物限度检查方法适用性研究  

Applicability of microbial limit test for miconazole nitrate cream with different excipients

作　　者：琚滢蓥 李亚东 朱小磊 JU Ying-ying;LI Ya-dong;ZHU Xiao-lei(Nanyang Institute for Food and Drug Control,Nanyang Henan 473001)

机构地区：[1]南阳市食品药品检验所,河南南阳473001

出　　处：《中南药学》2021年第9期1938-1941,共4页Central South Pharmacy

摘　　要：目的根据不同厂家硝酸咪康唑乳膏所用的辅料不同,建立对应的硝酸咪康唑乳膏的微生物限度检查法。方法根据不同厂家的硝酸咪康唑乳膏的辅料特性,选择破胶、萃取、静置等前处理方式,采用薄膜过滤法进行硝酸咪康唑乳膏的微生物计数检查,采用常规法进行硝酸咪康唑软膏的控制菌检查。结果针对不同辅料,采用合适的供试品前处理方法,可以很好地去除硝酸咪康唑软膏的抑菌性,并且解决样品难以过滤的问题,从而建立可靠的微生物限度检查方法。结论不同厂家硝酸咪康唑乳膏采用不同的辅料,可以灵活选用适宜的前处理方法,顺利解决样品的抑菌性和难以过滤的问题。Objective To establish a microbial limit test for miconazole nitrate cream with different excipients from different manufacturers.Methods According to the excipients characteristics of miconazole nitrate cream from different manufacturers,pretreatment methods,such as gel breaking,extraction and static treatment were selected.Membrane filtration method was used for the microbiological count of miconazole nitrate cream,and the specified micro-organisms of miconazole nitrate cream was determined by conventional method.Results The bacteriostatic properties of miconazole nitrate cream were well removed with appropriate pretreatments for different excipients,and the filter problem of the sample was solved to establish a reliable microbial limit test method.Conclusion For different manufacturers of miconazole nitrate cream with different excipients,we can select appropriate pretreatment,and solve the problem of antibacterial properties of the samples.

关 键 词：硝酸咪康唑 微生物限度检查 方法适用性研究 前处理 

分 类 号：R927[医药卫生—药学]