三种制霉素医院制剂微生物限度检查方法的建立  

Validation of Microbial Limit Test Method of Three Kinds of Hospital Nystatin Preparations

作　　者：张聪聪 程龙 毛腾霄 ZHANG Cong-cong;CHENG Long;MAO Teng-xiao(Chengdu Institute for Food and Drug Control,Chengdu 610046,China)

机构地区：[1]成都市食品药品检验研究院

出　　处：《海峡药学》2020年第1期71-73,共3页Strait Pharmaceutical Journal

摘　　要：目的建立三种制霉素制剂的微生物限度检查方法。方法采用常规法、培养基稀释法和薄膜过滤法对制霉素甘油搽剂、制霉素涂剂和制霉素软膏3种外用医院制剂进行微生物限度检查方法验证。结果制霉素甘油搽剂和制霉素软膏对细菌的抑制作用很小,制霉素涂剂对细菌则有一定的抑制作用,三种制剂均对白色念珠菌有较强的抑菌活性,采用培养基稀释法可有效地消除其抑菌活性。结论三种样品均为制霉素制剂,经验证后检验方法却不相同,故被检样品应进行微生物限度检查方法验证,才能确保检验方法的有效性和检验结果的准确性。OBJECTIVE To establish a method for the microbial limit test of three hospital nystatin preparations.METHODS The routine method,culture medium dilution method and membrane filtration method were respectively performed for microbial limit test validation of three hospital nystatin preparations.RESULTS Nystatin glycerol liniment and nystatin ointment hardly had antibacterial activity,while nystatin pigmentum showed inhibition effect on the bacteria.All three preparations showed antimicrobial effect on Candida albicans,which could be eliminated by culture medium dilution method.CONCLUSION It is necessary to carry out the validation of microbial limit test of different preparation types to ensure the correctness of test result.

关 键 词：制霉素 微生物限度检查 方法验证 

分 类 号：R927[医药卫生—药学]