退热贴微生物限度检查方法的验证

目的建立退热贴微生物限度检查方法。方法参照《中国药典》2010年版微生物限度检查方法,采用常规法进行该药品的微生物方法学验证。结果采用常规平皿法时,大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色假丝酵母菌、黑曲真菌的回收率均高于70%,细菌、真菌和酵母菌计数采用常规平皿法,控制菌金黄色葡萄球菌、铜绿假单胞菌采用常规法检查。结论常规法可用于退热贴的微生物限度检查。

The verification of the microbial limits tests methodology of the cooling paste

Objective To establish the methodology of the microbial limits tests of the cooling paste.Methods Referring to the microbial limits tests of "Chinese Pharmacopeia",2010 Edition,we use conventional method to do the microbiological methodology verification of the medicine.Results When using conventional plate method,the recovery of the escherichia coli,staphylococcus aureus,bacillus subtilis,candida albicans and aspergillus are all above 70%.The counting method of bacteria,fungi and yeasts is conventional plate method,the control bacteria,as staphylococcus aureus and pseudomonas aeruginosa use conventional methods.Conclusion The conventional method can apply in the microbiallimits test of the cooling paste.