升黄克痛软膏微生物限度检查方法学验证研究

目的：建立升黄克痛软膏微生物限度检查方法。方法：依据2005年版《中国药典》,用枯草芽孢杆菌、金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉对升黄克痛软膏进行微生物限度检查方法学验证实验。结果：采用常规法,仅有枯草牙孢杆菌、大肠埃希菌和黑曲霉的平均回收率分别为59%,62%和66%,其余各菌株试验组回收率均大于70%;采用培养基稀释法,所有验证菌试验组回收率均大于70%。结论：本品可按常规法进行微生物限度检查。

Methodological validation of microbial limit examination of Shenghuangketong ointment

Objective：To establish a method for microbial limit examination of Shenghuangketong ointment.Methods：Following the method for microbial limit examination in Chinese Pharmacopoeia（2005th edition）,the microbial examination of Shenghuangketong ointment was validated using Bacillus subtilis,Staphylococcus aureus,Escherichia coli,Candida albicans and Aspergillus niger.Results：The mean recoveries in Bacillus subtilis,Escherichia coli and Aspergillus niger were 59%,62% and 66% respectively,the recoveries in the rest strains were above 70% by conventional method.While,the recoveries in all tests were above 70% by culture medium-diluting method.Conclusion：The microbial limit examination of Shenghuangketong ointment can be used by conventional method.