哮喘片微生物限度检查法的建立及方法学验证

目的:建立哮喘片微生物限度检查的方法并验证.方法:按2010年版《中国药典》,用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉和白色念珠菌对哮喘片进行微生物限度检查方法学验证试验.结果:哮喘片对细菌中的金黄色葡萄球菌、枯草芽孢杆菌有较强的抑制作用.结论:本品对细菌的计数方法为培养基稀释法；霉菌、酵母菌计数方法为平皿法；控制菌检查可采用常规法检验.该方法用于哮喘片的质量控制有效、可行.

Establishment and Validation of Microbial Limit Method for Xiaochuan Tablets

Objective: To establish the validation of microbial limit test method for Xiaochuan tablets. Method: The microbial limit test mothod of Xiaochuan tablets was validated using Escherichia coli, Bacillu Subtilis, staphy lococcus aureus, Aspergillus niger and Candida albicans according to Chinese Pharmacopoeia Edition 2010. Result: Xiaochuan tablets has a strong inhibition on Staphylococcus aureus and Bacillus subtilis. Conclusion: Medium dilution method were used with count of bacterium. The routine method were used with counts mold and yeasts. Pathogenic bacteria can be tested when general method were used. The method is cogent, effective and can be used to the quality concrol of the Xiaochuan tablets.