海金护卫散微生物限度检查方法的验证

Validation Method for Microbial Limit Tests of Haijinhuwei Powder

目的:建立海金护卫散的微生物限度检查方法。方法:测定海金护卫散对5种阳性验证菌株的回收率,并对控制菌的检查方法进行验证。结果:常规法试验时,除枯草芽孢杆菌回收率不足70%外,金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉回收率均达70%以上;采用培养基稀释法(0.5ml)枯草芽孢杆菌回收率达70%以上。结论:海金护卫散可采用培养基稀释法进行微生物限度检查;控制菌检查可采用常规方法检验。

Objective： To estalish and verify the microbial limit tests for haijinhuwei powder.Methods：The recovery rate of 5 tested strains were detected and the microbial limit tests for the specified microorganisms was validated.Results：The recovery rates of Staphylococcus aureus,Escherichia Coli,Candida albicans,Aspergillus niger had reached over 70% by routine test,except Bacillus subtilis, the recovery rates of Bacillus subtilis had reached over 70% by medium diluted method（O.5ml） for microbial limit tests for haijin huwei powde;Routine method is suitable for specified microorganisms