赛霉安散微生物限度检查方法适用性试验

Suitability of the Test Method for Microbiological Examination of Saimeian Powder

目的建立赛霉安散2015年版中国药典微生物限度检查方法,并进行方法适用性试验。方法按《中国药典》2015年版四部非无菌药品微生物限度检查：微生物计数法、控制菌检查法和限度标准规定进行方法适用性试验。结果采用常规倾注法检查需氧菌总数、霉菌和酵母菌总数,试验组回收率均在0.5~2范围内;采用常规法检查金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌和梭菌,均能检出相应控制菌。结论赛霉安散成分中虽含抑菌成分,但《中国药典》2015年版微生物限度检查的计数法和控制菌检查法都可以采用常规法,方法简便,结果可靠。

OBJECTIVE To develop microbiological examination method of the Chinese Pharmacopoeia（ Ch. P） 2015 Edition for Saimeian powder. METHODS The test was carried out according to Ch. P 2015 Edition,microbiological examination of nonsterile products： microbial enumeration tests,tests for specified microorganisms and limit standard. RESULTS Taking advantage of coventional pour-plate method to check the total number of aerobic bacteria,the total number of mould and yeast,the recovery of microorganisms in the presence of product was in the range of 0. 5 ~ 2. 0. Using the conventional method to check the specified microorganisms,Staphylococcus aureu,Pseudomonas aeruginosa,Candida albicans and Clostridium sporogenes all could be detected. CONCLUSION It is simple and reliable that the enumeration tests and tests for specified microorganisms of microbial limit test for Saimeian powder according to Ch. P 2015 Edition are both carried out by the routine method.