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目的:建立活血膏(渗药)的微生物限度检查方法。方法:采用《中国药典》2010年版规定的常规法、培养基稀释法,通过验证确认所采用的方法是否适合于该药品的微生物限度检查。结果:细菌计数采用高稀释级的常规法,霉菌及酵母菌计数采用培养基稀释法,5种试验菌的回收率均高于70%。控制菌检查采用培养基稀释法,阳性对照菌检出,阴性对照菌未检出。结论:本方法可用于活血膏(渗药)的微生物限度检查。
Objective: To establish a microbial limit test method of Huoxue cream (seepage medicine). Methods: The Chinese Pharmacopoeia 2010 edition of the provisions of the conventional method, medium dilution method, through verification to confirm the method used is suitable for the drug’s microbial limit test. Results: Bacteria count was in accordance with the conventional method of high dilution, the counts of molds and yeasts were diluted by culture medium, and the recoveries of the five kinds of test bacteria were higher than 70%. Control bacteria test using medium dilution method, positive control bacteria detected, negative control bacteria were not detected. Conclusion: This method can be used for microbial limits of activated blood paste (seepage).