枸橼酸马罗匹坦原料药微生物限度检查方法的研究OA

In order to establish a microbial limit test method for maropitant citrate active pharmaceutical ingredient,this article employed the membrane filtration method to determine the total counts of aerobic bacteria and molds&yeasts,and to detect the specified microorganism Escherichia coli.The results showed that maropitant citrate exhibits antimicrobial activity.Rinsing the filter membrane with pH 7.0 sterile sodium chloride-peptone buffer four times(100 mL,each time)effectively eliminated the inhibitory effect.The recovery rates of aerobic bacteria,molds and yeasts were between 0.5 to 2.In the positive control group for Escherichia coli,the robust colony growth was observed,whereas no colony growth occurred in either the test sample group or the negative control group.The method met the requirements of the Chinese Veterinary Pharmacopoeia.These findings demonstrate that the membrane filtration method established in this study is accurate and feasible;it reliably eliminates the antimicrobial activity of maropitant citrate and is suitable for the microbial enumeration and Escherichia coli detection in maropitant citrate,providing a reference and a solid basis for the quality evaluation.