中国兽药杂志2026,Vol.60Issue(4):32-39,8.DOI:10.11751/ISSN.1002-1280.2026.4.05
枸橼酸马罗匹坦原料药微生物限度检查方法的研究
Study on the Microbial Limit Test for Maropitant Citrate Active Pharmaceutical Ingredient
岳永波 1杨芳 1李伟岭 1岳家田 2刘波 1罗妍1
作者信息
- 1. 保定冀中药业有限公司,河北 保定 071500||保定冀中药业有限公司石家庄分公司,石家庄 050066
- 2. 新疆农业大学动物医学学院,乌鲁木齐 830052
- 折叠
摘要
Abstract
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.关键词
枸橼酸马罗匹坦/微生物限度/薄膜过滤法/适用性试验Key words
maropitant citrate/microbial limit/membrane filtration/suitability test分类
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岳永波,杨芳,李伟岭,岳家田,刘波,罗妍..枸橼酸马罗匹坦原料药微生物限度检查方法的研究[J].中国兽药杂志,2026,60(4):32-39,8.