氟雷拉纳咀嚼片微生物限度检查方法的适用性试验  

Applicability Test of Microbiological Limit Test Method for Fluralaner Chewable Tablets

作　　者：白玉婷 张欣欣 于方凌 白玉彬 李海權 张继瑜[1] 李冰[1] BAI Yuting;ZHANG Xinxin;YU Fangling;BAI Yubin;LI Haiquan;ZHANG Jiyu;LI Bing(Key Laboratory of New Animal Drug Project of Gansu Province,Key Laboratory of Veterinary Pharmaceuticat Development,Ministry of Agriculture and Rural Affairs,Lanzhou Institute of Husbandry and Pharmaceutical Sciences of CAAS,Lanzhou 730050,China)

机构地区：[1]中国农业科学院兰州畜牧与兽药研究所,农业农村部兽用药物创制重点实验室,甘肃省新兽药工程重点实验室,甘肃兰州730050

出　　处：《中国兽医杂志》2025年第4期80-86,共7页Chinese Journal of Veterinary Medicine

基　　金：甘肃省重点研发计划(23YFNA0001)。

摘　　要：为了建立并验证氟雷拉纳咀嚼片微生物限度检查方法,本试验分别考察平皿常规法和平皿中和法去除氟雷拉纳咀嚼片中抑菌成分活性的效果,进行需氧菌(枯草芽孢杆菌、金黄色葡萄球菌、铜绿假单胞菌)、霉菌和酵母菌总数的测定,并对控制菌(大肠埃希菌和沙门菌)进行检查,筛选出最优的检查方法进行供试品微生物限度检查。结果显示,中和法可以较好地消除氟雷拉纳咀嚼片中抑菌成分的抑菌活性,使用中和法进行试验,需氧菌、霉菌和酵母菌的回收率均介于50%~200%,控制菌阳性对照组中菌落生长良好,供试品组和阴性对照组中均无细菌生长,符合《中华人民共和国兽药典》规定,可使用中和法进行供试品中微生物计数及控制菌大肠埃希菌和沙门菌检查。本试验所建立方法(中和法)准确可行,能有效去除氟雷拉纳咀嚼片处方中抑菌成分的抑菌性,适用于氟雷拉纳咀嚼片微生物限度检查,为氟雷拉纳咀嚼片的质量评价提供参考。To establish and validate the microbial limit test method for flurelanate chewable tablets,this study investigated the effects of the plate conventional method and the neutralization method in removing the antimicrobial activity of flurelanate chewable tablets.Aerobic bacteria(Bacillus subtilis,Staphylococcus aureus,Pseudomonas aeruginosa),molds,and yeast were measured,and tests were performed for the control bacteria(Escherichia coli and Salmonella).The optimal method for microbial limit testing was selected for the test sample.The results showed that the neutralization method effectively removed the antimicrobial activity in flurelanate chewable tablets.When the neutralization method was applied,the recovery rates of aerobic bacteria,molds,and yeast were between 50%and 200%.In the Positive control group for the control bacteria,the colony growth was good,and no bacterial growth was observed in the Test sample group and Negative control group.The method met the requirements of the Pharmacopoeia of the People's Republic of China and is suitable for the microbial count and control bacteria testing(Escherichia coli and Salmonella)in flurelanate chewable tablets.The method established in this study(neutralization method)is accurate and feasible,effectively eliminating the antimicrobial activity of the formulation and is suitable for the microbial limit test of flurelanate chewable tablets,providing a reference for the quality evaluation of flurelanate chewable tablets.

关 键 词：氟雷拉纳咀嚼片 微生物限度检查 适用性试验 中和法 

分 类 号：S859[农业科学—临床兽医学]