MPN法在注射用利福平中间体需氧菌总数检测中的研究  

Study on Total Aerobic Microbial Count of Rifampicin Intermediate for Injection by MPN Method

作　　者：王连国 易大为 周少彤 马辉 WANG Lian-guo;YI Da-wei;ZHOU Shao-tong;MA Hui(Liaoning Institute for Drug Control,Shenyang 110036,China)

机构地区：[1]辽宁省药品检验检测院,辽宁沈阳110036

出　　处：《品牌与标准化》2022年第4期57-60,64,共5页

摘　　要：目的:建立注射用利福平中间体需氧菌总数的检查方法,并进行适用性考察。方法:取本品30 mL、3 mL和0.3 mL,按薄膜过滤法处理,经增菌,记录每一稀释级微生物生长的管数,计算每100 mL供试品中需氧菌总数的最可能数(MPN值)。结果:经验证试验、抗菌活性去除试验、计数方法适用性试验、冲洗液无毒性证实试验,确定采用MPN法结合薄膜过滤法,以44℃含5%丙三醇的无菌SCDLP液体培养基为冲洗液,每次每膜冲洗100 mL,冲洗9次的方法可行,该方法的检出限为3 cfu/100 mL,低于本品微生物污染最大允许值10 cfu/100 mL。结论:本方法可用于利福平中间体需氧菌总数的检查。Objective:To establish a method about total aerobic microbial count of Rifampicin intermediate for injection,and examine its suitability. Methods 30 mL,3 mL and 0.3 mL of the product will be examined and incubated by membrane filtration,then read the number of growth tubes per dilution level,determine the MPN of microorganisms per 100 mL of the product. Results:After Verification test,removal test of antimicrobial activity,suitability test of counting method and non-toxic test of rinsing solution,the MPN method combined with membrane filtration method was adopted. The rinsing solution was SCDLP medium containing 5% glycerol at 44 ℃,with washing 100mL per membrane filter as 9 times. The detection limit of the method was 3 cfu/100mL,below the maximum permissible contaminated value 10 cfu/100mL. Conclusion:This method can be used to total aerobic microbial count of Rifampicin intermediate for injection.

关 键 词：利福平 中间体 需氧菌总数 MPN 

分 类 号：R927.1[医药卫生—药学]