过滤速率对阿奇霉素干混悬剂微生物限度检查方法的影响  

Effect of Filtration Rate on the Microbial Limit Test of Azithromycin for Suspension

作　　者：姬俊 牛萌萌 朱世真 刘婷婷 王立云 陈静 JI Jun;NIU Mengmeng;ZHU Shizhen;LIU Tingting;WANG Liyun;CHEN Jing(Qingdao Institute for Food and Drug Control·NMPA Key Laboratory for Quality Research and Evaluation of Traditional Marine Chinese Medicine,Qingdao,Shandong,China 266073;Qingdao Hospital of Traditional Chinese Medicine·Qingdao Hiser Hospital,Qingdao,Shandong,China 266000)

机构地区：[1]山东省青岛市食品药品检验研究院·国家药品监督管理局海洋中药质量研究与评价重点实验室,山东青岛266073 [2]山东省青岛市中医医院·青岛市海慈医院,山东青岛266000

出　　处：《中国药业》2023年第10期85-89,共5页China Pharmaceuticals

摘　　要：目的建立阿奇霉素干混悬剂的微生物限度检查方法,并探讨薄膜过滤法的冲洗液过滤速率与去除抗菌药物抑菌性的关系。方法按2020年版《中国药典(四部)》通则1105及1106要求进行方法适用性试验,需氧菌计数联用薄膜过滤法和稀释法,霉菌和酵母菌计数采用平皿法;控制菌检查联用薄膜过滤法和稀释法,所用薄膜过滤法设定冲洗液过滤速率为200,100,50 mL/min。结果需氧菌计数[1∶10(m/V)供试液,稀释至1∶500(V/V)]宜采用薄膜过滤法(过滤速率为50 mL/min)联合前加菌法,控制菌(大肠埃希菌)检查宜采用薄膜过滤法(5张滤膜,过滤速率为50 mL/min)联合培养基稀释法(增菌培养基体积为700 mL)。结论所建立的方法可用于阿奇霉素干混悬剂的微生物限度检查,并确定了适宜的薄膜过滤法冲洗液过滤速率。Objective To establish a microbial limit test of Azithromycin for Suspension,and to investigate the relationship between the filtration rate of the washing liquid in membrane filtration method and the removing bacteriostasis of antibacterial drugs.Methods The suitability test was conducted according to the requirements of general rule 1105 and 1106 of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ).The aerobic bacteria count was tested by the membrane filtration method combined with dilution method,and the mold and yeast counts were tested by the plate method.The specified microorganism was tested by the membrane filtration method combined with dilution method,and the filtration rates of the washing liquid were set to 200,100,50 mL/min in the membrane filtration method.Results Aerobic bacterial count[1∶10(m/V)test solution,diluted to 1∶500(V/V)]was suitable for test by the membrane filtration method(filtration rate of 50 mL/min)combined with bacteria-addition before filtration method.The specified microorganism(Escherichia coli)was suitable for test by the membrane filtration method(five filtration membranes,with filtration rate of 50 mL/min)combined with the culture-medium dilution method(with a volume of 700 mL of enrichment medium).Conclusion The established method can be used for the microbial limit test of Azithromycin for Suspension,and the suitable filtration rate of washing liquid in the membrane filtration method has been determined.

关 键 词：阿奇霉素干混悬剂 薄膜过滤法 过滤速率 微生物限度 

分 类 号：R978.1[医药卫生—药品]