摘要
目的按照《中国药典》2015版四部通则1101中无菌检查法对注射用头孢噻肟钠舒巴坦钠进行无菌检查方法适用性研究,建立出厂检验和上市抽验样品的无菌检查方法。方法采用薄膜过滤法,以0.1%无菌蛋白胨水溶液为冲洗液,分别以400、600和800 mL/筒冲洗量进行试验,并加入400万单位/100 mL的青霉素酶以消除样品的抑菌活性。根据出厂产品和上市抽验样品检验数量要求,分别进行试验和观察各组菌生长情况。结果样品组和阴性对照组均未见菌生长,在5天内所有阳性对照组及试验组,冲洗量600 mL/筒(上市抽验)、800 mL/筒(出厂检验),并均加青霉素酶400万单位/100 mL时生长良好。结论注射用头孢噻肟钠舒巴坦钠无菌检查,可采用薄膜过滤法,冲洗量为600 mL/筒(上市抽验)、800 mL/筒(出厂检验),再加入青霉素酶400万单位/100 mL,以大肠埃希菌作为阳性对照菌。
Objective To study the applicability of sterility test method for cefotaxime sodium and sulbactam sodium for injection according to the sterility test method in general rule 1101 of Chinese Pharmacopoeia(2015 edition),establish the sterility test method of factory inspection and sampling inspection on the market.Methods Using 0.1%sterile peptone aqueous solution as rinse solution,the membrane filtration method was adopted with rinsing volume of 400,600 and 800 mL/tube,respectively,and 4 million units/100 mL penicillinase was added to eliminate the antibacterial activity of the sample.According to the inspection quantity requirements of the products and market samples,the growth of each group was tested and observed.Results No bacterial growth was observed in the sample group and the negative control group.All positive control groups and test groups within five days showed good growth when the rinsing volume was 600 mL/tube(market sampling test)and 800 mL/tube(factory test),and 4 million units/100 mL penicillinase was added.Conclusion For the sterility test of cefotaxime sodium and sulbactam sodium for injection,the membrane filtration method can be adopted,with the rinsing volume of 600 mL/tube(market sampling test)and 800 mL/tube(factory test),and then 4 million units/100 mL penicillinase is added,with Escherichia coli as positive control.
作者
陈扣宝
吕小燕
CHEN Kou-bao;LYU Xiao-yan(Department of Microbiology,Hefei Food and Drug Inspection Center,Hefei Anhui,230088,China)
出处
《职业与健康》
CAS
2020年第13期1757-1760,共4页
Occupation and Health
关键词
头孢噻肟钠舒巴坦钠
无菌检查
方法适用性
Cefotaxime sodium and sulbactam sodium
Sterility test
Applicability of method
