硫酸镁在恩诺沙星注射液无菌检查中的应用  

Application of magnesium sulfate in the sterility test of enrofloxacin injection

作　　者：孙冰清 姜芹 张妤 顾欣 张文刚 Sun Bing-qing;Jiang Qin;Zhang Yu;Gu Xin;Zhang Wen-gang(Shanghai Institute for Veterinary Drug&Feeds Control,Shanghai 201103)

机构地区：[1]上海市兽药饲料检测所,上海201103

出　　处：《中国抗生素杂志》2020年第10期1049-1052,共4页Chinese Journal of Antibiotics

摘　　要：目的探讨恩诺沙星注射液无菌检查的方法。方法参照《中国兽药典》2015版第一部附录1101无菌检查方法,采用薄膜过滤法,样品过滤后使用含不同浓度硫酸镁溶液的缓冲液冲洗,随后加入含不同浓度硫酸镁的培养基,根据硫酸镁的浓度设置4组试验对恩诺沙星注射液进行无菌检查。结果按薄膜过滤法,样品过滤后使用0.1%无菌蛋白胨水溶液(含0.1mol/L MgSO4)冲洗4次,每次100mL,冲洗后向集菌器中加入100mL培养基(含0.05mol/L MgSO4),可消除恩诺沙星注射液的抑菌活性,试验菌均可正常生长。结论该方法可用于恩诺沙星注射液的无菌检查。Objective To discuss the method of the sterile test for enrofloxacin injection.Methods According to the aseptic test method of appendix 1101 of the first edition of Chinese veterinary pharmacopoeia 2015,the aseptic test was conducted by the membrane filtration method.After filtration,the samples were washed with buffer solution containing different concentrations of magnesium sulfate,and finally media containing different concentrations of magnesium sulfate was added.Four groups of tests were set up for the aseptic test of enrofloxacin injection.Results After filtration,the samples were rinsed with 0.1%peptone solution(containing 0.1mol/L MgSO4)for four times,100mL each time.After rinsing,100mL medium(containing 0.05mol/L MgSO4)was added into the bacteria collector to eliminate the bacteriostatic activity of enrofloxacin injection,and the test bacteria could grow normally.Conclusion This method can be used for the sterility test of enrofloxacin injection.

关 键 词：恩诺沙星注射液 无菌检查 薄膜过滤法 硫酸镁 

分 类 号：R978.1[医药卫生—药品]