苄星氯唑西林原料药的无菌检查方法研究  

Study on the sterility test method for cloxacillin benzathine bulk drug

作　　者：李应超[1] 吕涛[1] 王亚芳[1] 任伟[1] 张连彦[1] 孙志文[1] 魏镭[1] 张发明 

机构地区：[1]北京市兽药监察所,北京102609 [2]北京华都诗华生物制品有限公司,北京102609

出　　处：《畜牧与兽医》2015年第4期40-43,共4页Animal Husbandry & Veterinary Medicine

基　　金：2013年兽药行业标准制定和修订项目(农财发〔2013〕46号)

摘　　要：采用自然沉降-薄膜过滤-酶中和相结合的方法,按照《中国兽药典》2010年版一部附录进行试验,旨在建立苄星氯唑西林原料药的无菌检查法并进行验证。结果:以1.0%聚山梨酯80 p H 7.0氯化钠-蛋白胨缓冲液冲洗,冲洗量400 m L/膜,在最后的培养基中加入不少于600万U的青霉素酶可有效消除样品对各试验菌株的抗菌活性;验证试验中,各验证菌生长良好,各供试品管均未见菌生长,表明该方法可靠、准确,可用于苄星氯唑西林的无菌检查。This study aimed to establish and verify the sterility test for cloxacillin benzathine bulk drug. Natural sedimentation, membrane filtration and enzyme neutralization methods were used and verified on the basis of the appendix to Veterinary Pharmacopoeia of The people＇s Republic of China （2010 edition）. The results showed that the antibacterial activity of the drug to various strains could be eliminated with the combined application of the three methods, requiring at least 6 million units of penicillinase and 400 mL 1.0% polysorbate 80 sodium chloride （pH 7.0） -peptone buffer solution as flushing fluid. In the validation test, all the test strains grew well and no bacteria were found in the sample tubes. The results showed that the accurate and reliable method could be used for the sterility test of cloxacillin benzathine.

关 键 词：苄星氯唑西林 自然沉降法 薄膜过滤法 酶中和法 无菌检查 

分 类 号：S859.2[农业科学—临床兽医学]