注射用头孢唑林钠原料无菌检查方法的研究  

Study on Sterility Test Method of Cefazolin Sodium for Injection

作　　者：何军芳 厉昆 刘永权 彭欢 吴兴 彭雅丽 张杨琳 HE Jun-fang;LI Kun;LIU Yong-quan;PENG Huan;WU Xing;PENG Ya-li;ZHANG Yang-lin(Zhejiang Apeloatospo Pharmaceutical Co.,Ltd.,Dongyang 322118,China;Hengdian Group Holding Co.,Ltd.,Dongyang 322118,China;Zhejiang Apeloa Jiayuan Pharmaceutical Co.,Ltd.,Dongyang 322118,China)

机构地区：[1]浙江普洛得邦制药有限公司,浙江东阳322118 [2]横店集团控股股份有限公司,浙江东阳322118 [3]浙江普洛家园药业有限公司,浙江东阳322118

出　　处：《精细化工中间体》2021年第3期70-72,共3页Fine Chemical Intermediates

摘　　要：对头孢唑林钠原料药的无菌检查方法进行研究并确认。头孢唑林钠无菌原料药10 g,用适量生理盐水溶解稀释至500 mL,取1组三联集菌培养器分3筒过滤,每筒500 mL pH7.0氯化钠-蛋白胨缓冲液冲洗,加不少于200万单位的头孢菌素酶消除抑菌性来进行无菌检查。In this paper,the sterility test method of cefazolin sodium was studied and confirmed.Conclusion:cefazolin sodium sterile raw material 10 g,dissolved and diluted to 500 mL with appropriate amount of normal saline,take a group of triple bacteria incubator and filter it in three cylinders,each cylinder is washed with 500 mL pH7.0 sodium chloride peptone buffer,and no less than 2 million units of cephalosporin enzyme is added to eliminate the bacteriostasis for sterility test.

关 键 词：头孢唑林钠 薄膜过滤法 头孢菌素酶 无菌检查 

分 类 号：R917[医药卫生—药物分析学]