简化注射用头孢菌素无菌检查法的探讨  

Approach on predigestion of sterility test for cephalosporins for injections

作　　者：戴翚[1] 刘鹏[1] 马仕洪[1] 特玉香[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2007年第2期208-211,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:完善头孢菌素类药物注射剂的无菌检验方法标准。方法:以7种不同代注射用头孢菌素为例,通过对阳性对照菌,冲洗量及青霉素酶的加入顺序等条件的选择,建立了无菌检查方法。结果:不同代头孢菌素因抗菌谱的差异,对不同验证菌株的敏感性显著不同;无菌检查法必须建立在验证试验的基础上。结论:头孢菌素无菌检查方法的验证菌株可由目前2005年版中国药典规定的5株简化为2株,并从中选择最敏感的菌株作为无菌检查中的阳性菌株,即可保证无菌检查方法的有效性。Objective：To approach a method for predigestion of sterility test for cephalosporins for injections and to improve the process establishment of the test. Method：7 kinds of cephalosporins for injections in different generations were chosen as example. By choosing positive control bacteria, defining washing volumes and adding penicillinase sequence in sterility test, the sterility tests were established. Results：There are dramatically diferent antibacterial sensitivities to the validating bacteria among the generations of cephalosporins due to their different antibiotic profiles. It is necessary for validation of sterility tests. Conclusions：5 strains of validating bacteria required for sterility test of the cephalosporins according to the Chinese Pharmacopoeia 2005 may be reduced to 2 strains. The most sensitive one is being selected as the positive control bacterium, and meanwhile the validity of sterility test for the cephalosporins for injections is assured.

关 键 词：头孢菌素 无菌检查 薄膜过滤法 验证试验 

分 类 号：R917[医药卫生—药物分析学]