简化注射用头孢菌素无菌检查法的探讨

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。

Approach on predigestion of sterility test for cephalosporins for injections

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 genera- tions were chosen as example.By choosing positive control bacteria,defining washing volumes and adding penicillin- ase sequence in sterility test,the sterility tests were established.Results:There are dramatically diferent antibacteri- al sensitivities to the validating bacteria among the generations of cephalosporins due to their different antibiotic pro- files.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 sen- sitive one is being selected as the positive control bacterium,and meanwhile the validity of sterility test for the ceph- alosporins for injections is assured.