注射用头孢菌素无菌方法验证

目的完善头孢菌素类药品注射剂的无菌检验方法。方法以2种头孢菌素类注射剂为例,采用薄膜过滤法进行适度冲洗并加入适量青霉素酶消除供试品的抑菌作用,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优化,建立了无菌检查方法。结果头孢替安、头孢哌酮钠舒巴坦钠两种头孢菌素注射剂对7株阳性代表菌有不同程度的抗菌活性;无菌检查法必须建立在验证试验的基础上。结论本实验建立的无菌检查方法准确、可靠,建议将其收载入《中国药典》。

Validation of Sterility Test Method of Cephalosporins for Injection

Objective To establish a better sterility test method for cephalosporins for injection. Methods Two types of cephalosporins for injection were chosen as samples. Using membrane-filter procedures, the antibacterial activity of cephalosporins was counteracted by the added rinse solution and penicillinase. By choosing positive control bacteria, defining washing volumes and adding penicillinase sequence in sterility test, sterility tests were established. Results There were dramatically different antibacterial sensitivities to 7 strains of validating bacteria within cephradine cefotiam and ceftriaxone sodium-cefoperazone sodium. Validation of sterility tests proved to be necessary. Conclusion This method can serve as an effective standard operation process in sterility test. It is proposed that this method be included in China Pharmacopoeia .