三唑类抗真菌药物泊沙康唑注射液无菌检查方法研究

Sterility Test Method of Triazole Antifungal Drug Posaconazole Injection

目的建立三唑类抗真菌药物泊沙康唑注射液的无菌检查方法。方法通过无菌检查法的验证试验,对冲洗液、滤膜材质、冲洗量、阳性对照菌的筛选和优化,以及加入顺序等全过程的考察,完成无菌检查法的建立。结果泊沙康唑注射液的无菌检查选用薄膜过滤法,以白色念珠菌为阳性对照菌,冲洗液为SBECD溶液(pH 3.5),冲洗总量为1000 m L。结论该方法可行、结果可靠,可用于泊沙康唑注射液等三唑类抗真菌药物的无菌检查。

Objective To establish a method for sterility test of the triazole antifungal drug posaconazole injection.Methods Based on the verification test of sterility test,the establishment of sterility test method was completed through the whole process of washing solution,filter material,washing quantity,selection of positive control bacteria and adding sequence.Results Membrane filtration method was used for sterility test of posaconazole injection.During the test,Candida albicans was used as positive control bacteria,SBECD solution(pH 3.5)was used as washing solution,whose total amount was 1000 m L.Conclusion This method is feasible and reliable for the detection of triazole antifungal drugs such as posaconazole injection.