注射用伏立康唑无菌检查法的建立  

The establishment of sterility test for voriconazole injection powder

作　　者：张新妹[1] 胡昌勤[1] 赵霞[1] 刘鹏[1] 苏德模[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《天津药学》2003年第5期9-11,共3页Tianjin Pharmacy

摘　　要：目的 :确定新药伏立康唑注射用无菌粉末的无菌检查法。方法 :无菌检查法的验证试验——抑细菌和抑真菌试验及冲洗量试验。通过菌悬液的制备、培养基的检查、冲洗量的选择、阳性对照菌的选择及加入顺序等全过程 ,说明无菌检查法的建立 ,必须有验证试验的保证。结果 :该药的无菌检查选用薄膜过滤法 ,以黑曲霉为阳性对照菌 ,冲洗总量 15 0 0ml。结论 :通过验证试验保证的无菌检查条件检查该药 ,方法可行 ,结果可靠。应在药品检验工作中 ,逐步完善微生物检验方法学的内容 ,从而提高我国药品微生物检验工作的总体水平。Object: To establish the method of sterility test for new drug voriconazole injection powder. Methods: The validation for sterility test includes inhibition test for bacteria and fungi and irrigation test. It was illustrated that the establishment of sterility test must be reassured with validation test through the suspension preparation of germs, examination of culture medium, selection of irrigation volume, sequence of adding positive control germs. Results: The membrane filteration was used in the sterility test for voriconazole injection powder. Aspergillus niger was used as positive control germs and the total amount of irrigation fluid was 1 500 ml. Conclusion: It was applicable and reliable to adopt the conditions of sterility test reassured by validation test. The contents of microorganism test should be improved step by step, so that the general level of microorganism test in China could be elevated.

关 键 词：伏立康唑 无菌检查 薄膜过滤法 验证试验 微生物检验 质量检验 抗真菌药 

分 类 号：R978.5[医药卫生—药品] R927.11[医药卫生—药学]