更昔洛韦注射液的细菌内毒素检测法

Bacterial endotoxin detection for ganciclovir in jection

目的建立检测更昔洛韦注射液中细菌内毒素的实验方法。方法按《中国药典》2005年版第2部附录中细菌内毒素检测法进行实验。结果更昔洛韦注射液在质量浓度3.33 mg/ml下对细菌内毒素检查法无干扰作用,其细菌内毒素限值为0.30 EU/mg。结论采用细菌内毒素检测法检查更昔洛韦注射液的细菌内毒素是可行的。

Objective To establish a method for the bacterial endotoxins test of Ganciclovir injection.Methods The test was operated according to the method for examination of the bacterial endotoxin test in Ch.P（2005）Vol？？？sults Ganciclovir injection was in diluted concentrations 3.33 mg/ml under the bacterial endotoxin test for the role of non-interference, and its bacteriological endotoxin limit was 0.30 EU/mg.Conclusion Bacterial endotoxin test for Ganciclovir injection is feasible.