注射用奈达铂细菌内毒素检查法

目的：对注射用奈达铂进行凝胶法干扰试验，建立注射用奈达铂细菌内毒素检查的试验方法。方法：采用中国药典2005年版二部附录细菌内毒素检查法．结果：注射用奈达铂稀释至浓度为0．125mg·mL^-1时对细菌内毒素检查法无干扰作用。结论：使用细菌内毒素检查法检查注射用奈达铂中的细菌内毒素是可行的，可用细菌内毒素检查法代替家兔热原检查法。

Investigation of Bacterial Endotoxin Test's Methods for Nedaplatin for Injection

Objective： To establish a method for the determination of bacterial endotoxin of Nedaplatin for injection. Methods： According to the method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia 2005 edition. Results： The interference on the determination of bacterial endotoxin can be excluded when Nedaplatin for injection was diluted the concentration of 0.125 mg·mL^-1. Conclusion： It is feasible to detect the bacterial endotoxin of Nedaplatin for injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test.