摘要
目的:对注射用丝裂霉素进行凝胶法干扰试验,建立注射用丝裂霉素细菌内毒素检查法的试验方法。方法:采用中国药典2000年版二部附录细菌内毒素检查法。结果:注射用丝裂霉素稀释10倍(0.05mg/ml)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丝裂霉素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。
Objective.To establish a method for the determination of bacterial endotoxin of Mitomycin for Injection;Method： According to the method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia 2000 edition. Results： The interference on the determination of bacterial endotoxin can be excluded when Mitomycin for Injection was diluted 10 times. Conclusion：It is feasible to detect the bacterial endotoxin of Mitomycin for Injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test.
出处
《中国药品标准》
CAS
2006年第3期25-27,共3页
Drug Standards of China
