注射用两性霉素B脂质体细菌内毒素检查法研究

目的 建立注射用两性霉素B脂质体细菌内毒素检查法.方法 按2010年版<中国药典>附录"细菌内毒素检查法"进行实验.结果 注射用两性霉素B脂质体稀释至质量浓度0.05 mg·mL-1以下时,对细菌内霉素检查无干扰作用.结论 采用细菌内毒素检查法检查注射用两性霉素B脂质体的细菌内毒素,方法稳定可靠,可替代家兔热原检查法.

Study on bacterial endotoxin test of amphotericin B liposome for injection

Objective To establish the method for bacterial endotoxin test of amphotericin B liposome for injection.Methods The test for bacterial endotoxin was performed according to the method approved by Chinese pharmacopoeia 2010 edition.Results The interference on bacterial endotoxin test can be excluded when amphotericin B liposome for injection was diluted below 0.05 mg·mL^-1.Conclusion It is feasible to detect the bacterial endotoxin of amphotericin B liposome for injection by the method of the test for bacterial endotoxin,which may take the place of the pyrogen test with domestic rabbits.