论文部分内容阅读
目的:对注射用阿奇霉素枸橼酸二氢钠进行凝胶法干扰试验,建立注射用阿奇霉素枸橼酸二氢钠细菌内毒素检查的试验方法。方法:采用《中国药典》2010年版二部附录收载的细菌内毒素检查方法。结果:浓度为0.10 mg·ml~(-1)的样品稀释液对灵敏度为0.125 EU·ml~(-1)的鲎试剂无干扰作用。结论:建立的注射用阿奇霉素枸橼酸二氢钠细菌内毒素检查法可行,可代替家兔热原检查法。
OBJECTIVE: To establish a method for the bacterial endotoxin test of azithromycin sodium citrate injection by injecting azithromycin citrate sodium dihydrogen sodium for injection. Methods: Bacterial endotoxin test method was adopted in the appendix of “2010 edition of Chinese Pharmacopoeia”. Results: The sample diluent with the concentration of 0.10 mg · ml -1 had no interference with the strychni reagent with the sensitivity of 0.125 EU · ml -1. Conclusion: The established azithromycin sodium citrate injection for bacterial endotoxin test is feasible and can replace the pyrogen test in rabbits.