注射用氨苄西林钠舒巴坦钠细菌内毒素检测的研究

Study on the detection of bacterial endotoxin from ampicilin sodium and subbactam sodium for injection.

目的 探讨注射用氨苄林西钠舒巴坦钠细菌内毒素检测方法。 方法 参照中国药典 2 0 0 0年版二部细菌内毒素检测法要求 ,以干扰试验测定。 结果 该药在 0 80mg/ml浓度下不干扰内毒素试验。 结论 采用细菌内毒素检查法代替热原检查法 。

Objective To establish a method for detection of bacteria endotoxin from ampicillin sodium and subactam sodium for injection. Methods A interference test was conducted according to the method for detection of bacteria endotoxin of China Pharmacopeia 2000 edition second section. Results Apmicillin sodium and subactam sodium for jnjection did not interfere with the endotoxin experiment in the concentration of 0.80mg·ml -1. Conclusion The method is, instead of heat source testing method, simple and feasible for detection of endotoxin.