鲎试剂检查注射用美洛西林钠/舒巴坦钠细菌内毒素的探讨

Bacterial Endotoxin Test of Mezlocillin Sodium/Sulbactam Sodium for Injection

目的 探讨用鲎试剂检查注射用美洛西林钠 /舒巴坦钠细菌内毒素方法。方法 按《中华人民共和国药典》2 0 0 0年版附录细菌内毒素检查法要求进行试验。结果 注射用美洛西林钠 /舒巴坦钠的浓度为 7.5 mg/ m l时不干扰鲎试剂与细菌内毒素的凝集反应。结论 细菌内毒素检查法适用于检测注射用美洛西林钠 /舒巴坦钠中的内毒素。

OBJECTIVE To study the possibility of applying Tachypleus amebocyte lysate (TAL) to detect bacterial endotoxin in mezlocillin sodium/sulbactam sodium for injection. METHODS The tests were conducted according to appendix Ⅸ E of CP 2000. RESULTS Neither inhibition nor enhancement was found in the bacterial endotoxin test after mezlocillin sodium/sulbactam sodium for injection was diluted to 7.5 mg/ml. CONCLUSIONS Bacterial endotoxin test is suitable for the detection of bacterial endotoxin in mezlocillin sodium/sulbactam sodium injection.