头孢替坦二钠及注射用头孢替坦二钠的细菌内毒素检查

Study on Standard of Bacterial Endotoxin in Cefotetan Disodium and Cefotetan Disodium for Injection

目的建立头孢替坦二钠及注射用头孢替坦二钠细菌内毒素的检查法。方法按2005年版《中国药典(二部)》附录进行试验和结果判断。结果用两个不同生产厂家、不同标示灵敏度的鲎试剂对两个厂家生产的头孢替坦二钠及注射用头孢替坦二钠进行研究。其最大不干扰浓度均为1.67m g/m L。分别对原料及制剂进行检查,均无干扰作用,其细菌内毒素均小于0.15EU/m L。结论该产品可以用细菌内毒素检查法(凝胶法)控制细菌内毒素的含量。

Objective To establish the bacterial endotoxin determination methods for cefotetan disodium and cefotetan disodium for injection. Methods The experiment and the judgement of results were made according to the appendix XIE of the Chinese Pharmacopoeia （Vol II）. Restilts The reactions with two sensitivities of amebocyte lysate were not disturbed in 1.67 mg/mL for cefotetan disodium and cefotetan disodium for injection, which was the maximum non- disturbing concentration respectively. The endotoxin limit of the two preparations was less than 0. 15 EU/mL respectively. Conclusion It is feasible for the determination of endotoxin in cefotetan disodium and cefotetan disodium for injection.