目的 建立注射用盐酸头孢替安(Sefotiam Hydrochloride for Injection, SHI)的细菌内毒素检查法.方法 根据《中国药典》2010年版(二部)检验200例患者使用的SHI,确定SHI的细菌内毒素限值,通过干扰试验,确定其最大无干扰浓度并观察其临床不良反应.结果 SHI的细菌内毒素限值为0.05 EU/mg,最大无干扰浓度为2.5mg/Ml;疗效良好,出现不良反应均在可控范围类.结论 SHI可用细菌内毒素检查法控制热原.
Objective To establish a method of bacterial endotoxin test of Sefotiam Hydrochloride for Injection (SHI).Methods To determine the bacterial endotoxin limit of SHI of 200 patients. Determine the maximum uninterference concentration of SHI by the interference test and observe its clinical adverse reactions. Results The bacterial endotoxin limit of SHI is 0.05EU/mg and the maximum uninterference concentration of SHI is 2.5mg/ml. Clinical treatment effect was good and adverse reaction can control.Conclusion The bacterial endotoxin test can be used for the controlling of pyrogen of SHI.