复方醋酸钠注射液细菌内毒素检查法的可行性研究

The researches on the feasibility for the bacterial endotoxin inspection method of compound sodium acetate parenteral solution

目的 考察复方醋酸钠注射液的细菌内毒素检查法的可行性 ,以替代热原检查法。方法 按《中国药典》(二部 ) 2 0 0 0年版附录细菌内毒素检查法。结果 复方醋酸钠注射液对鲎试剂的凝聚反应无干扰作用 ,选用标示灵敏度为 0 2 5Eu·ml-1的鲎试剂检查细菌内毒素的方法可行、有效。结论 可以用细菌内毒素法替代家兔法作为医院日常检测复方醋酸钠注射液的热原检查。

AIM To study the feasibility for the bacterial endotoxin inspection method of Compound Sodium Acetate Parenteral Solution. If possible, to substitute the method for the pyrogen inspection method. METHODS To inspect bacterial endotoxin according to the method in addenda of China Pharmacopoeia (second part, 2000 edition). RESULTS There was no interference effects of Compound Sodium Acetate Parenteral Solution on the agglomeration reaction of tachypleus amebocyte lysate, so, the method of choosing tachypleus amebocyte lysate which sensitivity was labelled as 0 25 Eu·ml -1 to examine the bacterial endotoxin is capable and efficient. CONCLUSION For hospital routine pyrogen test of Compound Sodium Acetate Parenteral Solution, the domestic rabbit method can be replaced by the bacterial endotoxin inspection method.