三磷酸腺苷二钠注射液细菌内毒素检查方法的探讨

Discussion on Bacterial Endotoxin Inspection of Adenosine Disodium Triphosphate Injection

为建立三磷酸腺二钠注射液 (ATP)的细菌内毒素检查方法 ,参照中国药典 1995年版二部收载的细菌内毒素检查方法 ,通过干扰实验证明ATP对鲎试剂的凝集反应无干扰作用 ,用灵敏度为 0 5EU/ml的鲎试剂检查细菌内毒素的方法是可行、有效的。结果表明可以用细菌内毒素检查法替代家兔热原法来对ATP进行质量控制。

To establish the bacterial endotoxin inspection method of Adenosine Disodium Triphosphate Injection(ATP),the experiment of bacterial endotoxin inspection was performed. The interfering test showed that the reaction with Limulus amebocyte lysate was not disturbed by ATP,and it is effective that bacterial endotoxin can be tested by Limulus amebocyte lysate with accuracy of 0.5EU/ml. The results showed that Limulus amebocyte lysate method can be used instead of domestic rabbit method for the quality control of ATP.