参附注射液细菌内毒素检查法的研究

Study on the bacterial endotoxin inspection method of shenfu injection

目的 建立参附注射液的细菌内毒素检查法。方法 按《中国药典》2 0 0 0年版 (二部 )收载的细菌内毒素检查方法及指导原则进行实验。将参附注射液经 6倍稀释 ,用标示灵敏度为 0 5Eu·ml-1 的鲎试剂检测其细菌内毒素。结果 参附注射液稀释6倍对鲎试剂无干扰作用。

Aim To establish a bacterial endotoxin inspection method of shenfu injection.Methods The experiment is implemented according bactiral endotoxin test procedure and guiding principle in Chinese Phamacopoeia. To dilute shenfu injection six times, and bacterial endotoxin can be tested by amebocyte lysate with accuracy of 0 5 Eu·ml -1 .Results The interference elements can be excluded by diluting shenfu injection six times. Conclusion For pyrogen test of shenfu injection, bacterial endotoxin inspection method can be used instead of domatic rabbit method.