黄芪注射液细菌内毒素检查法的探讨

Study on Bactrial Endotoxin Text for Astragale Injection

目的 :建立黄芪注射液细菌内毒素检查法。方法 :按《中国药典》2 0 0 0年版 (二部 )附录收载的细菌内毒素检查方法及指导原则进行实验。结果 :干扰试验表明 ,供试品 10倍稀释液可消除干扰。结论 :细菌内毒素检查法可代替家兔法进行黄芪注射液热原的检查。

Objective: To establish a bacterial endotoxin text for astragale injection. Method: Bacterial endotoxin test procedure and guiding in Chinese phamacopoeia were used. Result: The test showed that the interfering reaction could be eliminated when astragale injection was diluted in ten times. Conclusion: Bacterial endotoxin test can be used instead of rabbit method to monitor pyrogen in astragale injection.