尼莫地平注射液细菌内毒素检查法研究

Study on Bacterial Endotoxin Test for Nimodipine Injection

目的 :建立尼莫地平注射液细菌内毒素检查方法。方法 :采用《中国药典》2 0 0 0年版附录细菌内毒素检查法。结果 :尼莫地平注射液在稀释至 8倍时检查细菌内毒素可完全排除干扰因素的影响。结论 :细菌内毒素检查法可代替家兔热原检查法。进行尼莫地平注射液中内毒素的检查。

Objective: To establish a method for examination of bacterial endotoxions of nimodipine injection.Method: The bacterial endotoxion test approved by Chinese Pharmacopoeia (edition 2000) was used.Result: The bacterial endotoxins test showed neither inhibition nor enhancement when nimodipine injection was diluted up to 8 stimes.Conclusion: The technique of TAL test can be used as an alternative method in the rabbit pyrogen test for nimodipine injection.