长春西汀注射剂细菌内毒素检查法研究

Bacterial Endotoxin Test for Vinpocetine Injection

目的建立测定长春西汀注射剂中热原物质的细菌内毒素检查法。方法参照2015年版《中国药典(四部)》中细菌内毒素检查法,测定长春西汀注射剂中的热原物质。结果使用细菌内毒素检查用水和0.75 mol/L氢氧化钠溶液稀释至长春西汀注射剂的(质量浓度为5 mg/mL)50倍及以上时,不干扰细菌内毒素的检查结果。结论细菌内毒素检查法可替代热原检查法,用以测定长春西汀注射剂中的热原物质,细菌内毒素检查法的限值可统一为0.5 EU/mg。

Objective To establish a bacterial endotoxin test for the determination of pyrogen in Vinpocetine Injection.Methods The pyrogen in Vinpocetine Injection was determined according to the bacterial endotoxin test method in the Chinese Pharmacopoeia(2015 Edition,VolumeⅣ).Results Vinpocetine Injection(5 mg/mL)did no interfere with the results of bacterial endotoxin test when diluted to 50 times or more with water for bacterial endotoxin test and 0.75 mol/L Sodium Hydroxide Solution.Conclusion Bacterial endotoxin test can replace pyrogen test to determine the pyrogen in Vinpocetine Injection.The limit value of Vinpocetine Injection in the bacterial endotoxin test can be unified as 0.5 EU/mg.