【摘要】 目的 建立甲钴胺注射液细菌内毒素检查方法。方法 参照《中国药典》2005版(二)部附录细菌内毒素检查法及其原则进行实验。结果 当甲钴胺注射液稀释至600倍(即浓度为0.000 833 mg/ml)时可消除对鲎试剂与细菌内毒素凝聚反应的干扰。 结论 甲钴胺注射液可用细菌内毒素检查法进行安全性质量检查。

    【关键词】 甲钴胺注射液; 细菌内毒素检查; 鲎试剂; 干扰试验

    Study of Bacterial Endotoxin test for Mecobalamin Injection

    XIE Dong-mei.Department of Pharmary, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui Province,Bengbu 233004, China

    【Abstract】 Objective To establish the bacterial endotoxin test in mecobalamin Injection.Methods According to the CHP(2005 Edt.), inhibition or enhancement test forbacterial endotoxin test was carried out of sodium bicarbonate injection.Results The interference could be eliminated when mecobalamin injection was diluted by 600 times 0.000 833 mg/ml.Conclusion Bacterial endotoxin test could be used for mecobalamin injection.

    【Key words】 Mecobalamin injection; Bacterial endotoxin test(BET); Tachypleus amebocyte lysate(TAL); Interference test

    甲钴胺注射液(mecobalamin injection)是一种内源性的辅酶B12,易转移至神经细胞器,从而促进核酸和蛋白质的合成,促进轴索内输送和轴索的再生,促进正红母细胞的成熟,分裂,改善贫血血象等 ......