甲钴胺注射液细菌内毒素检查法研究

Study of Bacterial Endotoxin test for Mecobalamin Injection

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0.000833mg/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。

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 candied 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.