注射用甲泼尼龙琥珀酸钠细菌内毒素检查研究

Application of the Bacterial endotoxins test For Methylprednisolone Sodium Succinate for Injection

目的 :对注射用甲泼尼龙琥珀酸钠进行细菌内毒素检查研究 ,建立检测注射用甲泼尼龙琥珀酸钠中内毒素试验方法。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 :注射用甲泼尼龙琥珀酸钠在药液稀释浓度1.5 mg/ ml以下时 ,与 TAL试剂反应无干扰因素影响。结论

Objective: Application of the bacterial endotoxins test for Methylprednisolone Sodium Succinate for Injection was studied. Method: According to the bacterial endotoxins test and eliminated interfere factors approved by Chinese pharmacopoeia 2000 edition. Results: Endotoxin added to Methylprednisolone Sodium Succinate for Injection was recovered in quantitative manner showing neither inhibition nor enhancement in diluted solution concentration 1.5 mg/ml Conclusion: These results suggested that the bacterial endotoxins test was suitable for the detection endotoxin in Methylprednisolone Sodium Succinate for Injection.