注射用氨苄西林钠的细菌内毒素检查

Determination of bacterial endotoxin in Ampicillin Sodium

目的 建立氨苄西林钠细菌内毒素的检查方法。方法 按 中国药典 2 0 0 0年版二部附录XIEXIXF进行实验和结果判断。结果 用标示量灵敏度 0 2 5EU·ml-1的鲎试剂,氨苄西林钠的有效检测浓度为 1 6 7mg·ml-1,3批氨苄西林钠内毒素均小于 0 15EU·ml-1。结论 本品可以用细菌内毒素检查法代替家兔热原检查法。

Objective To establish the bacterial endotorin determination method for Ampicillin Sodium.Methods The experiment and the judgment of its result were made according to the appendix XIE XIX F of Chinese pharmacopeia 2000 VolⅡ.Results The valid concentration was 1.67mg·ml -1 with 0.25EU·ml -1 sensitivity of TAL ,and the endotoxin content was less than 0.15EU·ml -1 in each of 3 lots.Conlusion Bacterial endotoxin can be used in place of rabbit method for Ampicillin Sodium.