无菌原料药头孢噻肟钠细菌内毒素的控制

细菌内毒素是热原的一种,当噻肟钠注射剂中含有过量的内毒素时会引起一系列的不良反应,所以在噻肟钠原料药中要严格控制内毒素的量。从内毒素的危害着手,验证了用0.06 EU/mL的鲎试剂凝胶法检验头孢噻肟钠中内毒素残留时,不干扰检测的浓度范围为1.25～5.0 mg/mL,确定了日常检测头孢噻肟钠溶液浓度为1.5 mg/mL。并根据内毒素的特性,结合生产实际,研究在生产过程中应从工艺用水,原辅料和日常的容器,工具清洗,工艺操作等方面控制细菌内毒素的产生。

Control of Bacterial Endotoxin in Cefotaxime Sodium Sterile Bulk

Bacterial endotoxin is a kind of pyrogen, injecting overweight bacterial endotoxin of eefotaxime sodium can cause a series of adverse reaction, so bacterial endotoxin should be controlled in cefotaxime sodium sterile bulk. The harm of bacterial endotoxin was introduced, and the no interferencerange detection concentration was validated ,which was 1.25-5.0 mg/mL, when using 0.06 EU/mL TAL to test the bacterial endotoxin residue by gel method.The routine test concentration of cefotaxime sodium was estabhshed ,which was 1.5 mg/mL.According to the feature of bacterial endotoxin and production, bacterial endotoxin should he control in the process water, raw materials, containers and tools cleaning and aseptic process design.