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注射用头孢唑林钠是临床上应用较普遍的抗生素,但用家兔法检查热原不够快速及时,而用细菌内毒素检查法则具有简便、快速、准确性高、稳定性好的优点。本文对注射用头孢唑林钠细菌内毒素检查进行了可行性试验,用于验证细菌内毒素检查法是否适用于本品检测。 1 实验材料 鲎试剂(湛江安度斯生物有限公司),复核灵敏度为0.25Eu/ml,批号:980121;细菌内毒素检查用水(湛江海洋生物制品厂),内毒素含量<0.03Eu/ml,批号:990419;细菌内毒素标准品(中国药品生物制品检定所),批号:9801,60Eu/支。注射用头孢唑林钠、上海四药股份有限公司,0.5g/瓶。 2 方法与结果 2.1 细菌内毒素理论限值(L) 我国细菌内毒素标准品的
Cefazolin sodium for injection is a more commonly used antibiotics in clinical practice, but it is not fast and timely to examine the pyrogen by the rabbit method. However, the bacterial endotoxin test has the advantages of simplicity, rapidity, high accuracy and good stability. In this paper, cefazolin sodium injection for bacterial endotoxin test was tested for the feasibility of bacterial endotoxin test for the detection of the goods. 1 Experimental Materials 鲎 Reagents (Zhanjiang Anduosi Biological Co., Ltd.), review sensitivity 0.25Eu / ml, batch number: 980121; bacterial endotoxin test water (Zhanjiang Marine Biological Products Factory), endotoxin content <0.03Eu / ml, : 990419; bacterial endotoxin standard (China Pharmaceutical and Biological Products Inspection Institute), batch number: 9801,60 Eu / branch. Cefazolin sodium for injection, Shanghai Siyao Co., Ltd., 0.5g / bottle. 2 Methods and Results 2.1 The theoretical limit of bacterial endotoxin (L) China’s bacterial endotoxin standards