【摘要】 目的探讨定量检测加替沙星葡萄糖注射液(GGI)中细菌内毒素的方法。方法采用《中华人民共和国药典》2000年版附录的细菌内毒素检查方法及指导原则进行实验。结果2个厂家4个批号的GGI在浓度≤0.167 mg.ml-1时,对细菌内毒素检查无干扰,所测样品(100 ml:0.2 g加替沙星:0.5 g葡萄糖)细菌内毒素的量均小于0.75 EU.mg-1,回收率在50%~200%之间。结论可建立GGI的细菌内毒素检查法代替热原法。更多还原

【Abstract】 AIM To investigate the feasibility to detect bacterial endotoxin test and provide the practical quality control of Gatifloxacin and Glucose Injection（GGI）.METHODS Gel-clot and kinetic turbidimetric methods were conducted according to appendix of Ch.P.2005.RESULTS After diluted to 166.7 mg·L^-1,non interference was determinated in four batchs of GGI,the content of bacterial exdotoxins in all samples were not more than 1500 EU·L^-1,the recovery rates of endotoxin in samples were in the range of 50%～200%.CONCLUSION The method of endotoxin detection in the Gatifloxacin and Glucose Injection（GGI） can instead of heat source testing method.更多还原