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乳酸环丙沙星已广泛用于临床,部分标准采用家兔法检查热原。本文通过细菌内毒素检查法,考察了乳酸环丙沙星注射液对鲎试验的干扰行为,结果表明,样品1:1稀释后,按常规鲎试验法检查热原是可行的,现报道如下。1.仪器与试剂 电热恒温水浴锅(上海医疗器械五厂),旋涡混合器(江苏泰县医疗器械厂制),弃G因子鲎试剂(0.5Eu/ml,0.1ml/支,971101),超纯水(10m/支971025)厦门鲎试剂厂,细菌内毒素国家标准品(981,9000Eu/支)中国药品生物制品检定所,乳酸环丙沙星注射液(980205 980228 980330)本院制剂室生产,热原检查合格。
Ciprofloxacin lactate has been widely used in clinical practice, some of the standard method of using the rabbit fever check. In this paper, the bacterial endotoxin test method was used to investigate the interference behavior of ciprofloxacin lactate injection. The results showed that it is feasible to check the pyrogen according to the routine test method after the sample is diluted 1: 1, and the report is as follows. 1. Instrument and reagent electric heated water bath (Shanghai Medical Devices Factory No. 5), vortex mixer (Jiangsu Taixian Medical Device Factory), G factor reagent rejection (0.5Eu / ml, 0.1ml / support, 971101), super Pure water (10m / branch 971025) Xiamen 鲎 Reagent Factory, national standard bacterial endotoxin (981,9000Eu / branch) China Pharmaceutical and Biological Products Inspection Institute, ciprofloxacin lactate injection (980205 980228 980330) , Pyrogen test qualified.