马来酸氯苯那敏注射液的细菌内毒素检查

目的:建立马来酸氯苯那敏注射液的细菌内毒素检查方法。方法:按照《中国药典》中的细菌内毒素检查法,用不同厂家不同灵敏度的鲎试剂对14个厂家生产的28批马来酸氯苯那敏注射液进行干扰试验和细菌内毒素检查。结果:样品浓度稀释到0.025mg·mL-1以下对所用细菌内毒素检查法无干扰作用,细菌内毒素的限值L为5EU·mg-1;按拟定标准,所有28批样品细菌内毒素检查均符合规定。结论:所建立的鲎试剂法可用于马来酸氯苯那敏注射液的细菌内毒素检查。

Bacterial Endotoxins Test of Chlorphenamine

OBJECTIVE： To establish a method for the bacterial endotoxin test of chlorphenamine maleate injection. METHODS： The interference test and bacterial endotoxin test of 28 batches of chlorphenamine maleate injections from 14 manufacturers were carried out inaccordance with the bacterial endotoxin test approved by Chinese Pharmacopeia （2005 edition）. RESULTS： Diluted to a concentration of below 0.025 mg·mL^-1, the samples showed no interference action on bacte- rial endotoxin test. The limit value of the bacterial endotoxin was 5 EU·mg^-1. The results of the bacterial endotoxin test of the 28 batches of samples were all accorded with the standard of the established quality control, CONCLUSION： The estab-lished TAL method is applicable for bacterial endotoxin test of chlorphenamine maleate injection.