氯解磷定注射液细菌内毒素检查法的建立

Establishment of Bacterial Endotoxin Test for Pralidoxime Chloride Injection

目的:建立氯解磷定注射液的细菌内毒素检查法。方法:根据《中国药典》2010年版(二部)附录"细菌内毒素检查法"进行。确定样品的细菌内毒素限值和稀释浓度,用2个不同厂家的鲎试剂对4批氯解磷定注射液进行了干扰预试验、干扰试验和细菌内毒素检查。结果:样品细菌内毒素限值确定为0.2EU·mg-1,其稀释至10mg·mL-1及以下浓度时,用灵敏度为0.25EU·mL-1的鲎试剂检测细菌内毒素,无抑制干扰作用;4批样品细菌内毒素检查均符合规定。结论:氯解磷定注射液可应用鲎试剂进行细菌内毒素检查。

OBJECTIVE： To establish a method to test bacterial endotoxin in Pralidoxime chloride injection. METHODS： The experiment was carried out in accordance to the bacterial endotoxin test in Chinese Pharmacopoeia （2010 edition）. The limit and di- lute concentration of bacterial endotoxin were determined. Preliminary interference test, interference test and bacterial endotoxin test of four batches of Pralidoxime chloride injection were performed with tachypleus amebcyte lysate （TAL） manufactured by 2 compa- nies. RESULTS： The limit of bacterial endotoxin was 0.2 EU.mg-1. The bacterial endotoxin was detected with TAL 0.25 EU,mL-1 when the maximum concentration of pralidoxime chloride was 10 mg. mL-1 without interference. The bacterial endotoxin test of 4 batches of samples was all up to the regulations. CONCLUSION： The results suggest that TAL can be used for the bacterial endotoxin test of Pralidoxime chloride injection.