布洛芬氯化钠注射液细菌内毒素检查方法的建立

Establishment of Bacterial Endotoxin Test Method of Ibuprofen Sodium Chloride Injection

目的:建立布洛芬氯化钠注射液细菌内毒素的检查方法。方法:按2015年版《中国药典》(四部)通则1143"细菌内毒素检查法"项下凝胶法的要求,通过干扰试验确定样品主成分最大无干扰质量浓度,并进行方法学验证。结果:样品稀释至含布洛芬质量浓度为1 mg/mL及以下时对细菌内毒素检查无干扰作用。结论:所建立的方法可用于布洛芬氯化钠注射液的细菌内毒素检查,其细菌内毒素限值确定为0.5 EU/mL。

OBJECTIVE ： To establish a method for the bacterial endotoxin test of Ibuprofen sodium chloride injection, METH- ODS： Maximum noninterference concentration of sample was determined by interference test according to bacterial endotoxins gel-clot test stated in the general principles 1143 of Chinese Pharmacopoeia 2015 edition （four）. And then methodology validation was conducted. RESULTS： Samples were diluted to 1 mg/rnL, which did not interfere with bacterial endotoxin test. CONCLUSIONS： The established method can be used for the bacterial endotoxin test of Ibuprofen sodium chloride injection, and the limitation of bacterial endotoxin was 0.5 EU/mL.