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目的建立布洛芬细菌内毒素检查方法。方法按中国药典2010年版二部,确定合理的布洛芬内毒素限值,并研究布洛芬对细菌内毒素与鲎试剂反应的干扰情况,以确定其最大不干扰试验浓度。结果根据临床实际应用情况,确定布洛芬的内毒素限值为L=0.20 EU.mg 1,使用2个厂家生产的鲎试剂试验,结果本品配制成≤0.625 mg.mL 1浓度对反应无干扰作用。结论细菌内毒素检查法可用于布洛芬细菌内毒素的检查。
Objective To establish an ibuprofen bacterial endotoxin test. Methods According to the Chinese Pharmacopoeia 2010 edition two, to determine a reasonable limit of ibuprofen endotoxin, and to study the interference of ibuprofen bacterial endotoxin and 鲎 reagent reaction to determine the maximum concentration does not interfere with the test. Results According to the clinical application, the limit of endotoxin of ibuprofen was determined to be L = 0.20 EU.mg 1, and the results of the test using two reagents produced by two manufacturers showed that the product was ≤0.625 mg.mL 1, Interference effect. Conclusion Bacterial endotoxin test can be used for the detection of bacterial endotoxin in ibuprofen.