布洛芬细菌内毒素检查法研究

Study on Testing for Bacterial Endotoxin in Ibuprofen

摘要: 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。

Abstract: OBJECTIVE To establish a method of examining bacterial endotoxin for ibuprofen. METHODS To determine the reasonable limit of bacterial endotoxin by Chinese Pharmacopoeia 2010; and study on testing for bacterial endotoxin to determine the noninterference concentration for ibuprofen. RESULTS According the dose of clinical medication to determine the most suitable limit of bacterial endotoxin in preparations for ibuprofen was 0.20 EU·mg^-1 and uesd the TAL of two manufacturers to test, and it was proved that the maximum noninterference concentration was 0.625 mg·mL^-1 and the best testing concentration was no more than 0.625 mg·mL^-1. CONCLUSION It was showed that the method is suitable for the ibuprofen of bacterial endotoxin test.