【摘要】 建立磺胺嘧啶钠注射液细菌内毒素的检查方法。采用《中国药典》2005年版附录细菌内毒素检查法。磺胺嘧啶钠注射液在12.5mg·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,无干扰因素影响。磺胺嘧啶钠注射液细菌内毒素限值确定为0.1EU·mg-1,可应用鲎试剂进行细菌内毒素法检查。更多还原

【Abstract】 To establish application of bacterial endotoxin test to Sulfadiazine Sodium Injection. The method based on the bacterial endotoxin test in Chinese pharmacopoeia 2005ed. It was proved that the maximum noninterference concentration of Sulfadiazine Sodium injection was 12.5mg·mL-1 and the sensitivity of TAL was 0.25EU·mL-1. The results suggest that bacterial endotoxin test is suitable for the detection of endotoxin in Sulfadiazine Sodium Injection and the bacterial endotoxin limit is 0.1EU·mg-1.更多还原