复方氯解磷定注射液细菌内毒素的检查方法
Application of bacterial endotoxin test to compound pralidoxime chloride injection
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摘要: 目的: 建立复方氯解磷定注射液细菌内毒素检查法。 方法: 采用《中国药典》2005年版附录细菌内毒素检查法。 结果: 复方氯解磷定注射液稀释至含氯解磷定10 mg/mL及以下浓度时,用灵敏度为0.25 EU/mL的鲎试剂检测细菌内毒素,无干扰因素影响。 结论: 复方氯解磷定注射液细菌内毒素限值确定为0.2 EU/mg,可应用鲎试剂进行细菌内毒素法检查。Abstract: Objective: To establish an application of bacterial endotoxin test to compound pralidoxime chloride injection. Methods: The expriment was carried out based on the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition. Results: It was proved that the maximum noninterference concentration of compound pralidoxime chloride injection was pralidoxime chloride 10 mg/mL and the sensitivity of TAL was 0.25 EU/mL. Conclusion: The results suggested that the bacterial endotoxin test was suitable for the detection of endotoxin in compound pralidoxime chloride injection and the bacterial endotoxin limit was 0.2 EU/mg.
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