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目的:建立注射用萘夫西林钠的细菌内毒素检查方法。方法:根据《中国药典》2010年版二部收载的细菌内毒素检查法的要求,用两个不同厂家鲎试剂对3批注射用萘夫西林钠进行干扰试验和细菌内毒素检查。结果:注射用萘夫西林钠在浓度为20 mg.ml-1时对鲎试剂与细菌内毒素之间的凝集反应有抑制现象,而浓度低于或等于10 mg.ml-1时不干扰细菌内毒素检查,样品的细菌内毒素限值确定为0.05 EU.mg-1。用标示灵敏度为0.25 EU.ml-1的鲎试剂检测细菌内毒素检查是有效的。结论:可以用细菌内毒素检查法来控制注射用萘夫西林钠的质量。
Objective: To establish a bacterial endotoxin test method of nafcillin sodium for injection. Methods: According to the requirements of the bacterial endotoxin test method contained in the 2010 edition of Chinese Pharmacopoeia (2), interference test and bacterial endotoxin test were conducted on three batches of nafcillin sodium for injection with two different manufacturers’ reagent. Results: Nafcillin sodium for injection inhibited the agglutination reaction between limulus reagent and bacterial endotoxin at a concentration of 20 mg.ml-1, but did not interfere with the bacteria when the concentration was lower than or equal to 10 mg.ml-1 For endotoxin testing, the bacterial endotoxin limit for the sample was determined to be 0.05 EU.mg-1. Bacterial endotoxin tests are validated using the limulus reagent with a labeling sensitivity of 0.25 EU.ml-1. Conclusion: The bacterial endotoxin test can be used to control the quality of nafcillin sodium for injection.