注射用乙酰谷酰胺的细菌内毒素检查  

Bacterial endotoxin test of aceglutamide for injection

作　　者：刘毅萍[1] 夏爱光 

机构地区：[1]浙江省杭州市药品检验所,浙江杭州310014 [2]浙江省温州康宁医院,浙江温州325007

出　　处：《安徽医药》2007年第1期37-38,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的确定注射用乙酰谷酰胺的细菌内毒素限值并进行干扰试验测定。方法建立注射用乙酰谷酰胺的细菌内毒素检查法。结果当注射用乙酰谷酰胺稀释至1g·L-1时,用标示灵敏度为2.5×10-4Eu·L-1的鲎试剂进行细菌内毒素检查是有效的。结论鲎试剂可用于注射用乙酰谷酰胺的细菌内毒素检查。Aim To establish a bacterial endotoxin testing method for Aceglutamide for Injection was established. Methods The limit of endotoxin was determined and validated by interference test. Results The experiment showed that the interference elements could be excluded by diluting Aceglutamide for injection to 1 g · L^-1 ,and it was effective that the bacterial endotoxin could be tested by amebocyte lysate with accuracy of 2.5 × 10^-4 Eu · L^- 1. Conclusion The bacterial endotoxin testing method can be used for Aceglutamide for Injection.

关 键 词：注射用乙酰谷酰胺 细菌内毒素检查 干扰试验 

分 类 号：R927[医药卫生—药学]