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目的建立注射用丙氨酰谷氨酰胺的细菌内毒素检查方法。方法参照中国药典2005年版收载的细菌内毒素检查法及指导原则进行干扰试验。结果注射用丙氨酰谷氨酰胺在稀释至10mg/ml时,对鲎试剂的凝集反应无干扰作用,采用灵敏度为0.125EU/ml的鲎试剂可进行细菌内毒素检查。结论本品用0.125EU/ml的鲎试剂进行细菌内毒素检查是可行的。
Objective To establish a bacterial endotoxin test for alanyl glutamine for injection. Methods According to the Chinese Pharmacopoeia 2005 edition contained bacterial endotoxin test methods and guidelines for interference test. Results When alanyl glutamine for injection was diluted to 10 mg / ml, there was no interference with the agglutination reaction of limulus reagent. The bacterial endotoxin test was performed using the limulus reagent with a sensitivity of 0.125 EU / ml. Conclusion This product is 0.125EU / ml of 鲎 reagent for bacterial endotoxin test is feasible.