论文部分内容阅读
目的 :建立右旋糖酐 40葡萄糖注射液的细菌内毒素检查法。方法 :考察右旋糖酐 40葡萄糖注射液对细菌内毒素检查法的干扰作用 ,按《中国药典》2 0 0 0年版 (二部 )细菌内毒素检查法进行实验。结果 :样品经过 4倍稀释可排除干扰因素 ,用标示灵敏度为 0 .12 5EU/ml的鲎试剂检测细菌内毒素方法可行、有效。结论 :可用鲎试验取代家兔法检查右旋糖酐 40葡萄糖注射液的热原
Objective: To establish a bacterial endotoxin test for dextran 40 glucose injection. Methods: To investigate the interference effect of dextran 40 glucose injection on bacterial endotoxin test, according to the Chinese Pharmacopoeia 2000 (two) bacterial endotoxin test method. Results: The samples were diluted 4 times to eliminate the interference factors. The method of detecting the bacterial endotoxin with the labeling reagent with the sensitivity of 0.25125U / ml was feasible and effective. CONCLUSION: The pyrogen test of dextran 40 glucose injections can be replaced by the rabbit test