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目的:确定白介素-2合理的内毒素限值,建立快速、准确的细菌内毒素检查法。方法:根据《中国药典》2005年版内毒素检查法并参考其他药物的内毒素限值,确定白介素-2的内毒素限值及最佳稀释倍数。结果:白介素-2的内毒素限值L= 1．5 EU／2 000IU。当用灵敏度为0．25 EU·ml-1的鲎试剂进行细菌内毒素检查时,白介素-2的稀释倍数为6。结论:白介素-2 内毒素限值按1．5 EU／2000IU进行内毒素检查是可行的。
Objective: To determine the reasonable endotoxin limit of interleukin-2 and to establish a rapid and accurate bacterial endotoxin test. Methods: According to the “Chinese Pharmacopoeia” 2005 edition endotoxin test method and reference to other drugs endotoxin limit, determine the endotoxin limit of interleukin -2 and the best dilution. Results: The endotoxin limit of interleukin-2 was L = 1.5 EU / 2 000 IU. IL-2 was diluted 6 when bacterial endotoxin test was carried out with limulus reagent with a sensitivity of 0.25 EU · ml-1. Conclusion: It is feasible to determine the endotoxin level of IL-2 by 1.5 EU / 2000IU.