摘要
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 set up a reasonable iimit of bacterial endotoxin in Interleukin -2 and establish a rapid and accurate method for examing bacterial endotoxin. Method： Examing technique introduced in Chinese pharmacopoeia 2005 edition was consulted. The limit of bacterial endotoxin for other drugs was used as reference to determine the best dilute times of the limit of bacterial endotoxin for interleukin -2. Result： The most suitable limit of bacterial endotoxin in Interleukin -2 was 1.5EU/2000 IU. The best testing concentration was 6 times diluted liquid with the bacterial endotoxin in the interleukin-2 by TAL having a sensitivity of 0.25 EU·ml^-1. Conclusion： It is feasible to test the bacterial endotoxin in the interleukin-2 by L = 1.5 EU/200OIU.
出处
《中国药师》
CAS
2006年第2期149-151,共3页
China Pharmacist
