Nakata T
Ibaraki Plant, Sumitomo Pharmaceuticals Company, Limited, Japan.
J Pharm Sci Technol. 1994 Mar-Apr;48(2):59-63.
The amount and pyrogenicity of challenged endotoxin (derived from E. coli 055:B5, 10,000 endotoxin units, EU) processed in a dry heat oven at 200 degrees and 250 degrees C was measured and compared with the predicted amount and pyrogenicity calculated from destruction kinetics. The values for the assayed amount and pyrogenicity of the endotoxin processed in the dry heat oven at 200 degrees and 250 degrees C were fairly close to the predicted values. When the challenged endotoxin was exposed for 60 min in a dry heat oven at 200 degrees C, the amount of destruction did not reach a 3 log cycle reduction, although the pyrogenicity of the endotoxin was sufficiently reduced. However, at 250 degrees C for 30 min in the dry heat oven, the amount of endotoxin destroyed quickly reached a 3 log cycle reduction, and the pyrogenicity was quickly reduced to a sufficient level.
对在200摄氏度和250摄氏度的干热烘箱中处理的受试内毒素（源自大肠杆菌055:B5，10,000内毒素单位，EU）的量和热原性进行了测量，并与根据破坏动力学计算出的预测量和热原性进行了比较。在200摄氏度和250摄氏度的干热烘箱中处理的内毒素的测定量和热原性值与预测值相当接近。当受试内毒素在200摄氏度的干热烘箱中暴露60分钟时，尽管内毒素的热原性充分降低，但破坏量未达到3个对数循环的减少。然而，在250摄氏度的干热烘箱中处理30分钟时，内毒素的破坏量迅速达到3个对数循环的减少，并且热原性迅速降低到足够的水平。
