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本实验采用具有较强穿透力的 C_0-60放射源,以577R(伦琴)/minγ- 射线辐照大肠杆菌内毒素的生理盐水稀释液,以观察内毒素生理活性的变化。生物体内的热原检查及体外鲎试验对照结果表明,电离辐射能降解或消除内毒素的生理活性,其有效剂量随内毒素的含量增加而加大。内毒素浓度为10～1000ng/ml,有效辐照剂量由1.0×10~6～1.4×10~6R。在本实验条件下,即能达到中国药典对注射剂中热原试验的要求。
In this experiment, C_0-60 radioactive source with strong penetrating power was used to irradiate Escherichia coli endotoxin physiological saline solution with 577R (roentgen) / minγ-ray to observe the change of endotoxin physiological activity. Pyrogen test in vivo and in vitro test results show that the ionizing radiation can degrade or eliminate the physiological activity of endotoxin, and its effective dose increases with the increase of endotoxin content. Endotoxin concentration of 10 ~ 1000ng / ml, the effective radiation dose from 1.0 × 10 ~ 6 ~ 1.4 × 10 ~ 6R. Under the experimental conditions, the requirements of Chinese Pharmacopoeia for pyrogen test in injection can be achieved.