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目的:研究细菌内毒素鞘内注射对家兔致热的规律,计算出发热的阈值,为我国药典的修订提供依据,为鞘内用注射剂质量控制提供参考。方法:按照2005年版中国药典规定的热原检查方法,家兔鞘内注射5个不同剂量组的细菌内毒素,记录并绘制升温曲线图,通过曲线拟合计算出家兔体温升高0.6℃时发热的阈剂量。结果:家兔鞘内注射细菌内毒素的发热阈剂量为1.8 EU.kg-1(换算成人发热阈剂量为0.6 EU.kg-1),发热峰值位于4～5.5 h,升温维持时间位于0.25～1.5 h。结论:由于家兔鞘内注射细菌内毒素发热阈值比国药典的规定值(0.2 EU.kg-1)大,因此中国药典规定鞘内用注射剂发热阈值为0.2 EU.kg-1较为严格。
OBJECTIVE: To study the rule of fever caused by bacterial endotoxin intrathecal injection in rabbits and to calculate the threshold value of fever to provide a basis for the revision of Chinese Pharmacopoeia and to provide a reference for the quality control of intrathecal injection. Methods: Bacterial endotoxin was injected into rabbits intrathecally according to the pyrogen test method stipulated in the 2005 edition of Chinese Pharmacopoeia, and the temperature rise curve was recorded and plotted. The body temperature of rabbits increased by 0.6 ℃ Fever threshold dose. Results The febrile threshold value of intrathecal injection of bacterial endotoxin was 1.8 EU.kg-1 (0.6 EU.kg-1 in terms of adult febrile threshold), the peak value of fever was between 4 and 5.5 hours, and the duration of warming was 0.25 ~ 1.5 h. CONCLUSIONS: Because the threshold value of bacterial endotoxin fever in intrathecal injection of rabbits is larger than that of the Chinese Pharmacopoeia (0.2 EU · kg-1), the Chinese Pharmacopoeia stipulates that the intrathecal injection fever threshold is 0.2 EU · kg-1.