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目的研究细菌内毒素不同给药方式对家兔致热的规律,计算出发热的阈值,为注射剂质量控制提供参考。方法按照我国2010年版《中国药典》规定的热原检查方法,家兔采用不同给药方式注射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。结果家兔皮下注射细菌内毒素的发热阈剂量为45.24 EU.kg-1,最大升温时间位于3.0~4.5 h,升温维持时间位于0.5~4.0 h;肌内注射发热阈剂量为25.97 EU.kg-1,最大升温时间位于2.5~4.5 h,升温维持时间位于0.5~3.0 h;鞘内注射发热阈剂量为1.8 EU.kg-1,最大升温时间位于4.0~5.5 h,升温维持时间位于0.3~1.5 h。结论细菌内毒素不同给药方式对家兔致热的规律有较大差别。
OBJECTIVE To study the regularity of heat-induced by different modes of bacterial endotoxin in rabbits and to calculate the threshold of fever, which can provide reference for the quality control of injection. Methods According to the method of pyrogen test in Chinese Pharmacopoeia (2010 edition), rabbits were injected with 5 different doses of bacterial endotoxin by different administration methods. The temperature rise curve was recorded and plotted. The body temperature Raise the threshold dose of fever at 0.6 ° C. Results The threshold value of fever threshold was 45.24 EU.kg-1 for subcutaneous injection of bacterial endotoxin in rabbits, the maximum temperature was between 3.0-4.5 h and the maintenance time was 0.5-4.0 h. The threshold dose of intramuscular injection was 25.97 EU.kg- 1, the maximal warming time is between 2.5 ~ 4.5 h, the warming temperature maintaining time is between 0.5 ~ 3.0 h, the intrathecal fever threshold dosage is 1.8 EU.kg-1, the max warming time is between 4.0 ~ 5.5 h, and the warming time is between 0.3 ~ 1.5 h Conclusion Different patterns of bacterial endotoxin administration to rabbits have a greater difference.