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The influence of high endotoxin-sensitive rabbits (HESR) and low endotoxin-sensitive rabbits (LESR) on the pyrogen test regulated in Korean Pharmacopeia, United State Pharmacopeia, and British Pharmacopeia was investigated. The experiment was performed on two injection solutions (Cefazolin and Chloramphenicol) using New Zealand White strain rabbits according to Korean Pharmacopeia. The febrile responses were increased with increasing the doses of endotoxin including 0.1, 1, 5, 10 ㎎/㎖/㎏ and the maximum febrile responses were occurred between 90 min and 120 min after the injection of endotoxin. The injection of cefazolin sodium (50 ㎎/㎖/㎏) increased body temperature by 0.6, 0.7, and 0.6 in three HESR, whereas 0.1, 0.1, and 0 in three LESR, thereby resulting in pyrogen-dubious (retest) in HESR and pyrogen-negative (release) in LESR by Korean Pharmacopeia regulation. The injection of chloramphenicol sodium succinate (150 ㎎/㎖/㎏) increased body temperature by 0.5, 0.5, and 0.5 in three HESR, whereas 0, 0.2, and 0.2 in three LESR, thereby resulting in pyrogen-dubious (retest) in HESR and pyrogen-negative (release) in LESR by Korean Pharmacopeia regulation. These results suggested that HESR should be selected for the rabbit pyrogen test to give high confidence for tested data and to increase the safety of injection materials for human and animals.
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