正常体温范围的家兔热原试验结果  

Pyrogen test results in rabbits with normal body temperatures

作　　者：张梅[1] 曾艳[1] 周丽[1] 黄文宇[1] 

机构地区：[1]长春生物制品研究所有限责任公司分包装室,吉林长春130062

出　　处：《中国生物制品学杂志》2014年第2期194-196,共3页Chinese Journal of Biologicals

摘　　要：目的观察符合热原试验要求的不同体温的家兔,在注射人血白蛋白后的升温情况。方法按照《中国药典》三部（2005版）中的＂热原检查法＂进行测定。试验分为2组：A组家兔体温在38.0~39.6℃之间;B组家兔体温在38.5~39.6℃之间。每批供试品（人血白蛋白）初试时使用3只家兔,复试时使用5只家兔。均经家兔耳缘静脉缓慢注入预热的供试品,0.6 g/kg,每隔30 min测量1次体温,连续6次。结果 A组供试品初试时的合格率（80.77%）与复试时的合格率（53.84%）差异有统计学意义（P〈0.05）;B组供试品初试时的合格率（96.15%）与复试时的合格率（92.31%）差异无统计学意义（P〉0.05）。A组供试品有15批结果相同,重复率为57.69%,B组供试品有25批结果相同,重复率为96.15%,两组检测结果的重复性差异有统计学意义（P〈0.005）。A组升温≥0.6℃家兔所占比例明显高于B组,差异有统计学意义（P〈0.005）。结论家兔对热原的敏感性随体温的高低有明显的差异,体温偏低的家兔对热原更敏感,其升温幅度大于体温偏高的家兔。Objective To observe the elevation of body temperatures of rabbits used for pyrogen test, at various ranges of normal body temperatures, after injection with human serum albumin（HSA）. Methods Pyrogen test was performed ac- cording to the requirements in Chinese Pharmacopoeia（Volume Ⅲ, 2005 edition）. The rabbits with body temperatures of 38. 0 - 39. 6 ℃ were served as group A, while those with body temperatures of 38. 5 - 39. 6 ℃ as group B. Each batch of test samples（HSA）was injected to three rabbits in primary test and five rabbits in retest. The pre-heated samples were injected slowly into the ear vein of rabbits at a dosage of 0. 6 g / kg. Body temperatures were measured every 30 min for 6 times. Results The qualification rates of samples in group A were 80. 77% and 53. 84% in primary test and retest re- spectively, which showed significant difference（P 0. 05）. However, the qualification rates in group B were 96. 15% and 92. 31% in primary test and retest respectively, which showed no significant difference（P〉 0. 05）. The test results of 15 batches of samples in group A were identical, with a reproducibility of 57. 69%. However, the results of 25 batches in group B were identical, with a reproducibility of 96. 15% which showed significant difference with that in group A（P〈 0. 005）. The percentage of rabbits with elevation of body temperature of not less than 0. 6 ℃ was significantly higher in group A than in group B（P〉 0. 005）. Conclusion The sensitivity of rabbits with various body temperatures to pyrogen were significantly different. The rabbits with low body temperatures were more sensitive to pyrogen.

关 键 词：体温 家兔 热原 白蛋白 

分 类 号：Q95-3[生物学—动物学] R392-33[医药卫生—免疫学]