獭兔在药品热原检查实验中的应用研究

Application of Rex Rabbit in Pyrogen Test

目的研究獭兔在药品质量检验热原检查项目中的应用前景。方法按中国药典(2015年版)分别用普通级獭兔和新西兰兔进行市售药品甘油果糖注射液等4种供试品进行热原检查以及细菌内毒素国家标准品(灵敏度测试)的热原实验,观察比较实验兔的体温变化。结果市售4种注射液分别用獭兔和新西兰兔进行热原检查结果均符合规定,细菌内毒素国家标准品按5EU·kg^-1、10EU·kg^-1剂量静脉注射给药,獭兔、新西兰兔均有升温超过0.6℃,且无明显差别。结论獭兔可应用于药品检验中的热原检查实验。

OBJECTIVE To study the application prospects of Rex Rabbit in pyrogen test items of drug quality inspection.METHODS According to the Chinese Pharmacopoeia(2015 edition),the pyrogen test of four kinds of commercial drugs,such as glycerol and fructose injection,and the pyrogen test of the national standard of bacterial endotoxin(sensitivity test)were carried out with conventional Rex Rabbits and New Zealand rabbits respectively.The temperature changes of experimental rabbits were observed and compared.RESULTS The pyrogen test results of four kinds of injections sold in the market were all in accordance with the regulations.The national standard of bacterial endotoxin was given intravenously at doses of 5EU·kg^-1 and 10EU·kg^-1.The temperature of Rex rabbit and New Zealand rabbit was over 0.6℃,and there was no significant difference.CONCLUSION Rex Rabbit can be used in pyrogen test in drug testing.