SPF家兔和普通家兔在热原实验中的比较研究  

Comparative study in pyrogen test between Conventional and SPF rabbits

作　　者：王金恒[1] 杜颖[1] 蔡彤[1] 张潇[1] 张横[1] 高华[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2011年第9期1764-1769,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：中国食品药品检定研究院中青基金项目(2009C7)

摘　　要：目的:将不同等级(普通级与SPF级)的家兔用于生物制品、细菌内毒素国家标准品的热原检测,研究普通级与SPF级家兔适应期对环境的适应能力、体温的均一性及对热原质的敏感性上是否存在差异,最终选择出更适合于热原检测的等级家兔。方法:按照中国药典2005版三部附录ⅫD热原检查法,分别对SPF级与普通级家兔进行适应期与筛选实验的比较、对细菌内毒素(G-)的敏感性比较以及对生物制品热原检测准确性的比较。结果:适应期、筛选合格率、筛选实验体温分布情况及筛选实验体温波动情况比较存在显著性差异;对内毒素敏感性和同一制品热原检查无显著性差异。结论:SPF级家兔在适应期中的适应性优于普通级家兔;SPF级家兔筛选合格率优于普通级家兔;SPF级家兔与普通级家兔对内毒素敏感性无明显差异;SPF级家兔与普通级家兔对同一制品热原检查准确性无明显差异。Objective：The differences of adaptation period,temperature uniformity and sensitivity of pyrogens between Conventional and SPF rabbits are studied to select the preferable level of rabbits for pyrogen tests,using rabbits of different levels（Conventional and SPF） for the pyrogen tests of national standards of biologics and bacterial endotoxin.Methods：According to Appendices Ⅻ D Pyrogen Test in Volume Ⅲ of the Chinese Pharmacopoeia 2005,comparative studies were made in adaptation period and screening experiments,the sensitivity of bacterial endotoxin（G-） and the accuracy of pyrogen tests for biologics,respectively,in the two levels of rabbits.Results：Significant differences exist in adaptation period,percent of pass in screening,temperature distribution and fluctuations of screening tests;differences are not significant in the sensitivity of bacterial endotoxin and pyrogen tests for the same biologics.Conclusion：Adaptability of SPF rabbits in adaptation period is better than that of Conventional ones;percent of pass in screening of SPF rabbits is better than that of Conventional ones;No significant differences in the sensitivity of bacterial endotoxin exist between Conventional and SPF rabbits;No significant differences in the accuracy of pyrogen tests for the same biologics exist between Conventional and SPF rabbits.

关 键 词：SPF级家兔 普通级家兔 热原检测 药品检验 药品安全 

分 类 号：R917[医药卫生—药物分析学]