家兔固定时间对热原试验结果的影响

目的　分析家兔固定时间对热原试验结果的影响。方法　按照《中国生物制品规程》2 0 0 0年版的生物制品热原质试验规程进行。结果　按规定测量 6次体温 ,制品均合格 ,而延长测温 2h ,变为不合格和复试的制品批次占总试验批次的 30 8% ,且存在显著性差异 (P <0 0 5 )。结论　家兔固定时间过长可致热原试验结果出现误差

Effect on Pyrogen Test by Rabbit Restrained Time

Objective To analyse the effect on pyrogen test by rabbit restrained time. Methods\ The pyrogen test of biologics of 《Chinese Requirements for biologics》 edited in 2000 was followed. Results\ Beying the Biologics, all batches of the products pass the test with 6 body temperature recorders. While prolonging the rabbit restrained time for 2 hours, the batches that fail and need to repeat the test accounted for 30\^8% in the total batches measured. The difference of the two results is significant (\%P\%<0\^05) as for the various restrained time. Condusion A long time-restrained rabbits could lead to a wrong result of pyrogen test.