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热原质大都是微生物的内毒素。其生理活性较强,很小量就能引起临床剧烈反应。为保证注射药剂的用药安全,很早就建立了热原质的检测手段。1942年美国药典12版首先收载家兔升温法(简称兔法)测定热原质。以后各国药典陆续收载此法,至今仍为各国测定热原的法定方法。经过半个世纪的实践考验,证明兔法在一定范围内大大增加了临床用药的安全性。由于热原本身是异质的,而且是无限异质的,造成剂量与反应间的不平行。在无法获得公认的参照品情况下,既不能做生物学的定量检定,也不能进行比较检定,因
Most pyrogen are microbial endotoxin. Its physiological activity is strong, a small amount can cause clinical severe reaction. In order to ensure the safety of the drug injection, early detection of pyrogen has been established. 1942 US Pharmacopoeia 12 version of the first collection of rabbits warming method (referred to as rabbit method) determination of pyrogen. Pharmacopoeia after another from now on this law, is still the statutory method for determination of pyrogen in various countries. After half a century of practice test, that rabbit law in a certain range greatly increased the safety of clinical medication. Since pyrogen itself is heterogeneous and infinitely heterogeneous, there is a non-parallel relationship between dose and reaction. In the absence of a recognized reference, neither the biometrics nor the comparative tests can be performed