鲎试剂在一些注射剂热原检测中的应用

<正> 热原的鲎试验法,自1972年 Cooper 氏首先应用于注射剂检查以来,国外已积累了许多资料。它与家兔法比较具有方法简便、快速、可靠、灵敏度高,且能定量,无生物差异等优点。美国食品和药品管理局已批准用它代替家兔法进行医疗器械和一些药品热原检查。美国药典ⅩⅩ版已收载鲎试验为测定细菌内毒素(即热原)浓度的方

The Application of TAL reagent to the Detection of Pyrogens in Some Injections

This report provides a Limulus test for detecting pyrogens in some injections.The reagent employed was Chinese Limulus Amebocyte Lysate obtained from aqueous extracts of the circulating amebocytes of Tachypleus tridentatus(called TAL reagent). Among the 34 samples of injections having undergone the pyrogen detecting test,15 samples were found to inhibit coagulation reaction of TAL reagent,and so also did Sodium Salicylate Injection. When the test dose for rabbit,the volume of TAL reagent,the incubation time and the sensitivity of TAL reagent were given and the samples of injections were diluted pr- operly,using a mininum amount of febrile-inducing endotoxins in rabbits as a referene standard,the TAL reagent lest and the rabbit test would be found uniformed. When the TAL reagent test showed negative,the rabbit test would also be negative, when the TAL reagent test was positive,another rabbit test was eaied out to cheek th- results,as the Limulus test was more sensitive than the rabbit test for pyrogens.