关键词: 热原检查, 替代法, 家兔, 内毒素

Abstract: The pyrogen test is an important index of quality management relating to druggery injection and instillation and the current common methods are domestic rabbit test and Bacterial Endotoxins Test. Since there are shortcomings and limitations of resources in these two methods , it's necessary to look for another new substitute. We have done the preliminary study of the feasibility of the pyrogen test with domestic rabbit's blood plasm, human's plasm and THP 1. The principle is as follows: after incubating the standard sample of bacterial endotoxins, glycogen anti coagulation whole blood extracting from the healthy domestic rabbit, extralin anti congealable whole blood from healthy volunteers, THP 1 cells together, measure the releasing amount of TNF and IL 6 from cell gene by the method of ELISA as a endogenesis index judging the pro heat role of endotoxin. The results indicate: the blood rabbit's whole blood, human's whole blood, or THP 1cell, their releasing amount of TNF and IL 6 are closely connected with the amount of acting endotoxins within a certain range. Three methods have their own peculiarities and some feasibilities as a new substitute method for pyrogen test with domestic rabbit.

Key words: Pyrogen test, Method of substitute, Domestic rabbit, Endotoxin