Pyrogen Test

Pyrogen test：Pyrogen test: is an experimental method for detecting and evaluating pyrogenic substances in drugs or biologics to ensure the safety and quality of the drug or biologics. The test usually uses animals as test subjects, and the presence or absence of pyrogenic substances is determined by observing the changes in body temperature and systemic reactions of the animals. The results of the pyrogen test are of great significance for drug development, production and quality control.

Methods:

Three pre-selected test rabbits were taken as a group, and the normal body temperature should be 38.0℃~39.6℃, and the difference of normal body temperature between rabbits in the same group should not be more than 1.0℃. The rabbits should stop feeding at least 1h before the test and be placed in a loose and suitable device. The precision of the temperature measuring device was ±0.1℃, and the depth and time of the temperature measuring probe inserted into the anus were the same among rabbits, with a depth of 6cm and a time of not less than 1.5min. The temperature was measured once every 30min, and a total of two measurements were taken. The difference between the two measurements should not be more than 0.2℃, and the average of the two temperatures should be taken as the normal temperature of the rabbit. Inject within 15 min after the measurement of normal body temperature, the injection dose is 10 mL/kg. 75% ethanol was used to sterilize the rabbit's ear vein before the injection, and the specified dose of the test material pre-warmed to about 38℃ was slowly injected into the ear vein. After the injection, the body temperature was measured every 30 min for 6 times. Subtract the normal body temperature from the highest of the 6 measurements, and the elevated temperature of the rabbit will be determined.