Verification of the new proposed version of pyrogen result judgment algorithm / 中国药学杂志

ABSTRACT

OBJECTIVE: To verify the new proposd version of pyrogen result judgment algorithm (NPRJA) and validate practicality, accuracy and reliability. METHODS: Six hundred and fifty-four batches of pyrogen test data from our laboratory in near three years were used; 3 648 rabbit body temperature fluctuations qualified in preview were statistically analyzed. Only single rabbit having lever was used to judge the pyrogen qualified or not; using logic anlysis method determined the NPRJA. RESULTS: According to the existing Chinese Pharmacopoeia volume III, suspicious rate of pyrogenic results was 28.0%, but the suspicious rate was only 10.4% in NPRJA. The new model can reduce over 60% of the repeat test. However, all failed samples were not leaked in new determiner. In preflight warm qualified rabbits, the temperature fluctuations were rather more than reach 0.4℃ within the first 3 h, they had more than 8% in whole rabbits. CONCLUSION: In pyrogen test rabbit own body temperature appears fluctuation, single rabbit warming≥ 0.6℃ serves as one of the criteria for re-examination of the sample, its results will lead to raising re-examination rate! The new proposed version of pyrogen result judgment algorithm was used to threshold of the sum of temperature rise of all tested rabbits, that not only guarantees the no changing of accuracy in existing present pyrogen test results, also significantly reduces the amount of animals and experimental repetitions. Thereby reducing the amount of experimental and labor costs. Meanwhile, it might be convenient and practical, as will as a worthy utilization and promoting patterns.