Determination of Bacterial Endotoxin in Influenza Split Vaccine by a Dynamic Turbidity Method / 中国药师

ABSTRACT

Objective:To investigate the feasibility of dynamic turbidity method for the detection of bacterial endotoxin content in influenza split vaccine. Methods: According to the bacterial endotoxin detection method described in general rule 1143 in Chinese Pharmacopoeia (2015 edition), the reliability test for standard curves of influenza split vaccine, the interference initial screening test, the interference verification test and the endotoxin content were performed or determined, and the results were compared with those by the gel method for the same batches of vaccine. Results:The results of reliability test for standard curves were accordance with the reg-ulations. In the interference initial screening test, vaccine was diluted by 160 times, 320 times and 640 times, and the recovery was between 50% and 200%, which showed no interference. The results of the interference verification test further proved that vaccine with 640 times dilution had no interference effect on test. The bacterial endotoxin contents of 10 batches of influenza split vaccine deter-mined by the turbidity method were less than the limit value of 20 EU·ml-1 , and the results were the same as those determined by the gel method. Conclusion:It is feasible to detect the content of bacterial endotoxin in influenza split vaccine by the dynamic turbidity method, which is worthy of promoted application.