Study on Pyrogen and Sensitization of Potassium Magnesium Aspartate Injection
OBJECTIVE To investigate whether potassium magnesium aspartate injection has pyrogen reaction after administration to rabbits and systemic anaphylaxis to guinea pigs,evaluate its safety and provide technical sup-port for clinical use.METHODS Set two dosage groups(0.5 mL·kg-1)and(1.0 mL·kg-1)to investigate the pyrogen reactions of 18 batches of samples from 18 production enterprises to rabbits;The sensitization test was con-ducted by referring to the methods of Appendix 1147 of Chp 2020,Part Ⅳ,and the Good Management Practice for Non-clinical Study of Drugs.The sensitization reaction of 18 batches of samples,raw and auxiliary materials and main impurities to guinea pigs was investigated.The results were analyzed by establishing a hyperkalemia model combined with the blood potassium concentration of guinea pigs.RESULTS Potassium magnesium aspartate injection had no pyrogen reaction to rabbits after administration,and 18 batches of samples and potassium aspartate excipients had sensitization reaction.CONCLUSION It is suggested that the pyrogen test item in the current standard should be uniformly administered(1.0 mL·kg-1);The anaphylactic symptoms of guinea pigs caused by potassium magnesium aspartate injection are caused by hyperkalemia,suggesting that attention should be paid to the blood potassium con-centration when using this product for treatment.