Experimental study of Aripiprazole Injection on muscular irritation, hemolysis and sensitization / 药物评价研究

ABSTRACT

Objective To evaluate the muscular irritation,hemolysis and sensitization of Aripiprazole Injection.Methods The local muscle irritation of Aripiprazole Injection was observed through sc injection on quadriceps femoris in rabbits.The 2％ red blood cell suspension in the blood of rabbit was used to check whether Aripiprazole Injection could cause the reaction of emolysis and erythrocyte agglutination.The method of systemic active allergic test (ASA) was used to evaluate the effect of Aripiprazole Injection on allergic reaction in Guinea pigs.Results No evidence ofhemolyzation and aggregation on rabbit erythrocyte in vitro was observed after Aripiprazole Injection treatment.Test substance was sc injected by single or multiple doses for 7 d,both of them had muscular irritation on New Zealand rabbits,the major pathologic change was the degeneration and necrosis of myofibers,myofibers broke apart and disappeared,lots of inflammatory cells immersed.After drug withdrawal,muscular irritation was recovered.No allergic reactions on Guinea pigs in vivo were observed at the low dose of 3.75 mg and the high dose of 7.5 mg.Conclusion Aripiprazole Injection has no hemolyzation and sensitization,but may cause muscle irritation at higher concentration.