Experimental studies and evaluation on safety of compound aluminum sulfate injection / 中国临床药理学与治疗学

ABSTRACT

AIM: To study the in situ stimulation effect of compound aluminum sulfate injection after i.m. in rabbit quadriceps and dog bladder. The absorption of aluminum and the healing of the bladder wall were also studied to give an evaluation on the safety of the compound injection. METHODS: Compound aluminum sulfate injection was i.m. injected into quadriceps of the rabbits. The in situ stimulation effect was observed macrographically. Blood samples were collected at different time after i.m. injection. Aluminum concentrations were determined by ICP-MS assay and simulated with DAS software. Tissue necrosis as well as the healing of the bladder wall were observed macrographically or pathologically after the injection was given into dog bladder. RESULTS:Severe stimulation was observed after intra quadriceps injection, however, there was no obvious elevation of blood aluminum concentration. The average AUC0-24 was 2.93±1.82 mg·h·L-1 (n=5), corresponding to a relative bioavailability of about 2.77%. Injecting in bladder muscle necrotized the bladder wall in situ, but fibroblast generated and took place of the necrotized membrane and muscle four weeks after injection. There was no bleeding or perforation on the bladder wall. CONCLUSION:Caused compound aluminum sulfate injection in situ necrosis which healed up in 4 weeks. Aluminum absorption is very low after injection, giving a further explanation to the safety of the compound injection.