New antibiotic compound-ceftriaxone sodium and sulbactam sodium for injection(2:1)

Ceftriaxone sodium and sulbactam sodium for injection (2:1, CTZ/SBT(2:1) is new anti-drug-resistant antibiotic compound. Pharmacological data in vitro shows that MIC₅₀ and MIC₉₀ of the combination for bacteria with beta-lactamase-producing were reduced significantly than that of CTZ alone. This antimicrobial advantage was also being proved in infected rats. The safety of the compound was demonstrated by toxicity assay using rats and dogs for 30 d system administration. Toleration experiment shows its safety ranges about 5.0 g in health volunteers. Phase I data also displayed that there were no statistical differences in the pharmacokinetic parameters of CTZ and SBT between its administrations alone or simultaneously. The multi-center randomized controlled blinded clinical trials displayed that the compound potency with 88.33%, 90.00% efficiency and 100.00%, 91.67% of the clearance rate and both 100.00% sensitive rate on acute bacterial respiratory and urinary infections, respectively, and with 5.79% adverse effect in full case. In conclusion, the compound was safety and effectively on bacterial infections, especially for the treatment of beta-lactamase-producing bacterial disease in clinical.