摘要
目的 :研究抗菌新药甲磺酸加替沙星粉剂的体外抗菌效果和体内保护作用 ,并与国家药品监督管理局已批准进入临床研究的加替沙星粉剂进行比较。方法 :按照我国二类新药抗生素类药效学实验指导原则 ,选用试管对倍稀释法作体外抗菌实验及KM小白鼠作体内保护实验。结果 :甲磺酸加替沙星和阳性对照药加替沙星对 14种 (2 3 2株 )临床菌株和质控菌株的最小抑菌浓度 (MIC)值、最小杀菌浓度 (MBC)值及杀菌速率均无显著差异。不同细菌接种量和不同培养基pH值对两药MIC值的影响也基本一致。体内保护实验显示 ,两药对金黄色葡萄球菌、铜绿假单胞菌感染的小鼠模型均具有很强的保护作用 ,且两者的ED50 及 95 %可信限基本相同。结论
Objective To investigate the antibacterial effect of novel antibiotic methanesulfonic acid gatixincin in vitro and in vivo ,comparing with the antibiotic gatixincin which has been in clinical trial with the approval of National Drug Surveillance and Manage Bureau.Methods According to the national pharmacodynamic experiment guideline of class Ⅱ novel antibiotic,the tube dilution method was selected for the antibacterial assay in vitro and KM mice were chosen for anti infection test in vivo .Results There was no significant difference between the MIC value, MBC value or KCs of methanesulfonic acid gatixincin and positive control drug gatixincin against 232 strains (clinical bacteria and control strains).Various bacteria amount did not significantly affect the MIC values of methanesulfonic acid gatixincin and positive control drug,however,low pH value did greatly inhibit methanesulfonic acid gatixincin and positive control drug's antibacterial activity.In the mice model infected by Staphylococcus aureus or Pseudomonas aeruginosa ,the methanesulfonic acid gatixincin and positive drug gatiffincin exerted similar effect.Conclusion There is no significant difference in the antibacterial activity between methanesulfonic acid gatixincin and gatiffincin.
出处
《东南大学学报（医学版）》
CAS
2003年第1期26-30,共5页
Journal of Southeast University(Medical Science Edition)
关键词
甲磺酸盐类
药理学
抗感染药
喹诺酮
对比研究
mesylates/pharmacology
anti infective agents,quinolone/pharmacology
comparative study
