摘要
目的:研究重组溶葡萄球菌酶(recombinant lysostaphin,rLysn)在深Ⅱ°烧伤患者创面给药后的药代动力学。方法:23例符合入组标准的深Ⅱ°烧伤患者创面外敷rLysn,单次给药(0.8×104～3.2×104ng.cm-2)和多次给药(2.4×104和3.2×104ng.cm-2)后,定时采血,以双抗夹心酶联免疫吸附法检测血药浓度。结果:所有受试者创面外敷给予rLysn后血浆中rLysn的浓度均低于本分析方法的定量下限2.8 ng.mL-1。结论:深Ⅱ°烧伤患者创面单次(0.8×104～3.2×104ng.cm-2)和多次(2.4×104和3.2×104ng.cm-2)给予rLysn,药物入血浓度低于检测限。
Objective： To study the pharmacokinetics of recombinant lysostaphin （rLysn） after topical use in patients with deep-partial thickness burn injury wounds. Methods：Twenty-three volunteers with deep Ⅱ° burns injury respectively received single administration of rLysn at the dose of 0.8 ×10^4 ,1.6 ×10^4 ,2.4 × 10^4 ,3.2 × 10^4 ng.cm^-2 or multiple administration of 2.4 × 10^4 and 3.2 ×104 ng. cm^-2 Blood samples were taken at predeter- mined time. Dual antibody enzyme linked immunosorbent assay method was used to detect the serum rLysn concen- trations. Results：The serum rLysn concentrations in all of the volunteers were lower than the lower limit of quantifi- cation of the assay method. Conclusion：rLysn cannot be detected in blood in deep Ⅱ° burns injury patients after single （0.8× 10^4 -3.2 × 10^4 ng.cm^-2） or multiple （2.4 × 10^4 and 3.2 ×10^4 ng,cm^-2） topical administration at the doses used in this study.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2012年第16期1864-1866,1877,共4页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项(2008ZX09101-032)
关键词
重组溶葡萄球菌酶
药代动力学
双抗夹心酶联免疫吸附试验
recombinant lysostaphin
pharmacokinetics
dual antibody enzyme linked immunosorbent assaymethod
