摘要
Abstract
Objective To evaluate the tolerance and pharmacokinetics of multiple - dose caderofloxacin lactate sodium chloride injection in Chi-nese health volunteers. Methods Tolerance was evaluated by Clinical symptoms, vital signs and laboratory tests before and after administration of the drug, especially the QT interval and OGTT. All data were calculat-ed by analysis of variance. For the PK trail, the serum samples of 12 healthy volunteer were collected after injecting 400 mg caderofloxacin lac-tate sodium chloride injection in 2 h for 7 days and were determined by HPLC method. Results The following pharmacokinetic parameters were calculated by WINNONLIN 5.2 software, Cmax was ( 7. 01 ± 1. 19 vs 13.46 ±1.87) mg·L-1, Cav was (2. 15 ±0.34) mg·L-1, AUCss was (55. 99 ± 9. 84) mg·L-1·h, Accumulation_Index was (1.08 ± 0. 05), DF was (310. 97 ±9. 854). Conclusion There were not clini-cal significance of change, including clotting function, routine urine tests, hepatic function, renal function, blood electrocardiogram, electro-encephalogram and OGTT. One subject was drowsiness and dry mouth on day 1-3 and days 5 during the administration, and one' s WBC, N value were slightly lower than normal, and his L value was lightly higher, but return to normal after 2 days . There are no serious ADR during the trial. In the PK part, there were no body accumulation after injecting 400 mg
caderofloxacin lactate sodium chloride once per day for 7 days.关键词
卡德沙星/连续给药/耐受性/药代动力学/高效液相色谱方法Key words
caderofloxacin/multiple - dose/tolerance/pharmacokinetics/HPLC分类
医药卫生
