中国药学(英文版)
中國藥學(英文版)
중국약학(영문판)
JOURNAL OF CHINESE PHARMACEUTICAL SCIENCES
2007年
4期
257-261
,共5页
氟罗沙星%高效液相色谱%荧光%药代动力学
氟囉沙星%高效液相色譜%熒光%藥代動力學
불라사성%고효액상색보%형광%약대동역학
Fleroxacin%HPLC%Fluorescence%Pharmacokinetics
目的 建立测定人血浆中氟罗沙星浓度的高效液相色谱方法,并用于其药代动力学研究.方法 氟罗沙星血浆样品经甲醇沉淀蛋白后直接进样.色谱柱为Diamonsil C18柱,流动相为1%三乙胺(磷酸调pH至4.8)/乙腈(80/20,V/V),流速1.0 mL·min-1.采用荧光检测器,激发波长290 nm,发射波长458 nm.氟罗沙星药代动力学研究采用双周期交叉试验设计.结果 氟罗沙星血浆浓度在0.025～8.00 μg.L-1 范围内线性关系良好,低、中、高浓度质控样品的日内、日间精密度不超过5.16%,方法精密度99.1%～100.9%,提取回收率86.7%～92.0%.健康志愿者口服400 mg氟罗沙星试验及参比制剂后主要药代动力学参数分别为:Cmax5.08±0.78和5.38±1.40μg.mL-1,tmax 1.72±0.79和1.82±0.78 h,t1/2 11.68±1.27和11.38±1.51 h-1,AUCo-∞ 78.44±11.44和76.53±13.24 μg·mL-1.h.结论 该方法灵敏度高、定量准确,适用于氟罗沙星人体药代动力学研究.
目的 建立測定人血漿中氟囉沙星濃度的高效液相色譜方法,併用于其藥代動力學研究.方法 氟囉沙星血漿樣品經甲醇沉澱蛋白後直接進樣.色譜柱為Diamonsil C18柱,流動相為1%三乙胺(燐痠調pH至4.8)/乙腈(80/20,V/V),流速1.0 mL·min-1.採用熒光檢測器,激髮波長290 nm,髮射波長458 nm.氟囉沙星藥代動力學研究採用雙週期交扠試驗設計.結果 氟囉沙星血漿濃度在0.025～8.00 μg.L-1 範圍內線性關繫良好,低、中、高濃度質控樣品的日內、日間精密度不超過5.16%,方法精密度99.1%～100.9%,提取迴收率86.7%～92.0%.健康誌願者口服400 mg氟囉沙星試驗及參比製劑後主要藥代動力學參數分彆為:Cmax5.08±0.78和5.38±1.40μg.mL-1,tmax 1.72±0.79和1.82±0.78 h,t1/2 11.68±1.27和11.38±1.51 h-1,AUCo-∞ 78.44±11.44和76.53±13.24 μg·mL-1.h.結論 該方法靈敏度高、定量準確,適用于氟囉沙星人體藥代動力學研究.
목적 건립측정인혈장중불라사성농도적고효액상색보방법,병용우기약대동역학연구.방법 불라사성혈장양품경갑순침정단백후직접진양.색보주위Diamonsil C18주,류동상위1%삼을알(린산조pH지4.8)/을정(80/20,V/V),류속1.0 mL·min-1.채용형광검측기,격발파장290 nm,발사파장458 nm.불라사성약대동역학연구채용쌍주기교차시험설계.결과 불라사성혈장농도재0.025～8.00 μg.L-1 범위내선성관계량호,저、중、고농도질공양품적일내、일간정밀도불초과5.16%,방법정밀도99.1%～100.9%,제취회수솔86.7%～92.0%.건강지원자구복400 mg불라사성시험급삼비제제후주요약대동역학삼수분별위:Cmax5.08±0.78화5.38±1.40μg.mL-1,tmax 1.72±0.79화1.82±0.78 h,t1/2 11.68±1.27화11.38±1.51 h-1,AUCo-∞ 78.44±11.44화76.53±13.24 μg·mL-1.h.결론 해방법령민도고、정량준학,괄용우불라사성인체약대동역학연구.
Aim To develop a sensitive and acctLrate HPLC methodfor the determination of fleroxacin in human plasma,and study its pharmacokinetics in healthy subjects.Methods The analytes were isolated from plasma by simple protein precipitation with methanol,separated on a Diamonsil C18 column by isocratic elution with the mobile phase consisted of 1%triethylamine at pH 4.8(adjusted with phosphofic acid)and acetonitrile(80/20,V/V) at a flow rate of 1.0 mL min-1,and analyzed by fluorescence detector with an excitation at 290 nm and emission 458 nm.The pharmacokinefic studv of fleroxacin was performed according to a double period crossover design.Results The weighted (1/x)calibration curve was linear over the plasma concentration railge of and extraction recoveries at three concentrations ranged from 99.1% to 100.9%,and 86.7%to 92.O%,respectively.FoUowing oral administration at a dose of 400 mg fleroxaein,the main pharmacokinetic parameters for test and reference capsules were for human pharmacokinetic study of fleroxacin.
