目的　建立人血浆中洛索洛芬钠浓度的HPLC测定方法 ,研究健康受试者口服国产洛索洛芬钠片的药代动力学 ,以进口洛索洛芬钠片作为参比制剂 ,计算两制剂的相对生物利用度 ,判断两种制剂是否等效。方法　血浆样品加入内标后经三氯乙酸沉淀蛋白、涡旋、离心 ,吸取上清液进样。色谱柱为ShimadzuVP ODS(15 0mm× 4 . 6mmi d ,5 μmC18) ,流动相为 0 . 0 5mol·L 1磷酸二氢钾 甲醇 (2 7∶73) (v/v) ,紫外检测波长 2 30nm。测定了 2 0名受试者单剂量口服两种洛索洛芬钠片 6 0mg后血药浓度 时间过程。结果　最低检测浓度 0 . 2 μg·ml 1,回收率大于 80 % ,日间和日内的变异系数小于 10 . 5 % ,线性范围为 0 . 2～12 . 0 μg·ml 1(r=0 9998) ,符合生物样品分析的要求。主要药动学参数分别为 :国产洛索洛芬钠片 :t1/2 为 1. 39± 0 . 15h ,AUC0 . 6h10 . 71± 1 .4 5 μg·h·ml 1,Cmax7. 2 3± 1 .0 2 μg·ml 1,tmax0 4± 0 1h ;参比制剂t1/2 为 1. 4 1± 0 .15h ,AUC0. 6h10 .4 6± 1 .32 μg·h·ml 1,Cmax7 4 9± 1 .2 6 μg·ml 1,tmax0 .4± 0 .1h。结论　建立的HPLC法简单快速 ,定量可靠准确 ,适合于洛索洛芬钠临床研究。洛索洛芬钠受试制剂的相对生物利用度为 (10 3 .2± 15 .1) %。经统计学分 Objective To establish a method for the determination of loxoprofen sodium in human plasma by HPLC and to study the pharmacokinetics of oral loxoprofen sodium tablets in healthy subjects. The relative bioavailability of the formulation determines whether the two formulations are equivalent. Methods Plasma samples were precipitated by trichloroacetic acid after adding the internal standard, vortexed, centrifuged, and the supernatant was aspirated. The column was ShimadzuVP ODS (15 0 mm × 4. 6mmi d, 5 μm C18) with a mobile phase of 0. 5mol·L -1 potassium dihydrogen phosphate methanol (2 7:73) (v / v) at UV detection wavelength of 230nm . The time course of blood concentration of 60 loxoprofen sodium tablets after oral administration of 20 doses of 20 subjects was determined. Results The lowest detection concentration was 0.2 μg · ml -1, the recovery was more than 80% and the coefficient of variation (CV) was less than 10.5% during the day and the day. The linear range was 0.2-2.0 μg · ml -1 (r = 0 9998 ), In line with biological sample analysis requirements. The main pharmacokinetic parameters were: domestic loxoprofen sodium tablets: t1 / 2 is 1. 39 ± 0 15h, AUC0 6h10 71 ± 1. 54 μg · h · ml 1, Cmax7 2 3 ± 1 .0 2 μg · ml 1, tmax0 4 ± 0 1h; reference formulation t1 / 2 was 1. 4 1 ± 0. 15h, AUC0.6h10 .4 6 ± 1 .32 μg · h · ml 1, Cmax7 4 9 ± 1 .2 6 μg · ml 1, tmax0 .4 ± 0 .1 h. Conclusion The established HPLC method is simple and rapid, accurate and reliable quantitative, suitable for clinical study of loxoprofen sodium. The relative bioavailability of loxoprofen sodium preparation was (103.2 ± 15.1)%. By statistics