目的:采用高效液相色谱法(HPLC)测定复尔康注射液中维A酸的血药浓度,计算药动学参数,并与维A酸对照品溶液比较其药动学特征。方法:色谱柱:Dikma Kromasil C18(250min×4.6mm,5μm);流动相:乙腈-0.1%磷酸溶液;流速:1.0ml·min^-1;检测波长:355nm;柱温:30℃;进样量:20μl。结果:复尔康注射液中维A酸和维A酸对照品溶液在家兔体内均符合开放二室动力学模型特征。复尔康注射液中维A酸的t1/2α=10.61min,t1/2β=99.44min,K10=0.022min^-1,AUC=257.15μg·min·ml^-1,CL=0.022mg·kg·min^-1;维A酸对照品溶液的t1/2α=8.61min,t1/2β=54.06min,K10=0.033min^-1,AUC=174.87μg·min·ml^-1,CL=0.032mg·kg·min^-1。结论:与维A酸对照品溶液相比,复尔康注射液中维A酸的消除速率减慢,生物利用度增加,在体内滞留时间延长。
Objective: To determine the plasma concentration of retinoic acid of Fuerkang injection by HPLC, calculate pharmacokinetics parameters and compare with reference retinoic acid solution. Methods:Column:Dikma Kromasil C18 (250 mm×4.6 mm, 5μm);Mobile phase: acetonitrile- 0.1%phosphoric acid; Flow rate: 1.0 ml· min^-1; Detection wave length: 355nm;Column temperature:30℃ and sample size was 20μl. Results:Retinoic acid of Fuerkang injection and reference solution showed typical characteristics of open two-compartment dynamic model. Retinoic acid of Fuerkang injection: t1/2α=10.61min, t1/2β=99.44min, K10=0.022min^-1, AUC=257.15μg-min-ml^-1, CL= 0.022mg· kg^-1 min^-1.Reference retinoic acid solution:t1/2α=8.61min, t1/2β=54.06min, K10=0.033min^-1, AUC=174.87μg- min·ml^-1,CL=0.032mg ·kg^-1 ·min^-1. Conclusion: Retinoic acid of Fuerkang injection compared with reference retinoic acid solution, the rate of elimination was slowed, the bioavailability was increased and the retention time in the body was prolonged.