奥扎格雷钠口服溶液人体尿药浓度研究

Study on Ozagrel in Human Urine

目的建立测定人尿中奥扎格雷钠浓度的HPLC方法;通过测定12名健康受试者单次po200mg奥扎格雷钠口服溶液后体内的尿药浓度,考察奥扎格雷钠体内代谢过程。方法采用Diamonsil C18柱(4.6mm×150mm,5μm),磷酸盐缓冲液(pH=3.0)-乙腈(94:6)为流动相,流速为1.5mL.min-1,咖啡因为内标,紫外检测波长为276nm。结果奥扎格雷钠在0.01～10mg.L-1内线性关系良好,r=0.9962;健康受试者服药后12h内有(41.77±15.47)%的奥扎格雷钠从尿中排出。结论此方法灵敏、准确、稳定,可用于奥扎格雷钠体内代谢研究;奥扎格雷钠主要以原型从尿中排出。

OBJECTIVE To establish a HPLC assay for determining ozagrel in urine and to investigate the metabolism of ozagrel in human urine. METHODS The separation was performed on a Diamonsil C18 column （4. 6 mm ×150 mm, 5 μm）. The mobile phase consisted of phosphate buffer（ pH = 3.0）-acetonitrile（94： 6）with a flow rate of 1.5 mL·min^-1. Caffein was used as the interal standard,the detection wavelength was at 276 nm. RESULTS The good linearity was obtained over the range of 0. 01 - 10 mg·L^-1 with good correlation coefficient （ r = 0. 996 2）. （41.77 ±15.47） % ozagrel was eliminated from body in 12 h. CONCLUSION The method was sensitive, accurate and stable. Ozagre was eliminated in urine from body as drug prototype.