中国临床药学杂志

目的　建立人血浆中格列吡嗪(Gli)浓度测定的HPLC法,观察Gli控释片在人体内的药动学特征。方法　2 0名受试者单剂量口服Gli控释片10mg后,在规定时间取血,采用HPLC法测定血药浓度。用统计矩法计算药动学参数,AUC用梯形法计算,tmax和cmax为实测值。结果　单剂量口服Gli控释片后的药动学参数为:AUC0→48(4371. 3±14 .74 5 ) μg·h·L-1,AUC0→∞(495 .2 2±2 110 . 5 ) μg·h·L-1,tmax(6 . 74±2. 77)h ,cmax(2 0 0 .1±5 4 .2 0 ) μg·L-1,MRT(16 . 6 7±1. 73)h。结论　Gli控释片达到缓释2 4h的效果。

AIM To investigate and validate the HPLC method for glipizide assay in human plasma. This method was employed in the pharmacokinetic (PK) study of glipizide control released tablets in healthy volunteers. METHODS Twenty healthy male volunteers were taken 10 mg glipizide control released tablets orally and were drawn the blood at the specified time. The established HPLC method was used to determine the concentration of glipizide. The pharmacokinetic parameter was calculated by noncompartment method. AUC was estimated using trapezoid method. t max and c max were represented by the practical values. RESULTS The average AUC 0→48, AUC 0→∞, t max, c max and MRT of 20 subjects were (4 371.3±1 474.5) μg·h·L -1, (4 952.2±2 110.5) μg·h·L -1, (6.74±2.77) h, (200.1±54.20) μg·L -1 and (16.67±1.73) h respectively, keeping in agreement with previous reports. CONCLUSION The pharmacokinetic profile of volunteers shows the control released tablets have 24-hour slow release effect.