摘要
为了研究氧氟沙星片剂的相对生物利用度和人体药动学,本实验用改进的HPLC法对人血清中氧氟沙星的浓度进行了测定.该法以c_(18)为固定相,乙睛-0.06mol/L柠檬酸(70:100v/v)为流动相,特马沙星为内标,荧光检测(E_X=360um,E_M=495um滤光片),氧氟沙星的最低检测限为5ng,平均回收率为99.5%,相对标准偏差<4.08%.10名健康男性志愿者po氧氟沙星片剂(300mg),待测片和标准片的主要动力学参数分别为:C_(max)3.59±0.66和3.41±0.58μg/ml,T_(max)1.02±0.70和1.04±0.46h,AUC23.68±5.92和23.97±5.30μg·h^(-1)·ml^(-1),经统计学处理,各参数间均无显著性差异(P>0.05),待测片的相对生物利用度为99.5%.
A HPCL method was established to detemine the concentration of ofloxacin in serium. AYWG-C18 column was used with a mobile phase of acetonitrile-0.06mol/L citic acid (70: 100v/v) at a flow rate of 1.5ml/min. Temafloxacin was chosen as internal standard. Fluoroscene detector was operated under the following conditions: Ex=360nm and Em= 495nm filter. The retention time of ofloxacin and the curve was linear in the range from 0. 10ug/ml to 5.00ug/ml (r=0. 9999). The average recovery was 99. 4% and the CV were< 4.08%. The pharmacokinetics of the standard and detected tablet were investigated in ten healthy male volunteers. The pharmacokinetic parameters of the standard and detected tablet were: Cmax3.59+0.66 and 3.41+0.58ug/ml; Tmax1.02±0.70 and 1. 04±0.46h: AUC23.68±5.92 and 23.79±5.30 (ug·h-1·ml-1) respectively. No statistical signifcant difference was observed (P>0. 05). The relative bioavailability of the detected tablet was99. 5%.
出处
《中国临床药学杂志》
CAS
1996年第1期10-12,共3页
Chinese Journal of Clinical Pharmacy
