摘要
采用反相高效液相色谱法测定口服甲磺酸左氧氟沙星后人血清及尿中左旋氧氟沙星药物浓度，色谱柱为ＡＬＬＴＩＭＡＣ１８５μｍ，２５０ｍｍ×４．６ｍｍ。流动相为０．００５ｍｏｌ／Ｌ磷酸溴化四丁基铵乙腈（１１１），ｐＨ＝２．８，流速１．５ｍｌ／ｍｉｎ，荧光检测激发波长２９８ｎｍ，发射波长４５８ｎｍ，以环丙沙星为内标，室温下血、尿样品用１０％三氯乙酸沉淀蛋白后，取上清液进样测定。此方法日内、日间误差均小于６％，平均血清回收率为９４．５２％，尿回收率为９８．６８％。最低检测浓度为２ｎｇ／ｍｌ。应用此方法研究了１６名健康男性志愿者分两组分别单剂口服１００或２００ｍｇ国产甲磺酸左氧氟沙星片的药代动力学。试验结果表明，甲磺酸左氧氟沙星片在健康志愿者体内表现为明显的线性药动学，血药浓度数据符合二室模型，大部分药物以原型从尿中排泄。本项研究结果为国产甲磺酸左氧氟沙星片的临床应用提供了科学依据。
A RP HPLC method was developed to determine the levofloxacin concentration in serum and urine and its Pharmacokinetics was studied in healthy volunteers. C 18 column was eluted with the mobile phase of mixture of acetonitrile: 0.005 mol/L tetrabutyl ammonium bromide phosphate buffer (11∶1, pH2.8) and the fluorescence absorbance was monitored at excitation wavelength 298nm; emission wavelength 458nm. CPLX was used as internal standard. The mean recoveries were 94.52% in serum and 98.68% in urine . The RSD for the intra day and inter day were less than 6% and the lowest detectable limits were 2ng·ml -1 in serum and in urine. 16 healthy volunteers were divided into 2 grups and ginven single oral dose of domestic levofloxacin mesylate 100mg and 200mg, respectively. The levofloxacin concentration in serum and urine was determined. It was found that the serum concentration time curves were fitted to a two compartment model and the pharmacokinetic parameters were linear. The cumulative urinary recovery rates of unchanged levofloxacin during 24h after a single dose ranged from 70.33% to 73.76%. This study will provide a scientific basis for the clinical application.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
1999年第1期77-80,共4页
Chinese Journal of Antibiotics
