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目的:建立测定非那吡啶血药浓度的气相色谱-质谱联用(GC-MS)分析方法,并研究其在大鼠体内的药动学。方法:6只大鼠均给予非那吡啶药物,给药后采集一系列血样,用GC-MS法测定其血药浓度,用3P97药动学程序处理血药浓度数据并计算参数。结果:该法在10～1000μg.L-1内线性关系良好(r=0.9991),最低检测质量浓度为1μg·L-1,平均萃取回收率为91.2%～95.4%。日内、日间RSD均低于5%。6只大鼠药-时曲线符合一室开放模型,非那吡啶在大鼠内吸收和消除迅速,分布广泛。主要药动学参数为tmax=(0.350±0.010)h,Cmax=(396±79)μg.L-1,AUC0-∞=(373±65)h·μg-1·L-1,CL=(94.2±5.9)mL·g-1·h-1。结论:建立了非那吡啶的GC-MS血药浓度测定方法。该法专属性强,灵敏度高,适用于非那吡啶的药动学研究。
OBJECTIVE: To establish a gas chromatography-mass spectrometry (GC-MS) method for the determination of phenazopyridine plasma concentration and to study its pharmacokinetics in rats. Methods: All the 6 rats were given phenazopyridine drugs. After administration, a series of blood samples were collected. The plasma concentration of the drugs was determined by GC-MS. The plasma concentration of 3P97 pharmacokinetics program was used to calculate the blood concentration. Results: The method showed good linearity (r = 0.9991) in the range of 10-1000μg.L-1 and the lowest detection concentration was 1μg · L-1. The average recovery was 91.2% -95.4%. Days, day RSD were below 5%. 6 rat drug-time curve in line with a model of open chamber, phenazopyridine absorption and elimination in rats rapidly, widely distributed. The main pharmacokinetic parameters were tmax = (0.350 ± 0.010) h, Cmax = (396 ± 79) μg.L-1, AUC0-∞ = (373 ± 65) h · μg- 94.2 ± 5.9) mL · g -1 · h -1. Conclusion: The method of determination of phenazopyridine by GC-MS was established. The method is highly specific and sensitive, suitable for phenazopyridine pharmacokinetic studies.