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目的 建立测定一类新药肿瘤放疗增敏药甘氨双唑钠及其代谢产物甲硝唑的方法 ,用于测定其血药浓度并进行I期临床药代动力学研究。方法 采用高效液相 -二极管阵列色谱法测定甘氨双唑钠的血药浓度。结果 甘氨双唑钠的校正标准曲线为 ^Y =0 2 436 +0 0 4891X(r=0 9996 ) ,其 5、5 0、5 0 0mg·L-13浓度的血样回收率分别为 76 93% ,88 44 % ,88 95 % ;精密度分别为 1 6 36 7% ,3 3376 % ,6 1412 %。静脉滴注 6 0 0 ,70 0 ,80 0mg·m-2 甘氨双唑钠后 ,Cmax分别为 11 740 4,2 0 5 199,38 7731mg·L-1。结论 此方法可满足测定要求 ,可用于肿瘤放疗增敏药的药代动力学研究
Objective To establish a method to determine the concentration of sodium glycinate and its metabolite metronidazole, a kind of new drug for radiotherapy of tumor radiotherapy, for the determination of its plasma concentration and its phase I clinical pharmacokinetic study. Methods The plasma concentration of glycopyrrolate sodium was determined by high performance liquid chromatography with diode array. Results The calibration curve of glycopyrrolate sodium was ^ Y = 0 2 436 +0 0 4891X (r = 0 9996). The recoveries of 5, 500, 500 mg · L-13 were 76 93 %, 88 44% and 88 95%, respectively. The precision was 1636 7%, 3376% and 6 1412% respectively. After intravenous infusion of 600, 800, 800 mg · m-2 sodium glycididazol, the C max were 11 740 4, 200 5 199, 38 7731 mg · L -1, respectively. Conclusion This method can meet the determination requirements and can be used to study the pharmacokinetics of tumor radiosensitizer