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目的 :测定了放疗增敏药甘氨双唑钠 ( GN)及代谢产物甲硝唑 ( Met)在尿中的排泄 ,评价 GN的安全性。方法 :2 1名肿瘤病人 ,随机分成 5组 ,分别 iv gtt5 0 0、6 0 0、70 0、80 0、90 0 m g/m2的 GN,于滴后设定时间段收集尿样 ,用高效液相色谱 -二极管阵列紫外法测定受试病人尿样中的 GN及代谢产物 Met的浓度 ,并计算出 5个剂量组的平均排泄率。结果 :GN在病人体内以原药肾排泄为主。各剂量组尿中 GN的排泄率分别为 74.33%、6 5 .47%、5 3.76 %、5 8.0 4%、5 4.79% ,而代谢产物 Met的排泄率分别为 4.5 7%、3.90 %、5 .11%、5 .16 %、3.74%。 GN在病人体内消除很快 ,5个剂量组在 4h内排泄量占总排出量的95 %以上。结论 :GN在病人体内无蓄积 ,是一个安全的药物
OBJECTIVE: To determine the excretion of glycine-diazoxide sodium (GN) and its metabolite metronidazole (Met) in urine and evaluate the safety of GN. METHODS: Twenty-one tumor patients were randomly divided into 5 groups: GN of gtt5 0 0, 60 0, 70 0, 80 0, and 90 0 mg / m2 respectively. Urine samples were collected at the set time after dripping. The concentrations of GN and metabolite Met in the urine samples of the patients tested were determined by liquid chromatography-diode array ultraviolet spectrophotometry, and the average excretion rate of the five dose groups was calculated. Results: GN was mainly excreted by the original drug in the patient’s body. The excretion rates of GN in urine were 74.33%, 65.47%, 5 3.76%, 5 8.04% and 5 4.79%, respectively, while the excretion rates of metabolites Met were 4.5 7%, 3.90%, 5 .11%, 5.16%, 3.74%. GN was quickly eliminated in the patient’s body, and the 5-dose group accounted for more than 95% of total discharge within 4 hours. Conclusion: GN does not accumulate in the patient’s body and is a safe drug