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目的:研究米屈肼注射液在健康人体内的药动学。方法:30名健康受试者随机平行分成3组,分别单次静脉滴注米屈肼注射液250、500和1 000 mg。采用液-质联用法测定人血浆中米屈肼的浓度,并采用DAS药动学软件估算给药后的药动学参数。结果:健康受试者单次静脉滴注米屈肼注射液后,在250～1 000 mg剂量范围内,米屈肼的Cmax、AUC0-24和AUC0-∞均与剂量呈线性关系。t1/2、CL和Vd不随米屈肼剂量变化而改变。结论:单次静脉滴注米屈肼剂量在250～1 000 mg范围内,米屈肼在中国人体内均呈线性药动学特征。
Objective: To study the pharmacokinetics of Meldonium in healthy volunteers. Methods: Thirty healthy subjects were randomly divided into 3 groups randomly. The mice were infused with 250, 500 and 1 000 mg of Meldonium in a single dose. The concentration of Meldonium in human plasma was determined by liquid chromatography-mass spectrometry and the pharmacokinetic parameters were estimated by DAS pharmacokinetics software. Results: After a single intravenous infusion of Meldonin in healthy subjects, the linear relationship between Cmax, AUC0-24 and AUC0-∞ of Meldonium and dose was obtained in the range of 250-1 000 mg. t1 / 2, CL and Vd do not change with the dose of mometasone. Conclusion: The single intravenous infusion of Meldonium dose in the range of 250 ~ 1 000 mg, Meldonium in Chinese human body showed a linear pharmacokinetic characteristics.