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目的 :研究健康中国人口服 5 单硝酸异山梨醇酯缓释片 (5 0mg)的药动学 ,并同时观察不良反应。 方法 :受试者口服单剂量 5 单硝酸异山梨醇酯缓释片 (5 0mg) ,气相色谱法测定血清中 5 单硝酸异山梨醇酯的浓度。结果 :5 单硝酸异山梨醇酯缓释片的AUC0 ∞ =(10 10 9± 16 47)ng·ml-1·h-1,Tmax=(4.7± 0 .5 )h ,Cmax=(784± 83)ng·ml-1,T1/2 =(8.4± 1.9)h ;5 单硝酸异山梨醇酯缓释片的不良反应发生率为 83.3% ,主要表现为头痛、头晕和嗜睡。结论 :中国人服用 5 单硝酸异山梨醇酯缓释片时应适当减小剂量。
OBJECTIVE: To study the pharmacokinetics of 5 isosorbide mononitrate sustained-release tablets (50 mg) administered orally to healthy Chinese and to observe adverse reactions. METHODS: Subjects were given a single oral dose of 5 isosorbide mononitrate sustained-release tablets (50 mg) and the concentration of isosorbide 5 mononitrate in serum was determined by gas chromatography. Results: AUC0 ∞ = (10 10 9 ± 16 47) ng · ml -1 · h-1 for isosorbide mononitrate sustained release tablets, Tmax = (4.7 ± 0.5) h, Cmax = (784 ± 83) ng · ml-1, T1 / 2 = (8.4 ± 1.9) h. The incidence of adverse reactions of isosorbide mononitrate sustained-release tablets was 83.3%, which was mainly headache, dizziness and drowsiness. Conclusion: Chinese should take 5 isosorbide mononitrate sustained-release tablets should be appropriately reduced dose.