摘要
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 and monitor the adverse drug reaction of isosorbide 5 mononitrate(5 ISMN) sustanied release tablets in 12 Chinese subjects.METHODS:The concentration of 5 ISMN in human serum was determined with gas chromatography.The pharmacokinetic study was conducted on healthy subjects after oral administration of 5 ISMN sustanied release tablets at a single dose of 50 mg.RESULTS:The pharmacokinetic parameters AUC 0 ∞ , T max , C max and T 1/2 of 5 ISMN sustanied release tablets were ( 10 109 ± 1 647 )ng·ml -1 ·h -1 ,( 4.7 ± 0.5 )h,(784±83)ng·ml -1 and ( 8.4 ± 1.9 )h respectively.The incidence of adverse drug reactions was 83.3% .The main adverse drug reactions found were headache,dizziness and drowsiness.CONCLUSIONS:The dosage of 5 ISMN sustanied release tablets should be reduced when they were administered to Chinese subjects.
出处
《中国医院药学杂志》
CSCD
北大核心
2000年第7期416-419,共4页
Chinese Journal of Hospital Pharmacy
关键词
单硝酸异山梨醇酯缓释片
气相色谱法
不良反应
isosorbide 5 mononitrate
gas chromatography
pharmacokinetics
adverse drug reactions
