5-单硝酸异山梨酯血药浓度测定及其在人的药代动力学

DETERMINATION OF ISOSORBIDE 5 MONONITRATE IN PLASMA BY GC ECD AND STUDY ON ITS PHARMACOKINETICS IN TEN VOLUNTEERS

采用气相色谱电子捕获检测法测定５单硝酸异山梨酯的血药浓度。样品经乙醚—正己烷混合溶剂提取，三氟醋酐进行衍生化后，用５％ＳＥ３０硅烷化玻璃填充柱分离，以硝酸异山梨酯为内标，６３Ｎｉ电子捕获检测器检测。此法操作简便，日内、日间误差分别小于４％和６５％，平均回收率为９９６２％±１１９％。在２０～８００ｎｇ·ｍｌ－１血浆浓度范围内呈线性关系（γ＝０９９９５）。最低检测浓度为２０ｎｇ·ｍｌ－１。应用此法研究了１０名健康志愿者单次口服２０ｍｇ５单硝酸异山梨酯片后的药代动力学。

A rapid, accurate and sensitive gas chromatographic method was developed for the determination of isosorbide 5 mononitrate(5 ISMN) in 0 5 ml plasma. The instrument was equipped with 5% SE 30 glass packed column (2 m×3 mm) and electron capture detector. Isosorbide dinitrate (ISDN) was used as internal standard. The plasma was extracted with a mixture of ethyl ether and n hexane (4∶1) to give mean recoveries of 100 1% of 5 ISMN. The extracts reacted with trifluoroacetic anhydride and the derivatives were analyzed. The calibration curves were linear over a wide range of concentrations (20～800 ng·ml -1 ), and the detection limit of 5 ISMN was 2 0 ng·ml -1 . The precisions (RSD%, n=5) of within day and day to day were less than 4% and 6 5%, respectively. The pharmacokinetic characteristics of 5 ISMN in ten human volunteers after a single oral dose of 20 mg 5 ISMN were investigated. The concentration time curve was fitted to a one compartment model.