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本文报道了应用毛细管气相色谱法以ＥＣＤ（Ｎｉ－６３）为检测器，采用外标法测定人血浆中的５－单硝基异山梨醇酯（ＩＳ－５－ＭＮ）．结果表明该方法精密度好，灵敏度高，线性关系良好；ｒ＝０．９９９９（ｎ＝６），最低检测限为０．０３ｎｇ，日内和日间平均变异系数＜６％。１０名健康志愿者口服国产和进口ＩＳ－５－ＭＮ片所得的药时曲线均符合二室模型，其药代动力学参数无显著性差异。吸收速率常数分别为４．６９，４．９１ｈ￣－１；达峰时间为０．８９，０．８１ｈ；峰浓度为２２５．１８，２２２．８０μｇ／ｌ；半衰期Ｔ１／２β为５．６０，５．６１ｈ；表观分布容积为０．０６３和０．０７０１；平均总体清除率为１３．０１和１２．４０１／ｈ，生物利用度Ｆ＝９８．２８±９．７６％。
This paper reports the determination of 5-mononitro isosorbide (IS-5-MN) in human plasma by external standard method using ECD (Ni-63) as a detector by capillary gas chromatography. The results showed that the method has good precision, high sensitivity and good linearity; r = 0.9999 (n = 6), the lowest detection limit was 0.03ng, and the average intra-and inter-day coefficient of variation was <6%. The pharmacokinetic profiles of 10 healthy volunteers oral and imported IS-5-MN tablets were in accordance with the two-compartment model with no significant difference in pharmacokinetic parameters. Absorption rate constants were 4.69,4.91h ~ -1; peak time was 0.89,0.81h; peak concentration was 225.18,222.80μg / l; half-life T1 / 2β was 5.60, 5.61h; the apparent volume of distribution was 0.063 and 0.0701; the average overall clearance rate was 13.01 and 12.401 / h, and the bioavailability F = 98.28 ± 9.76%.