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对５－单硝酸异山梨酯缓释片（ＳＲ）和普通片（ＩＲ）进行人体生物利用度比较，１０名健康男性志愿者随机交叉口服单剂量两种剂型后，利用气相色谱测得血药浓度。ＳＲ和ＩＲ的ＡＵＣ分别为３４３７．２±５６８．８ｎｇ／ｍｌ·ｈ和３８１０．８±８２２．７ｎｇ／ｍｌ·ｈ，ＭＲＴ分别为１５．７±１．０ｈ和９．４±１．５ｈ。ＳＲ的相对生物利用度为（９１．４±９．８）％。１０名受试者多剂量服用５－单硝酸异山梨酯ＳＲ和ＩＲ后，稳态时Ｃｍｉｎ分别为１６６．５±４７．９ｎｇ／ｍｌ和２３２．０±５５．０ｎｇ／ｍｌ，Ｃｍａｘ分别为６５０．１±１１８．５ｎｇ／ｍｌ和６２５．８±１２６．８ｎｇ／ｍｌ，两种制剂血药浓度的波动系数ＦＩ分别为１．１８±０．１８和０．９２±０．１６。经配对ｔ检验，两种制剂具有生物等效性。
Bioavailability of isosorbide 5-mononitrate sustained-release tablets (SR) and common tablets (IR) were compared. Ten healthy male volunteers were randomized to receive single-dose and two-dose oral dosage forms. Gas chromatography concentration. The AUC of SR and IR were 3437.2 ± 568.8 ng / ml · h and 3810.8 ± 822.7 ng / ml · h, respectively, with MRTs of 15.7 ± 1.0 h and 9.4 ± 1.5 h, respectively. The relative bioavailability of SR was (91.4 ± 9.8)%. After 10 and 10 doses of isosorbide mononitrate SR and IR, Cmin were 166.5 ± 47.9ng / ml and 232.0 ± 55.0ng / ml, respectively, with Cmax of 650 .1 ± 118.5ng / ml and 625.8 ± 126.8ng / ml respectively. The fluctuation coefficients FI of plasma concentration of the two preparations were 1.18 ± 0.18 and 0.92 ± 0.16, respectively. By paired t-test, both formulations were bioequivalent.