Objective: To study the
pharmacokinetics and
relative bioavailability of isosorbide 5 mononitrate (5 ISMN)
sustained release pellets in healthy volunteers Methods: A capillary gas chromatography with electron capture detection(CGC ECD) method was established for determination of plasma level of 5 ISMN after single oral dose of 40 mg domestic and imported 5 ISMN sustained release pellets in a randomized crossover design of 12 healthy men Results: The pharmacokinetic course of plasma level of 5 ISMN conformed to a two compartment open model The main pharmacokinetic parameters after single oral dose of 40 mg domestic and imported sustained release pellets were as follows:C max being(621 83±77 48) μg/L and (619 83±73 50) μg/L,t max (5 0±0 6) h and (5 2±0 9) h,MRT (12 67±1 10) h and (12 88±1 26) h,t 1/2 (7 83±1 21) h and (7 75±1 10) h,and AUC 0 36 (6824 4±618 9) μg·h/L and (6790 4±605 7) μg·h/L,respectively Conclusion: The
relative bioavailability of domestic 5 ISMN sustained release pellets was (100 63±5 86)% The results of statistical analysis for t max ,C max and AUC 0 36 showed that domestic and imported sustained release pellets were bioequivalent