Pharmacokinetic characteristics of sodium rabeprazole in humans

AIM To study the pharmacokinetics of sodium rabeprazole injection in humans.METHODS Thirty healthy volunteers were randomly divided into 3 groups who received the sodium rabeprazole injection,and the doses were 10 mg,20 mg and 30 mg,respectively.Each volunteer's blood samples were collected in 8 h after the injection.The 20 mg group' s volunteers were given multiply dose subsequently when the first dose tests were finished and the blood samples were collected.LC-MS/MS was used to determine plasma concentrations of rabeprazole and pharmacokinetic parameters were calculated by DAS software.RESULTS The main pharmacokinetic parameters of rabeprazole in the 10 mg,20 mg and 40 mg groups were as Mows:ρ_(max)were(699.89±198.89),(1 274.82±272.99)and(2 572.00±640.57)μg·L~(-1);t_(max)were(0.53±0.09),(0.43±0.09)and(0.52±0.09)h;t_(1/2)were(1.34±0.47),(0.97±0.29)and (1.43±0.39)h;AUC_(0→8)were(864.23±369.13),(1 477.88±311.65)and(3 444.86±1 175.38)μg·h·L~(-1); AUC_(0→∞)were(877.16±379.48),(1 484.05±313.24)and(3 501.05±1 236.70)μg·h·L~(-1),respectively.The main pharmacokinetic parameters of 20 mg group were as follows:ρ_(max)~(ss)was(1 299.50±290.20)μg·L~(-1);t_(max)was (0.53±0.10)h;t_(1/2)was(0.89±0.29)h;AUC_(0→8)~(ss)was(1 447.08±421.03)μg·h·L~(-1);AUC_(0→∞)~(ss)was (1 454.19±420.65)μg·h·L~(-1);DF was(22.58±5.50)%.CONCLUSION Sodium rabeprazole injection showes well linear pharmacokinetic characteristics in human body when the doses range from 10 mg to 40 mg.