Pharmacokinetics and bioequivlences study of d-peseudoephedrine hydrochloride sustained-release tablet

OBJECTIVE To study the pharmacokintics and the relative bioavailability of d-peseudoephedrine hydrochloride sustained-release tablet and normal tablet.METHODS The d-peseudoephedrine hydrochloride in concentrations in plasma were assayed by HPLC method.A single oral dose of the ordinary tablet and the sustained-release tablet were given to 20 volunteers respectively in an open randomized cross-over test.3P97 was used to process main pharmacokinetics parameters.RESULTS The pharmacokinetic parameters of daily dose were listed as following:C_max(371.9±99.6) μg·L~-1 and(205.1±29.8) μg·L~-1;t_1/2(Ke)(3.9±0.5)h and(5.7±1.2)h;AUC_0-24(2 386.8±246.1)h·μg·L~-1 and AUC_0-36(2 310.9±171.9) h·μg·L~-1;The relative bioavailability of the sustained-release tablet was(97.4±8.8)%.The parameters of cumulative dose in body,Cmin of the ordinary tablet and the sustained-release tablet were(126.6±18.2) μg·L~-1 and(147.9±18.2) μg·L~-1;C_max(307.9±24.1) μg·L~-1,(275.2±26.8) μg·L~-1,FI(0.79±0.22) and(0.58±0.14).CONCLUSION The result of statistical analysis showed that the two fomulations are bioequivalent.