Pseudoephedrine Sensitive Infiltration Pump Tablets

The content of Compound Pseudoephedrine Hydrochloride capsule is sustained release pellet and its release may be affected by gastrointestinal tract condition. This paper supposes to prepare the compound osmotic pump tablet of the two drugs to make the two components release more uniformly.Researches had been done on different kinds and quantity of osmotic agents to affirm the core of tablet and procedure, the prescription of coating solution was decided by direct analysis method.This compound osmotic pump tablet was prepared by the procession decided by this research. Work had been done on osmotic pump tablet release paths, osmotic pressure, release medium and peddle rotation to test the influence of drug release. These researches proved that the drug release route was single pore and the drug release process of this compound osmotic pump tablet was not influenced by different release media. Electron microscope scanning of the drug coating film of before and after drug release indicates that adding hydrophilic shaping agent could improve the penetration rate of the coating film. The research of in vitro release indicates that the two drugs of preparation both can reach the zero-order release.This paper employing self-contradistinguish double period cross trial method and using HPLC-MS as analysis equipment, studied the pharmacokinetics characteristics of this compound osmotic pump tablet and Compound Pseudoephedrine Hydrochloride capsule by analyzing the blood plasma of 8 Beagles. The drug blood concentration-time curve was done after detecting both of pseudoephedrine hydrochloride and chlorphenamine maleate blood concentrations at different time. Also AUC, t_1/2, the bio-availability of the preparation and other major pharmacokinetics parameters are acquired though this trial.Pseudoephedrine hydrochloride T_max of sample preparation and reference preparation were 5.75and 2.56h, C_maxwere 1110.86 and 1968.69ng/ml, t_1/2 were 3.36and 3.29h, AUC_0-t were 10755.43 and 13083.44ng·h/ml, AUC_0-∞ were 11472.38 and 13213.56ng·h/ml, calculated by AUCo-t the average bio-availability of pseudoephedrine hydrochloride was 85.8%; chlorphenamine maleate T_max of sample preparation and reference preparation were 4.06 and 2.19h, C_max were 5.02 and 8.59ng/ml, t_1/2 were 5.01 and 4.83h, AUC_0-t were 34.71...