Abstract��
OBJECTIVE To investigate the preparation of the double-layer tablet of tramadol hydrochloride(TMD)and tostudy its in vitro/in vivo release. METHOD Orthogonal design was used to determine theoptimal formulation of the sustained release layer of the tablets.The characteristics of the in vitro/in vivo- release were compared between the prepared tablets and the imported tablets.The dissolution was tested by rotating basket method and was determined by UVspectrophotometry.In vivo- study,rabbits' serum concentration was determined by HPLCmethod with a fluorescence detector. RESULT The sustained release property of theprepared double-layer tablets was remarkable and there was no significant differencebetween the pharmacokinetic parameters of the prepared and imported tablets. CONCLUSION TMD double-layer tablets provide an ideal preparation for the study of central analgesicsdomestic.
ZHANG Li-de,
CAO De-ying,
ZHANG Zhe-feng etc
.Studies on the double-layer tablet of tramadol hydrochloride[J] Chinese Pharmaceutical Journal, 2000,V35(11): 747-750