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말산클레보프리드 서방성 제제의 제조 및 약물동태학적 평가
류해원(Hae Won Ryou),이주한(Joo Han Lee),지용하(Yong Ha Chi),한양희(Yang Hee Hahn),단현광(Hyun Kwang Tan),이규흥(Kyu Heung Lee),김상린(Sang Lin Kim),전승윤(Seung Yoon Jeon),최영욱(Young Wook Choi) 한국약제학회 2000 Journal of Pharmaceutical Investigation Vol.30 No.3
Clebopride malate(Cm) is a new benzamide drug which has a potent central antidopaminergic activity possessing antiemetic and anxiolytic properties. A purpose of this study was to assess the feasibility of formulating sustained release preparation by dispersing a drug in hydrophilic polymeric matrices and double layered tablets(DLT), using HPMC, carbopol, PEO, PVP/VA and other polymers as a rate controlling barrier. The matrix and DLT showed optimum dissolution pattern up to 8 hours and the contents of polymer were optimized at 30% level in this preparation. After an oral administration in beagle dog, Cm concentration was determined by use of GC-ECD and pharmacokinetic parameters were calculated by Vallner`s method. The AUC of DLT showed similar results and the duration of action was increased 55% compared to that of regular release dosage form. The calculated absorption rate effectiveness(ARE) and controlled release effectiveness(CRE) for DLT increased 50% compared to that of matrix, the overall effectiveness(E) of this product appears to be about 70%. in vivo effectiveness test, DLT showed significant differences from control on antiemetic action of Cm. In consequence, it was possible to conclude that double layered tablet might be a good candidate for the sustained release dosage forms.