本文關(guān)鍵詞： 右旋酮洛芬氨丁三醇 速釋緩釋雙層片 藥物動力學(xué) 生物等效性　出處：《沈陽藥科大學(xué)學(xué)報》2015年08期 　論文類型：期刊論文

【摘要】：目的考察右旋酮洛芬氨丁三醇速釋緩釋雙層片與普通制劑在Beagle犬體內(nèi)的藥物動力學(xué)特征和生物等效性。方法以自制的右旋酮洛芬氨丁三醇速釋緩釋雙層片作為受試制劑,上市制劑"葵拉蘭"作為參比制劑,采用UPLC-MS/MS聯(lián)用技術(shù),測定受試制劑與參比制劑在Beagle犬體內(nèi)的血藥濃度經(jīng)時過程,數(shù)據(jù)經(jīng)DAS2.0軟件處理分析獲得藥物動力學(xué)參數(shù),對AUC0-t、AUC0-∞、ρmax及tmax的對數(shù)值進行方差分析、雙單側(cè)t檢驗、非參數(shù)檢驗等統(tǒng)計學(xué)處理,評價雙層片與普通制劑的生物等效性,利用Loo-Rigelman法評價其體內(nèi)外相關(guān)性。結(jié)果與參比制劑相比,受試制劑的ρmax降低,tmax有所延長,體內(nèi)外相關(guān)性中r=0.986 6。結(jié)論右旋酮洛芬氨丁三醇速釋緩釋雙層片較參比制劑具有速釋和緩釋特征,體內(nèi)吸收與體外釋放具有良好的相關(guān)性。
[Abstract]:Objective to investigate the pharmacokinetic characteristics and bioequivalence of dexketoprofen amitriol bilayer tablets and conventional preparations in Beagle dogs. The lamella was used as the test preparation. The blood concentration of the tested preparation and reference preparation in Beagle dogs was determined by UPLC-MS/MS combined with the method of "Quilalan" as a reference preparation. The pharmacokinetic parameters were obtained by DAS2.0 software. The logarithmic values of AUC0-t0 鈭，

本文編號：1485496