右旋酮洛芬氨丁三醇速释缓释双层片在Beagle犬体内的药物动力学及生物等效性

发布时间：2018-02-02 21:14

  本文关键词： 右旋酮洛芬氨丁三醇 速释缓释双层片 药物动力学 生物等效性　出处：《沈阳药科大学学报》2015年08期 　论文类型：期刊论文

【摘要】：目的考察右旋酮洛芬氨丁三醇速释缓释双层片与普通制剂在Beagle犬体内的药物动力学特征和生物等效性。方法以自制的右旋酮洛芬氨丁三醇速释缓释双层片作为受试制剂,上市制剂"葵拉兰"作为参比制剂,采用UPLC-MS/MS联用技术,测定受试制剂与参比制剂在Beagle犬体内的血药浓度经时过程,数据经DAS2.0软件处理分析获得药物动力学参数,对AUC0-t、AUC0-∞、ρmax及tmax的对数值进行方差分析、双单侧t检验、非参数检验等统计学处理,评价双层片与普通制剂的生物等效性,利用Loo-Rigelman法评价其体内外相关性。结果与参比制剂相比,受试制剂的ρmax降低,tmax有所延长,体内外相关性中r=0.986 6。结论右旋酮洛芬氨丁三醇速释缓释双层片较参比制剂具有速释和缓释特征,体内吸收与体外释放具有良好的相关性。
[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，

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