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目的:进行受试制剂多索茶碱缓释片与参比制剂多索茶碱片在Beagle犬体内的药代动力学研究,明确其是否具有缓释特征,为临床研究提供依据。方法采用两制剂两周期交叉试验方法,12只Beagle犬分别经口给予受试制剂和参比制剂400 mg,采用LC-MS法测定各时间点血浆中多索茶碱的浓度,药代动力学参数经DAS 2.0统计软件计算获得。结果受试制剂与参比制剂药代动力学参数:Cmax分别为(4.9±0.6)和(8.4±2.1)μg/mL,Tmax分别为(2.5±0.5)和(1.7±0.4)h,T1/2分别为(1.4±0.4)和(1.0±0.3)h,AUC0-12分别为(14.0±1.7)和(14.4±2.9)μg/mL×h。受试制剂在达峰浓度上明显小于参比制剂,达峰时间延迟,半衰期延长,具有缓释制剂特征。结论受试制剂多索茶碱缓释片具有缓释特征。“,”Objective To study the pharmacokinetics of Doxofylline Sustained Release Tablets and Doxofylline Tablet in Beagles. Methods A total of 12 male Beagles were randomly divided into two groups. They were assigned to receive Doxofylline Sustained Release Tablets (trial preparation) and Doxofylline Tablets (reference preparation) respectively. The plasma of Doxofylline were detected by LC-MS method after oral administration of 400mg. The pharmacokinetic parameters were calculated by the procedure of DAS 2.0. Results The Cmax of the two preparations were (4.9±0.6) and (8.4±2.1)μg/mL, Tmax were (2.5±0.5) and (1.7±0.4)h, T1/2 were (1.4±0.4) and (.0±0.3)h, AUC0-12 were (14.0±1.7) and (14.4±2.9)μg/mL*h. Trial preparation was significantly less than reference preparation in the peak concentration, while tmax and half-life was prolonged. Conclusion Doxofylline Sustained Release Tablets (trial preparation) was characterized by slow drug releasing.