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研究茶碱缓释干混悬剂(受试制剂)和茶碱缓释片(参比制剂)在Beagle犬体内的药动学和生物等效性。进行双周期交叉试验,每条Beagle犬单次口服给予受试或参比制剂200 mg。建立了HPLC法测定Beagle犬血浆中的茶碱,用非房室模型分析得到参比制剂与受试制剂的主要药动学参数,分别为cmax(9.75±1.91)和(8.94±0.86)μg/ml,tmax(2.58±0.92)和(2.67±0.82)h,AUC0→t(76.59±9.51)和(75.22±15.06)μg·ml-1·h,AUC0→∞(79.55±9.86)和(77.08±13.44)μg·ml-1·h,t1/2(3.19±0.95)和(3.18±0.63)h,MRT(5.80±0.55)和(6.08±0.83)h。统计分析结果表明茶碱缓释干混悬剂与市售茶碱缓释片生物等效。
To study pharmacokinetics and bioequivalence of theophylline sustained-release dry suspension (test preparation) and theophylline sustained-release tablets (reference preparation) in Beagle dogs. A two-cycle crossover study was performed. Each Beagle dog was orally given either 200 mg of the test or reference formulation. A HPLC method was established for the determination of theophylline in plasma of Beagle dogs. The pharmacokinetic parameters of reference preparations and test preparations were obtained by non-compartmental model analysis. The pharmacokinetic parameters were cmax (9.75 ± 1.91) and (8.94 ± 0.86) μg / AUC0 → ∞ (79.55 ± 9.86) and (77.08 ± 0.66) and AUC0 → ∞ (76.59 ± 9.51) and (75.22 ± 15.06) μg · ml- 13.44) μg · ml-1 · h, t1 / 2 (3.19 ± 0.95) and (3.18 ± 0.63) h, MRT (5.80 ± 0.55) and (6.08 ± 0.83) h, respectively. Statistical analysis showed that theophylline sustained-release dry suspension is bioequivalent to the commercially available theophylline sustained-release tablets.