【摘要】 目的:比较多索茶碱颗粒和口服液与普通片剂的生物利用度,评价多索茶碱在中国人体内药代动力学。方法:用反相HPLC法测定了24名健康志愿者分别单剂量口服400 mg多索茶碱后的经时血药浓度。结果:多索茶碱颗粒、口服液和普通片的主要药代动力学参数如下。峰浓度C_max分别为:2.88±:0.99,3.14±1.03和2.78±1.00mg·L^-1,达峰时间t_max分别为37.08±15.17,34.58±18.99和41.88±21.05 min,半衰期t_1/2分别为0.53±0.15、0.53±0.15和0.50±0.17h,药时曲线下面积AUC_0-4分别为4.35±1.83,4.44±1.80和4.58±0.02 mg·h·L^-1。多索茶碱颗粒与口服液的人体相对生物利用度分别为（95.76±10.07）％和（98.54± 9.87）％。结论:经方差分析及双单侧t检验结果显示,多索茶碱颗粒和口服液均与对照制剂具有生物等效性。更多还原

【Abstract】 OBJECTIVE: To study the bioavailability and pharmacokinetics of doxofylline granule and oral liquid in Chinese volunteer. METHODS: A single oral of 400 mg doxofylline were given to 24 male volunteers in a randomized cross over test. The drug concentration in plasma were assayed by reverse-HPLC method. RESULTS: The main pharmacokinetic parameters of granule, oral liqiuid and tablets were as follows: C_max were 2.88±0.99, 3.14±1.03 and 2.78±1.00 mg·L^-1; t_max were 37.08±15.17, 34.58±18.99 and 41.88±21.05 min, t_1/2 were 0.53±0.15, 0.53±0.15 and 0.50±0.17 h; AUC_0-4 were 4.35 ±1.83, 4.44±1.80 and 4.58±0.02 mg · h · L^-1, respectively. The relative bioavailability of granule and oral liquid were （95.76±10.07）% and （98.54 ±9.87）%. CONCLUSION: The results showed that the granule and oral liquid of doxofylline are bioequivalent with the reference preparation.更多还原