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目的 :比较拜新同 (硝苯地平控释片 ,剂量为 30mg/片 )与心痛定 (硝苯地平普通片 ,剂量为 1 0mg/片 )在兔体内的药代动力学及生物利用度。方法 :采用 6只健康家兔 ,分别口服拜新同控释片 ,1日 1次 ,1次1片 ,和硝苯地平普通片 ,1日 3次 ,1次 1片 ,用高效液相色谱法测定血浆药物浓度。结果 :硝苯地平控释片与普通片的主要药代动力学参数为 :控释片 (T1/ 2Ke=2 3 8966h、Tmax =0 8935h、Cmax =0 0 535μg/ml、AUC =1 7939μg/ml·h、ke =0 0 2 90 1 /h、Ka =3 1 4 30 1 /h) ;普通片 (T1/ 2Ke=2 582 9h、Tmax =2 0 671h、Cmax =0 0 30 7μg/ml、AUC =0 82 0 2 3μg/ml·h、ke =0 2 6831 /h、Ka =0 80 74 1 /h)。 结论 :硝苯地平控释片吸收快 ,起效时间明显提前 ,控释片与普通片的药代动力学参数有显著性差异 (P <0 0 5) ,控释片的生物利用度是普通片的 2 1 9 2 1 %。
OBJECTIVE: To compare the pharmacokinetics and bioavailability of Xintong (nifedipine controlled release tablet, 30mg / tablet) and xintongding (nifedipine tablet, 10mg / tablet) in rabbits. Methods: Six healthy rabbits were orally administered with Xindong GITS, once a day, once a day, and nifedipine common tablets, once a day for three times and once for one time. Determination of plasma drug concentration. RESULTS: The main pharmacokinetic parameters of nifedipine controlled release tablets and common tablets were as follows: controlled release tablets (T1 / 2Ke = 238966h, Tmax = 0 8935h, Cmax = 0 5353μg / ml, AUC = ml · h, ke = 0 0 2 90 1 / h, Ka = 3 1 4 30 1 / h); normal tablets (T1 / 2Ke = 2 582 9h, Tmax = 20671h, Cmax = 0 0 30 7 μg / ml , AUC = 0 82 0 2 3 μg / ml · h, ke = 0 2 6831 / h, Ka = 0 80 74 1 / h). Conclusion: Nifedipine controlled release tablets absorbed fast, the onset time was significantly earlier, the controlled release tablets and ordinary tablets pharmacokinetic parameters were significantly different (P <0 05), controlled release tablets bioavailability is normal 2 1 9 2 1% of the film.