摘要
6名男性健康志愿者分别口服盐酸环丙沙星缓释胶囊和普通片剂,以RP-HPLC法测定尿液中的药物浓度,研究其在人体内的药物动力学和相对生物利用度。结果受试制剂及参比制剂的(dxu/dt)max分别为(25.92±3.70)和(40.54±16.55)mg/h;Tmax为(4.17±1.60)和(2.58±0.66)h;MRT0→48h为(9.65±1.58)和(7.75±1.62)h。盐酸环丙沙星缓释胶囊相对普通片剂的生物利用度为(101.04±11.36)%,其体内吸收与体外释药具有显著的相关性。
The pharmacokinetics and relative bioavailability of ciprofloxacin hydrochloride sustained-release capsules and its conventional tablets were investigated in six healthy male volunteers. The concentrations of ciprofloxacin hydrochloride in urine were determined by RP-HPLC method. The main pharmacokinetic parameters of the two formulations were (dx0/dt) max (25.92 ± 3.70) and (40.54 ± 16.55) mg/h, Tmax (4.17 ± 1.60) and (2.58 ±0.66) h, MRT0→48h (9.65 ± 1.58) and (7.75 ± 1.62)h. The relative bioavailability of the sustained-release capsules was (101.04± 11.36) %. Significant correlation was found between in vitro release and in vivo absorption of the sustained-release capsules.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2006年第2期110-112,共3页
Chinese Journal of Pharmaceuticals