摘要
目的 研究阿莫西林胶囊的人体药代动力学和相对生物利用度。 方法 采用微生物法测定10 名健康志愿者单剂量口服250 mg 阿莫西林胶囊和对照品的血药浓度,计算药动学参数和相对生物利用度,并进行统计分析。结果 阿莫西林胶囊的试验品和对照品血药浓度—时间曲线符合一级吸收一房室开放模型,主要药动学参数如下: T12 Ka 分别为(145 ±028) 和(144 ±044) h , Tmax 分别为(049 ±019) 和(049 ±021) h , Cmax 分别为(365 ±041) 和(360±027) mg· L- 1 ; A U C0 ~∞分别为(1052 ±115) 和(1124±178) mg·h - 1· L- 1 。两种制剂的 Tmax 、 Cmax 和 A U C0 ~∞经方差分析差异均无显著性( P> 005) 。试验品的相对生物利用度9495 % ±1084 % 和9336 % ±1100 % 。
AIM To study pharmacokinetics and relative bioavailability of amoxycillin capsule in 10 young healthy volunteers. METHODS The serum concentration of amoxycillin was determined by bioassay in 10 volunteers after single oral administration 250 mg amoxycillin capsules. RESULTS Both serum concentration time curves of these two drugs fitted a first order absorption and one compartment open model.The pharmacokinetic parameters of amoxycillin capsule were as follows: T 2 K a (0 49±0 19) and (0 49±0 21)h, C max (3 65±0 41)and (3 60±0 27) mg·L -1 , T 2 K e (1 45±0 28)and (1 44±0 44)h, AUC 0~∞ (10 52±1 15) and (11 24±1 78) mg·h·L -1 ,respectively. The results of statistical analysis showed that there was no significant difference of T max 、 C max 、 AUC 0~8 and AUC 0~∞ between the two preparations ( P >0 05). The relative bioavailability of developed formulation ( F 1 and F 2) were 94 95%±10 84% and 93 36%±11 00% respectively. CONCLUSION Two preparations were bioequivalence.
出处
《中国药理学通报》
CAS
CSCD
北大核心
1999年第4期377-379,共3页
Chinese Pharmacological Bulletin