摘要
正常人体内药物动力学测定结果,国产格列齐特和进口达美康片的T_(1/2k)分别为10.16和11.41h;T_(max)分别为3.28和8.18h;C_(max)分别为5.58和1.12μg/ml;AUC分别为101.47和30.13μg·h^(-1)·ml^(-1)。若以po国产格列齐特片80mg的生物利用度为100％,则进口达美康相对生物利用度仅为29.7％。
The dissolution in vitro and the pharmacokinetics of gliclazide were investigated in 18 healthy Chinese volunteers. The blood levels of gliclazide at different time after single oral administration of 80 mg of the domestic and imported tablets were determined by HPLC, PKBP - N1 pharmacokinetic program was adopted for selection of ortipal compartment model and calculation of pharmacokinetic parameters by using the weighted nonlinear least square regression . The results showed that the plasma drug was in conformity with the one-compartment open model. T1/2k of domestic and imported tablets were respectively 10. 16±2. 50h and 11. 41 ± 4. 05h; Tmax3. 28 ± 1. 18h and 8. 18 ±4. 29h; Cmax5. 58 ±2. 45 and 1. 12±1. 45μg/ml;AUC 101. 47± 41. 31 and 30. 13± 25. 33 μg · h-1 · ml-1. The relative bioavailability of the imported gliclazide was as low as 29. 7% that of the domestic.
出处
《中国临床药学杂志》
CAS
1994年第2期14-18,共5页
Chinese Journal of Clinical Pharmacy
