国产与进口吲哚美辛缓释胶囊生物等效性评价

Evaluation of Bioequivalence of Domestic and Imported Indomethacin Capsula in Health Volunteers

比较国产与进口吲哚美辛缓释胶囊在人体内的生物利用度和生物等效性。 18名健康男性志愿者双周期随机交叉口服吲哚美辛缓释胶囊 75 mg,用反相高效液相色谱法测定达稳态后的血药浓度。受试制剂与参比制剂的达峰时间(Tpeak)分别为 (3.78± 1.0 0 ) h和 (3.5 0± 1.2 9) h;达峰浓度 (Cm ax)分别为 (7.5 1± 2 .74) μg/m l和 (8.0 5±2 .5 8) μg/m l;药时曲线面积 (AUC)分别为 (6 6 .41± 30 .12 )和 (6 3.90± 2 6 .5 0 ) μg· m l- 1· h- 1。多次给药达稳态条件下 ,国产的吲哚美辛缓释胶囊与进口制剂的相对生物利用度为 (10 3.2 0± 2 1.90 ) %。双单侧检验表明 ,国产与进口吲哚美辛缓释胶囊具有生物等效性。

To evaluate the bioequivalence of indomethacin capsulae, 20 health volunteers were randomly divided into groups A and B. Demestic and imported indomethacin capsulae were given respectively according to an open, two way crossover design. The plasma concentrations were determined by reverse phase HPLC. The data were calculated by 3p97 program. Results showed that Tpeak of Domestic and Imported capsulae was 3 78±1 00 h and 3 50±1 29 h, respectively. C max parameters were 7 51±2 74 ug/ml and 8 05±2 58 μg/ml respectively. AUC parameters were 66 41±30 12 and 63 90±26 50 μg/(ml·h), respectively. It was suggested that the pharmacokinetic parameters AUC ss and C max were calculated by the two direction one sided t test and showed that these two formulations were bioequivalent.