复方氨酚烷胺胶囊人体相对生物利用度研究

Relative bioavailability of paracetamol and amantadine hydrochloride compound capsules

目的:研究复方氨酚烷胺胶囊人体相对生物利用度。方法:20例健康志愿者单剂量口服复方氨酚烷胺胶囊受试验制剂或参比制剂后12 h内多点采集血样,采用HPLC法测定人血清中对乙酰氨基酚和咖啡因的浓度。采用双周期两制剂交叉试验设计。血药浓度-时间数据经DAS软件处理后得药动学数据,并进行等效性检验。结果:2种制剂中对乙酰氨基酚和咖啡因的血药浓度经时变化和药动学参数相近,以参比制剂做对照,受试制剂中对乙酰氨基酚和咖啡因的相对生物利用度如下:F值(以AUC0-t计算)分别为(102．05±14．19)％和(112．39±32．24)％,F’(以AUC0-∞计算)分别为(101．32±15．49)％和(105．27±45．63)％,均符合生物等效性要求。结论:2种复方氨酚烷胺胶囊的口服生物利用度具有生物等效性。

Objective： To study the relative bioavailability of paracetamol and amantadine hydrochloride compound （PAHC） capsules. Methods： Twenty healthy volunteers were orally administered with a single crossover dose of test and reference PAHC capsules. The serum samples from the volunteers were collected to measure concentration of paracetamol and caffeine within 24 hours after the administration by HPLC. The pharmacokinetic parameters were calculated using a DAS program. Results： The test and reference PAHC capsules showed coincident PK parameters in respect of AUCo0-t, AUC0-∞ , Cmax, Tmax and t1/2. The relative bioavailability of test paracetamol and caffeine was （ 102. 05 ± 14. 19 ） % vs.（112.39±32.24）% in the AUC0-t, setting, and （101.32 ±15.49）% vs. （105.27 ±45.63）% in theAUC0-∞ setting. Conclusion： The test PAHC capsules are bioequivalent to the reference PAHC capsules.