摘要
目的研究盐酸阿比朵尔(抗流感病毒药)颗粒剂、干混悬剂与胶囊剂的生物等效性。方法24名健康志愿者按拉丁方设计分成3组,用自身交叉对照单剂口服盐酸阿比朵尔颗粒剂、干混悬剂或胶囊剂600mg。用高效液相色谱法检测血浆中盐酸阿比朵尔的浓度,计算3种制剂的药代动力学参数及相对生物利用度,并进行生物等效性评价。结果3者的tmax分别为(0.88±0.46),(0.77±0.29),(1.35±0.97)h;Cmax分别为(1.15±0.53),(1.21±0.43),(1.04±0.47)μg.mL-1;AUC0-t分别为(7.02±2.94),(6.96±2.65),(6.90±2.56)μg.h.mL-1。盐酸阿比朵尔颗粒剂、干混悬剂的相对生物利用度分别为(102.3±19.5)%,(103.3±25.8)%。结论3者具有生物等效性。
Objective To study the bioavailability of arbidol hydrochlo- ride granule, suspension and capsule, and evaluate its bioequivalenee in healthy volunteers. Methods A single oral dose of 600 mg arbidol hydrochloride granule, suspension and capsule were given to 24 healthy male volunteers according to an open randomized 3 way crossover design. Plasma concentration of arbidol hydrochloride was determined by HPLC method. Results The pharmaeokinetie parameters of the three products were as follows ： tmax were （0.88 ± 0.46）, （0.77± 0.29） and （ 1.35± 0.97） h; Cmax were （1. 15±0.53）, （1.21 ±0.43） and （1.04±0.47） μg·mL^- 1 ; AUC0-t were （ 7.02 ± 2.94 ）, （ 6.96 ± 2.65 ） and （ 6.90 ±2.56）μg·h ·mL^- 1, respectively. The relative bioequivalence of arbidol hydroehloride granule and suspension were （102. 3 ± 19.5）%, （103.3±25.8）%, respectively. Conclusion The result demonstrated that three formations were bioequivalenee.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第4期292-295,共4页
The Chinese Journal of Clinical Pharmacology
