目的研究盐酸阿比朵尔胶囊剂、片剂与参比胶囊剂相对生物等效性。方法24名健康志愿者按拉丁方设计分成3组,单剂量三交叉po 600mg盐酸阿比朵尔胶囊剂、片剂或参比制剂。用高效液相色谱法检测血浆中阿比朵尔的浓度,计算3种制剂的药动学参数及相对生物利用度,并进行生物等效性评价。结果3者的实测t_max分别为(1.74±0.86),(1.60±1.22)和(1.66±1.21)h,实测ρ_max分别为(1031.24±405.55),(1101.32±530.17)和(1143.25±635.86)μg·L^-1。梯形法计算AUC_0-t分别为(7653.93±2880.87),(8087.31±3162.71)和(8126.53±3911.13)μg·h·L^-1。t_1/2分别为(13.10±4.13),(13.00±3.97)和(13.80±4.30)h。盐酸阿比朵尔胶囊剂、片剂的相对生物利用度分别为(99.1±21.5)%,(105.8±39.8)%。结论经统计学分析,3者具有生物等效性。

OBJECTIVE To study the bioavailability of arbidol hydrochloride capsule, tablet and reference, and evaluate its bioequivalence in healthy volunteers. METHODS A single oral dose of 600 mg arbidol hydrochloride capsule, tablet or reference, was given to 24 healthy male volunteers according to an open randomized 3 way crossover design. Plasma concentration of arbidol was determined by HPLC method. RESULTS The pharmacokinetics parameters of the three products were as follows:t_max (1.74±0.86),(1.60±1.22)and (1.66±1.21)h; ρ_max (1 031.24±405.55),(1 101.32±530.17)and (1 143.25±635.86) μg·L^-1; AUC_0-t (7 653.93±2 880.87),(8 087.31±3 162.71)and (8 126.53±3 911.13) μg·h·L^-1, t_1/2 (13.10±4.13),(13.00±3.97)and (13.80±4.30)h, respectively. The relative bioequivalence of arbidol hydrochloride capsules and tablets were (99.1±21.5)%,(105.8±39.8)%, respectively.CONCLUSION Three formations were bioequivalence by analysis of variance, two-one side test and 90% confidential interval.