阿比朵尔片剂与胶囊剂的人体生物等效性比较

Bioequivalence of Arbidol Tablets and Capsules

目的评价阿比朵尔片与参比制剂(阿比朵尔胶囊)是否等效。方法20名男性健康受试者随机分为2组,交叉口服受试制剂(阿比朵尔片)和参比制剂各200 mg后,以高效液相色谱法测定血浆中药物浓度。所得数据用3P87统计软件进行处理。结果阿比朵尔受试制剂和参比制剂的tmax分别为(1.08±0.61)和(1.63±1.06)h;ρmax分别为(408.5±167.4)和(417.8±240.7)μg.L-1;t1/2分别为(11.77±5.01)和(10.55±4.01)h;用梯形法计算,AUC0-48分别为(2 641.2±1 024.0)和(2 725.8±1 181.0)μg.h.L-1;AUC0-∞分别为(2 751.5±1 197.6)和(2 857.4±1 311.3)μg.h.L-1。以AUC0-48计算,盐酸阿比朵尔片的相对生物利用度平均为(96.9±42.3)%。结论2种制剂具有生物等效性。

OBJECTIVE To evaluate the bioequivalence of arbidol tablets and capsules. METHODS 20 Healthy male volunteers were divided randomly into two groups. A single oral dose of 200 mg test and reference formulation was given to them according to a self-controlled, randomized crossover study design. The extracted samples were analyzed by HPLC equipped with UV detection. Pharmacokinetic parameters were calculated by 3P87 software. RESULTS The main pharmacokinetic parameters ofarbidol test and reference formulations were as follows： tmax （1.08±0.61） vs （ 1.63＋1.06） h, ρmax （408.5±167.4） VS （417.8±240.7）μg·L^-1, t1/2 （11.77±5.01） vs （10.55±4.01） h, AUC0.48 （2 641.2±1 024.0） vs （2 725.8±1 181.0）μg·h·L^-1, AUC0-∞（2 751.5±1 197.6 ） vs （2 857.4±1 311.3）μg·h·L^-1. The relative bioavailability of arbidol tablet was （105.94±17.69） %. The results of statistical analysis showed that there was no significant difference between ρmax, tmax, AUC0.48 of the two preparations. CONCLUSION The arbidol tablets and capsules were of bioequivalence.