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目的 :研究盐酸氟西汀分散片和胶囊的生物等效性。方法 :2 2例健康男性志愿者 ,随机分成 2个序列。交叉单剂量口服 2 0mg盐酸氟西汀分散片或胶囊 ,定时取血样 ,以液相 质谱联用法测定血浆样本中氟西汀及其代谢产物去甲氟西汀的浓度 ,并对 2种制剂进行生物等效性评价。结果 :口服盐酸氟西汀分散片或胶囊后 ,氟西汀的Cmax分别为 (16 .96± 5 .4 0 )和 (17.0 2± 4 .73)ng·mL-1;Tmax分别为 (6 .8± 1.7)和 (6 .1± 1.2 )h ;AUC0～∞ 分别为 (971.0 8± 5 4 1.4 8)和 (10 18.72± 5 83.4 6 )ng·h·L-1;t1/ 2 分别为 (5 9.6± 18.9)和 (6 1.3± 2 0 .0 )h。口服 2种制剂后去甲氟西汀的Cmax分别为 (2 0 .0 5± 10 .33)和 (19.5 5± 8.10 )ng·mL-1;Tmax分别为 (74 .6± 5 3.1)和 (80 .0± 5 6 .4 )h ;AUC0～∞ 分别 (6 171.86± 332 0 .18)和 (6 312 .87± 30 2 5 .0 6 )ng·h·L-1;t1/ 2 分别为 (15 5 .6± 4 0 .7)和 (16 5 .7±6 5 .7)h。结论 :2 0mg盐酸氟西汀分散片和 2 0mg盐酸氟西汀胶囊为生物等效。
Objective: To study the bioequivalence of fluoxetine hydrochloride tablets and capsules. Methods: Twenty-two healthy male volunteers were randomly divided into two sequences. Crossover single oral dose of oral dose of 20mg fluoxetine hydrochloride tablets or capsules, blood samples taken regularly to determine the concentration of fluoxetine and its metabolite of norfluoxetine in plasma samples by liquid chromatography-mass spectrometry, and two formulations Bioequivalence assessment. Results: After oral administration of fluoxetine hydrochloride tablets or capsules, the Cmax of fluoxetine were (16.96 ± 5. 40) and (17.0 2 ± 4.73) ng · mL-1, respectively; the Tmax was .8 ± 1.7) and (6.1 ± 1.2) h respectively; AUC0 ~ ∞ were (971.0 8 ± 5 4 1.4 8) and (10 18.72 ± 5 83.4 6) ng · h · L -1 respectively (5 9.6 ± 18.9) and (6 1.3 ± 2.0 0) h. After oral administration of 2 kinds of preparations, the Cmax of norfluoxetine was (20.05 ± 10.33) and (19.5 ± 5.10) ng · mL-1, respectively; the Tmax was (74.6 ± 5 3.1) and (80.0 ± 56.4) h; AUC0 ~ ∞ were (6 171.86 ± 332 0.18) and (6 312.87 ± 30 2 5 .0 6) ng · h · L-1 respectively; t1 / 2 (15 5 .6 ± 4 0 .7) and (16 5 .7 ± 6 5 .7) h, respectively. Conclusion: 20mg fluoxetine hydrochloride tablets and 20mg fluoxetine hydrochloride capsules are bioequivalent.