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目的：比较两种国产盐酸氟桂利嗪胶囊在人体内的药物动力学及相对生物利用度。方法：１０ 名男性健康志愿者随机交叉口服单剂量１２ ｍｇ 盐酸氟桂利嗪胶囊后，用高效液相－ 紫外法测定血浆药物浓度。结果：血药浓度－ 时间曲线拟合表明该药体内过程符合有滞后时间的一级吸收，一室清除动力学模型，胶囊 Ａ 和 Ｂ 的主要药代学参数：： Ｃｍ ａｘ（４３７ ±６２） ｍ ｇ· Ｌ－ １ 和（４７４ ±１３８）ｍ ｇ· Ｌ－ １ ； Ｔｍａｘ（３０４ ±０５３） ｈ 和（３２８ ±１０４） ｈ ； Ｔ１／２ｋａ（１１４ ±０６８） ｈ 和（１２８ ±０９２）ｈ ； Ｔ１／２ｋｅ（５４４ ±２４１） ｈ 和（５５３ ±２７１） ｈ ； Ａ Ｕ Ｃ（５０７０ ±１５１０） ｍｇ·ｈ· Ｌ－ １ 和（５３４１ ±１１６０） ｍｇ·ｈ· Ｌ－ １ ； Ｍ Ｒ Ｔ（８２０ ±１５３） ｈ 和（８３４ ±１４１） ｈ ，各参数间均无统计学差异，胶囊 Ａ 相对于胶囊 Ｂ 的生物利用度为９７５ ％ ±３０９ ％ 。结论：两种胶囊剂具有生物等效性。
OBJECTIVE: To compare the pharmacokinetics and relative bioavailability of flunarizine hydrochloride capsules in humans. Methods: Ten male volunteers were randomized to receive a single dose of Flunarizine Hydrochloride Capsule 12 h after oral administration. The plasma drug concentrations were determined by HPLC - HPLC. Results: The blood concentration-time curve fitting showed that the in vivo process accorded with the first-order absorption with lag time and the kinetic model of one compartment removal. The main pharmacokinetic parameters of capsules A and B were Cm ax (437 ± 62) m g · L -1 and (474 ± 138) m g · L -1; Tmax (304 ± 053) h and (328 ± 104) h; T1 / 2ka (114 ± 068) h and (128 ± 092) h; T1 / 2ke (544 ± 241) h and (53 ± 271) h; AUC (507.0 ± 151.0) mg · h · L -1 and (5341 ± 1160) mg · h · L -1; M R T (820 ± 1.53) h And (8.34 ± 1.41) h, respectively. There was no significant difference among the parameters. The bioavailability of capsule A relative to capsule B was 97.5% ± 30.9%. Conclusion: The two capsules are bioequivalent.