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目的：比较氟康唑２种制剂在中国健康志愿者体内的药物动力学和生物利用度。方法：１０例中国健康志愿者随机交叉口服氟康唑２种（三维，辉瑞）胶囊各３００ｍｇ，采用反相ＨＰＬＣ法测定血中药物浓度。结果：氟康唑（三维）和氟康唑（辉瑞）ＡＵＣ分别为（２７９±６４）ｍｇ·ｈ／Ｌ和（２８９±５７）ｍｇ·ｈ／Ｌ；Ｃｍａｘ分别为（６．７±１．０）ｍｇ／Ｌ和（７．０±０．８）ｍｇ／Ｌ；Ｔｍａｘ分别为（１．９±０．７）ｈ和（１．９±０．７）ｈ；Ｔ１２β分别为（３７±７）ｈ和（３７±７）ｈ；Ｃｌ分别为（１．１４±０．２７）Ｌ／ｈ和（１．０８±０．２２）Ｌ／ｈ；Ｖｄ分别为（４１±２２）Ｌ和（３５±１１）Ｌ；Ｋｅ分别为（０．０４０±０．０１０）／ｈ和（０．０３０±０．０１０）／ｈ。氟康唑（三维）胶囊的相对生物利用度为９６％。差别无显著意义（Ｐ＞０．０５）。结论：氟康唑２种制剂在中国健康志愿者体内的药动学参数相似，具有生物等效性。
Objective: To compare the pharmacokinetics and bioavailability of fluconazole 2 in Chinese healthy volunteers. Methods: Ten Chinese healthy volunteers were randomized to receive 300 mg fluconazole (three-dimensional, Pfizer) capsules randomly. The blood concentration was determined by reverse-phase HPLC. Results: The AUC of fluconazole (three dimensional) and fluconazole (Pfizer) were (279 ± 64) mg · h / L and (289 ± 57) mg · h / (1.9 ± 0.7) h and (1.9 ± 0.7) h, respectively; T12β was (37 ± 0) mg / L and (1.14 ± 0.27) L / h and (1.08 ± 0.22) L / h, respectively; Vd was (41 ± 22) L and (35 ± 11) L; Ke were (0.040 ± 0.010) / h and (0.030 ± 0.010) / h, respectively. The relative bioavailability of fluconazole (three-dimensional) capsules was 96%. The difference was not significant (P> 0.05). Conclusion: The pharmacokinetic parameters of fluconazole 2 preparations in Chinese healthy volunteers are similar and bioequivalent.