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目的 :研究盐酸氟桂利嗪片在健康人体中的药物动力学及相对生物利用度。方法 :以哈尔滨北方制药厂生产的盐酸氟桂利嗪片为参比制剂 ,河南省濮阳市第二制药厂研制的盐酸氟桂利嗪片为受试制剂。采用高效液相色谱法 (HPLC)测定 8名志愿者单剂量交叉口服 5 0mg盐酸氟桂利嗪片后不同时刻的血药浓度。结果 :2制剂的血药浓度 时间曲线均符合一房室开放模型。其AUC分别为 (16 86± 2 16 ) μg·h·L-1和 (175 5± 15 1) μg·h·L-1;Cmax分别为 (172± 14) μg·L-1和 (16 5± 15 ) μg·L-1;Tmax分别为 (3 2 7± 0 19)h和 (3 32± 0 2 2 )h。受试制剂的相对生物利用度为 (10 3 7± 7 7) %。结论 :2制剂具有生物等效性。
Objective: To study the pharmacokinetics and relative bioavailability of flunarizine hydrochloride tablets in healthy volunteers. Methods: Flunarizine hydrochloride tablets produced by Harbin North Pharmaceutical Factory were used as reference preparations. Flunarizine hydrochloride tablets developed by No.2 Pharmaceutical Factory of Puyang City, Henan Province were tested. The plasma concentration of different concentrations of Flunarizine Hydrochloride Tablets in 8 volunteers at different time points was determined by high performance liquid chromatography (HPLC). Results: The plasma concentration time curves of 2 preparations all fit the one-compartment open model. The AUC were (16 86 ± 2 16) μg · h-1 and (175 5 ± 15 1) μg · h-1 respectively; the Cmax were (172 ± 14) μg · L-1 and 5 ± 15) μg · L-1; Tmax was (3 2 7 ± 0 19) h and (3 32 ± 0 2 2) h, respectively. The relative bioavailability of the test preparation was (10 3 7 ± 7 7)%. Conclusion: 2 formulations have bioequivalence.