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目的:比较盐酸氟桂利嗪(A)与参比片(B)的药物动力学和相对生物利用度.方法:采用HPLC荧光法测定10名健康受试者po 24mg A和B后,盐酸氟桂利嗪在血浆中的浓度,计算两者的药物动力学参数和相对生物利用度.结果:A和B的AUC_(0—∞)分别为(481.82±21.33)、(497.24±36.03)(μg·h)/L,t_(?)分别为(3.69±0.27)、(3.69±0.32)h,C_(?)分别为(4O.29±2.71)、(40.89±3.6Oμg/L,两者的AUC,t_(?)、c_(?)均无显著性差异(P>0.05).采用梯形法计算两者的AUCO_(0—t)分别为(459.26±14.75)、(468.32±34.44)(μg·h)/L,A的相对生物利用度为(98.4±6.6)%.结论:被试片剂与参比片剂具有生物等效性.
OBJECTIVE: To compare the pharmacokinetics and relative bioavailability of flunarizine hydrochloride (A) with reference tablets (B) .METHODS: Fluorescein hydrochloride The plasma concentrations of cinnarizine were calculated and the pharmacokinetic parameters and relative bioavailabilities of the two drugs were calculated.Results: The AUC_ (0-∞) of A and B were (481.82 ± 21.33) and (497.24 ± 36.03) μg (3.69 ± 0.27) and (3.69 ± 0.32) h respectively, and C_ (?) Were (40.29 ± 2.71) and (40.89 ± 3.6.0 μg / L, AUC, t_ (?), C_ (?) Showed no significant difference (P> 0.05) .The AUCO_ (0-t) calculated by trapezoidal method were (459.26 ± 14.75), (468.32 ± 34.44) · H) / L, the relative bioavailability of A was (98.4 ± 6.6)% .Conclusion: The tested tablets and reference tablets are bioequivalent.