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目的:研究国产盐酸噻氯匹定(A)和进口片(B)的药物动力学和相对生物利用度.方法:采用HPLC法测定10名健康志愿者po 500mg A和B后,盐酸噻氯匹定在血浆中的浓度,计算两者的药物动力学参数和相对生物利用度,并进行统计学分析.结果:A和B的AUC分别为(14.29±0.66)和(15.08±0.64)mg·h/L,t_(max)分别为(1.72±0.09)和(1.54±0.09)h,c_(max)分别为(1.817±0.247)和(1.998±0.199)mg/L,两者的AUC,t_(max)、C_(max)均无显著性差异(P>0.05).采用梯形法计算两者的AUC_(0-t)分别为(13.61±0.65)和(14.14±0.70)mg·h/L,A的相对生物利用度为(96.62±6.47)%.结论:国产胶囊与进口片剂具有生物等效性.
OBJECTIVE: To study the pharmacokinetics and relative bioavailability of domestic ticlopidine hydrochloride (A) and imported tablets (B) .METHODS: Ten healthy volunteers were used to determine the bioavailability of ticlopidine The pharmacokinetic parameters and relative bioavailability of the two drugs were calculated and statistically analyzed.Results: The AUC of A and B were (14.29 ± 0.66) and (15.08 ± 0.64) mg · h / L and t max respectively were (1.72 ± 0.09) and (1.54 ± 0.09) h and (max) were 1.817 ± 0.247 and 1.998 ± 0.199 mg / L, respectively max and C max had no significant difference (P> 0.05). The AUC 0 -t calculated by trapezoidal method was (13.61 ± 0.65) and (14.14 ± 0.70) mg · h / L, The relative bioavailability of A was (96.62 ± 6.47)%. Conclusion: Domestic capsules and imported tablets are bioequivalent.