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目的研究格列吡嗪胶囊人体药物代谢动力学及相对生物利用度。方法用ＨＰＬＣ法测定１０名受试者 单剂量交叉口服５ｍｇ格列吡嗪胶囊和片剂后的血药浓度，ＭＣ－ＰＫＰ药动学程序拟合，得药动学参数，计算胶囊剂的 相对生物利用度（Ｆ）。结果胶囊剂的Ｃｍａｘ为（４５６±６０）ｎｇ／ｍｌ、Ｔｍａｘ为（２．９５±０．６）ｈ、ＡＵＣ为（２３３５±１８０）ｈ·ｎｇ／ｍｌ。以 上参数经双单侧 ｔ检验等统计分析，与片剂比无显著差异。 Ｆ值为（１０３±４）％。结论格列吡嗪（２．９５±０．６）ｈ血 药浓度达高峰，峰浓度为（４５６±６０）ｎｇ／ｍｌ。且胶囊与片剂为生物等效制剂。
Objective To study human pharmacokinetics and relative bioavailability of glipizide capsules. Methods The plasma concentrations of 10 mg glipizide capsules and tablets were determined by HPLC method after 10 doses of crossover oral administration. The pharmacokinetic parameters of MC-PKP were fitted and the relative pharmacokinetic parameters of capsules were calculated Bioavailability (F). Results The capsule had Cmax of (456 ± 60) ng / ml, Tmax of (2.95 ± 0.6) h and AUC of (2335 ± 180) h · ng / ml. The above parameters by double-sided t test and other statistical analysis, no significant difference with the tablet. The F value was (103 ± 4)%. Conclusion The plasma concentration of glipizide (2.95 ± 0.6) h reached the peak at a peak concentration of (456 ± 60) ng / ml. And capsules and tablets are bioequivalent formulations.