格列吡嗪缓释胶囊人体相对生物利用度研究

 目的 研究格列吡嗪缓释胶囊在正常人体内相对生物利用度。方法 采用反相高效液相色谱法测定16名健康男性志愿者单剂量 po 10 mg和多剂量 po 格列吡嗪缓释胶囊及控释片后的血浆药物浓度，计算两制剂的药代动力学参数及相对生物利用度，以c_max，AUCo～₄₈等指标，利用方差分析、双单侧t检验及(1-2α)置信区间分析判定两制剂生物等效性。结果 两制剂药-时曲线有双峰，连续服药4 d达稳态，单剂量与多剂量给药主要药代动力学参数经统计分析无显著差异(P＞0.05)。结论 格列吡嗪缓释胶囊与控释片生物等效。

Study on the relative bioavailability of glipizide sustained-release capsule in human

OBJECTIVE To study the relative bioavailability of glipizide sustained-release capsule in healthy volunteers.METHODS The plasma concentrations of gliplzide sustained-release capsule and controlled-realease tablet were determined with HPLC in 16 healthy male volunteers after 10 mg orally single dosage and multiple dosage.The pharmacokinetic parameters and relative bioavailability of two drugs were calculated.The c_maxand AUC_0～36were used to evaluate the bioequivalence of the two drugs with analysis of variance and double single t-test.RESULTS The concentration-time curves of these two drugs had two peaks.The stable phase could be attained after the drugs were taken in consecutive 4 days.The main pharmacokinetic parameters between single dosage and multiple dosage had no singificant difference by statistic analysis.CONCLUSION The glipizide sustained-release capsule was bioequivalent to the glipizide controlled-release tablet.