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格列吡嗪缓释胶囊人体相对生物利用度
研究
摘要：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Cmax, AUQ 48等指标，利用方差分析、双单侧t检验及 (1-2 a )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4d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 >)。结论格列吡嗪缓释胶囊与控释片生物等效。关键词：格列吡嗪；缓释；高效液相色谱；生物利用度
中分类号：+5 文献标识码：A
文章编号：1001-2494(2000)09-0610-04
Study on the relative bioavailability of glipizide susta in ed- release capsule in huma n
QU Fu-j un ,SUN Hua,ZHANG Li-xi n, GUO Xiao-j un
(Clinical Pharmacy and Drug Institute at the Second Hospital of
Harbin Medical Un iversity,Harbi n 150086)
ABSTRACT OBJECTIVE To study the relative bioavailability of glipizide susta in ed-release capsule in healthy vol un The plasma concen trati ons of gliplzide susta in ed-release capsule and con trolled-realease tablet were determ ined with HPLC in 16 healthy male volun teers after 10 mg orally sin gle dosage and multiple pharmacok in etic parameters and relative bioavailability of two drugs were c maxand AUC 〜36 were used to evaluate the
bioequivale nee of the two drugs with an alysis of varia nee and double sin gle t- The concen trati on-time curves of these two
drugs had two stable phase could be atta ined after the drugs were take n in con