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,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。
Abstract
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 cmaxand AUC0~36were 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.
关键词
格列吡嗪 /
缓释 /
高效液相色谱 /
生物利用度
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Key words
glipizide /
sustained-release /
HPLC /
bioavailablity
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曲福军 孙华 张立新 郭晓军.
格列吡嗪缓释胶囊人体相对生物利用度研究[J]. 中国药学杂志, 2000, 35(09): 610-613
QU Fu-jun;SUN Hu;ZHNG Li-xin;GUO Xio-jun.
Study on the relative bioavailability of glipizide sustained-release capsule in human[J]. Chinese Pharmaceutical Journal, 2000, 35(09): 610-613
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参考文献
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脚注
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