国产格列吡嗪片剂生物等效性研究 |
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引用本文: | 崔一民,孙培红,刘玉旺,孙忠民. 国产格列吡嗪片剂生物等效性研究[J]. 中国新药杂志, 2001, 10(3): 194-195 |
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作者姓名: | 崔一民 孙培红 刘玉旺 孙忠民 |
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作者单位: | 北京大学第一临床医学院药剂科, |
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摘 要: | 目的研究国产格列吡嗪片剂的生物等效性。方法10名健康男性志愿者随机交叉单次口服国产和进口格列吡嗪片剂10mg,用高效液相色谱法测定血清中格列吡嗪的浓度,并用3P97程序对试验数据进行处理。结果国产及进口格列吡嗪片剂的C
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关 键 词: | 格列吡嗪 药代动力学 生物利用度 生物等效性 |
文章编号: | 1003-3734(2001)03-0194-02 |
Study on bioequivalence ofdomestic and imported glipizide tablets |
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Abstract: | Objective:To study the bioequivalence of domestic and im ported glipizide tablets.Methods:10 healthy male volunteers were treat ed with a single dose of 10 mg domestic and imported glipizide tablet in crossov er order,then their serum drug level were determined by HPLC and data obtained w ere analyzed by 3P97 program.Results:The pharmacokinetic parameters fo r domestic an imported tablets were:Cmax[(1 449.40±196.36) and (1 310.00 ±231.41)ng/ml],Tmax[(2.00±0.75) and (3.45±0.83)h],AUC0~∞[(8 591.66±164.23) and (8 917.91±2 065.68)(ng*h)/ml].The relative bioavailabili ty of domestic glipizide tablet was (101.40±29.93)%.Conclusion:The do mestic and imported glipizide tablets were bioequvalent. |
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