| 盐酸多西环素调释胶囊生物等效性研究 |
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| 引用本文： | 韩珂,张媚媚,吴琳娜,陈宝,江少平,刘阳,陈美婉,吴传斌.盐酸多西环素调释胶囊生物等效性研究[J].药学进展,2008,32(11):505-509. |
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| 作者姓名： | 韩珂 张媚媚 吴琳娜 陈宝 江少平 刘阳 陈美婉 吴传斌 |
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| 作者单位： | 中山大学药学院,广东,广州,10080 |
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| 摘 要： | 目的：考察自制（受试）与进口（参比）盐酸多西环素调释胶囊两种制剂的药动学与人体生物等效性。方法：20名男性健康志愿者按交叉单剂量双周期试验设计，随机单剂量口服含100mg多西环素的两种制剂。以HPLC内标法测定各时间点的多西环素血药浓度，计算两种制剂的药动学参数和相对生物利用度，并评价其生物等效性。结果：受试和参比制剂的Cmax分别为（859．2±253．1）和（917．2±220．6）μg/L，tmax分别为（3．8±0．8）和（4．4±1．8）h，t1／2分别为（18．9±2．8）和（18．0±3．5）h，AUC0-72分别为（18．2±5．9）和（18．7±3．9）mg·h／L，AUC0-inf村分别为（18．7±5．9）和（19．2±3．9）mg·h／L，受试制剂的相对生物利用度为94．56％。结论：自制与进口盐酸多西环素调释胶囊生物等效。
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| 关 键 词： | 盐酸多西环素调释胶囊 高效液相色谱法 药动学 生物等效性 |
A Study on Bioequivalence of Doxycycline Hyclate Modified-release Capsules |
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| HAN Ke,ZHANG Mei-mei,WU Linna,CHEN Bao,JIANG Shao-ping,LIU Yang,CHEN Mei-wan,WU Chuan-bin.A Study on Bioequivalence of Doxycycline Hyclate Modified-release Capsules[J].Progress in Pharmaceutical Sciences,2008,32(11):505-509. |
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| Authors: | HAN Ke ZHANG Mei-mei WU Linna CHEN Bao JIANG Shao-ping LIU Yang CHEN Mei-wan WU Chuan-bin |
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| Institution: | HAN Ke,ZHANG Mei-mei,WU Lin-na,CHEN Bao,JIANG Shao-ping,LIU Yang,CHEN Mei-wan,WU Chuan-bin(School of Pharmaceutical Sciences,Sun-yat Sen University,Guangzhou 510080,China) |
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| Abstract: | Objective:To investigate the bioequivalence and pharmacokinetics of self-made(tested) and imported(reference) doxycycline hyclate modified-release capsules in healthy volunteers.Methods:A single oral dose of 100 mg tested and reference doxycycline hyclate capsules was randomly given to 20 healthy male volunteers in a two-period cross-over trial.The plasma drug concentrations at different time points were determined by HPLC method using internal standard.The relative bioavailability and main pharmacokinetic ... |
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| Keywords: | Doxycycline hyclate modified-release capsule HPLC Pharmacokinetics Bioequivalence |
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