论文部分内容阅读
１２名男性健康受试者采用随机交叉给药方法。单剂量口服试验药阿莫西林－克拉维酸钾干混悬剂（４∶１）和对照药阿莫西林－克拉维酸钾（４∶１）干混悬剂，阿莫西林５００ｍｇ，克拉维酸钾１２５ｍｇ，进行人体生物利用度和药代动力学比较。用ＨＰＬＣ荧光检测同时测定阿莫西林和克拉维酸钾血浓度。结果试验药和对照药中阿莫西林的Ｔ_（ｍａｘ） １．５８ ± ０．３６和１．５６ ± ０．３４ｈ； Ｃ１３．９４± ２２０和１３．３８±２．６７ ｍｇ·Ｌ_（－１）； Ｔ_（１／２）； １．５７ ± ０．１９和１．５３ ± ０．２３ｈ； ＡＵＣ ５２．２８ ± ８．２２和５０．２４ ±９．４４ ｍｇ·ｈ·Ｌ~（－１），相对生物利用度１０４．８９％ ± ７．７３％。克拉维酸钾的Ｔ_（ｍａｘ） ０．９６±０．３７和１０６±０．５０ｈ；Ｃ_（ｍａｘ） ２．１３±０．４４和２６９±０．９９ｍｇ· Ｌ~（－１） Ｔ_（１／２） １．２７±０．１９和 １．２８ ± ０３２ｈ； ＡＵＣ ５．３８ ± ０．８３和 ５．６６ ±１．０４ｍｇ· ｈ· Ｌ~（－１），相对生物利用度９５．９１％±１１．２１％。两种制剂的ＡＵＣ和Ｃ_（ｍａｘ）经方差分析和双单侧ｔ检验，Ｔ_（ｍａｘ）用非参数法统计，两种制剂中阿莫
Twelve male healthy subjects were randomized to crossover therapy. A single dose oral test drug amoxicillin - clavulanic acid potassium dry suspension (4: 1) and the control drug amoxicillin - clavulanate potassium (4: 1) dry suspension, amoxicillin 500mg, Potassium 125mg, for human bioavailability and pharmacokinetic comparison. Simultaneous determination of amoxicillin and clavulanate potassium concentration by HPLC fluorescence detection. Results T max of 1.58 ± 0.36 and 1.56 ± 0.34h for amoxicillin and 13.38 ± 2.67 mg · L -1 for amoxicillin in test and reference drugs, respectively ); T_ (1/2); 1.57 ± 0.19 and 1.53 ± 0.23h; AUC 52.28 ± 8.22 and 50.24 ± 9.44 mg · h · L -1 ), Relative bioavailability 104.89% ± 7.73%. The K_ (max) of clavulanate 0.96 ± 0.37 and 106 ± 0.50h; C_ (max) 2.13 ± 0.44 and 269 ± 0.99mg · L -1 T_ (1) / 2) 1.27 ± 0.19 and 1.28 ± 032h; AUC 5.38 ± 0.83 and 5.66 ± 1.04mg · h · L -1, relative bioavailability 95.91 % ± 11.21%. AUC and C_ (max) of the two preparations were analyzed by ANOVA and double unilateral t test, T_ (max) by nonparametric method, Amo