| 两种头孢羟氨苄胶囊的药代动力学与生物等效性研究 |
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| 引用本文： | 孟玲,张静,邵志高.两种头孢羟氨苄胶囊的药代动力学与生物等效性研究[J].中国药房,2002,13(12):735-737. |
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| 作者姓名： | 孟玲 张静 邵志高 |
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| 作者单位： | 南京医科大学附属第一医院,南京市,210029 |
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| 摘 要： | 目的 :研究两种头孢羟氨苄胶囊在正常人体的药代动力学与生物等效性。方法 :22名健康志愿受试者随机交叉口服1000mg头孢羟氨苄胶囊和仙逢久胶囊后 ,采用高效液相色谱 (HPLC)法 ,以阿莫西林作内标 ,测定头孢羟氨苄(CFO)血浆药物浓度。结果 :两种胶囊剂均符合一级吸收开放性一室模型 ,主要药代动力学参数 :T1/2ke分别为 (1.40±0.15)h、(1.44±0.23)h ;Tmax分别为(2.3±0.5)h、(2.2±0.3)h ;Cmax分别为 (30.59±4.25) μg/ml、(30.57±4.24) μg/ml;AUC分别为 (99.31±14.50) μg/(ml·h)、(99.22±15.11h) μg/(ml·h)。结论 :两种胶囊剂生物利用度为(100.42±7.62) % ,具有生物等效性
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| 关 键 词： | 头孢羟氨苄 高效液相色谱法 药代动力学 生物等效性 |
| 文章编号： | 1001-0408(2002)12-0735-03 |
| 修稿时间： | 2002年5月14日 |
Study on Pharmacokinetics and Bioequivalence of Two Products of Cefadroxil Capsules in Healthy Volunteers |
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| MENG Ling,ZHANG Jing,SHAO Zhigao.Study on Pharmacokinetics and Bioequivalence of Two Products of Cefadroxil Capsules in Healthy Volunteers[J].China Pharmacy,2002,13(12):735-737. |
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| Authors: | MENG Ling ZHANG Jing SHAO Zhigao |
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| Abstract: | OBJECTIVE:To study the bioequivalence between cefadroxil capsules and its reference capsules and pharmacokinetics in 22 male healthy volunteers METHODS:A dose of 1 000mg cefadroxil(test and reference products)was given according to a randomized cross-over design Plasma concentrations of cefadroxil and internal standard(amoxicillin) were determined by HPLC RESULTS:The concentration-time curves of both preparations fitted to a one-compartment model The main parameters of test and reference products were as follows:T1/2ke were (1 40±0 15)h and (1 44±0 23)h;Tmax were (2 3±0 5)h and (2 2±0 3)h;peak concentrations(Cmax) were (30 59±4 25)μg/ml and(30 57±4 24)μg/ml,AUC were(99 31±14 50)μg/(ml·h) and (99 22±15 11)μg/(ml·h)respectively CONCLUSION:Relative bioavailability was(100 42±7 62)% The two formulations were bioequivalent |
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| Keywords: | cefadroxil HPLC pharmacokinetics bioequivalence |
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