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2种阿奇霉素制剂的人体生物等效性研究 被引量:1

Study on Bioequivalence of 2 Kinds of Azithromycin Preparations in Healthy Volunteers
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摘要 目的:研究2种阿奇霉素制剂的人体生物等效性。方法:18名男性健康志愿者采用随机、自身对照、交叉法单剂量口服阿奇霉素分散片(受试制剂)与阿奇霉素胶囊(参比制剂)后,采用微生物法测定血浆中阿奇霉素的血药浓度,利用3p97软件计算主要药动学参数,并进行生物等效性评价。结果:受试制剂与参比制剂的药动学参数分别为:tma(x2.40±0.48)、(2.29±0.55)h,Cmax(0.34±0.06)、(0.30±0.06)μg·mL-1,AUC0~14(42.80±0.80)、(2.82±1.44)μg·h·mL-1,AUC0~∞(2.95±0.67)、(2.91±1.68)μg·h·mL-1。2种制剂的主要药动学参数无显著性差异(P>0.05)。阿奇霉素分散片的相对生物利用度(F)为(99.29±3.85)%。结论:2种阿奇霉素制剂具有生物等效性。 OBJECTIVE:To study the bioequivalence of 2 kinds of azithromycin preparations.METHODS:18 male healthy volunteers were enrolled in randomized controlled crossover design and given a signal oral dose of azithromycin dispersible tablet(test preparation) and azithromycin capsule(reference preparation).Plasma concentration of azithromycin was detected by microbiological method and pharmacokinetic parameters were calculated using 3p97 software.Bioequivalence of 2 kinds of azithromycin preparations were evaluated.RESULTS:Main pharmacokinetic parameters of test preparation vs.reference preparation were as follows:Cmax(0.34±0.06)μg·mL^-1 vs.(0.30±0.06)μg·mL^-1;tmax(2.40±0.48)h vs.(2.29±0.55)h;AUC0~144(2.80±0.80)μg·h·mL^-1 vs.(2.82±1.44)μg·h·mL^-1;AUC0~∞(2.95±0.67) μg·h·mL^-1 vs.(2.91±1.68) μg·h·mL^-1.There was no significant difference between pharmacokinetic parameters of 2 kinds of preparations(P〉0.05).The relative bioavailability of azithromycin dispersible tablets was(99.29±3.85)%.CONCLUSION:2 kinds of azithromycin preparations are bioequivalent.
出处 《中国药房》 CAS CSCD 北大核心 2010年第30期2832-2834,共3页 China Pharmacy
关键词 阿奇霉素分散片 阿奇霉素胶囊 生物利用度 生物等效性 微生物法 Azithromycin dispersible tablets Azithromycin capsule Bioavailability Bioequivalence Microbiological method
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  • 1王玉花,陈俊杰,陈本美,张毕奎.液质联用测定血浆中阿奇霉素及其人体药动学和相对生物利用度研究[J].中国药学杂志,2006,41(1):51-54. 被引量:14
  • 2C. T. Viswanathan,Surendra Bansal,Brian Booth,Anthony J. DeStefano,Mark J. Rose,Jeffrey Sailstad,Vinod P. Shah,Jerome P. Skelly,Patrick G. Swann,Russell Weiner.Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays[J].Pharmaceutical Research.2007(10)
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