篇名 | Cefuroxime Axetil錠劑相對生體可用率之研究 |
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卷期 | 7:1 |
並列篇名 | Relative Bioavailability Study of Cefuroxime Axetil Tablets |
作者 | 宋國峻 、 張簡雅青 、 陳本全 、 陸重隆 、 韓若怡 、 林瑜瑩 |
頁次 | 45-51 |
關鍵字 | 相對生體可用率 、 藥物動力學 、 生體相等性 、 Cefuroxime axetil 、 Cefuroxime 、 Relative bioavailability 、 Pharmacokinetics 、 Bioequivalence 、 MEDLINE 、 Scopus 、 SCIE |
出刊日期 | 199903 |
本研究旨在評估兩種cefuroxime axetil錠劑之生體相等性。試驗品為Cefxin錠,參考品為 Zinnat 錠。十二位健康成年男性自願者,以隨機雙盲交叉之實驗設計方式給予cefuroxime axetil 錠,兩次給藥間有一星期的間隔時間。每位受試者口服兩粒cefuroxime axetil 錠後,於十小時內抽血十三次,此血液樣本透過高效液相層析儀分析其中 cefuroxime 之濃度。 由藥物血中濃度 - 時間之數據得到藥物動力學參數後作 ANOVA、統計能力分析、90 %信賴區間等統計比較。結果顯示兩種 cefuroxime axetil 錠之 AUC,AUC,尖峰血中濃度及平均滯留時間,在統計學上均沒有顯著之差異; 亦即兩種藥品之吸收程度和吸收速度沒有差異。根據以上之結果,可證明 Cefxin 和 Zinnat 之生體可用率在統計學上沒有顯著之差異。
The Study was to assess the bioequivalence of two cefuroxime axetiltablets. The test product was Cefxin tablet; the reference product was Zinnattablet. Twelve healthy adult male volunteers participated in the study. Everysubject received each formulation according to a completely double-blindrandomized cross-over design with a one-week washout period before the seconddose. Following oral administratio of two cefuroxime axetil tablets, bloodsamples were drawn thirteen times over a period of ten hours. These samples wereanalyzed for cefuroxime concentrations using a sensitive and specific highperformance liquid chromatography. Statistical assessments were performed,including ANOVA, power analysis and 90% confidence interval of ratio on variouspharmacokinetic parameters derived from the plasma drug concentration-timeprofiles. The results indicated that the AUC,AUC, peak concentration and meanresident time for the two products were not statistically significant different,i.e., the two products showed no difference in the rate and extent of drugabsorption. Namely, there is no statistically significant difference between thebioavailability of Cefxin and Zinnat.