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題 名 | Relative Bioavailability Study of Cefuroxime Axetil Tablets=Cefuroxime Axetil錠劑相對生體可用率之研究 |
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作 者 | 宋國峻; 張簡雅青; 陳本全; 陸重隆; 韓若怡; 林瑜瑩; | 書刊名 | 藥物食品分析 |
卷 期 | 7:1 1999.03[民88.03] |
頁 次 | 頁45-51 |
分類號 | 418.284 |
關鍵詞 | 相對生體可用率; 藥物動力學; 生體相等性; Cefuroxime axetil; Cefuroxime; Relative bioavailability; Pharmacokinetics; Bioequivalence; |
語 文 | 英文(English) |
中文摘要 | 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。 |
英文摘要 | The Study was to assess the bioequivalence of two cefuroxime axetil tablets. The test product was Cefxin tablet; the reference product was Zinnat tablet. Twelve healthy adult male volunteers participated in the study. Every subject received each formulation according to a completely double-blind randomized cross-over design with a one-week washout period before the second dose. Following oral administratio of two cefuroxime axetil tablets, blood samples were drawn thirteen times over a period of ten hours. These samples were analyzed for cefuroxime concentrations using a sensitive and specific high performance liquid chromatography. Statistical assessments were performed, including ANOVA, power analysis and 90% confidence interval of ratio on various pharmacokinetic parameters derived from the plasma drug concentration-time profiles. The results indicated that the AUC,AUC, peak concentration and mean resident time for the two products were not statistically significant different, i.e., the two products showed no difference in the rate and extent of drug absorption. Namely, there is no statistically significant difference between the bioavailability of Cefxin and Zinnat. |
本系統中英文摘要資訊取自各篇刊載內容。