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題 名 | Comparative Pharmacokinetics of Two Atenolol Products=兩種Atenolo產品藥動性質之比較 |
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作 者 | 林慧玲; 陳柏芬; 李宜臻; 陳瑞龍; | 書刊名 | 藥物食品分析 |
卷 期 | 11:1 2003.03[民92.03] |
頁 次 | 頁4-7+73 |
分類號 | 418.1 |
關鍵詞 | 相對生體可用率; 藥動學; Comparative bioavailability; Pharmacokinetics; Atenolol; |
語 文 | 英文(English) |
中文摘要 | 本研究為一種開放性之單劑量隨機交叉試驗,目的在比較兩種廠牌之Atenolol錠劑之生體可用率及藥動學性質,計有12名健康受試者參加試驗。 每名受試者在各給藥期中服用單劑100 mg Atenolol錠劑後,按時採集血液檢品,再用高效能波相層析法 (HPLC) 及螢光法檢測血漿中之Atenolol濃度。此測定法之同日內及異日內的變異係數 (coefficient of variation; CV) 均不超過12%,檢測限量為0.02mg/L。Ateol®錠劑 (生達製藥) 及 Tenormin®錠劑(Imperial Chemical Industries Limited) 之生體可用率及藥動學參數分別為:血漿中尖峰濃度(Cmax):0.98 ± 39 mg/L、0.85 ± 0.32 mg/L;達尖峰血漿中濃度時間 (Tmax):2.88 ± 1.03 hours、2.96 ± 1.16hours;血漿中半衰期(T1/2);6.19 ± 1.01 hours、6.19 ± 1.38hours;血漿濃度-時間曲線下面積 (AUC0→∞);8.74 ± 3.85 mg-hr/L、7.88 ± 2.69 mghr/L;AUC0→28;8.34 ± 3.66 mg-ml/L、7.50 ± 2.61 mg-hr/L;第一動差血中濃度曲線下之面積(AUMC); 81.03 ± 37.62 mg-hr2/L、74,86 ± 26.67 mgmg-hr2/L;平均滯留時間(MRT); 9.27 ± 0.75 hours 、9.50 ± 1.35hours 。 經對數轉換,兩廠牌之AUCs及Cmax不具統計學上的差異 (p>0.05) ,狹窄的信賴區間(CI90%)、高的檢定力及雙重單尾t-檢定的結果均顯示兩個產品具生體相等性。此研究所得的藥動學參數與過去文獻報導者相似。 |
英文摘要 | The purpose of this study was to determine the pharmacokinetics and comparative bioavailability of atenolol tablets manufactured by two different drug companies. Pharmacokinetics (PK) and comparative bioavailability of atenolol tablets manufactured by two different drug companies were investigated in 12 healthy volunteers in an open, randomized cross-over trial. After a single oral dose of 100 mg atenolol tablets, the concentration of atenolol in plasma was determined by a modified high performance liquid chromatographic (HPLC) method with fluorimetric detection. Intra-day and inter-day coefficients of variation (CV) were within 12%. The detection limit was 0.02mg/L for plasma samples. The average bioavailability and pharmacokinetic parameters of the two atenolol tablets were as follows: peak plasma concentration (Cmax): 0.98 ± 0.39 mg/L, 0.85 ± 0.32 mg/L; time to peak plasma concentration (Tmax): 2.88 ± 1.03 hours, 2.96 ± 1.16 hours; plasma half-life (T1/2): 6.19 ± 1.01 hours, 6.19 ± 1.38 hours; area under the plasma concentration-time curve (AUC0→∞): 8.74 ± 3.85 mg-hr/L, 7.88 ± 2.69 mg-hr/L; AUC0→28: 8.34 ± 3.66 mg-hr/L, 7.50 ± 2.61 mg-hr/L; area under the first moment-time curve (AUMC): 81.03 ± 37.62 mg-hr2/L, 74.86 ± 26.67 mg-hr2/L; mean residence time (MRT): 9.27 ± 0.75 hours, 9.50 ± 1.35 hours for Ateol® tablets (Standard) and Tenormin® tablets (ICI), respectively. No statistically significant differences were observed for the PK parameters between the two products (p > 0.05). The narrow CI90% values, high power values and the results of two one-sided t-tests also showed that the two products are very similar. The PK parameters obtained in this study are similar to those reported previously. |
本系統中英文摘要資訊取自各篇刊載內容。