- 學位論文
葛根湯、芍藥甘草湯、疏經活血湯之傳統水煎劑與科學濃縮製劑中指標成分之藥物動力學研究
Pharmacokinetic Studies of Bioactive Constituents between Commercial Extract and Traditional Decoction of Ge-Gen Tang, Shu-Ching-Huo-Hsieh Tang and Shao-Yao-Gan-Cao Tang
摘要
本研究對於葛根湯、芍藥甘草湯以及疏經活血湯之傳統水煎劑型以及科學濃縮製劑在家兔體內的藥物動力學進行評估。開發一個快速有效之高效液相層析法分別定量血漿檢品中兩種指標成份甘草甜素及芍藥苷。並驗證此方法具有選擇性、精確性以及安定性。 藥物動力學研究方面，經由交叉實驗設計下取六隻大白兔，分別給予三種方劑之水煎劑及濃縮製劑後，血漿中之甘草甜素皆呈現一室體模式，經過分析比較藥物動力學參數，發現葛根湯中甘草甜素之曲線下面積 (AUC0-∞) 於投予科學濃縮製劑後，顯著 (p值<0.05) 高於傳統水煎劑 (49.28 ± 16.9 and 17.89 ± 2.01)，且血中最高濃度 (Cmax) 於投予科學濃縮製劑後，也顯著的高於傳統水煎劑 (3.61 ± 0.25 μg/ml and 1.24 ± 0.16 μg/ml)。而比較甘草甜素之藥物達血中濃度之時間 (Tmax) 後，發現投予芍藥甘草湯之傳統水煎劑顯著地短於投予科學濃縮製劑 (6.89 hr and 10.94 hr) ，疏經活血湯也有相同的結果，傳統水煎劑之Tmax為7.08 hr，科學濃縮製劑為8.30 hr。以上研究可供葛根湯、芍藥甘草湯以及疏經活血湯在製劑品管、臨床藥物動力學之研究參考。
並列摘要
The study aims to evaluate the pharmacokinetic differences of bioactive constituents between commercial extract and traditional decoction of Ge-Gen Tang, Shu-Ching-Huo-Hsieh Tang and Shao-Yao-Gan-Cao Tang. The rapid and sensitive quantitative methods for glycyrrhizin and paeoniflorin in plasma samples are developed and validated by using HPLC. After oral administration of Ge-Gen Tang, Shu-Ching-Huo-Hsieh Tang and Shao-Yao-Gan-Cao Tang, the plasma levels-time profiles of glycyrrhizin were adequately described by an one-compartment model. The results showed that after oral administration of commercial extract in New Zealand rabbit, the AUC 0-∞, C max is significantly larger than traditional decoction in GT (AUC 0-∞: 49.28 ± 16.9 and 17.89 ± 2.01; C max : 3.61 ± 0.25 μg/ml and 1.24 ± 0.16 μg/ml), the T max in decoction was shorter than commercial extract of SYGCT (T max 6.89 hr and 10.94 hr), and after oral administration SCHACHT showing same result. The T max of traditional decoction was 7.08 hr and of commercial extract was 8.30 hr. So the pharmacokinetic results are useful for quality control and clinical pharmacokinetic studies of commercial extracts and traditional decoctions of GT, SCHHT and SYGCT.