頁籤選單縮合
| 題 名 | 建立中藥濃縮製劑國際品質規範=Establish International Quality Standards for Concentrated Preparations of Traditional Chinese Medicine |
|---|---|
| 作 者 | 余建志; | 書刊名 | 中醫藥年報 |
| 卷 期 | 13 2024.10[民113.10] |
| 頁 次 | 頁(17)1-(17)110 |
| 分類號 | 414.7 |
| 關鍵詞 | 臺灣中藥典; 藥典規格; 中藥濃縮製劑; Taiwan Herbal Pharmacopeia; Pharmacopoeia specifications; Concentrated traditional Chinese medicine preparations; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 研究目的 針對常用中藥濃縮製劑進行鑑別及分析方法開發研究,探討檢驗方法朝向國際新 技術發展趨勢修訂之可行性,精進中藥濃縮製劑品質規範與提升中藥產業競爭力。 研究方法 舉行四次中藥製劑小組專家會議;編修三個複方和二個單方中藥濃縮製劑個論, 分別是逍遙散、四物湯、濟生腎氣丸(複方)、丹參和苦杏仁(單方);調查一般檢驗數 據、進行鑑別及分析方法開發研究;以濟生腎氣丸為例,評估層析指紋圖譜應用於中 藥濃縮製劑質量評估之可行性;收集具體資料、相關文獻和實驗結果,藉由中藥製劑 小組專家小組會議,提供專業諮詢並協助藥典的編輯。 結果與討論 本計畫已順利完成原規劃的項目,主要包括:1.苦杏仁、丹參及濟生腎氣丸的乾燥 減重、總灰分、酸不溶性灰分、水抽提物、稀乙醇抽提物,薄層層析鑑別與含量測定 相關規範之訂定;2.逍遙散與四物湯之部分組成中藥材薄層層析鑑別方法分析開發;3. 濟生腎氣丸指紋圖譜應用之開發;4.二項濃縮製劑【逍遙散及四物湯】個論內容之滾動 編修;5.三項濃縮製劑【苦杏仁、丹參及濟生腎氣丸】個論之增修。其中指紋圖譜的應 用經專家會議討論後確認可用於中藥品質管制,但欲應用於品質鑑定仍需更深入研究。此研究成果將有助於中藥濃縮製劑的品質管制與技術提升,增加臺灣濃縮中藥製 劑產品的國際競爭力。 |
| 英文摘要 | Aim Include the research on the development of identification and analysis methods for commonly used traditional Chinese medicine (TCM) concentrates, exploration on the feasibility of revising inspection methods towards international trends of new technology development, and improvement of the quality specifications of TCM concentrates and the elevation of the competitiveness of the TCM industry. Method 1. Hold four expert meetings to discuss experimental results, referring to academic literatures and related pharmacopeias. 2. Edit the regulatory specification of three compound and two single TCM concentrates, including Xiao-Yao San, Si-Wu Tang and Ji Sheng Shen Qi Wan (compound), Dan shen, and Bitter Almonds (single) with the assistance of the expert meetings. 3. Investigate general inspection data, conduct identification and analytical method development. 4. Evaluate the feasibility of the chromatographic fingerprint of Ji Sheng Shen Qi Wan in quality control of concentrated TCM preparations. Results & Discussion All the scheduled items in this project have been accomplished, including the majors: (1) The settings of loss on drying, total ash, acid-insoluble ash, water extract, dilute ethanol extract , TLC identification and assay related specifications of Bitter almond, Dan shen, and Ji Sheng Shen Qi Wan. (2) Method development of TLC identification analysis of Xiao-Yao San and part of composition in Si-Wu Tang. (3) Development of the application of the chromatographic fingerprinting of Ji Sheng Shen Qi Wan. (4) Rolling editing two concentrated preparations [Xiao-Yao San and Si-Wu Tang] monographs. (5) Edition of three new monographs of concentrated preparations [Bitter Almonds, Dan shen, and Ji Sheng Shen Qi Wan]. Among these, the feasibility of the application of the chromatographic fingerprinting to quality control of TCM has been confirmed by the expert meetings. However, its application to quality identification requires further in-depth research. These accomplishments will facilitate the quality control and technological improvement of concentrated TCM preparations, and elevate the international competitiveness of Taiwan's concentrated Chinese medicine preparations. |
本系統中英文摘要資訊取自各篇刊載內容。