頁籤選單縮合
| 題 名 | 精進中藥濃縮製劑品質規範=Advanced Qulity Specification for Concentracted Preparations of Traditional Chinese Medicine |
|---|---|
| 作 者 | 余建志; | 書刊名 | 中醫藥年報 |
| 卷 期 | 12 2023.10[民112.10] |
| 頁 次 | 頁(13)1-(13)116 |
| 分類號 | 414.7 |
| 關鍵詞 | 臺灣中藥典; 藥典規格; 中藥濃縮製劑; 品質規範; Taiwan Herbal Pharmacopeia; Pharmacopoeia specifications; Concentrated traditional Chinese medicine preparations; Quality specification; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 研究目的: 評估臺灣中藥典新增濃縮製劑品項規範,針對常用中藥濃縮製劑進行鑑 別及分析方法開發研究,強化品質科學分析方法,精進中藥濃縮製劑品質規 範。 研究方法: 舉行四次臺灣中藥典中藥製劑小組專家會議;編修三個複方和四個單 方中藥濃縮製劑個論,分別是複方之四物湯、逍遙散與濟生腎氣丸,以及單 方之丹參、苦杏仁、川芎與麻黃;調查川芎與麻黃之一般檢驗數據、進行鑑 別及分析方法開發研究;擇葛根湯中藥濃縮製劑,進行指紋圖譜分析方法開 發;收集具體資料、相關文獻和實驗結果,藉由臺灣中藥典中藥製劑小組專 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.濟生腎氣丸、四物湯、 逍遙散之部分組成中藥材薄層層析鑑別方法分析開發;2.五項濃縮製劑【丹 參、苦杏仁、濟生腎氣丸、逍遙散、四物湯】個論內容之滾動編修;3.川芎 與麻黃中藥濃縮製劑的乾燥減重、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;4.兩項單方濃縮製劑 【川芎、麻黃】個論之增修;5.葛根湯中藥濃縮製劑指紋圖譜分析方法開發。 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: Evaluate the specifications of the new concentrated preparation items in the Taiwan Herbal Pharmacopoeia, including the research on the development of identification and analysis methods for concentreted preparations of traditional Chinese medicine (TCM) in common use, strengthening scientific analysis methods of quality, and advancement the quality specifications for concentreted preparations of TCM. Method: 1. To hold four expert meetings to discuss experimental results, referring to academic literatures and related pharmacopeias. 2. To edit the regulatory specification of three compound and four single TCM concentrates, including Xiao-Yao San, Si-Wu Tang and Ji Sheng Shen Qi Wan (compound), Dan shen, Ku-Xing-Ren, Chuan-Qiong, and Ma-Huang (single) with the assistance of the expert meetings. 3. To investigate general inspection data of Chuan-Qiong, and Ma-Huang, conduct identification and analytical method development. 4. To develop the chromatographic fingerprint of Ge Gen Tang Concentrated. Preparation. Results & Discussion: All the scheduled items in this project have been accomplished, including the majors: (1) Method development of TLC identification analysis of part of composition in Ji Sheng Shen Qi Wan, Xiao-Yao San,and Si-Wu Tang. (2) Rolling editing five concentrated preparations [Dan shen, Ku-Xing-Ren, Ji Sheng Shen Qi Wan, Xiao-Yao San, Si-Wu Tang] monographs. (3) The settings of loss on drying, total ash, acid-insoluble ash, water extract, dilute ethanol extract, TLC identification and assay related specifications of Chuan-Qiong, and Ma-Huang. (4) Edition of two new monographs of concentrated preparations [Chuan-Qiong, and Ma-Huang]. (5) Develop the chromatographic fingerprint of Ge Gen Tang Concentrated. 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。