頁籤選單縮合
| 題 名 | 強化中藥濃縮製劑品質規格=Strengthening the Quality Specifications of Chinese Medicine Concentrated Preparations |
|---|---|
| 作 者 | 余建志; | 書刊名 | 中醫藥年報 |
| 卷 期 | 13 2024.10[民113.10] |
| 頁 次 | 頁(21)1-(21)108 |
| 分類號 | 414.7 |
| 關鍵詞 | 臺灣中藥典; 藥典規格; 中藥濃縮製劑; 品質規格; 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格,針對常用中藥濃縮製劑進行鑑別及分析方 法開發研究,提升品質科學分析方法,強化中藥濃縮製劑品質規格。 研究方法 舉行四次臺灣中藥典中藥製劑小組專家會議;協助回應藥典有關中藥濃縮製劑問題 與意見;調查白芍、牡丹皮及桂枝之一般檢驗數據、進行鑑別及分析方法開發研究;完 成【白芍、牡丹皮與桂枝】等 3 項中藥濃縮製劑中藥典個論草案;檢討「中藥典中藥濃 縮製劑檢驗規格製訂工作指南」;針對開發中藥濃縮製劑個論進行濃縮倍數探討,並收 集與比較分析臺灣及國際間藥典;參加臺灣中藥典相關編修會議並提供中藥濃縮製劑相 關專業意見。 結果與討論 本計畫已順利完成原規劃的項目,主要包括: 1. 【白芍、牡丹皮、桂枝】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;2.三項單方濃縮製劑【白芍、牡丹皮、桂枝】個論草案之 增修;3.一項濃縮製劑【麻黃】個論草案內容之滾動編修;4. 檢討「中藥典中藥濃縮製 劑檢驗規格製訂工作指南」。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. Assist in responding to questions and opinions on the pharmacopoeia's issues related to concentrated preparations of traditional Chinese medicine. 3. To investigate general inspection data of Paeoniae Radix Alba, Moutan Radicis Cortex, and Cinnamomi Ramulus, conduct identification and analytical method development. 4. To Complete the regulatory specification of three single TCM concentrates, including Paeoniae Radix Alba, Moutan Radicis Cortex, and Cinnamomi Ramulus with the assistance of the expert meetings. 5. Review the "Guidelines for the Formulation of Test Specifications for Concentrated Chinese Medicine Preparations in THP 6. Discuss the concentration multiples of monographs on the development of concentrated preparations of traditional Chinese medicine. In addition, it is necessary to collect, compare and analyze Taiwan and international pharmacopoeias. 7. participate in the relevant editing meetings of the THP and provide professional advice on concentrated Chinese medicine 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 Paeoniae Radix Alba, Moutan Radicis Cortex, and Cinnamomi Ramulus. (2) Edition of three new monographs of concentrated preparations [Paeoniae Radix Alba, Moutan Radicis Cortex, and Cinnamomi Ramulus]. (3) Rolling editing one concentrated preparations [Ephedrae Herba] monographs. (4) Reviewed the "Guidelines for the Formulation of Test Specifications for Concentrated Chinese Medicine Preparations in THP". 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。