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| 題 名 | 臺灣中藥典第四版英譯編修及工作坊=Translation, Compilation and Workshop of the 4th Taiwan Herbal Pharmacopeia |
|---|---|
| 作 者 | 張永勳; | 書刊名 | 中醫藥年報 |
| 卷 期 | 12 2023.10[民112.10] |
| 頁 次 | 頁(12)1-(12)53 |
| 分類號 | 414 |
| 關鍵詞 | 臺灣中藥典第四版; 英譯; 臺灣中藥典第四版英文版; 國際趨勢; 品質規格工作坊; The 4th Taiwan Herbal Pharmacopeia; English translation; English version of the 4th Taiwan Herbal Pharmacopeia; International trend; Workshops on quality control; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 研究目的: 臺灣中藥典第四版已於 110 年 9 月公告出版,內容收載 394 種品項,含 中藥 355 個品項、中藥飲片 30 個品項及 9 個中藥製劑品項,檢驗規格也大 幅修改,為促進臺灣中藥典國際化,強化臺灣中藥典國際影響力,提供國際 專家學者及國內中藥製藥業者外銷藥品參考,進行臺灣中藥典第四版英譯 版編修。為利國內中藥產業界遵循,加強產業對臺灣中藥典第四版品質規格 訓練,辦理兩場臺灣中藥典第四版中藥品質規格工作坊,使中藥典更符合產 業需求,提升製藥產品品質及促進產業發展。同時培訓中藥典編輯人才,參 加歐洲藥典中醫藥工作小組會議,持續吸取先進國家檢驗分析技術新知與 藥典編修近況,提供臺灣中藥典編修政策參考。 研究方法: 本計畫組成臺灣中藥典第四版英譯版編輯工作專家小組,並召開 1 次 第四版臺灣中藥典英文編修會議,結案時提供網路電子版外也將印製臺灣 中藥典第四版英譯版紙本 500 本,安排我國專家學者參與國外藥典相關會 議,吸取先進國家檢驗分析技術新知與藥典編修近況,採視訊方式辦理 2 場 臺灣中藥典第四版品質規格工作坊,參加人員以中藥製藥廠及相關檢驗公 司為主。 結果: 本計畫已於 4 月 20 日召開一次臺灣中藥典第四版英文版編輯工作視訊 會議確保英譯內容之正確性,符合國際化常用之中藥用語。並於 111 年 12 月出版臺灣中藥典第四版英文版,並協助寄送至衛生福利部指定單位及編 修委員。主持人也於 1 月、5 月及 10 月參加 3 次 EDQM 中藥工作小組視訊 會議,參與歐洲藥典中藥品項規格之討論。已於 6 月 21 日及 8 月 23 日視 訊辦理 2 場臺灣中藥典第四版品質規格工作坊,內容包含臺灣中藥典第四 版增修說明、中藥基原修訂、檢驗規格分析方法、中藥製劑規格訂定及中醫 臨床編修等,工作坊提供參加者終身學習及持續教育學分認證,並全程錄影。 第一場共有 125 人出席,第二場共有 140 人出席,參加人員以中藥製藥廠 及藥師人數為最多。 討論: 臺灣中藥典第四版英譯版,翻譯新增之部分並根據第四版中文版修正 的部分同樣進行修正,並召開臺灣中藥典第四版英譯版編輯工作專家小組, 確保英譯內容之正確性,符合國際化常用之中藥用語為促進臺灣中醫藥國 際化並與世界各國接軌,並舉辦線上臺灣中藥典第四版品質規格工作坊,以 提升藥廠中藥品管檢驗能力、分析方法確效與品保觀念,落實臺灣中藥典第四版之實施。 |
| 英文摘要 | Aim: The 4th edition of Taiwan Herbal Pharmacopeia (THP) was promulgated and published in September, 2021 with 394 items including 355 herb items, 30 decoction pieces and 9 concentrated TCM preparations. The detection specifications were also greatly elevated and revised. In order to promote the internationalization of THP, strengthen the international impact of THP, provide references for international experts and facilitate the export of herbal pharmaceutical companies, this project translated and compiled the English version of the 4th edition of THP. To facilitate the herbal pharmaceutical companies to cope with the new THP specifications and strengthen the training of the quality specification of the 4th THP, this project held two training workshops on the quality specification of the 4th THP for the herbal industry to make the THP to meet the need of the industry to elevate the quality of the herbal products and promote the development of the herbal industry. In order to train the experts on herbal pharmacopeia, this project will also assign expert to attend the international pharmacopeia meetings to learn the new analytical technology and the current trend of the international herbal pharmacopeia and provide reference for policies of the compilation of THP. Method: This project organized an expert committee for editing the English version of the 4 th edition of the THP, and held a editorial committee meeting on the English version of the 4 th edition of THP. As the project ended, besides providing the online electronic version of the 4 th edition of the THP, 500 hard copies will also be printed. We also arranged experts and scholars to participate in foreign pharmacopoeia related conferences, learned the latest state of inspection and analysis technology in advanced countries and the current status of herbal pharmacopoeia editing. Two workshops on the quality specification of the 4 th edition of the THP via virtual mode were held. The participants are mainly from TCM pharmaceutical factories and related inspection companies. Results: This project had held a video conference on the editing work of the English version of the 4 th edition of the THP on April 20, 2022 to ensure that the English translation is correct and in line with the international commonly used terms. In December, 2022, the hard copies of the English version of the 4 th edition of the THP was published. We also help to send the hard copies to related institutes and the editorial committee members the Ministry of Health and Welfare designated. The PI also participated in three EDQM TCM Working Party virtual meetings in January, May, and October, 2022 and joined discussions on the specifications of TCM monographs in the European Pharmacopoeia. On June 21st and August 23rd, 2022, two workshops on the quality specification of the 4 th edition of the THP were held via virtual mode, the titles covered included the supplementary explanation of the 4 th edition of the THP, the revision of the plants origins of the herbs, the analytical methods of test specifications, and the specification of TCM preparations preparation of traditional Chinese medicine and related clinical issues. The workshops provided participants with lifelong learning and continuing education credits certification, and the whole process were videotaped. A total of 125 participants attended the first session, and 140 participants attended the second session. Most of the participants were from TCM pharmaceutical factories and pharmacists communities. Discussion: For the English translation work of the 4 th edition of the THP, both newly added parts and the revised parts of the Chinese version of the 4 th edition were translated. An expert committee meeting for editing the English version of the 4 th edition of the THP was held, to ensure the accuracy and the correct terms used. In order to promote the internationalization of Taiwanese traditional Chinese medicine and bring it in line with other countries in the world, online workshops on the quality specification of the 4 th edition of the THP were held to improve the inspection capabilities of pharmaceutical companies and the accuracy of analysis methods. The concept of efficacy and quality assurance were assured and facilitate the implementation of the 4 th edition of the THP. |
本系統中英文摘要資訊取自各篇刊載內容。