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| 題 名 | 精進中藥濃縮製劑品質規格及中藥典釋義編修研析計畫--分項計畫2:中藥製劑規格技術規範編修與諮詢=A Research and Analysis Plan to Improve the Quality Specifications of Traditional Chinese Medicine (TCM) Concentrated Preparations and the Interpretation of Taiwan Herbal Pharmacopoeia--Compilation and Consultation of Technical Specifications for TCM Preparations (Sub-project 2) |
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| 作 者 | 余建志; | 書刊名 | 中醫藥年報 |
| 卷 期 | 14 2025.12[民114.12] |
| 頁 次 | 頁(11)1-(11)56 |
| 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: 完善臺灣中藥典第五版濃縮製劑部分,以精進中藥濃縮製劑品質規範並提升中藥 產業競爭力,俾提供未來中藥典檢驗規格之制訂及業界品管規範之參考。 研究方法: 透過 4 場臺灣中藥典中藥製劑小組編修委員會議,同時邀請藥典其他工作小組編 委員出席增加橫向溝通。針對 22 個濃縮製劑個論中,「鑑別」、「雜質檢查及其他」、「含 量測定」及相關通則等內容之增刪或校對工作,或依據衛福部最新公告之製劑相關異常 物質限量標準,更新或校對藥典內容,提送 110-112 年度中藥製劑小組編修委員會議相 關決議(包含工作指南修正草案及製劑個論草案)編修建議予藥典聯席會議審議,並提供 中藥典第五版修正對照表。完成 4 項複方中藥濃縮製劑【參苓白朮散、炙甘草湯、清肺 湯及止嗽散】之乾燥減重、總灰分、酸不溶性灰分、水抽提物、稀乙醇抽提物之調查分 析。針對衛福部 112 年度「中藥濃縮複方製劑指標成分管理」計畫研究結果,研議納編 中藥典。完成 3 項複方中藥濃縮製劑【參苓白朮散、炙甘草湯及止嗽散】之中藥典個論 草案。其他中藥典編修小組會議有涉,須中藥製劑相關專業意見之提案,進行討論回覆。 參加各式藥典相關編修會議與共識營,並提供中藥製劑相關意見。 結果與討論: 本計畫已順利完成原規劃的項目,主要包括: 1. 【參苓白朮散、炙甘草湯、清肺 湯及止嗽散】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並提出個論草案;2.三項單方濃縮製劑 【陳皮、土茯苓、桂枝】與一項複方【止嗽散】之個論草案暫時擱置;3.回顧臺灣中藥 典第四版,編修了 9 個品項,亦回顧 111-112 年相關研究計畫,新增 10 個品項;4.檢討 「中藥典中藥濃縮製劑檢驗規格製訂工作指南」。相關研究成果將有助於中藥濃縮製劑 的品質管制與技術提升完善中藥典第五版濃縮製劑部分,以精進中藥濃縮製劑品質規 範並提升中藥產業競爭力,俾提供未來中藥典檢驗規格之制訂,將有助於中藥廠品質管 制與技術提升。 |
| 英文摘要 | Aim: To improve the concentrated preparation section of the fifth edition of the Taiwan Herbal Pharmacopoeia (THP), enhancing the quality standards of TCM concentrated preparations and increasing the competitiveness of the TCM industry, in order to provide a reference for the formulation of future inspection specifications in the Pharmacopoeia and industry quality control standards. Methods: Through four meetings of the Taiwan Herbal Pharmacopoeia TCM Preparation Editorial Committee, other committee members from the pharmacopoeia's working groups were invited to enhance horizontal communication. Regarding the 22 individual concentrated preparations, work on the addition, deletion, or proofreading of content related to 'identification,' 'impurity checks and others,' 'assay,' and relevant general principles was conducted. Additionally, based on the latest announcement from the Ministry of Health and Welfare regarding the limit standards for abnormal substances in preparations, updates or proofreading of the pharmacopoeia content were made. Resolutions related to the 110-112 annual meetings of the TCM Preparation Editorial Committee (including drafts for work guidelines and individual preparation articles) were submitted for review by the joint committee meeting, along with a correction comparison table for the fifth edition of the pharmacopoeia. Investigative analyses were completed for four compound TCM concentrated preparations: Shenling Baizhu San, Zhi Gan Cao Tang, Qing Fei Tang, and Zhi Sou San, focusing on loss on drying, total ash, acid- insoluble ash, water extract, and dilute ethanol extract. Based on the results of the Ministry of Health and Welfare’s 112-year “Indicator Ingredient Management of TCM Concentrated Preparations” project, it is proposed to compile the Pharmacopoeia. Drafts for individual articles in the pharmacopoeia were completed for three compound TCM concentrated preparations: Shenling Baizhu San, Zhi Gan Cao Tang, and Zhi Sou San. Other meetings of the pharmacopoeia editorial group were held to discuss proposals requiring professional opinions related to TCM preparations. Participation in various pharmacopoeia-related revision meetings and consensus workshops was undertaken, providing relevant opinions on TCM preparations. Results & Discussion: This project has successfully completed the originally planned items, which mainly include: 1. The establishment of specifications for the loss on drying, total ash, insoluble ash, water extract, dilute ethanol extract, thin-layer chromatography identification, and assay of TCM concentrated preparations, specifically for Shenling Baizhu San, Zhi Gan Cao Tang, Qing Fei Tang, and Zhi Sou San, along with the submission of individual article drafts; 2. The temporary shelving of individual article drafts for three single concentrated preparations (Chen Pi, Tu Fu Ling, Gui Zhi) and one compound preparation (Zhi Sou San); 3. A review of the fourth edition of the Taiwan Herbal Pharmacopoeia, with nine items revised and a review of the related research projects from 111-112 years, adding ten new items; 4. A review of the 'Guidelines for the Formulation of Inspection Specifications for TCM Concentrated Preparations' in the Pharmacopoeia. The relevant research results will contribute to the quality control and technical enhancement of TCM concentrated preparations, improving the quality standards in the concentrated preparation section of the fifth edition of the Pharmacopoeia and enhancing the competitiveness of the TCM industry, thereby providing assistance for the formulation of future inspection specifications in the Pharmacopoeia, which will aid in quality control and technical improvement for TCM manufacturers. |
本系統中英文摘要資訊取自各篇刊載內容。