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| 題 名 | 建立中藥濃縮製劑藥典品質規範=Establishment of Pharmacopoeia Quality Specification for the Chinese Medicine Concentracted Preparations |
|---|---|
| 作 者 | 吳育澤; | 書刊名 | 中醫藥年報 |
| 卷 期 | 12 2023.10[民112.10] |
| 頁 次 | 頁(8)1-(8)268 |
| 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 Pharmacopoeia; THP; Pharmacopeia specifications; Chinese medicine concentrated preparation; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 研究目的: 臺灣中藥典預計於 110 年出版第四版,新增 7 項中藥濃縮製劑品項個論 內容,提升中藥濃縮製劑品質管制標準。本計畫經由 4 次藥典製劑小組專家 會議,共同研議編修甘草、大黃、延胡索、葛根、小青龍湯、半夏瀉心湯及 葛根湯中藥濃縮製劑品項個論內容。計畫中亦研議制定了逍遙散和四物湯的 雜質檢查,含量測定和鑑別方法的規範,以及進行中藥檢驗新技術開發之可 行性。 研究方法: 本年度共舉行了 4 次製劑小組專家會議,討論實驗結果,參考不同國家 的藥典及學術文獻,並徵詢專家意見,研議甘草、大黃、延胡索、葛根、小 青龍湯、半夏瀉心湯及葛根湯等中藥濃縮製劑個論內容。此外,本計畫進行 半夏瀉心湯的實驗數據蒐集,以完成該品項的檢驗規格制定;並執行逍遙散 及四物湯的薄層層析(thin layer chromatography, TLC)方法開發以及當歸指標 成分一測多評的檢驗方法開發與可行性評估。 結果: 完成編修 7 項甘草、大黃、延胡索、葛根、小青龍湯、半夏瀉心湯及葛 根湯中藥濃縮製劑個論內容,滾動編修加味逍遙散與黃芩濃縮製劑個論。完 成訂定逍遙散與四物湯的乾燥減重、總灰分、酸不溶性灰分、水抽提物、稀 乙醇抽提物規範及逍遙散與四物湯之部分組成中藥材 TLC 鑑別方法分析開發。本計畫也完成丸劑通則草案編修及開發當歸指標成分一測多評方法,經 專家會議討論後確認評估此方法對於中藥品質管制的可行性,但欲使此方法 用於品質鑑定需更進一步的深入研究。 結論: 本計畫的研究目的與 11 項工作內容皆已完成,此次計畫中滾動編修 2 項 濃縮製劑【加味逍遙散及黃芩】個論內容,增修 7 項濃縮製劑【甘草、大黃、 延胡索、葛根、小青龍湯、半夏瀉心湯及葛根湯】個論,衛生福利部已於 109 年 11 月 4 日針對臺灣中藥典第四版 9 項中藥濃縮製劑個論草案公開徵求意 見。此外本計畫中研議了逍遙散與四物湯的數項檢驗規範。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: The Taiwan Herbal Pharmacopoeia (THP) is expected to be published in the fourth edition in 110 years of the Republic of China. There are seven items of Chinese medicine concentrated preparations will be added into revised THP, that will enhanced the quality of Chinese medicine concentrated preparations in Taiwan. The aims of this project were to discuss and draft the regulatory specifications of Chinese medicine preparations of Gan Cao (GC), Da Huang (DH), Yan Hu Suo (YHS), Ge Gen (GG), Xiao Qing Long Tang (XQLT), Ban Xia Xie Xin Tang (BXXXT) and Ge Gan Tang (GGT) and the general rules and technical guidelines of Chinese medicine preparations in THP via holding four expert meetings of. In addition, this project also discusses and comfirms the regulatory specifications of the impurity inspection, content determination, and identification method for XiaoYao San (XYS) and Si-Wu Tang (SWT). The feasibility of a new methodology for the quality control of Chinese medicine preparations was also evaluated. Method: Four expert panel meetings were conducted to discuss experimental results and refer to academic literature pharmacopeias of different countries and expert opinions to draft the regulatory specifications, including GC, DH, YHS, GG, XQLT, BXXXT, GGT, as well as the general rules and technical guideline of specifications for Chinese medicine preparations through meetings of the Chinese medicine preparation group. In addition, we conducted the experimental data collection of BXXXT to complete the drafting of the regulatory specification of this item. We conducted method development of the thin layer chromatography (TLC) for XYS and SWT; the method development of and feasibility evaluations for the quantitative analysis of multi-components by single-marker (QAMS) for Chinese Angelica Root preparations. Results: The regulatory specifications and monographs, including GC, DH, YHS, GG, XQLT, BXXXT, GGT were drafted. In addition, the monographs of Jaiwan Xiaoyao San (JWXYS) Concentrated Praparation and Scutellaria Root (SR) Concentrated Praparation were reviewed and edited. The specifications of assay, loss on drying, water-soluble extractive, diluted ethanol-soluble extractive, total ash, acid insoluble ash of XYS and SWT were discussed and confirmed. The TLC identification methods for XYS and SWT were discussed, modified, and confirmed. The general rule of pills has been discussed and drafted. Finally, the results of QAMS for Chinese Angelica Root preparations were discussed to evaluate its feasibility for quality control purposes, which still needs more studies to make this method practicals. Conclusion: The regulatory specifications and monographs, including GC, DH, YHS, GG, XQLT, BXXXT, GGT were drafted. In addition, the monographs of Jaiwan Xiaoyao San (JWXYS) Concentrated Praparation and Scutellaria Root (SR) Concentrated Praparation were reviewed and edited. The specifications of assay, loss on drying, water-soluble extractive, diluted ethanol-soluble extractive, total ash, acid insoluble ash of XYS and SWT were discussed and confirmed. The TLC identification methods for XYS and SWT were discussed, modified, and confirmed. The general rule of pills has been discussed and drafted. Finally, the results of QAMS for Chinese Angelica Root preparations were discussed to evaluate its feasibility for quality control purposes, which still needs more studies to make this method practicals. |
本系統中英文摘要資訊取自各篇刊載內容。