中藥材品質管制基準制定之研究

中國醫藥大學機構典藏 China Medical University Repository, Taiwan > 藥學院 > 中國藥學研究所(已停用) > 研究計畫 > Item 310903500/12861

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题名:	中藥材品質管制基準制定之研究
作者:	張永勳(Yuan Shiun Chang);何玉鈴
贡献者:	藥學院中國藥學研究所;中國附醫藥劑部中藥局
关键词:	中藥材;乾燥減重;總灰分;酸不溶性灰分;稀醇抽提物;水抽提物;指標成分;高效液相層析法;Chinese crude drugs;loss on drying;total ash;acid-insoluable ash;diluted ethanol-soluable extractive;water-soluable extractive;Marker constituents;HPLC
日期:	2009-12-31
上传时间:	2009-09-01 16:08:10 (UTC+8)
摘要:	行政院衛生署中醫藥委員會經數年努力完成國內第一部中華中藥典，於九十三年三月九日公告，並自九十三年五月一日起實施。第一版中華中藥典收載中藥品項僅約200種，距離大陸中華人民共和國藥典及日本藥局方收載之品項仍有相當大之距離，須在再版中增補品項，因此未來新收載品項之化學規格的建立，實在為極重要之課題。本計畫針對以全民健保用藥分析選出常用方劑之組成藥物及單味濃縮藥與2005年版中華人民共和國藥典一部收載但中華中藥典中未收載之中藥材品項，扣除近 94~97年度已進行之品項，及去除台灣地區較少或未見使用之品項，98度選擇20種中藥藥材，進行乾燥減重、總灰分、酸不溶灰分、稀醇抽提物及水抽提物五項試驗之檢測，以作為未來中華中藥典改版時之參考規格。另外選擇6種藥材進行指標成分之定量分析，探討中藥材指標成分之分析方法並進行含量分析，以提供中藥及相關中藥材指標成分之分析方法與含量參考範圍。計畫執行期間將倚重藥檢局過去之經驗，邀請相關人員參與計畫之執行，並向藥檢局、中藥廠之品管人員及學術界學者代表請教，舉辦座談會，分享其經驗及討論實驗結果，提供未來中華中藥典增編時較完整可行之參考規格。 Through years of efforts, Committee of Chinese Medicine and Pharmacy completed the first version of Chinese Herbal Pharmacopeia which was announced on March 9, 2004 and had been implemented on May 1, 2004. The first version included 200 Chinese crude drugs species which were too less comparing to the numbers of items included either in the Pharmacopeia, PRC, 2000 or Japanese Pharmacopeia, 14th Edition, 1996. More items should be included in the upcoming revised version. Then chemical specification of those new items needed to be established. In view of this demands, the Committee of Chinese Medicine and Pharmacy listed the establishment of chemical specification of crude drugs as priority projects in the last few years. This project will select 20 items which chemical specification had not been established. Five tests including loss on drying, total ash, acid-insoluable ash, diluted ethanol-soluable extractive, water-soluable extractive of 20 samples of each herb will be analyzed. Additionally, six herbs will be selected and HLPC analysis of their marker constituents will also be analyzed. During the project period, we will consult staffs from Bureau of Food and Drug Analysis and QC staffs from major GMP Pharmaceutical factories to ensure the feasibility of the specification. The results will be provided as major references for revising the new edition of the Taiwanese Herbal Pharmacopeia.
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