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CCMP101-RD-036 臺灣與境外中藥濃縮製劑規範異同及品質分析暨我國濃縮製劑發展政策之探討

  • 資料來源:中醫藥司
  • 建檔日期:102-08-08
  • 更新時間:111-02-14

臺灣與境外中藥濃縮製劑規範異同及品質分析暨我國濃縮製劑發展政策之探討

江秀梅
中國醫藥大學
本計畫旨在探討臺灣與境外中藥濃縮製劑規範異同及品質分析暨提出我國濃縮製劑發展政策建議,計畫首先將搜集兩岸對中藥濃縮製劑之查驗登記、品質要求、符合GMP情形及進口政策等進行瞭解。接著購買臺灣及境外市售之白芍、葛根及柴胡等3種品項單方濃縮製劑各3家產品,進行品質項目、顆粒之物性測定、重金屬、農藥及微生物等之檢驗。比較其差異再召開產官學研專家會議討論,並進行臺灣與境外之中藥濃縮製劑之SWOT分析,並提出我國濃縮製劑發展之政策建議。
關鍵字:中藥濃縮製劑;白芍;葛根;柴胡

Comparison the guideline and quality of cross-strait concentrated Chinese medicinal preparations and investigation on the development strategy of mentioned preparations in Taiwan

Hsiu-Mei Chiang
China Medical University
This project aims to comparison the guideline and quality of concentrated Chinese medicinal preparations cross-strait. In addition,this project will investigate the development strategy of the preparations in Taiwan for making a suggestion on the policy development. First, the Registration, Quality Requirement, Fitting of GMP and Importing Policy of concentrated Chinese medicinal preparations cross-strait will be collected. Second, three brands of concentrated Chinese medicinal preparations of Paeonialactiflora, Puerarialobata (Willd.) ohwi and Bupleurumchinensiswill purchase from Taiwan and Mainland China, respectively, and the preparations will be subjected to the quality analysis, physical characteristicanalysis of particles, and heavy metal, pesticides and microbiological examination. Third, a symposium of experts from business, government and academy will hold for discussion the difference between Taiwan and Mainland China. After the SWOT analysis of concentrated Chinese medicinal preparations cross-strait, the suggestion on developing of concentrated Chinese medicinal preparations will be made.
關鍵字:concentrated Chinese medicinal preparations; Paeonialactiflora; Puerarialobata (Willd.) ohwi;Bupleurumchinensis