張永勳 中國醫藥大學
國內第一部中華中藥典（已改名台灣傳統藥典），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200種，經中醫藥委員會多方努力，中華中藥典第二版將於2012年底公告，收載品項增至300種，檢驗規格也大幅修改，距離大陸中華人民共和國藥典及其他國家藥典收載之品項仍有相當大之距離，為迎合未來新檢驗技術之開發，須在未來再版中繼續增補品項及品管規格。 本計畫將在過去之研究基礎上每年新增台灣全民健保濃縮中藥使用品項但中華中藥典第二版300種中藥品項中未收載之常用中藥，每年增加10種，三年共30種，每種藥材由全省各地收集10批，經鑑定後進行藥材之藥典品質規格研究，包含藥材性狀、顯微鑑別、化學規格、TLC鑑定及HPLC定量分析等，並兩次邀請產官學研界對藥材品項逐項討論，研擬各品項之檢驗內容，以達實用之目的，作為中華中藥典未來增修之參考。 本計畫三年執行之中藥材化學規格研究內容將供未來中華中藥典改版時之參考。透過每年定期以科學化及系統性方法建立國內藥材品質管制規格，促進台灣中藥製劑品質之均一性。
關鍵詞：中藥典、中藥材、顯微鑑別、化學規格、薄層層析鑑定、高效液相層析鑑定
Scientific standard study on quality control of TCM in Chinese Herbal Pharmacopeia (3-1)
Yuan-Shiun Chan Institute of Chinese Pharmaceutical Sciences, China Medical University
The first version of Chinese Herbal Pharmacopeia was announced on March 9, 2004 and implanted since May 1, 2004. The first version recorded 200 items of crude drugs. Through the efforts of CCMP, Department of Health, The second edition of Chinese herbal Pharmacopeia will be announced by the end of 2012 with 300 items of Chinese crude drugs and new specifications. Comparing to PRC pharmacopeia and other pharmacopeias, there are many items needed to be added in the upcoming revised version. New detection methods and new items needed to be developed for the future revision. Based on previous project results, this three year project will develop quality specification for 10 new Chinese crude drugs each year that are used in Taiwan National Health Insurance but not listed in the 300 version. A total of 30 species will be studies. Ten batches specimen of each species will be collected around the islands. After identification, morphological identification, microscopic identification, chemical specification, TLC identification and HPLC assay will be carried out for each species. Two panel discussion with representative from TFDA, CCMP, GMP pharmaceutical companies will be held to discuss the methods developed to ensure the practical application of these methods and provide reference for the future revision of Chinese herbal pharmacopeia. Through the three year project, the quality control specification of 30 Chinese crude drugs will be developed. Through the scientific and systematic studies of the quality specification of the crude drugs studies, it will provide a good background for the homogeneity of the herbal preparations and elevate the quality standard of TCM herbs and herbal preparations in Taiwan.
