中華中藥典第二版之編修研究（3-2）

張永勳
中國醫藥大學中國藥學暨中藥資源學系
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，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。
本計畫將在過去之研究基礎上新增台灣傳統藥典之品項，先確認原有200種品項及弘光科技大學何玉鈴助理教授原增修之50種，每年新增台灣全民健保濃縮中藥使用品項但台灣傳統藥典中未收載之常用中藥，第一年增加50種，第二、三年各增加25種，三年共100種，作為中華中藥典編修之參考，定期召開藥典委員會議，檢討已出版藥典品項中不恰當之規格要求，以達實用之目的。除此之外也將參考目前日本藥局方與中華人民共和國藥典在中藥相關重金屬及農藥雜質限量，與食品藥物管理局人員、學者專家及藥廠品管人員進行討論，並在第二版中華中藥典增加重金屬及農藥殘留之限量標準，以提升中藥用藥安全。
本計畫於第一年期末將印製200本中華中藥典第二版300種中藥品項初稿，供中醫藥委員會出版公告之參考。第二、三年續增編之內容將供未來中華中藥典改版時之參考。
第二年起，每年比照香港中藥材標準化計畫之精神，進行5種中藥材之研究，並在過去累積之化學規格資料，編修25種藥典新增品項。每年定期召開四次藥典編修會議，檢討藥典相關議題，提出討論，對已公告藥典內容不妥之處，加以檢討修正，使中華中藥典能符合國內中藥界之需求，提升國內中藥及中藥製劑之品質。
關鍵字：中華中藥典、全民健保、化學規格、重金屬、農藥殘留

Investigation on the second version of Taiwan Herbal Pharmacopeia (3-2)

Yuan-Shiun Chang
School of Chinese Pharmaceutical Sciences and Chinese Medicine Resources China Medical University
The first version of Taiwanese Herbal Pharmacopeia was announced on March 9, 2004 and implanted since May 1, 2004. The first version recorded 200 items of crude drugs. Comparing to PRC pharmacopeia and Japanese pharmacopeia, there are many items needed to be added in the upcoming revised version.
Based on previous project results, this project will draft new pharmacopeia items. The content of the 200 items in the first version and 50 items compiled by Dr. Yu-Ling Ho will be reviewed. Fifty new items will be drafted for the first year and 25 items will be drafted in the second and third year. A total of 100 new items will be added in a three year period. The contents will be reviewed and discussed by the review board meeting. Unsuitable specification will be revised to meet the need. The limit of heavy metal content and pesticide residue of the herbs in JP and PRC pharmacopeia will be compared and discussed with staffs from TFDA, herbal industry and academic experts. Those limits will be listed in the second version of Taiwanese herbal pharmacopeia to ensure the safety of TCM herbs.
By the end of first year, 200 copies of the draft of the second version of Taiwanese herbal pharmacopeia will be printed and submitted to CCMP for public announcement. The contents added in the second and third year will also be submitted to CCMP for future reference.
From the second year, we will carry out five TCM herb studies each year followed Hong Kong Chinese Materia Medica Standard methods. We will draft 25 new pharmacopeia items based on previous project results. Four regular pharmacopeia committee meeting will be held to review issues on Taiwanese herbal pharmacopeia. Improper contents will be revised so as to make the Taiwanese herbal pharmacopeia suitable for Taiwanese herbal communities and elevate the quality stand of TCM herbs and herbal preparations in Taiwan.
關鍵字：Taiwanese Herbal Pharmacopeia, National health insurance, Chemical specification, Heavy metal, Pesticides residue