中藥材品質管制基準制定之研究(II)

張永勳
中國醫藥大學
臺灣市售中藥材絕大部分仰賴進口，品種繁多而複雜，藥材品質常因來源不同而有很大差異，為確保藥材品質與療效，中藥品管之制度化乃刻不容緩之事。而五官鑑別之品級與理化試驗值之間，有無平行關係等問題，亦有待釐清與規範。另外，由於目前中藥材仍欠缺法定規格，因此，傳統中醫藥之成效，常被指責為缺乏科學依據，為使中醫藥與現代西方醫藥能相輔相成，首先應將中藥材之規格包括基原、性狀及化學規格予以規範。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（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，其中所列各藥材之化學規格，大部份仰賴行政院衛生署藥物食品檢驗局過去數年在中醫藥委員會所資助之研究經費下完成。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。為此行政院衛生署中醫藥委員會特將中藥材檢驗規格之建立列為本年度之研究重點。本計畫針對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，扣除近上年度已進行之品項，及去除台灣地區較少或未見使用之品項，選擇45種藥材，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，另外並選擇三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，以提供中藥集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，並向藥檢局及中藥廠之品管相關人員請教，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。
關鍵字：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

Study on the Standards Establishment for Quality Control on Chinese Crude Drugs (II)

Yuan-Shiun Chang
China Medical University
Most of the crude drugs sold in Taiwan markets were imported from Mainland China, the quality of the drugs may vary due to various factors. In order to assure the quality of the crude drugs, a guide line for the quality control of the crude drugs is essential which includes their origin, morphological characteristics and chemical specifications. 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. The chemical specification of those items were based on the data from three projects carried out by Bureau of Food and Drug Analysis, Department of Health, sponsored by Committee of Chinese Medicine and Pharmacy. However the items included 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 current year.
關鍵字：Chinese crude drugs；loss on drying；total ash；acid-insoluable ash；diluted ethanol-soluable extractive；water-soluable extractive；Marker constituents；HPLC