建立中藥材品質管制之規格研究

董明兆
國立中國醫藥研究所

中藥材來源分歧，品質不易控制，極需針對常用中藥材進行國內相關藥材品質管制規格之監測，以了解相關檢驗之差異性，並提供中藥較完整可行之參考資料，成為中藥典建立之依據。有鑑於此，如何發展有效快速之鑑定進而管控中藥材，為當前刻不容緩的重要課題。本計畫將針對50種中藥材進行系統性的分析，包括名稱、性狀、感觀鑑別、顯微鑑別、色譜及光譜鑑別；雜質、灰分、水分之檢查；同時對其中10種中藥材開發HPLC指紋圖譜分析方法，並將其有效成分或指標成分進行結構鑑定與含量測定，以期提供完整之藥材鑑別資料，做為未來建立台灣傳統藥典之依據。
關鍵字：中藥材、品質管制、中華中藥典、指紋圖譜
建立中藥材品質管制之規格研究

董明兆
國立中國醫藥研究所

中藥材來源分歧，品質不易控制，極需針對常用中藥材進行國內相關藥材品質管制規格之監測，以了解相關檢驗之差異性，並提供中藥較完整可行之參考資料，成為中藥典建立之依據。有鑑於此，如何發展有效快速之鑑定進而管控中藥材，為當前刻不容緩的重要課題。本計畫將針對50種中藥材進行系統性的分析，包括名稱、性狀、感觀鑑別、顯微鑑別、色譜及光譜鑑別；雜質、灰分、水分之檢查；同時對其中10種中藥材開發HPLC指紋圖譜分析方法，並將其有效成分或指標成分進行結構鑑定與含量測定，以期提供完整之藥材鑑別資料，做為未來建立台灣傳統藥典之依據。
關鍵字：中藥材、品質管制、中華中藥典、指紋圖譜

Establishment of quality control methods for traditional Chinese medicines

Ming-Jaw Don
National Research Institute of Chinese Medicine
In Taiwan, most of traditional Chinese medicine (TCM) comes from mainland China and the source materials are usually obtained from the different location. So, it is necessary to establish methods for ascertain the quality of TCM and understand the difference between them. In 1994, a guideline for TCM was published by Department of Health, Executive Yuan, in which only 200 TCM items were collected. In order to continue and increase the items of TCM materials, in this proposal, we will follow the previous guideline and plan to establish the quality control methods for additional 50 TCM items. The collected TCM materials will be done by the following works including name, description, organoleptic tests, microscopic identification, foreign matter tests, ash tests, and determination of water. We will also establish the HPLC fingerprints of selected 10 TCM items and identify the active ingredients or markers. The above results will be provided as references for setting up the future guideline of TCM.
關鍵字：traditional Chinese medicine; quality control; The Pharmacopoeia of the Republic of China; finger print