高駿彬 新生醫護管理專科學校
為達成藥材品質均質化，療效確實化及確保用藥之安全，行政院衛生署中醫藥委員會積極建立國內藥材品質管制規格，惟為配合新藥開發、現代化檢驗方法及法規要求而需適時予以修正或增補。並期望更新速度與美國藥典、日本藥局方、英國藥典及歐洲藥典等相去不遠，因此，將藥典編修列為每年必須持續進行之工作，定期以科學化與系統性方法建立國內藥材品質管制規格，最後促進台灣中藥製劑品質之均一性。
本計畫依衛生署中醫藥委員會年度研究重點「中華中藥典相關科學應用研究」，第二年進行南板藍根等25種使用含毒性化學物質進行薄層層析鑑別之中藥材，及藥廠建議修正鑑別方法之紅耆等20種未使用毒性化學物質之中藥材，加以評估分析其方法之可行性與開發建立較安全之溶媒系統，並建立薄層層析圖譜資料，提供中華中藥典編修及中藥業界之參考。
另外，選擇大黃等5種藥材及紫菀等10種藥材進行高效液相層析方法開發與確認，探討中藥材指標成分之分析方法並進行含量分析，以提供中藥及相關中藥材指標成分之分析方法與含量參考範圍。計畫執行後將邀請相關人員參與計畫之執行，並向食品藥物管理局、中藥廠之品管人員及學術界學者代表請教，舉辦座談會，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；薄層層析；高效液相層析法
Applying research of the chemical method in Chinese Pharmacopoeia (2-2)
Chun-Pin Kao Hsin Sheng College of Medical Care and Management
In order to control the quality and effectiveness of Chinese medicine, the Committee on Chinese Medicine and Pharmacy has been actively establishing quality control specifications, and expecting to update the pharmacopeia as soon as other countries. Hence, editing Pharmacopoeia becomes an annual work that needs to be updated regularly for the establishment of the specifications by scientific and systematic methods. Finally, it will promote the uniformity of quality of traditional Chinese medicine preparations. Viewing the importance of this issue, the Committee on Chinese Medicine and Pharmacy, Department of Health, listed “The science and applied research related to the Taiwan Herbal Pharmacopeia” as a research proposal priority. This project will select 25 kinds of Chinese herbs including Baphicacanthus Rhizome and Root which involve the use of toxic chemical substances in the TLC solvent system and also select another 20 kinds of Chinese herbs including Hedysarum Root which do not involve of the use of toxic chemicals in the TLC solvent system. By evaluating the chemical identification methods, it is anticipated that new solvent systems without toxic solvents could be developed. A color TLC atlas will also be established to provide reference to the revision of Taiwan Herbal Pharmacopeia and herbal industries in Taiwan. Additionally, 5 kinds of Chinese herbs including Rhubarb and 10 kinds of Chinese herbs including Tatarian Aster Root and Rhizom will be selected to undergo HLPC analysis and their marker constituents will also be analyzed. In the end period of project, we will consult staffs from the Food and Drug Administration and QC staffs from major GMP Pharmaceutical factories to ensure the feasibility of the specifications. The results will be a major source of reference for revising the new edition of the Taiwan Herbal Pharmacopeia.
關鍵字：Chinese crude drugs, TLC, HPLC
