Facing the quandary of the modern medicine, medications from natural resources have been paid more and more attention worldwide once again. According to the development trends of the global healthcare requirement, nations from all over the world have been continuously relaxed the restraints on TCM. As the modernization of TCM promotes, the position of it has been enhanced globally, and it also has broad development prospects. However, since the medication mechanism of TCM is different from that of the Western Medicine, the major obstacle of TCM's internationalization is that it cannot meet the internationally well-acknowledged drug testing standard, therefore preventing it from entering the international market in the form of therapeutic drugs. Thus, evaluating and standardizing the quality of TCM has become the key issue. This dissertation studies the development situation of plant medicine/TCM in the international market, thus determines the problems as well as opportunities of development of plant medicine/TCM in the international market. Meanwhile, this dissertation analyses the different requirements on plant medicine/TCM in the pharmacopoeias and/or drug standards from different countries/regions, and chooses three countries China, Japan, and Korea, which have similar culture background, to carry out a comparative analysis on their TCM quality standard. Seven crude drug which have the same original plant are chosen as examples from the pharmacopoeias of these three countries, standard testing methods and limitation value of these seven crude drugs are compared. Combined with the key technologies of existing international commercial quality standard for TCM, this dissertation studies the frame of the key technologies for international commercial quality standard,and designs and establishes the preliminary draft international commercial quality standard for two commonly used TCM, Panax notoginseng and Salvia, and practically optimizes the preparation and analytical technologies in quality control for these two ТСМ. This dissertation independently and thoroughly analyzes the present situation and characteristics of Macau's TCM industry, as well as the significance of establishing TCM quality evaluation standard in promoting the leaping development of Macau's TCM industry, its industrial economic restructuring, and the development of medical technology industry in Macau. Based on research, this dissertation reveals the great marketing potential of plant medicine/TCM in the international market, as well as the existing obstacles in the aspect of TCM quality control. It finds out the alterations of plant medicine/TCM quality control regulations, which is beneficial to the development of TCM, among state (regional) pharmacopoeias or drug standards in the world. This dissertation puts forward the framework of key techniques in international commercial quality standards for TCM, while designs and establishes the preliminary draft international commercial quality standard for TCM. Also, it gives suggestions on the formulation of TCM quality standard in Macau. Keywords: TCM quality, quality control, commercial standard, Macau iv

摘要 面對現代醫藥的一些窘境,天然藥物在全世界被重新重視。從全球健康需求 的發展趨勢來看,目前,世界各國正不斷放寬對中醫藥的限制。隨著中醫藥現代 化的推進,中醫藥在國際上的地位不斷提高,有著廣闊的發展前景。但由於中藥 與西藥的用藥機理不同,其國際化的主要障礙之一則是無法滿足國際上公認的藥 品檢測標準,以至於無法以治療藥物的形式進入國際市場。因此評價和規範中藥 質量是中藥進入國際市場的關鍵問題。 本論文研究了植物藥/中藥在國際市場中的發展現狀,從而分析出了植物藥/ 中藥在國際市場中發展存在的问题與机遇同時分析了國際市場中各國家(地區) 藥典或藥品標準對植物藥/中藥的不同要求,其中選擇有著相似文化背景的三個 亞洲國家中國、日本和韓國,分別對其中藥質量標準要求進行了一定的對比分 析,並選擇了七種這三個國家的藥典收載的基源植物相同的生藥材作為具體案 例,對其標準檢測方法和限度值進行了比較。 本論文結合已有中藥國際商用質量標準的關鍵技術,研究了中藥國際商用質 量標準的關鍵技術框架,并具體完成了兩種常用中藥(三七和丹參)國際商用質 量標準草案的設計與建立,從實際對這兩種中藥在質量控制中的製備技術與分析 技術進行了優化。 本論文獨立且詳細地分析了澳門中藥產業的現狀及特點,以及建立中藥質量 評價規範對促進澳門中藥產業跨越式發展,推動澳門產業經濟結構調整,發展澳 門醫藥科技產業的意義。 通過本論文的研究,發現了植物藥/中藥在國際市場的發展市場潛力巨大, 但是在對中藥質量控制方面尚存在諸多障礙;發現了各國家(地區)藥典或藥品 標準对植物藥/中藥質量要求法規中有利於中藥發展的變化;提出了中藥國際商 用質量標準關鍵技術的框架及設計與建立中藥國際商用質量標準關鍵技術的草 案;提出澳門中藥質量標準的制訂建議。 關鍵字:中藥質量、質量控制、商用規範、澳門