澳門大學碩士畢業論文 ABSTRACT With the notional change on health in world, the application of traditional medicine is more and more extensive, the international market of plant medicine extends gradually, the Traditional Chinese medicine is extensively accepted in the international market, and becomes the potential trade, but its development and internationalization worm for the low quantity level. With the standard of the internationalization more and more considered, according the Traditional Chinese medicine internationalizing and the technique reforming, the study has established the complete quantity control system which has Chinese medicine special features and the internationalizing potential and the international commercial standard which is accepted in the world, and will offer the reference and example which research the species of the international market, and offer the base of theory and practice which establish the international identity system of Traditional Chinese medicine quantity standard. The study research the actuality of international plant medicine registering and quantity controlling, and summarize three modes about controlling the plant medicine quality, namely which the chemistry composition of the plant medicine is controlled in Europe and America, and the standard soup dose is controlled in Japan, and according the traditional production and quality controlling, including in Southeast Asia, Hong Kong, Macau, Korea, etc. And the study has analyzed homology or dissimilarity between the Japanese mode and the Euro-American mode, inquiry into the development trend of the plant medicine quality control. The author thinks that the trend of the international plant medicine quality control emphasizes that the relativity between the chemistry composition and the security and validity. The relativity is very good, so we can control the stability quantity of product with the consistency composition, and control the product quantity from the line of the single composition to the nonlinear of the many composition, more and more strictly control the poisonous and harmful material 1 and the whole production line. The author put forward that we should establish the guidance idea of the traditional Chinese medicine quantity standard, and thinks that the international commercial standard of the traditional Chinese medicine should comply with Chinese medicine theories, according to modern life technology, well considering international feasibility, emphasizing the overall quantity control, standing out the exclusive and diathesis of standard, well considering the factors that affect the traditional Chinese medicine quantity, and making use of the parameter control. The author suggests that the commercial standard should combine management principle and support with the technique, the guideline consider the traditional Chinese medicine special features and international need. the author has put forward to include the traditional Chinese medicine material, poisonous Chinese medicine, contrast, Chinese medicine compound prescribe product, safety evaluation etc. a few and part of quantities control system. The study leads into the international advanced management principle, puts forward that establishing the commercial standard of Traditional Chinese medicine should regard customer's benefit and outstanding quantity, and insist always systematical thought. The author have overstepped to the low-grade quantity target and the pure technique standard before. The author still inquiries into linking up between the commercial standard of Traditional Chinese medicine and the quantity standard of authorities. The author thinks the commercial standard of Traditional Chinese medicine not only notice to link up with native medicine standard, but also notice to link up with international medicine standard. One of the standard purposes of establishing the commercial standard of Traditional Chinese medicine offer the quantity standard consults to enter the international market, the product quantity is completely enhanced. But the product quantity reforming and promoting make effect on the profits of the business enterprise in many ways, so directly determine the business enterprise whether can extend the earnings. The study inquiries into the exaltation quantity to the importance of the business enterprise, according to relation between the quantity economic, cost and customer approval, relation between quantity standard and business enterprise competition ability, market prestige and sale means. The internationalization of the Traditional Chinese medicine is not to accomplish in the short time, and demand the proceeding of the step. The study yet inquiries Traditional Chinese medicine which can first proceeding internationalizing standard research, which primarily is medicine material,new medicine which have the clear and definite curative effect to the difficulty disease, and old species for confirming the safety in clinical application in the long time. According to the relativity ofthe intelligent property right, the study thinks technique patent -the patent standardizing- standard admitting that is a viable road and will effectively protect Traditional Chinese medicine. Key words: Traditional Chinese medicine International Commercial Quality standard

澳門大學碩士畢業論文 中文摘要 隨著全球健康觀念的轉變,各種傳統醫藥的應用越來越廣泛,國際植物藥市場逐 漸擴大,中藥在國際市場的接受度明顯提高,成為極具市場潛力的行業,但是其發展 和國際化進程卻因為品質水準低下而受到嚴重牽制。 國際化的標準越來越受到關注,本課題從中藥國際化的目的出發,以技術革新為 保障,建立既體現中醫藥特色,又具國際化潛力的中藥全面品質控制體系,用於建立 國際市場認同的中藥國際商用標準,為擬進入國際市場的品種研究提供參考和範例, 並為建立國際化的中藥品質標準認證體系提供理論和實踐基礎。 本課題研究了國際植物藥註冊和品質控制現狀,總結出植物藥品質控制的三種主 要模式,即以歐美發達國家的植物藥為首的化學成分控制模式、日本漢方製劑的標準 湯劑控制模式,以及按傳統方式生產及質控的模式,包括香港、澳門、韓國等東南亞 國家和地區。並分析了以歐美為首的化學成分控制模式和日本為首的標準湯劑控制模 式的相同點和不同點,探討了植物藥品質控制的發展趨勢,認為國際植物藥品質控制 的趨勢在於強調化學指標與安全性和有效性之間的相關性,因為只要化學指標與安全 性和有效性之間的相關性良好,則可以通過控制化學指標的一致性來控制成品品質的 穩定性;對產品品質的控制從單成分的線性控制向多成分的非線性控制轉變;對有毒 有害物質的控制越來越嚴格,以及整個生產過程線上控制的逐漸細化。 課題提出了建立中藥國際商用品質標準的指導思想,認為中藥國際商用標準的建 立應以中醫藥理論為指導,以現代生命科技為手段,充分考慮國際化的可行性,注重 整體的品質控制,要體現標準的專屬性和特異性,並儘量細化影響中藥品質的因素, 實現參數化控制。 課題建議商用標準要結合管理理念和技術支援,在指標的選擇上要兼顧中醫藥特 色和國際化需求,提出了包括中藥材、有毒中藥、對照品、中藥複方製劑、安全性評 價等幾個部分的品質控制指標體系。 課題引入了國際先進的管理理念,提出中藥商用標準的建立應以客戶為導向,以 卓越品質為目標,並始終堅持系統化的思維。超越了以往的准入性的品質目標和純技 術性的標準建立思路。 課題還探討了中藥國際商用品質標準與官方標準的銜接問題。認為中藥國際商用品質標準不僅要注意與國內藥品標準的銜接,也要注意與國際醫藥法規和藥品標準的 銜接。 建立中藥國際商用標準的目的之一,是為一些企業建立可以進入國際市場的品質 標準提供參考,其實質是產品品質的根本提高。而產品品質的改造和提升對於企業的 利潤有多方面的影響,從而決定了企業是否能擴大盈利。課題從品質經濟性與成本、 顧客滿意度的關係,品質標準與企業競爭力、市場信譽度及銷售手段的關係,探討了 提高品質對企業的重要性。 中藥的國際化不是一蹴而就的,需要有步驟的進行。課題探討了可以首先進行國 際化標準研究的中藥,主要是藥材、對於疑難病症有明確療效的新藥以及療效和安全 性已經為長期臨床應用所證實的中成藥老品種。 在與知識產權的相關性上,本課題認為技術專利化-專利標準化一標準許可化是 一條可行的道路,有助於實現對中藥的有效保護。 關鍵字: 中藥 國際 商用品質標準