China Medical College Taichung, Taiwan
According to World Health Organization’s statistics report, about 60％ to 80％ of world population use herbal medicine for health care. Just now, chemical drugs face some bottlenecks in the process of development. Therefore, a lot of scientists in many countries turn to study deeply in traditional medicine and hope to find some valuable leads to overcome some problems with chemical drugs.
The market of herbal medicine in USA has increased annually by over 20％ in recent years. In this context, the US FDA announced“The Draft of Guidance for industry Botanical Drug Products”on August 10th 2000. With this announcement, it is much easier to develop drugs from dietary supplements. At the same time, this step also pushes forward research and development in herbal medicine.
On May 2nd 2002.the WHO announced“WHO Traditional Medicine Strategy 2002-2005”. It includes objective, strategic components and expected outcomes. It highlights the importance of internationalization of traditional medicine. Business companies across the straits must push through the upgrading and transformation of the manufacturing processes and other related work vigorously.
Herbal medicine is a traditional treasure of Chinese medicine. It is not an easy task to promote the internationalization of traditional Chinese medicine. Herbal medicine is made from natural plants, animals or minerals. There are many factors affecting its quality such as place of origin, cultivation, harvest time, methods of processing and storage, etc. Therefore, we must rectify the weaknesses of insufficient quantitative data in basic and clinical research of herbal medicine and aim at several important tasks such as:
(1) to strengthen the education of Chinese medicine and cultivate biotechnological talents,
(2) to strengthen the quality control of Chinese herbs,
(3) to innovate and develop new extraction procedures and formulations, (4) to conduct clinical efficacy assessment of Chinese medicine,
(5) to cultivate herb-planting bases without pollution,
(6) to comprehensively set up GMP and cGMP factories,
(7) to edit the pharmacopoeia and monographs of Chinese herbs,
(8) to develop and apply microchips for therapy or diagnosis in Chinese medicine,
(9) to seek alternatives to endangered species used in Chinese medicine, (10) to develop health-promoting products,
(11) to revise the regulatory and collect marketing information,
(12) to conduct risk assessment and strategic alliance.
We must overcome all these problems to develop safe and efficacious new herbal medicine, with standardized and reproducible quality. In this way, herbal medicine can fulfill criteria of international standards, and the developed products can enter the global market to create a great profit.
中草藥未來的發展與策略
張成國
根據世界衛生組織(WHO)的統計，全球有六~八成的人口採用草藥作為某種程度的保健醫療，目前，西方醫藥在很多方面的進展已面臨瓶頸，使得各科學家均已逐漸向傳統醫藥領域，以期能從中發掘寶藏，以突破西方醫藥所面臨的問題。在鑒于中草藥產品在市場之銷受額每年成長率超過20%，所以美國食品與藥品管理局(FDA)在2000年8月10日公佈“植物性藥品準則草案(The Draft of Guidance for Industry Botanical Drug products)”，此舉使得美國市場銷售的膳食補充品更容易發展成藥品，帶動中草藥新藥的研發。
另WHO在2002~2005年傳統醫藥策略“(WHO Traditional Medicine Strategy 2002-2005)”內容包括實施目標、具體措施、期望產值，顯示了中草藥國際化將是必然的趨勢，海峽兩岸業界必須積極推動中草藥產業升級及轉型的相關工作。
中草藥是我國固有傳統，欲將我國民族醫藥發揚光大，並達到國際化之目標，實非憑空可得。由於中草藥主要來自天然的動、植、礦物，其產地、栽種、採收時間、炮製方法及貯存等是否適宜，均會影響藥材的品質，所以必須針對過去中醫藥在基礎與臨床上研究數據化之不足等問題，如
1.中草藥之教育及培育生物科技人才；
2.加強中藥品質管制；
3.製程、劑型的創新研發；
4.推動中草藥臨床療效評估；
5.中草藥綠色基地的發展；
6.全面實施GMP及推動GMP中藥廠；
7.編輯中藥典與藥品專論(Monographs)；
8.中醫藥診斷、治療芯片之開發及其應用；
9.保育類中藥材替代品之研究；
10.保健產品的開發；
11.中草醫藥相關法規的制訂與信息搜集；
12.風險評估與策略聯盟等各方面加以努力，力求突破，才能發展出安全、有效且品質達到均一性與再現性的中草藥新藥，使中草藥早日達到國際所要求的標準，而使所研發的產品能進軍市場，為業界創造商機。
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