中草藥研發技術平台的效益實證

Abstract

中草藥近年來逐漸在歐美各國流行，2005年全球中草藥銷售額已超過二百億美元。中國、日本、韓國、德國及美國分別是亞洲、歐洲及美洲三個地區發展中草藥的代表，全球中草藥也以這三個地區為主。台灣近年來也積極投入，希望能在中草藥領域創造國家優勢。行政院通過『加強生物技術產業推動方案』、成立了『生物技術與製藥工業發展推動小組』，著重於生物技術集中草藥的開發，期望將台灣發展成具特色之生技醫藥產業發展中心 中草藥國際化發展面臨最大的問題，就是品質的掌握及嚴謹的臨床實驗。中草藥臨床研究較之西方醫藥臨床研究其複雜度與技術門檻均高出許多。中草藥之原料取材自天然植物，無論是原料自體變異性、基源、藥理活性、活性成分都僅依賴經驗傳承的漢方古籍提供不完整的線索，也缺乏嚴謹的科學驗證。 本研究從中草藥臨床前研究探討中草藥國際化的問題。可以發現中草藥在臨床前的安全驗證與品質一致性是攸關中草藥未來發展的關鍵因素。以知識合作的角度探討，可以發現獨立研究中心的垂直型研究可以發揮專業化的效率但卻無法創造合作的效益。必須建立效率化的專業臨床服務又能兼顧知識合作的效益，才能符合中草藥臨床前基礎研究的未來需求。 本研究利用” 中草藥抗病毒機制高通量篩選平台”的個案調查，從基礎研究的角度分析配合產業價值鏈的定位。本研究發現在中、西醫邏輯架構迴異的情況下，硬性將中醫藥學納入西醫學的框架中，可能會造成中草藥的價值喪失。基礎研究過程的知識庫與知識平台的管理能力。透過標準程序的臨床前檢驗，累積中草藥相關的驗證數據，才能構建出對中草藥有實質效益的知識管理平台。而研究平台在產業價值鏈的定位與貢獻，會因為學界與產業界的認知缺口造成現有研究成果無法對產業價值鏈產生效益。因此，除了技術上的合作或移轉外，知識合作成為另一項必須關注的重點。開放性的研究平台與技術加上知識的整體合作，才能使中草藥基礎研究發揮實質效益，順利的與產業價值鏈接軌，提高中草藥國際化發展的可行性。

In recent years, botanical drugs have become more and more popular in western countries. Global sales for botanical drugs exceeded 20 billion US dollars in 2005. China, Japan, South Korea, Germany, and the United States are the primary countries for the development of botanical drugs in Asia, Europe, and America, which are the leading areas for botanical drugs worldwide. Taiwan has also invested in the research and development of botanical drugs in recent years in order to create a competitive edge for the country in the field of botanical drugs. The Executive Yuan approved the Promotion Plan for the Biotechnology Industry and founded the Biotechnology and Pharmaceutical Industries Program Office to transform Taiwan into a primary development center for the biotechnology and pharmaceutical industries. The most challenging issues for globalization of the development of botanical drugs lie in the areas of quality control and stringent clinical trials. The complexity and technical barriers for clinical trials of botanical drugs are much higher than for those of western medicine. The raw materials for botanical drugs come from natural plants. Therefore, the autonomic diversities, sources, pharmacological activities, and active components of the raw materials depend on the sharing and learning of experiences from ancient Chinese medical texts, to help deal with incomplete information that lacks stringent scientific validation. This study investigated critical issues for the globalization of botanical drugs from pre-clinical studies of botanical drugs. Pre-clinical safety evaluation and quality conformity for botanical drugs were identified as the critical factors for the development of botanical drugs in the future. Investigation from the perspective of knowledge collaboration revealed that vertical research by independent research centers could utilize professional efficiency, but did not create the benefit of collaboration. It was deemed necessary to establish efficient professional clinical services and employ knowledge collaboration to meet future demands in the fundamental pre-clinical study of botanical drugs. The present study used a platform of high-throughput screening for the antiviral mechanism of botanical drugs to analyze the position of the value chain of supportive industries from the perspective of fundamental research. The present study discovered that simply fitting Chinese medicine into the framework of western medicine, combining the separate architectures of Chinese medicine and western medicine, would result in a loss of value for botanical drugs. A knowledge management platform of substantial value to botanical drugs can be constructed based on the management competence of a knowledge database and platform during a course of fundamental research and through standard procedures for pre-clinical analysis to accumulate validated data related to botanical drugs. The position and contribution of the research platform in the value chain of supportive industries may not provide any benefit for the accomplishment of current research due to the misperceptions of the academic community and the industrial sector. Therefore, knowledge collaboration has become another critical factor to be taken into consideration along with technical collaboration or transfer. An open research platform and integrated collaboration of technology and knowledge will allow fundamental research of botanical drugs to provide substantial value. As a result, research can combine with the industrial value chain to increase the feasibility of the international development of botanical drugs.