建立快速檢測生藥粉末添加及品質評估之核心技術

江伯源
中興大學
中(草)藥是我國固有醫學精髓之一，數千年的使用經驗奠定我國執全世界中草藥之牛耳定位。近年來全世界正掀起一股研究開發中草藥生理、療效、保健及多元化產品之風潮。WHO於2000年發報告全球中草藥市場相關產值達650億美元，並以10%年成長率成長，預估至2008年可達到1000億美元，前景十分美好。傳統中(草)藥製程大都將收穫之藥草，經選材、清洗、飲片加工、炮製，再進行不同劑型之製備，隨著科技發展，〝科學濃縮中藥〞是全球中(草)藥的主要商品型態，〝液〞、〝粉〞、〝粒〞、〝膠囊〞常是市場上販售的主要劑型，〝磨粉〞、〝萃取〞、〝濃縮〞、〝賦型(造粒)〞常是重要加工步驟；隨著科技發展，中藥濃縮製劑使用方便性，已成現在應用之主流，賦型劑之添加成為關鍵之技術，近年國內許多中藥濃縮製劑業者常添加生藥粉末作為賦型劑，但因生藥粉末常存有許多問題如添加量、藥效性，另其可能含有較多之農藥殘留、重金屬及細菌污染等問題，十分值得重視及投入相關之研究。本年度衛生署中醫藥委員會的〝中藥品質管制暨中醫政策類〞委託研究計畫重點項目—中藥品質管制類，研究重點1-3：鑑定中藥濃縮製劑添加賦形劑（如生藥粉末）之品質研究，將添加生藥粉末之製劑品質，可行性，合理性與技術性等進行探討作為研究重點。 本計劃〝建立快速檢測生藥粉末添加及品質評估之核心技術〞，擬將研究項目分為三項主題進行：(一)建立快速物性檢測生藥粉末添加之核心技術，包括色澤、粒徑大小、粉末外觀、總體積密度、混濁物、沈降速率及相對黏度。(二)建立快速化性檢測生藥粉末添加之核心技術，包括：藍價、膨潤力、水溶性指標、凝膠延展性、十字偏光性、粗纖維、纖維單醣組成分分析。(三)評估生藥粉末添加之理化性質及品質評估，包括：糊化連續黏度、示差掃描熱分析、掃描式電子顯微鏡、ELISA、重金屬、農藥、微生物及生理活性物質等分析項目。以上研究，除作深入應用性研究外，未來希盼能對中草藥品質管制及安全性做出貢獻。
關鍵字：中草藥；萃取；賦型劑；生藥粉末

Establishes the core technologies of the fast sense method of raw drugs powder adding and evaluate its quality

Chiang, Po-Yuan
National Chung Hsing University
Chinese medicinal herb is one of the inherent medicinal essences of our country and its million years of application has made our country hold leadership all over the world in herbal medicine. In recent years, the world has raised the research development of the physiology, curative effect, health care and multiple product of medicinal herb. In 2000, WHO reported that the correlation output value of medicinal herb in the global market amounted to 650 billion US dollars with a growth rate of 10%. It estimated that in 2008, the correlation output value may reach 1000 billion US dollars, which shows an excellent prospect. In the traditional processing of medicinal herb, the medicinal herb is mostly harvested, selected, cleansed, decoction processing, packaged, and then manufactured into different product types. Along with technological development, “scientifically concentrated medicinal herb” is one of the main global product types, “liquid”, “powder”, “granules”, “capsule” are the main product types sold in the market, and “milling”, “extraction”, “concentration”, and “excipient (granulization)” are the important processing steps. Along with technological development, the use of concentrated medicinal herb is convenient, and has already become the main types of usages.
關鍵字：herb medicine；extract；excipient；raw medicine powder