生物檢定法運用於天然物的安全性及品質管制的重要性   全文下載

Application of Bioassay in the Safety and/or Quality Control of Herbal Products

天然物的使用在我國極為普遍，由於「藥食同源」的觀念，國人常飲用或食用天然物。可是，這些具有療效的物質，其品質管制與安全性相形之下也成為重要的課題。儘管植物學鑑定、分子鑑定以及化學分析等方法已應用於植物類產品的品質分析，但這些鑑定方法仍會因為一些因素而影響其結果的正確性，例如：不同植物產地所造成的差異性，或者不同草藥收成季節可能影響其藥效。生物檢定法為近代生物醫學的重要工具，其應用範圍包括新藥開發、待測物質之生物活性檢測、內生性調節因子功能探討、藥物毒性測定、天然草藥或污染物之濃度測定等。這些可能影響天然物品質鑑定結果的干擾因子，可賴生物檢定法來加予排除。應用適當的生物檢定法可以免除動物或者人體試驗的道德疑慮、降低試驗成本，不但事半功倍，也能獲得更多具有生物活性物質的結果。然而，我們必須要強調的是，目前，單一的鑑定方法並不能保證其結果的完全正確性，因此，追加運用生物檢定法，同時合併植物學鑑定與分子鑑定才能夠提供最安全、有效的天然物品管及毒性安全的控制。

Bioassays are useful tools in modern biosciences. The applications include development of new drugs; measurement of biological activity in undefined substances; investigation of endogenous mediator function; determination of drug toxicity; and measurement of the concentration of known substances such as pollutants or herbal products. As medicinal plants are very popular on market, the safety and/or quality control of these phytotherapeutic agents become an important issue. Currently, botanical identification, molecular identification and chemical analysis are often utilized for the quality analysis of plant products. However, the methods are not totally reliable due to factors such as seasonal and geographical variations in plant growth. An important development of herbal product quality analysis has been the use of biological assay systems which can test many samples for activity in a short period of time. The advantages of using bioassays in this aspect are many-fold. The tests can avoid the ethical and financial constraints of using human subjects or larger animals. Bioassay-guided isolation of ‘active’ compounds can be achieved and much smaller amount of test material is needed. However, it is important to realize that there is no single method to assure absolute quality. Bioassays combined with plant macro and microscopic data, chemical profiling and DNA fingerprinting would probably offer the safest and most efficacious herbal products.