中藥品質的保障體系   全文下載

Quality Assurance of Chinese Herbal Medicines (CHMs)

隨著中藥在國際上使用日漸廣泛，其安全性也隨之引起世人的關注。中藥的鑒定與標準化為基礎性的工作。本文重點介紹了保障中藥品質的幾個主要方法，包括原植物的分類鑒定、藥材性狀鑒定與顯微鑒定、化學指紋圖譜、dna 分析，各種方法的應用範圍與優缺點。此外，本文還討論了與中藥品質相關的農藥殘留與重金屬含量問題、炮製加工問題等。一種中藥分析鑒別的新方法MaLdi-ToFMS 也予以介紹。本文還討論了與中藥品質密切相關的中藥資訊交流現代化的問題。

As more and more people worldwide are using Chinese Herbal Medicines (CHMs), the safety of their use has raised international concern. Authentication and standardization of CHMs are needed. Authentication of a CHM includes both identifying its botanical origin and evaluating its pharmaceutical quality. In this paper, the important parameters for quality assurance are discussed. Quality control methods such as the examination of taxonomic, morphological and/or microscopic characters, fingerprint chromatography, DNA molecular marker are described and compared. Some topics related to herbal quality control such as contamination, processing as well as the new method MALDI-TOFMS are also introduced. Finally, modernization of Chinese medicine information was brought up.