中藥材內黴菌毒素污染之研究

鄧正賢
亞洲大學
傳統中藥常被認為是天然無毒的，人們經常會大劑量或長期服用它們來調整陰陽體質以預防或治療疾病，然而中藥材成份複雜且來源不一，可能會受天然界的污染而當攝食超過容許劑量時將會對人體器官造成傷害，所以對中藥進行品質管制是刻不容緩的事。本計劃主要是希望能完成下列目標：(1)以酵素聯免疫分析法ELISA大規模分析中藥材黴菌毒素污染，希望取得足夠黴菌毒素污染中藥材的數據，並以免疫親和管純化及液相層析確定其數值。(2)進行中藥材有害物質毒性背景值資料與相關檢驗技術，並完成風險評估。內容包括植物肝腎毒性成分、農藥、重金屬、防腐劑殘留、偽品毒性等。(3)研訂限量標準。本計劃為期一年半(2006-2007)，分分三大部份進行。子計畫一進行基礎酵素免疫分析研究，著重於建立中藥材內具肝腎毒性黴菌毒素簡單、快速、靈敏的篩檢分析方法；子計畫二則將上述所得數據以液相層析螢光儀確認；子計畫三則進行中藥材有害物質風險評估並研訂限量標準，標準之研訂流程遵循聯合國食品安全委員會(Codex)之作業準則，並依中藥材與食品共通性及差異性進行資料之調整。上述結果可與預定2008年實施之300種中藥材應明確標示包含「品名、重量、製造日期、有效期限、廠商名稱及地址」的政策實施後市場品受黴菌污染狀況做一對照性比較，以證實該政策之前瞻合理性。
關鍵字：酵素聯免疫分析；風險評估

Study of mycotoxins contamination in traditional Chinese medicines

Deng Jeng Shyan
Asia University
Traditional Chinese medicines (TCM) is widely considered to be nature and completely unharmful, people usually take them as diet supplements to prevent or heal disease by maintaining or restoring yin-yang balance in large dose or for long time. But TCM come from various sources and possess complex components. TCM may be naturally contaminated by some chemical components that may become toxic for the human organism if the total amount ingested through consumption exceeds a certain tolerable dose. The quality management of TCM materials is very important. The project is designed to accomplish the following goals: (1) Investigation of the presence of ochratoxins, fumonisins, aflatoxins and vomitoxin in a large amount of traditional Chinese medicines by Elisa method. Then, the datas was determination by using organic solvents extraction, immunoaffinity column clean up and HPLC to analyze. (2) Risk assessment of hazardous substances including nephrotoxicant and hepatoxicant compound in herbs, mycotoxins, pesticides, heavy metal, preservers and incorrect herb material provided (misuse) (3) Establishment of maximum residue limit of hazardous substances in TCM. The duration of this research project will be 1.5 years (2006-2007).
關鍵字：ELISA；Risk assessment