中 文 摘 要 傳統中藥材常被認為是天然無毒的,民眾經常會未經醫師處方而大劑量或長期服用以調整體質或預防及治療疾病,然而中藥材成份複雜且來源不一,有可能會受到天然有害物質的污染,而當攝食超過容許劑量時更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。 目前國內有關中藥材有害物質之風險分析研究論述並不多,所以本研究擬從肝腎毒性成分、農藥、重金屬、黴菌毒素、防腐劑殘留、偽品毒性方面著手進行風險分析,希望建立有關中藥材污染物質風險評估的模式。@Risk (Palisade Corporation, 4.5版本) 是一種定量風險評估之應用軟體,可應用於中藥材有害物質風險評估分析,透過 @Risk 輸入數據的步驟,藉由 Monte Carlo 模擬分析,完成風險評估。廣義上來說,風險分析分為定性及定量兩種,本研究屬於第三層次定量風險評估,相關結果可準確的為施政者參考。 關鍵詞:風險評估,中藥材,標的致癌風險(TR),標的危害商數(THQ)
ABSTRACT Traditional Chinese medicine (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 risk assessment software @Risk were used to assess the potential risks of consuming hazardous substances comtaminated in TCM. @Risk 4.5 uses the technique of Monte Carlo simulation for risk analysis. With the technique, untertain input values in your spreadsheet are specified as probability. In a broad sense, risk analysis is any method — qualitative and/orquantitative — for assessing the impacts of risk on decision situations. The goal of any of these methods is to help the decisionmaker choose a course of action, given a better understanding of the possible outcomes that could occur. Keywords:Risk assessment,Traditional Chinese medicine (TCM),Target cancer risk (TR),Target hazard quotient (THQ)