中藥濃縮製劑黃麴毒素污染檢測及風險評估

鄧正賢
亞洲大學
中藥濃縮製劑具有服食方便及節省煎煮時間的優點，除此之外中藥濃縮製劑由GMP中藥廠經嚴格管控生產，可避免藥材基原錯誤及重金屬、微生物、黴菌毒素的汙染。故中藥濃縮製劑目前為使用主要的劑型且受健保局給付的標準。然目前中藥濃縮製劑其製程添加原生藥粉末者是否會造成品質差異則必須進一步研究。 本研究樣品選擇以衛生署公告易受黃麴毒素污染藥材的單味濃縮製劑及選擇收集國內市售使用量前三十名的十個廠牌之濃縮製劑進行測試，預計以液相層析螢光柱後光化學反應法檢測中藥濃縮製劑污染狀況，並確定其數值，希望取得足夠黃麴毒素污染濃縮製劑的數據，進而進行中藥濃縮製劑黃麴毒素污染的風險評估及研訂限量標準。 本計畫擬以取樣設計採雙重採樣設計 (Double Sampling Plan)，免疫親合管純化及液相層析螢光柱後光化學反應法 (非碘衍生化反應) 檢測中藥濃縮製劑內黃麴毒素B1、B2、G1及G2，預定檢驗共 500 個樣品，以完成污染背景值分佈，並進行風險評估及研訂限量標準。 故本計畫為期一年，分三大部分進行進行。(一)第一部份為基礎分析研究 (Determination)，著重於建立中藥濃縮製劑內黃麴毒素污染的液相層析螢光柱後光化學反應法。(二)第二部份為調查 (Survey) 台灣地區中藥廠濃縮製劑內黃麴毒素的污染狀況。(三)第三部份為完成中藥濃縮製劑黃麴毒素風險評估 (Risk assessment)及研訂限量標準。
關鍵字：中藥濃縮製劑；黃麴毒素

Survey and Risk Assessment of Aflatoxins Contamination in Concentrated Chinese Medicinal Preparations

Jeng-Shyan Deng
Asia University
The advantages of concentrated chinese medicinal preparations (CCM) was conveniented to consume and saved time in preparing traditional decoction. Besides, CCM was manufactured under strictly controlled GMP standards thus avoiding the risk of using the wrong herbs for preparing medicines, professionally tested for heavy metals, microbial and mycotoxicity. Reliability and safety are therefore ensured, and has already become the main types of usages. In recent years, many domestic businesses of CCM products often add raw medicine powder to manufacture excipients, but owing to the numerous problems of adding raw medicine powder, like the possible contents of more pesticide residue, heavy metals and bacterial infection, it is worth it to value and invest in these relative researches. In this survey, 500 samples were purchased in order to investigate the aflatoxins contamination in CCM.
關鍵字：Concentrated Chinese Medicinal Preparations、Aflatoxins