生物有效性體外試驗應用於健康風險評估之問題與展望

Problems and Perspectives in the Application of Gastrointestinal Bioavailability in-vitro Test to Health Risk Assessment

10.6288/TJPH2006-25-01-01

江舟峰(Chow-Feng Chiang)；張芳華(Fang-Hua Chang)；許惠悰(Hui-Tsung Hsu)

絕對生物有效性係數 ； 相對生物有效性係數 ； 體外試驗 ； 體內試驗 ； 風險評估 ； absolute bioavailability factor ABF ； relative bioavailability factor RBF ； in-vitro test ； in-vivo test ； risk assessment

台灣公共衛生雜誌

25卷1期（2006 / 02 / 01）

1 - 10

繁體中文

本文首先闡述絕對生物有效性及相對生物有效性之意義及各種計算公式，接著評析1992-2003年體外生物試驗的重要發展沿革及成果，特別著重不同試驗程序及操作參數比較。本研究建議修改反應槽設計、攪拌方式及溫控設備，以避免開放系統的揮發逸散，並建議評估一階段胃相試驗程序，以簡化操作程序。試驗參數如：樣品前處理、溫度、酵素添加量、pH值與反應時間等，經過歷年的研究，雖然已漸趨一致，但本研究發現仍待釐清的三個問題為：是否應控制氧化還原電位？是否應模擬胃環境之蠕動強度？是否應控制胃之排空比？本研究另發現，不同體外試驗方法仍難相互評比，主要是因為並未建立系統品管基準，本文建議四種管制樣品：空白管制、重複管制、代理參考物質(surrogate reference material，SRM)管制及介質管制(matrix control)，期盼藉由後續實証研究，建立簡化且有效的評估程序，以應用於土壤改良劑、受污土壤、食品、中藥、牙材、玩具等健康風險評估。

As a methodological review, this paper begins by introducing the concepts and definitions of absolute bioavailability factor (ABF) and relative bioavailability factor (RBF) and the relevant mathematical equations for the bioavailability test of gastrointestinal function. The critical literature review was then concentrated on the historical development of in-vitro test and important outcomes reported during 1992-2003. Based on this review, we suggest modifying the reactor design, mixing method, and temperature control to reduce fugitive emission from the unsealed reactor. We also identified three key issues for the in-vitro test: the control of oxidation-reduction potential (ORP), the simulation of actual mixing intensity in the stomach, and the range of liquid-to-solid ratio. This study further concludes that a set of systematic quality control criteria must be established for the in-vitro test. Four types of control sample are available for quality control test in parallel with the test sample: blank materials, replicated sample, surrogate reference material (SRM), and matrix control. The ultimate goal of this study is to develop a simple but reliable in-vitro bioavailability method for assessing the potential risk of waste recycling materials, such as soil conditioners, contaminated soil, food, Chinese herbs, orthodontic appliances, and toys.

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