新穎性食品及特殊營養食品原料與食品添加物之安全性評估：活體免疫誘發式新穎性食品之基因毒性試驗

Safety assessment of special dietary foods and novel food: Genotoxicity of BDI derivatived from in vivo animal treatment.

游雅婷(Ya-Ting Yu)

指導教授 ： 鄭幼文

臺北醫學大學/藥學院/藥學研究所/碩士(2010年)

摘要

隨著食品科技的進步，各式各樣的加工食品、添加物食品、營養食品、機能性食品、健康食品、基因改造食品乃至最近萌生的奈米食品等，不斷的以不同的形式呈現在人們的眼前。而這些食品，為了達到消費者的關注，利用加工方式、製造過程、甚至生物科技的方式改變食品的本質，使得其和以往傳統的食品相較下，更增加了食品的附加功能，有些食品中的成分，甚至可以讓人們攝取到相當於數百倍傳統食品成份之劑量。而這些脫離原來食用經驗的食物在「劑量」的觀點而言，已介於”食品”與”藥品”之間，其安全與功能都需要重新考量與被評估。
隨著高度發展的食品科技之後，食品安全的問題也日益嚴重，從中國爆發奶粉汙染事件、日本水餃含殺蟲劑成份甲胺磷汙染事件、速食店炸油含砷超標以及肉毒桿菌中毒事件，讓食品安全問題漸漸浮上檯面。民眾由新聞報導得知食品安全問題對健康的危害，政府此時若無法及時提供相關資訊做為參考，將會造成民眾不必要的恐慌。相較於國外提供的資訊，國內對於這樣的資料提供極為缺乏然而國外資訊不易被所有民眾閱讀及了解，各個國家的飲食文化也不同，更應該要建立屬於國內的食品資訊資料庫。面對將會層出不窮的食品安全問題，建構各方面食品資訊的相關資料庫是迫切需要的，並且是龐大且刻不容緩的工作。
本論文第一個章節，特殊營養食品原料與食品添加物的安全性評估，也是一群安全性資料建構不完全的特殊食品之一。針對此一大類原料與添加物，我們著手開始對於食品安全相關資訊做收集、處理及分析的工作，以將生物資訊萃取並轉換成實用的知識。分為四個步驟：了解研究動機、資料搜尋、報告呈現以及風險評估。除了花費非常多的時間，最後將八個品項的資訊以報告呈現並做初步評估的結果呈現之外，在經過一連串的資料搜尋的工作中，我們建立了「食品安全風險評估研究流程」以提供往後相關研究之研究程序，以達到作業程序清楚化為第一個目標。並且，為了達到在過去對於資料搜尋所需要花費非常龐大的人力及時間，以減少作業時間、增加作業速度的第二個目標，我們還建立了「食品安全風險評估標準作業程序 ( Risk Assessment Standard Operating Procedure, Risk Assessment SOP )」，期望往後接到類似的研究，可以達到經驗加成、效率提升的效果。
以上敘述的工作是純粹使用電腦作業的dry lab，這樣的工作扮演著將資訊彙整呈現以提供利用的角色；而當資料蒐集的工作沒有辦法從網路上將需要的資訊蒐集完整時，dry lab便成了規劃並分配下游工作的執行者，藉由wet lab將實驗的數據產出。在第二個章節的主題：免疫誘發式新穎性食品 ( 簡稱BDI )，是以新的概念製造出來的食品，因為非自然存在，所以缺乏歷史食用資訊。此物質宣稱有療效，若欲研發成健康食品，至少會被列於第三類健康食品，需完成基因毒性、亞慢性毒性試驗及致畸胎試驗。最後將其試驗結果提供審察所需。本論文將對於BDI進行三項致基因突變性試驗：體外微生物基因毒性試驗法 ( Ames Test )、體外哺乳動物染色體畸變試驗 ( In Vitro Mammalian Chromosome Aberration Test ) 以及哺乳動物體內微核分析 ( In Vivo Mammalian Micronuclei Assay )。實驗之最高濃度均選用FDA guideline規定使用之最高劑量為最高濃度，結果均顯示無基因毒性反應，因此可初步判定，在正常食用劑量下，此項食品不造成基因毒性。
在本論文的第二個章節，藉由實驗獲得安全性評估的必要資訊，其最終目標是提供給第一個章節的風險評估做為依據。目前，我們已經對於過去零散無規劃的評估作業，提供「食品安全風險評估研究流程」，達到作業程序清楚化；並且，為了達到在過去對於資料搜尋所需要花費非常龐大的人力及時間，以減少作業時間、增加作業速度，我們還建立了「食品安全風險評估標準作業程序 ( Risk Assessment SOP )」，以提升資料搜尋的效率，期望能加速達到食品安全知識透明化這個迫切的目標，加速食品安全相關資料庫的建立。

關鍵字

新穎性食品 ； 風險評估 ； 基因毒性

並列摘要

With the development of food technology, there are many kinds of foods such as nutritional food, functional food, health food, genetically modified food ( GMO ) and nanofood. The food industry changes the character of food by using different process or fuse biotechnology in order to give rise to consumers. These kinds of food are different from traditional food. People sometimes ingest hundredfold of dosage from novel food than from traditional food. The characteristics between food and drug in “dosage” are different from our experience. Therefore, we need to reconsider the functionality and safety of novel food.
With the development of food technology, food safety issues are getting more and more serious. People receive the news about food safety issues, for example, the melamine event, fast food restaurant’s arsenic event and clostridium botulism food poisoning. If the government can’t provide relative information to explain these issues in time, it will be a panic among people. Compared to the foreign countries, the information is extremely lack in our government. However, the information in foreign web site is not popular to all people. Furthermore, the food culture is different from each country. Moreover, the food safety issues are going to come out one after the other. Therefore, building up a database relative to food information is of great urgency.
The first chapter of this thesis: “Safety assessment of special dietary foods and food additives”, is one of the database that is lack of information. Using this topic, we start to collect, deal with, and analyze relative information in order to extract practical knowledge from bioinformatics. It includes four steps: Step.1 Research motivation. Step.2 Research methods. Step.3 Reports presentation. Step.4 Risk assessment. Except spending much time in completing eight items and giving some preliminary assessment, moreover, we build a “Risk Assessment Flow Chart” to provide clear research procedure for the first goal. Due to the huge consumption of time in searching information ( Step.2 ), we build up a “Risk Assessment Standard Operating Procedure, Risk Assessment SOP” for the second goal. May this SOP can help to accumulate experience and improve efficiency.
The above work uses computer only, it is called “dry lab.” This kind of work plays a leading role in risk assessment. When there is lack of information in the web site, dry lab need to distribute related work among the downstream. Wet lab produces experimental data and then applys to dry lab to provide for risk assessment. In chapter two, the novel food is produced by a new method, BDI for short. It is claimed curative effect but lacking of edible information. If it is expected to be health food, genotoxicity test, subchronic test and teratogeny test is necessary. We are going to test BDI by three genotoxicity test: Ames Test, In Vitro Mammalian Chromosome Aberration Test, In Vivo Mammalian Micronuclei Assay. These experiment are base on FDA guideline. The results from this study indicated no observed genotoxicity induced by the BDI in three assays. We primary concluded that BDI did not exert genotoxicity in this study.
In chapter two, we know how to obtain necessary information from experiment. The purpose is to apply to dry lab for risk assessment. We have built a “Risk Assessment Flow Chart” to provide clear research procedure. Due to the huge consumption of time in searching information, we have built up a “Risk Assessment Standard Operating Procedure, Risk Assessment SOP” to accumulate experience and improve efficiency. Hope to help build up food safety databases as soon as possible.

並列關鍵字

novel food ； risk assessment ； genotoxicity

參考文獻

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