| 摘要: | 在重視生命權的理念下，非動物非生命毒性檢測已是世界趨勢。連細胞培養因需胎牛血清也遭受批評。美國、歐盟、加拿大和日本在2009年共同簽署了一項ICCVAM和NICEATM國際間協調替代實驗方法的文件。美國政府為提倡非動物毒性研究，每年投資至少450萬美元開發和驗證。但我們政府及產業界在這方面的研發卻付之闕如。非動物非生命之偵測毒性的技術Eytex，目前是由美國Invitro International公司獨家開發出來，目前也獲得歐盟，美國FDA、環保署以及運輸部等政府單位的認證。在台灣，本研究團隊歷經7年研發終於突破關鍵技術的部分，生物液膜組成為一大分子規則結構而呈現澄清透明狀，若加入的待測物質會破壞有規則的結構，而讓生物液膜變成混濁，表示這些物質具有刺激毒性，可被目視或在OD405nm偵測出來。因為會破壞有機規則的結構也就會破壞眼睛，使細胞造成傷害。生物液膜方法擁有正確、省錢、省時、之特點。動物刺激實驗要6週5萬元；生物液膜只需5小時，成本只需動物百分之一，並減少不必要動物犧牲。本研究計畫將大規模測試已在歐盟登錄毒性的各類化學物。了解生物液膜與動物眼睛刺激性及Eytex相關性。提供廠商一個由生物液膜取代傳統動物的眼睛刺激實驗毒性評估標準，進而讓廠商從研發、生產到販售皆有所依循。
In view of the right to live, non-animal in vitro toxicological testing has become the global trend. Even cell culture which requires fetal calf serum is also criticized. In 2009, the USA, European Union, Canada and Japan signed ICCVAM and NICEATM documents about alternative experimental methods. The USA government has long been promoting non-animal toxicological research, and has invested at least US$4,500,000 each year in relevant research and development and experiments. However, the Taiwan government and industrial circle has not spent comparable effort to this field. The non-animal in vitro toxicological testing, solely developed by the US In vitro International Co., Ltd., has been certified by the European Union, and the US FDA, EPA and DOT. In Taiwan, this research team has made a breakthrough in the key technique after seven years of research and development. With the composition of proteins, glucoproteins, lipids and low molecular weight substances, bioplasma simulates the regular structure of living cell membranes so when the added test substances destroy the regular structure, the transparent bioplasma will become turbid, indicating the added substances are toxic. The turbidity can be either visually observed or detected at OD405nm. Substances that can destroy the regular structure can also damage eyes and cells. Bioplasma method is accurate, low-priced and time efficient. An animal irritation experiment requires six working weeks and costs NT$50,000, but bioplasma test can be completed within 5 hours and costs only 1/30-1/100 of the expenditure on animal experiments. Most importantly, it can avoid unnecessary sacrifice of animals. The research project is intended to provide manufacturers the bioplasma toxicological test standard, in place of the traditional eye mucous irritation test on animals, to serve as the reference for research and development, production and marketing. |
