化妝品之品質衛生管理標準建立---化妝品安全性評估建立之研究(II)

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Title:	化妝品之品質衛生管理標準建立---化妝品安全性評估建立之研究(II) The Study in Safe Evaluation of Cosmetics (II)
Authors:	郭俊成
Contributors:	化妝品應用與管理系行政院衛生署
Keywords:	化妝品安全評估體外細胞毒性測試化妝品 safe evaluation cosmetics IN VITRO TEST
Date:	2003
Issue Date:	2008-11-21 10:35:34 (UTC+8)
Abstract:	在過去化妝品安全評估主要以動物測試為主,如皮膚刺激試驗就用兔子,天竺鼠,大白鼠等.這些試驗被動物保護團體批評為不人道. 在目前世界趨勢上，要以細胞層次來取代動物試驗。在本研究中我們計畫建立化妝品細胞毒性測試以取代數項傳統動物測試項目，以期用細胞毒性法搭配傳統方法以建立一套完善快速的化妝品安全性檢測模式。目前國內化妝品衛生管理條例暨有關法規，所定化妝品安全性，是以已知一成份和含量去訂定安全標準並沒有檢驗方法，但此法之缺失如化妝品含數種成份，每種劑量依目前法規皆在安全值內，但其混合是否安全，則不得而知。所以有須要建立一套完善的化妝品安全性檢測模式，只需將化妝品直接用生物檢測即知。如有新成份則更須有檢測方法方可知其是否安全。在我們提出三年計畫之第一年計畫執行中,我們主要以洗劑去測試細胞毒性試驗和動物毒性實驗相關性,以便能使用細胞毒性試驗取代動物毒性實驗.我們以各種國內外廠牌頭髮及身體清潔劑及介面活性劑,純陽離子清潔劑,陰離子清潔劑,兩性離子清潔劑,非離子清潔劑,依其使用方式及對細胞的毒性,我們將其分成四大類:1.頭髮用劑使用不超過隔夜,如洗髮精. 2.頭髮用劑使用超過隔夜,如護髮精. 3.身體用劑不使用超過隔夜,如沐浴精. 4.身體用劑使用超過隔夜,如面霜除皺油美白保養品.經細胞毒性測試其對細胞毒性強度1>3>2>4其毒性出現濃度經三種細胞二種方法訂定為1(0.1μl/ml),2(10μl/ml), 3(0.2μl/ml), 4(100μl/ml).此種方法我們稱之為細胞安全濃度檢測法,詳細討論已在期中報告.我們實驗結果確立一般毒性,陽離子清潔劑大於陰離子清潔劑大於兩性離子清潔劑大於非離子清潔劑,此結果在細胞及動物實驗上均可見,並且依照細胞安全濃度檢測法,去測試各種國內外廠牌頭髮及身體清潔劑,結果顯示大部分產品,毒性出現濃度均符合我們所訂定之細胞安全濃度檢測法濃度,但年輕貴族綠藻60秒活髮素,在我們三種細胞二種方法,及動物眼毒性測試,其毒性出現濃度,小於我們所訂定細胞安全濃度檢測法濃度,顯示其有較高的毒性.由於其成分僅標示有效成分,未標示主要介面活性劑成份.因此其較高的毒性,可能來自介面活性劑,如使用陽離子清潔劑,或其他成分或添加物.我們的目標,是要訂出一套標準,將要上市的化妝品不管其成分如何(因混合成分後,其毒性並不能由單獨成分去推測.因此要根據實際生物毒性顯示)且要檢測出其全部成分是非常困難,然而依據本方法,只要依其使用時接觸人體時間長短,分成四大類. 依其種類作細胞毒性測試.只要其細胞毒性超過我門所訂定濃度標準.則表示可能有毒性.需做進一步動物毒性,或人體測試.以確認其毒性,並防止其上市,妨害大眾健康.若其細胞毒性測試毒性不超過我門所訂定標準,則表示可準其上市.因細胞毒性是一最敏感測試方法,在截至目前我們對各項產品,實驗結果顯示,只要在細胞未出現毒性之劑量或種類,則動物之各項測試,也不會出現毒性.因此這方法便可作為穩定,快速及大量檢定用.不過此結論仍需更多樣品來確認. 在我們第二年計畫中,我們要檢測美白,防曬的化妝品，並建立有毒的評估值。在我們第一年研究成果上,目前為止,我們有達成預期結果,並建立細胞安全濃度檢測法模式. 希望藉由第二年.及第三年的繼續研究而累積成果,能為國內化妝品訂定一適當安全品質的檢測法規,以提供化妝品廠商製造產品的安全依歸,進而能達到對使用大眾的安全把關. In the past, researcher routinely performed in vivo skin-irritancy studies on animal models-usually rabbits, guinea pigs or rats-and patch reasons. Animal-welfare groups criticize the use of animals in screening and testing, posing potential public-relations problems for companies using animal studies. Experiments using human volunteer, on the other hand, are time-consuming and expensive. Hence, researcher have been urgently working to develop appropriate alternatives to in vivo tests. In vitro models currently provide validates data applicable to the evaluation of human skin-irritation potentials to have found official approval for cosmetic safety testing. The close relationship is found between in vitro test and animal test (including skin irritation, eye irritation and phototoxicity) )(r>0.8). Therefore, the search for simple and reproducible in vitro screening procedures to estimate skin irritancy contimues in taiwan. In vitro cultures of submerged monolayers of keratinocytes or fibroblasts cell lines have been used in various in vitro irritation assays. In this study, we investigated whether the LDH leakage assay, neutral red uptake and MTT reduction test-methods for testing cytotoxicity in cultured fibroblasts-may br useful alternative models to replace the human patch and rabbit intradermal safe test. They are based in different endpoints: the neutral red uptake is based on incorporation of neutral red dye into lysosomes of vable cells; the MTT assay determines reduction of yellow MTT tetrazolium salt to a blue formazan by mitochondrial succinate dehydrogenase activity of uninjured cells; and the LDH assayuses the principle that lactate dehydrogenase leaks from cells after damage. The concentration that induced 50% inhibition relative to controls (IC50) is calculated for each test, ceel line and chemical. We developed protocols for cytotoxicity screening of cosmeticc representative of know skin irritants and set the data base in order to set up the model for in vitro screening procedures for cosmetic safety testing in taiwan.
Relation:	計畫編號：DOH92-TD-1113
Appears in Collections:	[Dept. of Cosmetic Science and institute of cosmetic science] Other Projects

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