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題 名 | 化粧品添加中藥材研究=Studies on the Application of Chinese Herbal Medicines on Cosmetic Additives |
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作 者 | 陳榮秀; | 書刊名 | 中醫藥年報 |
卷 期 | 29:5 2011.09[民100.09] |
頁 次 | 頁33-99 |
專 輯 | 傳統藥材生技之研究 |
分類號 | 414.33 |
關鍵詞 | 中草藥; 化粧品; 有效性; 安全性; 法規; 管理; Chinese herbs; Cosmetics; Effectiveness; Safety; Regulations; Control; |
語 文 | 中文(Chinese) |
中文摘要 | 全球化粧品與美容相關市場高達2 仟億美元,且該產業並以每年7%速度成長,超越世界GDP 成長率的兩倍之多。化粧品市場之成長主要來自產品功效之提昇,而整體護膚功效分析,與護膚產品相關的基本功能包含抗老化、保濕、去角質、潔膚、消炎、美白、防曬等。利用中草藥理論記載完整的先天優勢以及現代科技的反覆驗證,使中國傳統醫學與現代美容科技整合,符合世界潮流,並且化粧品添加中草藥可說是連接傳統簡單清潔及美化的化粧品與使用於特定治療藥效之藥物之間的橋樑。 隨著天然物應用於化粧品之熱潮而起的是相關法規制定與衍生之管理問題,許多產品標榜天然素材的添加,使消費者以為「天然的」就是安全及有效的,但是事實不然,有些天然物對皮膚會產生刺激性,若沒有詳加規範會產生糾紛及傷害。因此本計畫希望透過資料蒐集、研究了解中草藥添加於化粧品之安全性及有效性,以提供相關單位建立管理規範的參考。 本計畫實施方法及結果: 1.資料蒐集-蒐集內容包括: A.醫藥品先進國之中草藥可添加於化粧品之品項; B.國外對於天然物添加於化粧品之管理規範; C.典籍文獻記載之中草藥應用於化粧品之資料。 2.中草藥萃取-依據各方資料所歸納之中草藥,經過基原鑑定後,進行萃取工作。 3.有效性評估-建立化粧品功效篩選與評估平台,進行in vitro 有效性評估測試,確認中草藥添加於化粧品之有效劑量,測試項目包含:美白、防曬、保濕、抗氧化及抗菌等功效。 4.安全性評估-化粧保養品的使用需直接接觸皮膚,因此評估其對皮膚的安全性與刺激性是很重要的。本計畫檢測中草藥萃取物對皮膚是否具毒性,因此在in vitro 方面以細胞毒性試驗測試中草藥萃取物之安全與刺激性反應。 5.管理辦法擬定-召開專家會議,根據本計畫之安全性及有效性評估測試,及國外相關管理經驗,擬定中草藥添加於化粧品之建議方案,作為管理單位之重要參考資料。 6.資訊網站-建立中草藥添加化粧品諮詢網站,提供產、官、學、研各界在各國法規及相關研究成果之查詢與資訊交流網站。 結論: 1.本計畫共篩選66 種中草藥,部分藥材在美白、防曬、保濕、抗氧化及抗菌等具有極佳功效,並且無明顯細胞毒性,顯示中草藥具有添加於化粧品之潛力,期望將來能利用已建立之篩選平台,繼續篩選中草藥,擴大中草藥在化粧品之應用。 2.在法規方面共整理台灣、美國、日本、歐盟、加拿大、 韓國、馬來西亞、澳大利亞及中國等九個國家化粧品管理相關法規簡介及各國家所規範之中草藥添加之化粧品之負面表列。 |
英文摘要 | It has been estimated that the value of global market of cosmetics and beauty products is as high as 200 billion US dollars with an annual increase rate of 7% that is two times higher than the growth rate of global GDP. The growing of cosmetic market is attributed mainly to the increasing knowledge in respect to the wide range of use of cosmetics and their effectiveness to the users that the topical protective effects could be related to basic mechanisms such as anti-aging, moisture retention, removal of excessive corneum, surface cleaning, anti-inflammatory, skin whitening, and sun-light screening effects, etc.. By using the many basic therapeutic theories and experience with combination of extensive verification by current scientific technology, the Chinese medicine has been shown to be useful when integrated with the beauty technology. It has been a part of the trend in the world that the addition of herbal materials into traditional cosmetic preparations can serve as a bridge for the connection between cosmetic products for simple cleaning uses and beauty application and the therapeutic use of related products. With the increasing use of natural materials in cosmetic preparations, the need of the implementation of regulatory binding is impending that the quality of cosmetic products must be watched and controlled for the benefit of general publics. It has been found occasionally that some cosmetics claimed the beneficial incorporation of natural materials to convince users that the natural materials are safe and valuable. It has been found also that some natural materials may be irritant to the skin that control of such formulations is needed to protect users from being harmed. It has been the purpose of this study to collect the information regarding the safety and effectiveness of cosmetic preparations when Chinese herbal materials are added. Accordingly the result of this study can be an informative source for the initiative of regulatory actions. The study was focused on the followings: I. Collection of the following Information: A. The Chinese herbal materials that are legally allowed to be incorporated into cosmetic preparations by countries of advanced medical and pharmaceutical technology; B. The international regulatory guidances on the control of the incorporation of natural materials into cosmetic preparations; C. Information provided by traditional medical and pharmaceutical documents regarding the use of Chinese herbal materials for cosmetic purposes. II. Extraction of target herbal materials: Some target material evidenced with potential cosmetic uses were identified for their botanical origins and then were extracted and fractionated with solvents. III. Evaluation of the effectiveness: A general platform for the screening and evaluation of the cosmetic effects was established. The in vitro effectiveness evaluations were performed to confirm the effectiveness along with the required dosages. The testings included in the evaluation were whitening, screening, moisture retention, anti-oxidative and antibacterial effects. IV. Safety evaluation: The safety and irritant effect of the proposed formulations were evaluated since cosmetics are generally used with direct contact with users’ skin. To evaluate the toxicity and irritant effect of the extracts of Chinese herbal materials to the skin, the in vitro cytotoxicy test was performed. V. Generation of a proposal for the regulatory control: Meetings of expert committee were called. Based on the information provided by the safety evaluation done in this study as well as the major information regarding regulatory enforcement in reference countries, a proposal for the regulatory control in our country is established that should be informative to the regulatory agency of our country. VI. Implementation of a web site: A web site has been established to provide information regarding the use of Chinese herbal materials in cosmetic formulations. The web site will be accessible by regulatory agency and all individuals, who are interested in cosmetic regulations, working in industry, academic and research institutions and information regarding international cosmetic regulatory issues and research activities will be provided. Conclusions: 1. Sixty six Chinese herbal materials were tested for whitening, screening, moisture retention, anti-oxidative and antibacterial effects and their good effectiveness were found without cellular toxicity. The results showed the great potential for the incorporation of Chinese herbal material into cosmetic preparations. The currently established evaluation platform will be used in the further screening studies for more extensive use of Chinese herbal materials in cosmetic areas. 2. Current laws or enforcements on the regulatory affairs regarding the incorporation of herbal origin materials in cosmetics in Taiwan, United States, Japan, EU, Canada, Korea, Malaysia, Australia and China were collected. Brief statements of all collected regulatory issues are shown in the full text of the report with Herbal materials that are not allowed to be incorporated into cosmetic preparations. |
本系統中英文摘要資訊取自各篇刊載內容。