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| 題 名 | 中草藥可添加於化妝品之品項資料研究與安全性及有效性評估=Study on the Chinese Medicine Herb Added in Cosmetics and Evaluate the Methods of Safety and Effectiveness Assessment |
|---|---|
| 作 者 | 張聰民; | 書刊名 | 中醫藥年報 |
| 卷 期 | 29:5 2011.09[民100.09] |
| 頁 次 | 頁101-279 |
| 專 輯 | 傳統藥材生技之研究 |
| 分類號 | 414.33 |
| 關鍵詞 | 中草藥; 化妝品; 安全性; 有效性; Chinese herb; Cosmetic; Safety; Effectiveness; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 研究目的: 透過資料之蒐集,建議可添加於化妝品之中草藥品項。利用網際網路資訊搜尋與整理,瞭解各國針對含中藥化妝品的相關規定。完成各項實驗驗證文獻資料蒐集與整理:進行中藥與化妝品之安全性與有效性等各項試驗方法文獻資料蒐集與查證。完成可添加於化妝品內中藥材品項藥材之安全性與有效性評估模式之建立,並且提出具體管理方案之建議。 研究方法: 利用電腦網路資訊搜尋工作,蒐尋和整理國內外的含中藥化妝品相關資料。參考歐洲、美國、日本、大陸資料等,瞭解各國針對含中藥化妝品的相關規定,以作為國內參考依據。科學文獻資料蒐集與查證,整理可添加於化妝品內中藥材品項的安全性與有效性評估模式與方法。 結果與討論: 中國大陸化妝品組成中禁用之中草藥共108 項,但是可以添加於化妝品之中草藥則未明文規定。美國針對化妝品組成中禁用之中草藥無明文規定,美國「化妝品原料評價委員會」評估可以限量使用之中草藥共35 項。歐盟針對化妝品組成中禁用之中草藥共36 項,可以添加於化妝品之中草藥則未明文規定。日本針對化妝品組成中禁用之中草藥無明文規定,可以限量使用之中草藥共3 項。關於安全性與有效性評估的方法,均有標準方法可循。建議主管機關審慎評估欲公告可添加於化妝品之中草藥品項之前,應確定於人體使用之最大限量,而安全性與有效性評估模式與方法則可舉辦相關公聽會後討論公告之,針對安全性方面首重皮膚刺激性與敏感性測試。 |
| 英文摘要 | Aim: Review the regulations and laws of Chinese herb-containing cosmetic products announced from different countries, and establish the standard evaluation platform of safety and effectiveness of Chinese herb-containing cosmetic products. Method: First, we searched related news and data of Chinese herb-containing cosmetics by network and literature. Second, we want to collect the regulations and laws of Chinese herb-containing cosmetics from different countries. Results & Discussion: There are 108 items of Chinese herb that cannot be applied into cosmetic formulations announced from mainland of China. The American Cosmetic Ingredient Review announced 35 items of herb could be added into cosmetic formulations with limited concentration. The European Cosmetic Affiliation announced 36 items of herb could not be added into cosmetic. Japan government announced 3 items of herb preparations could be added into cosmetic formulations with limited concentration. We suggested the maximum local safety concentration of any Chinese herb should be identified before announcement. The standard assay platform of safety and effectiveness of Chinese herb-containing cosmetic products should be discussed in public and then be announced by the government. |
本系統中英文摘要資訊取自各篇刊載內容。