臺灣博碩士論文加值系統

所謂化妝品為施於人體外部，以潤澤髮膚、刺激嗅覺、掩飾體臭或修飾容貌之物品，因為使用對象為人的皮膚，所以必須對皮膚作用溫和，不產生任何傷害，因此應用在化妝品之中藥材，需先完成安全性試驗，充分了解中藥材對皮膚的影響。
本實驗先選擇十五種常用於中藥化妝品的中藥材做試驗，其分別為 : 白芷、茯苓、白及、杏仁、當歸、天花粉、人參、檀香、知母、何首烏、天門冬、麥門冬、紫草、黃苓和晉耆等。藥材經確認後，分別用水溶液萃取和50％酒精溶液萃取，並取其萃取液測試。
依照常用的Draize氏法和其他的修改方法，以兔子和大白鼠作為試驗對象。兔子皮膚刺激性試驗結果，上述十五種藥材，除了當歸、紫草之50％酒精溶液萃取液表現輕微的刺激性，其他的中藥材萃取液，均沒有刺激的現象。兔子眼睛刺激性採用低劑量眼睛刺激性試驗，十五種中藥材，均沒有明顯的眼睛刺激性。單一劑量毒性試驗，十五種中藥材之萃取液，一次口服劑量在10000mg/kg時，均沒有明顯的毒性反應。

Cosmetics are applied to moisturize skin and hair, stimulate smell,deodorize, and enhance normal appearance. Since cosmetics are applied on human skin, they should not contain any ingredients that may cause adverse health effects. Chinese herbs are common ingredients in cosmetics. Thus, the evaluation of safety for the usage of Chinese herbs as the ingredients in the cosmetics formulation is necessary and plays an important role.
Both the aqueous and the ethanol extracts of fifteen Chinese herbs will investigate for the evaluation of safety. These fifteen Chinese herbs are:Angelicae dahuricae, Poria cocos, Bletilla striata, Armeniaca mandshurica,Angelicae sinensis, Trichosanthes kirilowii, Panax ginseng, Santalum album,Anemarrhena asphodeloides, Polygonum multiflorum, Asparagus cochinchinensis,Ophiopogon japonicus, Lithospermum erythrorhizon, Scutellaria baicalensis, and Hedysarum mongholicum.
The Draize test and its modifications were used to identify irritants in this study. The test subjects were rabbits and white rats. The rabbit skin test results showed that only the 50% alcohol solutions containing Angelica sinensis and Lithospermum erythrorhizon had mild irritation, while no reactions were found with other solutions. The eyes of the rabbits had no reaction to all fifteen herbs while performing the low-volume eye irritation test. The acute toxicity test showed that within dose of 10000 mg/kg, all fifteen herbs had no significant toxicity reaction.

中文摘要………………………………………………………….Ⅰ
英文摘要………………………………………………………….Ⅱ
圖表索引………………………………………………………….Ⅲ
壹、緒論………………………………………………………….　　　　1
1-1 前言………………………………………………………　 1
1-2 皮膚的結構……………………………………………..　 3
　 1-2-1 化妝品與皮膚……………………………………　　6
　 1-2-2皮膚的吸收……………………………………….　　8
1-3 化妝品的安全性評估…………………………………　　 10
　 1-3-1 中草藥的安全性……………………………….　　 10
　 1-3-2 皮膚刺激反應………………………….………　　 12
　 1-3-3 安全性評價的檢測……………………….………　 14
貳、實驗部分……………………….………….………….…..　　　　26
2-1 藥品、儀器………………….………….………….….　 26
2-2 實驗方法……………….………….………….….……　 27
2-2-1 中藥材之萃取…….………….…….….……….　　　27
2-2-2 皮膚刺激性試驗………….…….….…………..　　　28
2-2-3 眼黏膜刺激性試驗…….…….….……………..　　　29
2-2-4 單一劑量毒性試驗….…….….………………..　　　30
參、結果….…….….………………..….…….………………　　　　34
肆、討論….…….….………………..….…….………………　　　　59
伍、結論.…….….………………..….…….…………………　　　　62
陸、參考文獻.….………………..….…….………………….64
柒、附錄.…….….………………..….…….…………………　　　　69
7-1實驗中藥的基原與成份..….…….……………………　　69

1.周欣初 編譯，中草藥與化妝品，渡假出版社，民國82年
2.常兆生 于靜波 胡嶸 編著，實用中藥美容，千華出版公司，民國81年
3.Johann W. Wiechers, (2000). Cosmetic Testing in 2000 and Beyond, Cosmet.
Toil. 115 (1), 37-41
4.張俊祥 金鳴鐸 邱顯清 合著，皮膚科學手冊，合記圖書出版社
5.Howard Donsky, (1985). Beauty is skin deep, Rodale Press, Emmaus,
Pennsylvania
6.蘇信義 羅文福 編譯，基礎皮膚科學，合記圖書出版社，民國75年
7.光井武夫編 新化妝品學，南山堂株式會社出版，合記圖書出版社發行，1992
8.Johann W. Wiechers, (2000). Avoiding Transdermal Cosmetic Delivery, Cosmet.
Toil. 115 (2), 39-46
9.P. Morganti, A. Fionda and L. Tiberi, (1999). The transdermal cosmetic
delivery system, Cosmet. Toil. 114 (2), 53-58
10.周欣初 編譯，天然物化妝品，渡假出版社，民國80年
11.郁仁貽 編譯，最新化妝品學，復文書局，民國81年
12.包于珊 主編，化妝品學，中國紡織出版社，1998
13.張麗卿 編著，化妝品檢驗，中國紡織出版社，1998
14.Anon, (1986). Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Offical Journal of the European Communities L358, 1-29
15.Charles Fox, (2001). Literature and Patent Review: Analytical and Test Methodologies 1999-2000, PartⅠ, Cosmet. Toil. 116 (4), 69-86
16.Moskowitz, H. R. (1984). Cosmetic Product Testing, Marcel Decker, New York.
17.Rietschel, R.L.,Spencer,T.S.(1990). Methods for Cutaneous Investigenation,Marcel Decker, New York.
18.Bruce,R.D.(1985). An Up-and-Down Procedure for Acute Toxicity Testing. Fundam Appl. Toxicol. 5, 151-157
19.Draize,J.H., Woodard, G., and Calvery, H.O., (1944). Method for the study
of irritation and toxicity of substances applied topically to the skin and
mucous membrances. J. Pharmacol. Exp. Ther. 82,377-390
20.Michael K. Robinson, Rosemarie Osborne and Mary A. Perkins, (1999).
Strategies for the assessment of acute skin irritation potential, J. Pharmacol
Toxicol, 42, 1-9
21.Federal Register: Methods of Testing Primary Irritant Substances, 38 (187),
1500, 41, September 27, 1973
22.Lansdown, A.B.G.(1972). An Appraisal of Methods for Detecting Primary Skin
Irritants. J Soc Cosme Chem, 23, 39-72
23.江建勳，眼刺激試驗之新判定基準，藥物食品簡訊第153期，4頁，民國82年
24.L. K. Earl, A. D. Dickens and M. J. Rowson, (1997). A Critical Analysis of
the Rabbit Eye Irritation Test Variability and its Impact on the Validation of
Alternation Methods, Toxicology in Vitro,11, 295-304
25.M. Cottin and A. Zanvit, (1997). Fluorescein Leakage Test: a Useful Tool in
Ocular Safety Assessment, Toxicology in Vitro, 11, 399-405
26.Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics,
Association of Food, Drugs Officials of the United States. 1959.
27.D. A. Basketter, M. Chamberlain, H. A. Griffiths, M. Rowson, E. Whittle and
M. York, (1997). The Classification of Skin Irritants by Human Patch Test,
Food and chemical toxicology, 35, 845-852
28.Michael Balls, James Bridges, Jacqueline Southee. Ed., (1991). Animal and
Alternative in Toxicology. Macmillan Academic and Professional Ltd.
29.江建勳，實驗動物可以取代嗎？，國家實驗動物繁殖及研究中心簡訊，第6卷，第2期
，2-6頁，民國87年
30.Freeberg,F.E., Nixon,G.A., Griffith,J.F.,(1986). Human and Rabbit Eye
Responses to Chemical Insult, Fund. Applied Toxicol. 7, 626-634
31.J. J. M. van de Sandt and A.A.J.J.L. Rutten, (1995). Differential Effects
of Chemical Irritants in Rabbit and Human Skin Organ Cultures, Toxicology In
Vitro, 9, 157-168
32.R. Roggeband, M. York, M. Pericoi and W.Braun, (2000). Eye irritation
responses in rabbit and man after single application of equal volumes of
undiluted model liquid detergent products, Food and Chemical Toxi., 38, 727-734
33.Jacques LeClaire, Odile de Silva, (1998). Industry experience with
alternative methods, Toxicology Letters, 102-103, 575-579
34.M. Balls, (1992). What should the cosmetic industry do about the animal
testing controversy?, Int J Cosmet Sci., 14, 1-9
35.L. Gilleron, S. Coecke, M. Sysmans, E. Hansen, (1997). Evaluation of the
HET-CAM-TSA Method as an Alternative to the Draize Eye Irritation Test,
Toxicology. In vitro. 11, 641-644
36.M. Boue-Grabot, G. Bernardin, S. Chaumond and J. F. Pinon, (1995).
Alternative methods: Hen’s egg chorioallantoic membrance and in vitro
cytotoxicity – a complementary approach, Int J Cosmet Sci,17, 207-215
37.Katrin Kriwet and Nancy L. Parenteau, (1996). In Vitro Skin Models: Tools
for testing topical formulations, Cosmet. Toil. 111 (2), 93-102
38.J. N. Lawrence, S. Starkey, F. M. Dickson and J. Benford, (1996). Use of
Human and Rat Keratinocyte Culture to Assess Skin Irritation Potential,
Toxicology in Vitro,10, 331-340
39.Griffith,J.F., (1987). The Low Volume Eye Irritation Test: A More
Predictive and More Human Approach to Eye Irritancy Evaluation. Soap/Cosmetics/
Chemical Specialties, April, 32-67
40.S. D. Gettings, R. A. Lordo, P. I. Feder and K. L. Hintze, (1998). A
comparison of Low Volume, Draize and In Vitro Eye Irritation Test Data.Ⅱ. Oil/
Water Emulsions, Food and Chemical Toxicology, 36, 47-59
41.何敏夫 編著，臨床生化學，合記出版社，民國79年
42.甘偉松，藥用植物學，國立中國醫藥研究所出版
43.林景彬 林宗平 林宗旦 編著，中藥藥理學，華香園出版社，民國85年
44.高本釗，新編中藥大辭典，新文豐出版公司
45.陳榮福 編著 顏焜熒 校審，中藥藥理學，國立中國醫藥研究所，民國85年
46.顏焜熒 編著，常用中藥之藥理，國立中國醫藥研究所