中藥美白化妝品其安全,品質與療效之評估; The safety and quality studies of Chinese herbs and their in vivo evaluations of whitening effect on human subjects

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题名:	中藥美白化妝品其安全,品質與療效之評估;The safety and quality studies of Chinese herbs and their in vivo evaluations of whitening effect on human subjects
作者:	張惠淇;Hui-Chi Chang
贡献者:	中國醫藥學院中國藥學研究所
关键词:	中草藥;安全性;酪胺酸;總抗氧化力;超氧歧化;麴酸;安定性;人體美白實驗;herbs;safety;tyrosinase;total antioxidant activity;SOD;kojic acid;stability;human whitening test
日期:	1991
上传时间:	2009-12-03 09:37:16 (UTC+8)
摘要:	參考歷代方劑中記載具美容功效之中藥材共五十四種，本研究進行包括藥材之安全試驗，美白、抗氧化及擬超氧歧化?活性之功效篩選，品質之評估，與人體療效之測定。安全性試驗內容包括：十五種中藥材的水及50%酒精萃取物之老鼠單一劑量口服致死劑量（LD50），結果顯示無毒性。以Draize氏法評估五十四種中藥材水萃取液之兔子皮膚及眼睛刺激性試驗。除合歡皮水萃取液初期皮膚有輕微紅斑外，其餘均無刺激性或眼睛刺激性。本研究將中藥材之水、甲醇萃取物與酪胺酸及酪胺酸?，在37℃、pH 6.8的條件下反應30分鐘，測其抑制酪胺酸?氧化作用的效果。水萃取物部分，牡丹皮、天門冬、桃仁等，有大於65% 的酪胺酸?活性抑制率。甲醇萃取物部分，白芷、桃仁、桔梗等，有大於60%的抑制率。利用ABTS/H2O2/HRP分析系統，作為抗氧化活性測定，結果顯示牡丹皮、女貞子、桑葉等，有高的總抗氧化力活性。以NBT還原法測試藥材中清除·O2-的能力，間接測定SOD的量。結果顯示女貞子、益智仁、細辛等，具有強的擬超氧歧化?活性。本研究另進行美白對照品麴酸之安定性分析，分解之檢品以高效液相層析與二極體列陣檢測分析層析峰之純度。麴酸溶液受pH值及溫度之影響，其反應皆遵循擬一級分解反應模式。本研究篩選出有潛力的中藥材：女貞子、牡丹皮、白芷，製成凝膠劑。進行凝膠之粘度、pH、味道及外觀之安定性試驗。顯示該凝膠劑之品質無變化。本研究另對美白試驗之對照品麴酸，進行安定性分析，已分解之檢品以高效液相層析與二極體列陣檢測，分析層析峰之純度，同時，亦研究麴酸於不同溫度下、酸鹼溶液中之安定性。三十五名受試者進行美白試驗，為期四週。結果顯示，實驗組之黑色素指數明顯下降。; Fifty-four Chinese herbs, which were listed in Chinese medical textbook as the whitening material for cosmetics, had been used to evaluate: the safety, the inhibition of tyrosinase activity, the total antioxidant activity, and the SOD-like activity. Both aqueous and 50% ethanol extacts showed no toxicity and no skin and eye irritation response. Even mild skin and eye irritation were found in the aqueous extracts of Albizziae Cortex, Arctium lappa, and Angelicae Sinensis Radix. All the fifty-four herbs were considered no irritation according to Draize’s evaluation standard. The extracts of Moutan Radix Cortex, Persicae Semen, Asparagi Radix, Angelicae Dahuricae Radix and Platycodi Radix, showed a potent inhibitions of tyrosinase. The Moutan Radix Cortex, Ligustri Lucidi Fructus, and Mori Folium showed the highest total antioxidant activity (TAA) levels. The Ligustri Licidi Fructus, Alpiniae Oxyphyllae Fructus and Asari Herba Radice showed the strongest SOD-like activities. The extracts of potential herbs: Ligustri Lucidi Fructus, Moutan Radix Cortex, and Angelicae Dahuricae Radix, were then prepared as the gel dosage from. The stability test of these gels were performed. Kojic acid was used as a control in human whitening test. A stability indicating HPLC procedure and stability study of kojic acid were investigated. The whitening gels were applied to 35 volunteers for four weeks. The melanin index showed that the test groups were significantly lower.
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