含維他命A酸軟膏之安全性評估

Evalution of the Safety of Vitamin a Acid-Containing Liniment

連淑華(Shwa-Hwa Lian) ； 魏秀義(Shiow-Yin Wey) ； 江建勳(Chieng-Hsun Chiang) ； 林嘉伯(Chia-Po Lin)

《藥物食品檢驗局調查研究年報》 12號 (1994/09) Pp. 140-147

https://doi.org/10.6946/ASRNL.199409.0140

摘要

用含藥化粧品維他命A酸軟膏來治療青春痘和保養皮膚已逐漸被人們廣泛接受，為了解其安全性，本實驗利用白兔及天竺鼠作為動物模式，進行皮膚毒性實驗及血清生化值、血液值檢測，以評估塗抹維他命A酸軟膏後是否會對皮膚及動物生理功能有不良影響。實驗結果顯示在進行皮膚毒性試驗時，動物均呈現皮膚刺激性反應，塗抹2~8星期時其皮膚有明顯範圍之紅斑和中度至嚴重性紅斑產生，這期間內之刺激反應程度似乎沒有顯著變化，但若塗抹至10星期後則動物皮膚刺激性反應增加，有中度至嚴重性紅斑或嚴重性紅斑甚至有輕微疤痕產生之現象，故顯示長期塗抹維他命A酸軟膏後會對皮膚產生刺激作用。據推測實驗動物塗抹0.025%維他命A酸軟膏之後，只有2.25%會經皮膚吸收參入體內(上標 (6))，其量甚小，而所測得之血清生化值和血液值皆正常，因此局部長期（10星期）塗抹維他命A酸軟膏似乎不會改變動物體內器官之正常功能。

關鍵字

維他命A酸 ； 皮膚毒性 ； 血清生化學 ； 血液學

並列摘要

Using medicinal cosmetics, such as vitamin A acid-containing liniment, to treat acne and to preseve skin health is gradually accepted by the public. To determine their safety, this study adopted rabbits and guinea-pigs as animal models to conduct dermal toxicity tests and to measure values of blood chemistry and hematology to evaluate the skin reactions and physiological functions after application of the liniment. The results show that all experimental animals revealed skin irritation reactions in varying degrees. During the local dermal application of liniment for two to eight weeks, the skins of both kinds of animals produce erythema, with obvious demarcation to erythema of a severe degree. After application of the liniment for 10 weeks, the degree of skin irritation reaction worsened. Erythema of a severe degree, even with scar formation was observed. It is clear, that local application of vitamin A acid-containing liniment over a long term will induce skin irritation reactions of different degrees. It is estimated that after application topically with 0.025% vitamin A acid-containing-liniment, only 2.25% of the liniment will be absorbed into the body through the skin. The values of blood chemistry and hematologay of experimental animals did not differ significantly from the normal. Local application of this liniment to the skin for 10 weeks did not change the normal physiological function of animals tested.