4MSK水膠面膜的配方與品管方法的開發

The Development of Formula and Quality Control Method for 4-Methoxy Salicylic Acid Hydrogel Mask

蔡易融(Yi-zong Tasi)

指導教授 ： 許世興

朝陽科技大學/理工學院/應用化學系/碩士(2010年)

摘要

4MSK(4-methoxy salicylic acid KCl)是一種藥用美白成分，其成分是從水楊酸衍生而來的。當4MSK在水溶液中是呈離子狀態，需要在酸性緩衝液才能保持穩定。
4MSK的主要作用在對於受到紫外線照射導致角質異常，而引起黑斑、雀斑的肌膚加以改善。具有「抑制麥拉寧(melanin)的生成，並且預防黑斑及雀斑的產生」。
本研究是建立一套新的 HPLC 分析方法來檢測水膠面膜中 4MSK美白成分的穩定性，移動相為0.1 % H3PO4 緩衝液 pH 3.0：甲醇，其比例為 40：60，連接 ODS Hypersil 250×4.6 mm(5μm) 的層析管柱，偵測波長為 254 nm，流速為 1.0 mL/min，注射量為 10μL，此分析條件可在6分鐘內完成。
在分析確效方面，4MSK 的線性迴歸係數R2 = 0.9998，精密度實驗的相對標準偏差RSD介於0.16 % ~ 0.69 % 之間；準確度實驗的回收率則介於98.7 % ~ 98.9 %。
在經皮穿透試驗方面，將自製的4MSK水膠面膜在 Nylon 濾膜及豬皮的穿透性，4MSK 在 3 hr 後的釋離率分別為 28.24 % 和 17.87 %；及其相對標準偏差( RSD )分別為 6.16 % 以下和 6.71 % 以下；穿透試驗的結果可以當作藥物經皮穿透數值的參考。
將本研究的4MSK水膠面膜放置於室溫( 25±2℃)及加速( 40±2℃)的安定性試驗條件下進行6個月的實驗，室溫試驗的4MSK含量衰退至98.4 %，而加速試驗的4MSK含量衰退至 92.5 %。

關鍵字

四甲氧基水楊酸鉀鹽 ； 高效能液相層析儀

並列摘要

4MSK(4-methoxy salicylic acid KCl) is one kind of whitening medicinal ingredients, which is derived from salicylic acid. 4MSK is ionized when dissolved in the water, which is stable in the acidic buffer condition. When skin was seriously suffered by the ultraviolet radiation to result in the abnormal cuticle of skin and arise from the formation of melasma and freckles. 4MSK can help to treat and improve these skin disease symptoms and restrain the formation of melanin and prevent the production of melasma and freckles.
In this research, a HPLC method was developed to determine the whitening ingredient of 4MSK in hydrogel mask. The mobile phases were prepared with 0.1 % H3PO4 buffer solution adjusted at pH 3 and methanol with the ratio of 40 to 60. Chromatographic methods were performed with a HPLC system equipped with ODS Hypersil 250×4.6 mm(5μm) column with UV/Vis absorption set at 254 nm, flow rate set at 1.0 mL/min and an injection of 10 μL as well as each runtime about six minutes.
In the result of analytical method validation, the linear regression coefficient (R2) was 0.9998, the relative standard deviations(RSD) of precision experiments were between 0.16 % ~ 0.69 %, and the recoveries of accuracy experiment were between 98.7 % ~ 98.9 %.
In the tests of transdermal penetration, the hydrogel masks of 4MSK were placed in nylon membrane and pig skin to do penetrating experiments, the release rates of 4MSK for three hours for nylon membrane and pig skin were 28.24 % and 17.87 %, respectively. The relative standard deviations(RSD) of penetration tests for nylon membrane and pig skin were 6.16 % and 6.71 % below, respectively. The results of penetration tests can be used as the reference of transdermal medicine.
In this experiment, the 4MSK hydrogel mask was placed in the room temperature condition( 25±2℃) and the accelerated condition(40±2℃) for six-month stability tests, the content of 4MSK was declined to 98.4% in the room temperature test and was declined to 92.5% in the accelerated test at the sixth month.

並列關鍵字

4MSK ； HPLC

參考文獻

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