- 學位論文
Amorolfine 抗甲癬劑指甲油配方及品管方法開發
The Development of Formula and Quality Control Method for Amorolfine in Antifungal of Nail Polish
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摘要
本研究將自製的指甲油，添加抗黴菌成份Amorolfine ，待其乾後即可形成有效持續穿透指甲角質層的防水薄膜。並建立一套新的HPLC分析方法來檢測指甲油中的Amorolfine成分；移動相使用的是甲醇：緩衝溶液 (0.3%三乙胺水溶液，pH 3 )＝85︰15，撘配ODS Hypersil 250×4.6 mm(5 μm)的層析管柱，偵測波長為220nm，注射量10 μL，流速1.0 mL/min，此分析方法可在8分鐘內完成。 在分析方法確效方面，Amorolfine的線性迴歸係數R2 = 0.9993，精密度實驗的相對標準偏差( RSD )介於0.03 % ~ 0.34 %之間，準確度實驗的回收率則介於98.1 % ~ 101.5 %。 將自製的Amorolfine不同顏色指甲油在室溫( 25±2℃)及加速( 40±2℃)的安定性試驗條件下進行6個月實驗，室溫試驗的Amorolfine含量衰退至80.4 % ~89.6%之間，而加速試驗的Amorolfine含量衰退至68.5% ~77.3%之間。
並列摘要
In this research, the antifungal ingredient, Amorolfine, was added to homemade nail polish when it was dry to form the effective and continuous waterproofing membrane and penetrate the nail cuticle. A HPLC method was established to detect the amorolfine nail polish with the mobile phase [methanol: buffer solution (0.3% triethylamine aqueous solution, pH 3) = 85:15]. Chromatographic methods was performed with a HPLC system equipped with ODS Hypersil 250×4.6mm(5 μm) column with UV/Vis absorption set at 220 nm, flow rate set at 1.0 mL/min and an injection of 10 μL as well as each runtime about ten minutes. In the result of analytical validation, the linear regression coefficient R2 was 0.9993, the relative standard deviations (RSD) ranged from 0.03% to 0.34%, and the recovery of the experiment ranged from 98.1% to 101.5%. In this experiment, the Amorolfine nail polish was placed in the room temperature condition(25±2℃) and the accelerated condition(40±2℃) for six-month stability tests, the content of Amorolfine was declined between 80.4% and 89.6% in the room temperature tests and was declined between 68.5% to 77.3% in the accelerated tests.
參考文獻
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