Flurbiprofen水性藥膠布配方改良及品管方法建立

The Improvement of Formula and The Development of Quality Control Method for Flurbiprofen Water-based Medical Patch

張呈彰(Cheng-Chang Chang)

指導教授 ： 許世興

朝陽科技大學/理工學院/應用化學系/碩士(2011年)

摘要

氟比洛芬是丙酸類的非類固醇止痛及抗發炎藥物(non-steroid anti-inflammatory drug；NSAID)，主要的作用是能抑制體內造成關節疼痛和發炎腫脹的化學物質「前列腺素」的產生。但是現有的口服用藥模式，往往會傷害消化道、腎臟、肝臟，因而導致不幸或死亡的藥物副作用，經皮膚治療是比較安全的給藥模式。
本實驗建立新的分析方法來檢測含有Flurbiprofen水性藥膠布，使用的移動相為甲醇：0.15%醋酸水溶液(26mM，pH為3 )＝75︰25，搭配Eclipse XDB-C18 4.6 ×250mm (5 μm)的層析管柱，偵測波長設定在 254 nm，流速為1.0 mL/min，注射量10 μL。在確效方面，Flurbiprofen 的線性回歸係數R2＝0.9999，相對標準偏差(RSD)介於0.021 %〜0.766 %之間。平均回收率為97.07 %。偵測極限和定量極限分別為0.1 ppm（2 ng）以及0.3 ppm（6 ng）。
將消炎藥物Flurbiprofen添加至自製的水性藥膠布中，利用高效能液相層析儀(High-performance liquid chromatography；HPLC)，經過長時間及不同溫度來分析成份的含量，藉以探討其成份的安定性。自製的Flurbiprofen水性藥膠布在室溫( 25 ±2°C／60 ±5% RH )及加速( 40 ±2°C／75 ±5% RH )的安定性試驗條件下進行6個月實驗，室溫試驗的Flurbiprofen含量衰退 3.57 %；加速試驗的Flurbiprofen含量衰退4.44 % 。

關鍵字

水性藥膠布 ； 品管方法 ； 氟比洛芬

並列摘要

Flurbiprofen is a member of propionic acid derivative family of used non-steroid anti-inflammatory drug (NSAID) which is used to inhibit the chemical substances "prostaglandins" that caused swelling of joint pain and inflammation in human body. Report show that the mode of oral dosage form medication form Flurbiprofen injures the digestive tract, kidney and liver, and the adverse effect patch dosage form result in the illness or even death, While the mode for skin absorption is relatively safe.
This study gave a new analytical method for detecting Flurbiprofen contained water-based platch containing Flurbiprofen. Chromatographic determination with a HPLC system is equipped with Eclipse XDB-C18 4.6×250mm (5μm) column, The mobile phase is methanol and 26mM acetic acid with of ratio 75 to 25, UV-Vis absorption set at 254 nm, flow rate set at 1.0 mL/min and an injection of 10 μL. In the result of validation experiment, the linear regression coefficient (R2) of Flurbiprofen is 0.9999, the relative standard deviation (RSD) is in between 0.021 % and 0.766 %, the average recovery was 97.07 % and the limits of detection and quantification is 0.1 ppm ( 1 ng ) and 0.3 ppm ( 3 ng ), respectively.
The high-performance liquid chromatography (HPLC) is used to analyze the content of Flurbiprofen of self-made water-based medical patch during a period of time under different temperature conditions. The self-made Flurbiprofen water-based medical patch was placed in the room- temperature condition (25±2°C / 60±5%RH) and the accelerated condition (40±2°C / 75±5%RH) for six-month stability tests, the content of Flurbiprofen declines 3.57 % in the normal-temperature tests and declines 4.44 % in the accelerated tests.

並列關鍵字

Water-based Medical Patch ； Flurbiprofen ； Quality Control Method

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