Diclofenac sodium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 Diclofenac sodium Water-based Medical Patch

戴文介(Wen-jie Tai)

指導教授 ： 許世興 ； 林美靜

朝陽科技大學/理工學院/應用化學系/碩士(2009年)

摘要

中文摘要
本實驗建立新的分析方法來檢測含有diclofenac sodium水性藥膠布，使用的移動相緩衝溶液0.005 M 磷酸鹽緩衝溶液（取等量0.005 M磷酸及0.005 M磷酸二氫鈉液混合。以1 %磷酸調pH 2.5 ）：甲醇＝20：80，搭配ODS Hypersil 250 × 4.6 mm (5 μm)的層析管柱，偵測波長設定在 280 nm，流速為1.0 mL/min，注射量10 μL。在確效方面，diclofenac sodium 的線性回歸係數R2＝0.9998，相對標準偏差(RSD)介於0.17 %〜1.62 %之間。準確度實驗的回收率則介於94％∼99.7％。將消炎藥物 diclofenac sodium 添加至自製的水性藥膠布中，利用高效能液相層析儀，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diclofenac sodium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diclofenac sodium含量衰退 6 %；加速試驗的diclofenac sodium含量衰退6.5 %。

關鍵字

雙氯酚酸鈉 ； 水性藥膠布

並列摘要

Abstract

The formulation of skin patch may alleviate pain and inflammation effectively,and eliminate the side effects.The mobile phases used for the analysis of diclofenac sodium water-based medical patch were prepared with mixing equal volumes of 0.005 M Phosphoric acid and 0.005 M monobasic sodium ohosphate .The 0.005 M NaH2PO4 and 0.005M Na2HPO4 buffer solution adjusted to pH 2.5 by 1% phosophoric Acid solution in Phosphates buffer solution and methanol which ratio was 20 to 80. Chromatogrphic determination was performed with a HPLC system equipped with ODS Hypersil 250 × 4.6 mm (5 μm) column. The analytical conditions were UV-Vis absorption set at 280 nm, flow rate set at 1.0 mL/min and an injection of 10 μL. In the result of validation experiments, the linear regression coefficient (R2) of diclofenac sodium was 0.9998, the relative standard deviation (RSD) was between 0.17% and 1.62%, the average recovery was 94%~99.7% .
The high-performance liquid chromatography (HPLC) was used to analyze the content of diclofenac sodium of self-made water-based medical patch during a period of time and in the different temperature conditions in order to probe into the stability of formulation. The self-made diclofenac sodium 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 dclofenac sodium declines6 % in the normal-temperature tests and declines 6.5 % in the accelerated tests.

並列關鍵字

Water-based Medical Patch ； Diclofenac sodium

參考文獻

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