Indomethacin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 Indomethacin Water-based Medical Patch

陳志安(Chih-An Chen)

指導教授 ： 許 世 興

朝陽科技大學/理工學院/應用化學系/碩士(2009年)

摘要

indomethacin為一種「非固醇類止痛及抗發炎」藥物，主要的作用是解除關節僵硬、疼痛、發炎的現象。但是現有的口服用藥模式，往往會傷害消化道、腎臟、肝臟，因而導致不幸的藥物副作用或死亡意外。將非類固醇類消炎藥物製備成外用藥布後，不但可以有效止痛消炎，而且還可以降低或避免口服非類固醇類消炎藥物的副作用。
本實驗建立新的分析方法來檢測含有indomethacin水性藥膠布，使用的移動相為0.0025 M NaH2PO4及0.0025 M Na2HPO4 (以0.2 N NaOH溶液調整pH值至8.0)溶於35%乙腈水溶液，搭配ODS Hypersil 250 × 4.6 mm (5 μm)的層析管柱，偵測波長設定在 268 nm，流速為1.0 mL/min，注射量10 μL。在確效方面，indomethacin的線性回歸係數R2＝0.9996相對標準偏差(RSD)介於0.12 %〜0.21 %之間。準確度實驗的回收率則介於94％∼97％。將消炎藥物indomethacin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indomethacin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indomethacin含量衰退 5.78 %；加速試驗的indomethacin含量衰退6.02 % 。

關鍵字

水性藥膠布 ； Indomethacin

並列摘要

indomethacin being as non-steroid anti-inflammatory drug medicine function mainly to relieve the symptoms of stiffness pain inflammation . The treatment of these medicine by oval means may often cause damage to kidney liver and dugestung track and even to death due to severe side effect.
The formulation of these as skin patch may alleviate pain and inflammation effectively and eliminate the as we side effects The mobile phases used for the analysis of indomethacin water-based medical patch were prepared with 0.0025 M NaH2PO4 and 0.0025M Na2HPO4 solution in acetonitrile and water which ratio was 35 to 65. The 0.0025 M NaH2PO4 and 0.0025M Na2HPO4 buffer solution was adjusted to pH 8 by 0.2 N NaOH solution. 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 268 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 indomethacin was 0.9996 the relative standard deviation (RSD) was between 0.12 % and 0.21 %, the average recovery was 94%~97 % .

The high-performance liquid chromatography (HPLC) was used to analyze the content of indomethacin 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 indomethacin 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 indomethacin declines 5.78% in the normal-temperature tests and declines 6.02 % in the accelerated tests.

並列關鍵字

Water-based ； Indomethacin

參考文獻

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