Lidocaine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 Lidocaine Water-based Medical Patch

廖柏翔(Po-hsiang Liao)

指導教授 ： 許世興

朝陽科技大學/理工學院/應用化學系/碩士(2012年)

摘要

神經痛，即是因為神經系統受損而造成的疼痛。神經痛是一種症狀，可由各種不同的神經疾病造成，它的表現跟一般組織損傷後的疼痛不同，包括刺痛、針扎、電擊、撕裂、灼熱、冰冷、麻痺、癢等等，有時會合併產生不同程度的異常感覺，使用Lidocaine貼布可治療神經痛，大大減少口服藥物的副作用，對於可能需服用多種藥品的老年人來說，是一大福音。
本實驗建立新的分析方法來檢測含有Lidocaine 水性藥膠布，使用的移動相為甲醇及3%二乙胺水溶液(pH 4 )比例為60︰40，搭配Hypersil-ODS
C18 4.6 × 250mm (5 μm)的層析管柱，偵測波長設定在 263 nm，流速為1.0 mL/min，注射量10 μL。在確效方面，Lidocaine 的線性回歸係數R2 ＝ 0.9996，相對標準偏差(RSD)介於0.063%與0.554 之間，三重覆平均回收率為97.4%。偵測極限和定量極限分別為1.3 ppm以及4.3 ppm。
在自製的Lidocaine水性藥膠中，利用高效能液相層析儀(HPLC)，經過長時間及不同溫度來分析成份的含量，藉以探討成份的安定性。自製的Lidocaine水性藥膠布在室溫( 25 ±2°C/75 ±5% RH )及加速( 40 ±2°C/60 ±5% RH)的安定性試驗條件下進行6個月實驗，室溫試驗的Lidocaine含量衰退3.5%；加速試驗的Lidocaine含量衰退5.7%。

關鍵字

利度卡因

並列摘要

Neuralgia is a kind of pain caused by damage nervous system. This symptom comes with different pains. However, it is quite different from the pain of tissue injury. Such pains are like stabbing, electric shocking, freezing, paralyzing, and itching etc. Sometimes, the pains will combine with the different feeling of pains. Lidocaine patch is a medicine for treating Neuralgia. The drug delivery via skin will reduce a lot of side effects compared with taking pills and also have a huge benefit for old age people, who often need to take pills.
This study developed a new analytical method for detecting Lidocaine water-based patch. Chromatographic determination with a HPLC system is equipped with Hypersil-ODS C18 4.6 × 250mm (5μm) column. The mobile phase is methanol mixed with 3% ethylenediamine, pH 4 aqueous solution with the ratio of 60 to 40, UV-Vis absorption set at 263 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 Lidocaine is 0.9996, the relative standard deviation (RSD) is between 0.063% and 0.554%, the average recovery was 97.4 % and the limits of detection and quantification is 1.3 ppm and 4.3 ppm, respectively.
The high-performance liquid chromatography(HPLC) was used to analyze the content of Lidocaine in self-made water-based medical patch during a period of time under different temperature conditions. The self-made Lidocaine 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 Lidocaine declines 3.5% in the normal-temperature test and declines 5.7% in the accelerated test.

並列關鍵字

Lidocaine

參考文獻

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