美洛昔康的含量測定和穩定性考察

制藥工程論文編號:ZY077    論文字數:10038,頁數:26

目  錄
中文摘要 I
英文摘要 II
目錄 III
1. 緒論 1
 1.1 概述 1
 1.2 紫外可見光譜 2 
 1.3高效液相色譜法 4
2. 實驗部分 8
 2.1 儀器與試劑 8
 2.2 紫外實驗 8
 2.3 HPLC實驗 9
3. 結果與討論 11
 3.1 紫外的結果與討論   11
 3.2 高效液相色譜的結果與討論  13
4．總結與展望 18
致謝 20
參考文獻 21

摘要：美洛昔康是一種非甾體抗炎藥，有很強的抗炎鎮痛作用。臨床研究表明美洛昔康可有效地治療風濕關節炎和骨關節炎，相對于傳統的抗炎藥更加安全、長效，且副作用更低。本論文用紫外分光光度法來測定制劑中美洛昔康的含量，用高效液相色譜法來考察美洛昔康的穩定性并測定美洛昔康的有關物質及降解產物的含量。結果表明，美洛昔康的最大吸收波長為372nm，美洛昔康在0.580～0.869µg/ml濃度范圍內線性關系良好，可得回歸方程為：Y=0.4785X+0.0138，R=0.9996；美洛昔康的有關物質及降解產物的測定采用反相高效液相色譜法，流動相選擇為0.05mol/L磷酸二氫銨(pH4.5)—甲醇(47:53)，檢測波長370nm，結果表明，美洛昔康對酸、氧化劑、光不穩定，對堿和高溫較穩定。
關鍵字：紫外—可見分光度法；高效液相色譜法；美洛昔康

Abstract: Meloxicam is a non-steroidal anti-inflammatory drugs. It has a strong anti-inflammatory analgesic effect. Clinical studies show that meloxicam is effective in treating rheumatoid arthritis and osteoarthritis. Compared with traditional anti-inflammatory drugs, meloxicam is safer, long-lasting, less side effects.  In this thesis, the content of meloxicam was assayed by ultraviolet spectrophotometry method in preparations. High performance liquid chromatography was used to study the stability of meloxicam and to detect the related substances and degradation products of meloxicam. The results show that meloxicam maximum absorption at wavelength of 372nm. In the range of 0.580 ~ 0.869μg/ml, a good linear relationship isaccepted with, the availability of the regression equation: Y = 0.4785X +0.0138, R = 0.9996; U.S. Related substances and degradation products of meloxicam was determined by RP-HPLC, with the mobile phase 0.05mol / L ammonium dihydrogen phosphate (pH4.5) - methanol (47:53), the detection wavelength: 370nm. The results suggest that meloxicam is instable on acid, oxidants, light couditions and it is stable on alkali and heat couditions.
Keywords：UV - Vis Spectrophotometry；HPLC；Meloxicam