美洛昔康的含量测定和稳定性考察

制药工程论文编号:ZY077    论文字数:10038,页数:26

目  录
中文摘要 I
英文摘要 II
目录 III
1. 绪论 1
 1.1 概述 1
 1.2 紫外可见光谱 2 
 1.3高效液相色谱法 4
2. 实验部分 8
 2.1 仪器与试剂 8
 2.2 紫外实验 8
 2.3 HPLC实验 9
3. 结果与讨论 11
 3.1 紫外的结果与讨论   11
 3.2 高效液相色谱的结果与讨论  13
4．总结与展望 18
致谢 20
参考文献 21

摘要：美洛昔康是一种非甾体抗炎药，有很强的抗炎镇痛作用。临床研究表明美洛昔康可有效地治疗风湿关节炎和骨关节炎，相对于传统的抗炎药更加安全、长效，且副作用更低。本论文用紫外分光光度法来测定制剂中美洛昔康的含量，用高效液相色谱法来考察美洛昔康的稳定性并测定美洛昔康的有关物质及降解产物的含量。结果表明，美洛昔康的最大吸收波长为372nm，美洛昔康在0.580～0.869µg/ml浓度范围内线性关系良好，可得回归方程为：Y=0.4785X+0.0138，R=0.9996；美洛昔康的有关物质及降解产物的测定采用反相高效液相色谱法，流动相选择为0.05mol/L磷酸二氢铵(pH4.5)—甲醇(47:53)，检测波长370nm，结果表明，美洛昔康对酸、氧化剂、光不稳定，对碱和高温较稳定。
关键字：紫外—可见分光度法；高效液相色谱法；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