美洛昔康温敏性水凝胶的制备及质量控制

Preparation and Quality Control of Thermosensitive Meloxicam Hydrogel

目的：制备美洛昔康温敏性水凝胶并建立其质量控制方法。方法：以泊洛沙姆P407、P188为基质制备温敏性水凝胶；采用紫外分光光度法测定其中主药的含量。结果：所制制剂为水溶性淡黄色或淡黄绿色透明凝胶，鉴别、检查均符合2005年版《中国药典》中的相关规定；美洛昔康检测浓度的线性范围为1．95619．56mg·L^-1（r=0．9997）；平均回收率为98．42％（RSD=1．53％）。结论：本制剂制备工艺简单，质量可控。

OBJECTIVE： To prepare thermosensitive meloxicam hydrogel and establish its quality control method METHODS： The hydrogel was prepared with poloxamer 407 and poloxamer 188 as base. The content of meloxicam in the thermosensitive gel was determined by UV spectrophotometry. RESULTS： The thermosensitive meloxicam hydrogel was yellowish or flavovirens in color, with its identification and tests all in conformity with the related specification stated in Chinese Pharmacopeia （2005 edition）. The linear response range of meloxican was 1.956-19.56 mg · L^-1 （r = 0.999 7）. The average recovery was 98.42% （RSD = 1.53%） . CONCLUSION： The preparative technique is simple, and the quality of the preparation is controllable.