氟比洛芬涂膜剂的制备与质量控制

Preparation and Quality Control of Flurbiprofen Plastic

目的研制氟比洛芬涂膜剂,并建立质量控制方法。方法选用壳聚糖、卡波姆为成膜材料,按药剂学原理制备氟比洛芬涂膜剂;采用紫外分光光度法进行定性鉴别;采用高效液相色谱法测定氟比洛芬含量。结果氟比洛芬质量浓度在10～90μg/mL范围内与峰面积线性关系良好,平均回收率为100.21%,RSD为0.53%(n=9)。结论该品制备工艺合理,质量控制方法可靠。各项指标均符合2010年版《中国药典》涂膜剂项下相关规定。

Objective To prepare flurbiprofen plastic and to establish the standard for its quality control. Methods According to the pharmaceutical principle,flurbiprofen plastic was prepared with cbitosan and carbomer as the plastic materials. The spectropbotometry was used to qualitatively differentiate and HPLC was used to determine the content of flurbiprofen. Results The linear relationship range of flurbiprofen was 10-90 ug/mL,the average recovery rate was 100.21% ,and RSD 0. 53% （n =9）. Conclusion The preparing process is reasonable and the quality control method is reliable. Various indexes are accorded with the related slipulation under the plastic item in the Chinese Pharmacopoeia（edition 2010）.