复方奥硝唑口腔溃疡膜的研制与质量评价

Preparation and quality control of compound ornidazole and dexamethason acetate oral ulcer film

目的对复方奥硝唑口腔溃疡膜的配制、含量测定和稳定性进行研究。方法用壳聚糖、甘油、明胶为主要辅料,流涎法制备复方奥硝唑口腔溃疡膜,用紫外分光光度法,分别对奥硝唑和醋酸地塞米松进行含量测定,并考察其稳定性。结果奥硝唑和醋酸地塞米松的平均回收率分别为99.4%和99.58%,RSD为1.07%和0.75%(n=3)。结论该制剂制备工艺简单,质量可控。

OBJECTIVE To study the prescription and preparation of compound ornidazole oral ulcer film, and set up a method of quality control. METHODS The film was prepared using chitosan as main excipients. Ornidazole and dexamethason acetate was determined by UV-spectrophotometry. RESULTS The average recoveries of ornidazole and dexamethason acetate were 99,4 % and 99.58 %, with RSD 1.07 % and 0.75 % （n = 3）, respectively. CONCLUSION The preparation process was simple and the quality could be controlled.