复方奥硝唑壳聚糖口腔溃疡药膜的制备及其质量控制

Preparation and Quality Control of Compound Ornidazole Chitosan Oral Ulcer Pellicles

目的：制备复方奥硝唑壳聚糖口腔渍疡药膜，并对其质量进行控制。方法：以奥硝唑为主药配伍地塞米松，以壳聚糖为载体制备复方奥硝唑壳聚糖口腔溃疡药膜。采用高效液相色谱法测定其中奥硝唑的含量。结果：所制制剂为半透明淡黄色薄膜，鉴别、检查项均符合2010年版《中国药典》中的相关规定；奥硝唑检测质量浓度的线性范围为1．2-24μg／ml（r=0．9999），平均回收率为99．1％，RSD为1．68％。结论：本制剂制备工艺简便可行，质量稳定可控。

OBJECTIVE ： To prepare Compound omidazole chitosan oral ulcer pellicles, and to control the quality of it. METH- ODS： Ornidazole was used as main component to prepare dexamethasone. Compound ornidazole chitosan oral ulcer pellicles were prepared by using chitosan as carrier. The contents of omidazole were determined by HPLC. RESULTS： The preparation was semi- transparent yellowish pellicles. Its identification and check fitted to the regulation of Chinese Pharmacopeia （2010 edition）. The lin- ear ranges of omidazole were 1.2-24 μg/ml （r=0.999 9） with an average recovery of 99.1% （RSD=1.68%）. CONCLUSIONS： The preparation technique is simple, feasible and controllable in quality.