复方奥硝唑壳聚糖阴道生物黏附膜的制备及质量控制

摘 要 目的:制备复方奥硝唑壳聚糖阴道生物黏附膜并建立其质量控制方法。方法: 以奥硝唑、盐酸环丙沙星为主药制备复方奥硝唑壳聚糖阴道生物黏附膜，采用高效液相色谱法测定其中主药的含量。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；盐酸环丙沙星、奥硝唑分别在27～540 mg·L^-1 （r=0.999 9），26.5～530 mg·L^-1 （r=0.999 9）范围内呈良好线性关系，方法的平均回收率：盐酸环丙沙星为99.52%，RSD为1.0%；奥硝唑为97.98%，RSD为0.41%。结论:本制剂制备工艺简便可行，质量稳定可控。

Preparation and Quality Control of Compound Ornidazole Chitosan Vaginal Bioadhesive Films

Objective： To prepare compound omidazole chitosan vaginal bioadhesive films and establish the quality control meth- od. Method： Compound ornidazole ehitosan vaginal bioadhesive films were prepared using ciprofloxacin hydmchloride and ornidazoie as the main ingredientsl The contents of the chief ingredients were determined by HPLC. Result： The preparation was semitransparent yellowish films and met the requirements of identification and test items in China Pharmacopeia （2010 edition）. The linear range of ciprofloxaein hydrochloride and ornidazole was 27-540 mg·L^-1 （ r = 0. 999 9 ） and 26.5-530 mg ·L^-1 （ r = 0.999 9 ） , respectively. The average recovery was 99.52% （ RSD = 1.0% ） and 97.98 % （ RSD = 0.41% ） accordingly. Conclusion： The preparation proeedure is simple and feasible, and the quality is stable and controllable.