复方盐酸洛美沙星凝胶的制备及质量控制  

Preparation and Quality Control of Compound Lomefloxacin Hydrochloride Gel

作　　者：王树平 张广求 刘文 

机构地区：[1]湖北省黄冈市第一人民医院药剂科,湖北黄冈438000

出　　处：《中国药业》2008年第11期40-42,共3页China Pharmaceuticals

摘　　要：目的制备复方盐酸洛美沙星凝胶并建立其质量控制方法。方法以盐酸洛美沙星和替硝唑为主药、以壳聚糖和甘油为基质制备水溶性阴道凝胶;采用等吸收双波长紫外分光光度法测定含量,并进行稳定性试验。结果凝胶的pH值为3.5～4.5,其他各项检查均符合有关规定。盐酸洛美沙星质量浓度的线性范围为2.4～10.8μg/mL(r=0.9999),平均回收率为99.62%,RSD=0.64%;替硝唑质量浓度的线性范围为3.2～14.4μg/mL(r=0.9995),平均回收率为99.58%,RSD=0.89%。结论该制剂制备工艺简单,性质稳定,质量可控。Objective To prepare compound lomefloxacin hydrochloride gel and to establish a method for its quality control. Methods The vaginal gel was prepared by taking lomefloxacin hydrochloride and tinidazole as main components,chitosan and glycerol as base material. The determination of its content was established with equal absorption at two different wavelengths by UV- spectrophotometry. Stability test was also preformed. Results The gel pH value was 3.5- 4. 5, other tests accorded with the requirements of gel. The linear range of lomefloxacin hydrochloride was 2. 4 - 10. 8 μg/mL （ r = 0.999 9）. The average recovery rate was 99.62% and RSD was 0. 64%. The linear range of tinidazole was 3.2- 14.4 μg/mL （r= 0.999 5）.The average recovery rate was 99.58% and RSD was 0.89%. Conclusion The preparation of the gel is simple. The gel is stable and its quality can be controlled.

关 键 词：盐酸洛美沙星 替硝唑 壳聚糖 凝胶 制备 质量控制 

分 类 号：R944.15[医药卫生—药剂学] R978.69[医药卫生—药学]