复方左氧氟沙星喷雾剂的制备及质量控制

Preparation and Quality Control of Compound Levofloxacin Spray

目的:研制复方左氧氟沙星喷雾剂并对其质量进行控制。方法:将左氧氟沙星和其它辅药制成喷雾剂,用紫外分光光度法测定盐酸左氧氟沙星含量。结果:盐酸左氧氟沙星浓度在2-8μg·ml-1范围内,线性关系良好(r=0．999 9,n=5),平均回收率99．9％,RSD=0．4％。结论:本制剂处方合理,质控方法可靠。

Objective： To study the methods of preparation and quality control of compound levofloxacin spray. Method： The spray was prepared by hydrochlorid levofloxacin and other subsidiary ingredient, the concentration of levofloxacin hydrochloride was measured by UV spectrophtometry. Result： Liner range was 2-8μg· ml^-1（ r = 0. 999 9, n = 5 ）, the average recovery was 99.9%, with RSD 0.4%. Conclusion： The prescription of preparation is rational, and the method of quality control is relible.