复方地塞米松搽剂的制备及质量控制

Preparation and Quality Control of Compound Dexamethasone Liniment

目的:制备复方地塞米松搽剂并建立其质量控制方法.方法:以氮酮为促透剂、乙醇为溶剂制备复方地塞米松搽剂,采用高效液相色谱法测定制剂中主药醋酸地塞米松和维生素 E的含量.结果:醋酸地塞米松、维生素 E检测浓度分别在 2～ 40μ g/ml、 80～ 800μ g/ml范围内呈良好线性关系,平均回收率分别为 100.5％（ RSD=0.82％）、 98.6％（ RSD=0.59％）.结论:该制剂处方合理,质量控制方法简便、准确.

OBJECTIVE： To establish a method for preparation and quality control of compound dexamethasone liniment. METHODS： The compound dexamethasone liniment were prepared with dexamethasone acetate and vitamin E, the contents were determined by HPLC. RESULTS： The calibration curves of dexamethasone acetate and vitamin E were linear in the range of 2～40μg/ml and 80～800μg/ml respectively, and their average recoveries were 100.5% （RSD= 0.82%） and 98.6% （RSD= 0.59% ） respectively. CONCLUSION： The preparation is reasonable in formula, simple and accurate in quality control.