复方地塞米松搽剂的制备及质量控制

目的:研制复方地塞米松搽剂,建立该制剂的质量控制标准.方法:以乙醇为溶媒,应用溶解法制备复方地塞米松搽剂.采用紫外分光光度法测定复方地塞米松搽剂中醋酸地基米松的含量.结果:制备的制剂澄清、透明,醋酸地塞米松在7.5～17.5 mg/L范围内线性关系良好,回归方程:C=28.5299A 0.05125,r=0.9999(n=5,P＜0.01),高、中、低浓度平均回收率分别为102.55%,101.40%和102.08%,平均RSD分别为0.69%,1.35%和1.16%.结论:本制剂简单、合理,质量控制方法快速、准确.

Study on the preparation and quality control of compound dexamethasone liniment

Objective: To investigate the preparation and quality control of compound dexamethasone liniment. Methods: The compound dexamethasone liniment was prepared by taking alcohol as a solvent. The content of dexamethasone acetate in the formulation was determined by ultra-violet spectrophotometry. Results: The liniment was homogenous and transparent. The calibration curve of dexamethasone acetate was linear over the concentration range of 7.5 to 17.5mg/L. The regression equation was: C=28.5299.4 0.05125, r=0.9999(n=5,P<0.01), the average recoveries of high, medium and low concentrations for dexamethasone acetate were 102.55% , 101.40% and 102.08%, respectively. The mean relative standard deviations(RSD) were 0.69%, 1.35% and 1.16%, respectively. Conclusion: The formulation is simple and reasonable. The method of quality control is rapid and accurate.