摘要
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基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。
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. 5 mg/L. The regression equation was： C = 28. 5299A ＋ 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.
出处
《药学实践杂志》
CAS
2005年第6期359-361,共3页
Journal of Pharmaceutical Practice
关键词
醋酸地塞米松
制备
紫外分光光度法
质量控制
dexamethasone acetate
preparation
ultra-violet spectrophotometry
quality control
