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醋酸地塞米松冰片霜的制备及质量控制
Preparation and Quality Control of Dexamethasone Acetate Borneol Cream
【摘要】 目的:制备醋酸地塞米松冰片霜并建立其质量控制方法。方法:以研磨法制备霜剂;采用薄层色谱法鉴别醋酸地塞米松与苯酚,紫外分光光度法测定其中主药的含量。结果:所制制剂鉴别、检查等均符合2005年版《中国药典》相关规定;醋酸地塞米松检测浓度的线性范围为12.06~28.14μg.mL-1(r=0.9997),平均回收率为98.52%(RSD=0.66%)。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。
【Abstract】 OBJECTIVE:To prepare dexamethasone acetate borneol cream and to establish its quality control method.METHODS:Dexamethasone acetate borneol cream was prepared by grinding method;dexamethasone acetate and phenol were identified by TLC,and the content of the principal agent was determined by ultraviolet spectrophotometry.RESULTS:The prepared cream fitted the description of China Pharmacopeia(2005 edition) in identification and tests etc.The linear range of dexamethasone acetate was 12.06~28.14 μg·mL-1(r=0.999 7),and the average recovery rate of 98.52%(RSD=0.66%).CONCLUSION:The preparation is reasonable in compounding,simple and feasible in techniques,and its quality is stable and controllable.
【Key words】 Dexamethasone acetate borneol cream; TLC; Ultraviolet spectrophotometry; Preparation; Quality control;
- 【文献出处】 中国药房 ,China Pharmacy , 编辑部邮箱 ,2008年04期
- 【分类号】R94
- 【被引频次】3
- 【下载频次】122