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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。
Objective: To prepare dexamethasone acetate ice cream and establish its quality control method. Methods: The cream was prepared by grinding method. Dexamethasone acetate and phenol were identified by TLC. The content of main drug was determined by ultraviolet spectrophotometry. Results: The identification and examination of the prepared preparations were in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of dexamethasone acetate test was 12.06-28.14μg.mL-1 (r = 0.9997) with the average recovery of 98.52% (RSD = 0.66%). Conclusion: The preparation group is reasonable, the preparation process is simple and feasible, the quality is stable and controllable.