肤美松乳膏的制备及质量控制

目的:制备肤美松乳膏并建立其质量控制方法。方法:以尿素、醋酸曲安奈德、樟脑、氮酮等为组方,用水包油基质制备乳膏;采用高效液相色谱法测定其中主药醋酸曲安奈德的含量。结果:所制制剂为白色乳膏,各项检查均符合2005年版《中国药典》的相关规定;醋酸曲安奈德检测浓度的线性范围为2.06~20.6μg·mL-1(r=0.9996),平均回收率为99.6%(RSD=1.0%,n=9)。结论:本制剂制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of Fumeisong Cream

OBJECTIVE: To prepare fumeisong cream and establish its quality control method. METHODS: Ingredients including carbamide, triamcinolone acetonide acetate, camphor, and laurocapram were mixed in an oil-in-water matrix for preparation of fumeisong cream. HPLC was adopted to determine the content of triamcinolone acetonide in the cream. RESULTS: The prepared cream was white in color, with test items all in line with specifications stipulated in 2005 version of China Pharmacopoeia. The linearity concentration range of triamcinolone acetonide was 2.06～20.6 μg·mL-1(r=0.999 6) and the average recovery rate was 99.6% (RSD=1.0%,n=9). CONCLUSION: The cream is simple and feasible in preparation techniques, and its quality is stable and controllable.