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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。
OBJECTIVE: To prepare psoriasis cream and establish its quality control method. Methods: Urea, triamcinolone acetonide, camphor, azone and so on were used as the prescriptions to prepare creams with oil-in-water matrix. The contents of triamcinolone acetonide acetate were determined by high performance liquid chromatography. Results: The preparations were white cream. All the tests were in accordance with the requirements of the 2005 edition of “Chinese Pharmacopoeia”. The linear range of the concentration of triamcinolone acetonide was 2.06 ~ 20.6μg · mL-1 (r = 0.9996) The recovery was 99.6% (RSD = 1.0%, n = 9). Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.