目的:制备复方维A酸乳膏并建立其质量控制方法。方法:以维A酸、尿囊素和维生素E 3种有效成分为原料采用乳化法制成O/W型复方维A酸乳膏;通过UV光谱扫描,薄层层析,以及化学显色等方法进行定性鉴别3种成分;采用HPLCUV法伴梯度洗脱对乳膏中3种成分进行测定,外标法定量并同时对主药维A酸的异构化产物异维A酸进行监测。结果:按本研究所确定工艺制得的复方乳膏外观性状良好,药物在基质中分布均匀,细腻;该乳膏中3种成分的UV光谱,TLC和显色行为均与对照品一致。HPLC法使四种化合物达基线分离,呈现良好的线性关系(r>0.999),精密度RSD<1%,平均回收率为98.5%~99.8%。结论:该制剂制备方法可行,质量控制方法简单、准确、重复性好,所建立的HPLC法不仅可用于三种活性成分的测定而且可用于异构化产物的测定。 Objective: To prepare compound dimension A acid cream and establish its quality control method. Methods: O / W compound vitamin A cream was prepared by the emulsification method using the three active ingredients of retinoic acid, allantoin and vitamin E as raw materials. UV spectroscopy, thin layer chromatography and chemical colorimetry Three components were identified by HPLC. The three components in cream were determined by HPLC UV with gradient elution. The isomerase A was monitored by external standard method and quantitatively. Results: The appearance and properties of the compound creams prepared by this study were good, and the drugs were evenly and finely distributed in the matrix. The three components of the cream had the same UV spectrum, TLC and color development. HPLC method for the baseline separation of the four compounds showed a good linear relationship (r> 0.999), RSD precision <1%, the average recovery was 98.5% to 99.8%. Conclusion: The preparation method is feasible, the quality control method is simple, accurate and reproducible. The established HPLC method can not only be used for the determination of three active ingredients, but also for the determination of isomerization products.