复方维A酸乳膏的制备及质量控制

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E3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HPLC-UV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.

Preparation and Quality Control of Compound Tretinion Cream

Objective：To study the preparation of compound tretinion cream and establish the quality control method.Methods：The compound tretinoin ointments were composed of tretinion,allantoin and vitamin E as the main active ingredients and prepared by routine emulsifying procedures for O/W type cream.The three ingredients were identified by UV scanning,TLC and chemical coloration reaction,and quantitatively analyzed by HPLC-UV with gradient elution and using an external method.Isotretinoin of tretinoin was also monitored by HPLC.Results：The compound cream had good appearance and uniform drug distribution in the matrix.The three ingredients in the cream were all coincident with the reference substances in UV spectra,TLC and chemical coloration reaction behavior.The excellent resolution was obtained by HPLC with good linearity （r 〉 0.999） and precision （RSD 〈 1%）.The average recovery was 98.5%-99.8%.Conclusion：The preparation method is feasible,and the qualitative methods are simple and reliable.The HPLC-UV method developed can be used not only to measure the 3 active ingredients,but also to measure isomerization product.