复方维A酸乳膏的制备及质量控制.pdf

ww·zgys·org 研究简报 复方维A酸乳膏的制备及质量控制 王栋1 张志勤1 姜氏毅1 韩国柱2 唐泽耀2 (1．大连市皮肤病医院药剂科辽宁大连116021；2．大连医科大学 药理教研室) 摘要 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 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 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。 关键词 复方维A酸乳膏；制备；质量控制；高效液相色谱；薄层层析 文献标识码：A 中图分类号：R944．2+1 文章编号：1008-049X(2014)06-1044-04 and Controlof TretinionCregJll PreparationQuality Compound of of WangDon91，ZhangZhiqinl，JiangShiyil，HanGuozhu2，TangZeya02(1．DepartmentPharmacy，DalianHospital Dalianl of Medical oning 16021，China；2．DepartmentPharmacology，DalianUniversity) ABSTRACT the of tretinioncreamandestablishthe control objective：Tostudypreparationcompound quality The tretinoinOintmentswere of andvitaminEasthemainactive and compound composedtretinion，allantoin ingredientspreparedby routine for0／W cream．1’Ilethree wereidentifiedUV andchemicalcolora— emulsifyingprocedurestype ingredients by scanning．-ILC tion witll reaction．and HPLC．UV elutionand anexternalmethod．Isotretinoinoftretinoinwas quantitativelyanalyzedby gradient using alsomonitored creamhad anduniformdistributioninthematrix．Thethree HPLC．Results：The by compound goodappearance drug inthecreamwereallcoincidentwiththereferencesubstancesinUV andchemicalcolorationreactionbehav— ingredients spectra．TLC ior．TheexcellentresolutionwasobtainedHPLCwith by