醋酸甲地孕酮分散片的制备与质量评价.pdf

·1340 · Herald of Medicine Vol郾32 No郾10 October2013 醋酸甲地孕酮分散片的制备与质量评价* 方旦旦,邓茂芳,施菁 (浙江医学高等专科学校,杭州摇 310053) 摘摇 要摇 目的摇 筛选醋酸甲地孕酮分散片的最优处方及工艺并评价制剂质量。 方法摇 用正交实验设计方法对处方 工艺进行筛选与优化,制成醋酸甲地孕酮分散片;采用紫外鄄可见分光光度法测定其溶出度,高效液相色谱法测定主药及 有关物质的含量。 结果摇 优选出的处方为:醋酸甲地孕酮53%、乳糖20%、羟丙甲纤维素1%、微晶纤维素8%、羧甲基 淀粉钠10%,微粉硅胶3%、硬脂酸镁1%。 实验表明该分散片崩解时限90 s,分散均匀性较好,15 min 溶出度85%。 结论摇 所优选的处方合理,制备工艺简便,符合2010年版《中华人民共和国药典》有关分散片的质量要求。 关键词摇 甲地孕酮,醋酸;分散片;制备;质量评价 中图分类号摇 R979.2;R927.2摇 摇 摇 文献标识码摇 A摇 摇 摇 文章编号摇 1004-0781(2013)10-1340-04 Preparation and Quality Evaluation of Megestrol Acetate Dispersible Tablets FANG Dan鄄dan,DENG Mao鄄fang,SHI Jing(Zhejiang Medical College,Hangzhou310053,China) ABSTRACT摇 Objective摇 To optimize the preparation technology and the formula of megestrol acetate dispersible tablets 4 and evaluate the quality.摇 Methods摇 Orthogonal L (3 ) test was designed to optimize the prescription.UV spectrophotometry 9 was used to detect dissolution of megestrol acetate dispersibletablets and HPLCmethodwas establishedto determinethe content of megestrol acetate and the related substances.摇 Results摇 The optimized prescription assembly was53% of megestrol acetate, 20% of lactose,1% of hydroxypropyl methyl cellulose,8% of microcrystalline cellulose,10% of sodium carboxy methyl starch, 3% of colloidal silicon dioxide,1% of magnesium stearate.The test showed that disintegration time was less than 90 seconds, dispersible homogeneitywasgood,anddissolutionrateat 15 minwasmorethan85%.摇 Conclusion摇 Theoptimalprescriptionis feasible,the preparation technology was simple and convenient.The dispersible tablets conform to the quality standard in the Chinese Pharmacopoeia2010 edition of gen