醋酸甲地孕酮分散片的制备与质量评价

Preparation and Quality Evaluation of Megestrol Acetate Dispersible Tablets

目的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-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。

ObjeCtive T0 Optimize the preparation technology and the formula of megestrol acetate dispersible tablets and evaluate the quality, Methods Orthogonal L9 （ 3^4 ） test was designed to optimize the prescription. UV spectrophotometry was used to detect dissolution of megestrol acetate dispersible tablets and HPLC method was established to determine the content of meges｜rol acetate and the related substances. Results 20% of lactose , 1% of hydroxypropyl methyl Cellulose, 8% 3% of colloidal silicon tli0xide, 1% ~ inagnesium stearate The optimized prescription assembly was 53% of megestrol acetate, of microcrystalline cellulose, 10% of sodium carboxy methyl starch, The test showed that disintegration time was less than 90 seconds, dispersible homogeneity Was good,and dissolution rate at 15 min was more than 85%. Conclusion The optimal prescription is feasible, the preparatiori technology was simple and convenient. The dispersible tablets conform to the quality standard in the ~Chinese Pharmacopoeia 2010 edition of general preparations.