盐酸乙哌立松片的制备研究
Study on Preparation of Eperisone Hydrochloride Tablets
熊莉平 1张怡 1王书兰 1李禄年2
作者信息
- 1. 西南药业股份有限公司,重庆 400038
- 2. 太极集团有限公司,重庆 401120
- 折叠
摘要
目的:优化盐酸乙哌立松片的处方工艺.方法:采用正交设计法,以填充剂比例为因素A,润滑剂为因素B,片子平均硬度为因素C,以溶出度相似因子作为考察指标.结果:最优化的条件为:填充剂(玉米淀粉、微晶纤维素质量比例20∶20),润滑剂(1％硬脂富马酸钠),平均硬度(40 N),3批验证的f2均大于50,与参比制剂溶出行为相似.结论:该处方设计合理,工艺简单,容易操作,体外溶出度良好.
Abstract
Objective:To optimize the formulation of eperisone hydrochloride tablets.Methods:The orthogonal design method was used,with the proportion of filler as factor A,the lubricant as factor B,the average hardness of the tablets as factor C,and the dissolution similarity factor as the index.Results:The optimal conditions were as follows:the proportion of filler(m(corn starch)∶m(microcrystalline cellulose)=20∶20),lubricant(1％Sodium Stearyl Fumarate),average hardness(40 N),f2 of 3 batches verified were all greater than 50,which was similar to the dissolution behavior of the reference preparation.Conclusion:The prescription was reasonable in design,simple in process,easy to operate and good in vitro dissolution.
关键词
盐酸乙哌立松片/正交设计/相似因子Key words
eperisone hydrochloride tablets/orthogonal design/similarity factor引用本文复制引用
出版年
2024
NETL
NSTL
万方数据