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盐酸乙哌立松片的制备研究

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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.
Study on Preparation of Eperisone Hydrochloride Tablets
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.

eperisone hydrochloride tabletsorthogonal designsimilarity factor

熊莉平、张怡、王书兰、李禄年

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西南药业股份有限公司,重庆 400038

太极集团有限公司,重庆 401120

盐酸乙哌立松片 正交设计 相似因子

2024

山东化工
山东省化工研究院 山东省化工信息中心

山东化工

影响因子:0.249
ISSN:1008-021X
年,卷(期):2024.53(14)