滑石粉分散片的制备及处方优化
Chinese Journal of Experimental Traditional Medical Formulae(2013)
Abstract
目的:制备滑石粉分散片并优选其处方工艺.方法:以崩解时限、分散均匀性或软材成型情况为指标,通过单因素试验筛选滑石粉分散片的辅料种类;选取滑石粉、崩解剂、填充剂用量为考察因素,以崩解时限、分散均匀性和混悬稳定性为综合评价指标,采用综合评分法和D-最优混料设计优选滑石粉分散片处方.结果:最佳制备工艺为以微晶纤维素为填充剂,含羟丙基甲基纤维素(HPMC)的30%乙醇溶液为黏合剂,交联聚乙烯吡咯烷酮(PVPP)为崩解剂,最优处方比例为滑石粉-微晶纤维素-PVPP(0.447∶0.400∶0.123).结论:优选的制备工艺稳定可行;D-最优混料设计可用于滑石粉分散片处方的优化,建立的数学模型具有良好预测性.
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Key words
Talci Pulvis,dispersible tablets,single factor test,comprehensive evaluation method,D-optimal mixture design
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