仙曲片粉体学性质考察及处方设计
Chinese Traditional Patent Medicine（2020）
Abstract
目的 考察仙曲片粉体学性质,并进行处方设计.方法 在质量源于设计(QbD)理念的基础上,确定颗粒流动性、可压性作为关键质量属性,原料吸湿性、流动性、压缩成型性及颗粒含水量作为关键物料属性,进行合理的处方设计.结果 原料易吸湿,流动性差,可压性良好,故处方设计时将片剂中原料含有量提高至90％.湿法制粒后,颗粒成型率高,粒度分布均匀,流动性、压缩成型性良好,吸湿率显著降低.结论 将QbD理念应用到仙曲片粉体学性质考察中时,可在确定原料物理特性的同时为处方设计提供参考,而且辅料用量减少,处方重复性良好.
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