羟丙甲纤维素QbD样品对硝苯地平骨架片释放的影响

目的：研究羟丙甲纤维素的不同关键材料属性（CMAs）的样品（QbD样品）对以难溶性药物硝苯地平（溶解度11μg/ml）为模型药物的亲水凝胶骨架缓释片的药物释放的影响。方法：采用直接压片的方式，分别使用粘度、粒度和羟丙基含量等属性分别接近标准上下限范围的羟丙甲纤维素QbD样品和其他辅料一起制成硝苯地平骨架缓释片，并按标准规定的方法对体外释放曲线进行测定。结论：在标准规定范围内羟丙甲纤维素的粘度、粒度和羟丙基含量的波动对硝苯地平亲水凝胶骨架缓释片的释放没有显著的影响。

Influence of Hypromellose QbD Sample with Different CMA on Drug Release of Extended Release Nifedipine Hydrophilic Matrix Tablets

Objective：The objective of this study was to study the influence of different critical quality attribute samples of hypromellose （QbD sample） on hydrophilic extended release matrix tablets of water insoluble drug nifedipine （solubility in water, 11μg/ml） as model drug. Methods：The nifedipine extended release matrix tablets were manufactured by direct compression （DC） method with hypromellose QbD sample and other excipients, which critical material attributes （CMAs） of viscosity, particle size and hydroxypropoxyl content close to the range of limitation. The invitro drug release profiles from extended release hydrophilic matrix tablets were tested according to the method of criteria. Conclusion：The variation of viscosity, particle size, and hydroxylpropoxyl content of hyprom-ellose within the limit has no significant influence on drug release profile of nifedipine extended release matrix tablets.