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水飞蓟素缓释片的制备与处方优化

Preparation and formulation optimization of silymarin sustained-release tablets

  • 摘要: 本文研制了水飞蓟素缓释片,以延缓药物的释放,减少给药次数,提高患者的顺应性。由于水飞蓟素在水中几乎不溶,本文首先采用溶剂法,以PVP K30为载体,制备了水飞蓟素固体分散体,以提高水飞蓟素的水溶性。采用全粉末直接压片的工艺,制备了水飞蓟素缓释片。以体外释放度为主要评价指标,考察了骨架材料的种类及用量对缓释片释药性能的影响,并对处方进行了优化。结果表明,优选的处方以山榆酸甘油酯为缓释骨架材料、微晶纤维素为填充剂、硬脂酸镁为润滑剂,具有良好的缓释效果、重现性和可压性。

     

    Abstract: In the present study,silymarin sustained-release tablets were developed to delay the drug release,reduce dosing frequency and improve patient compliance.Due to aqueous insolubility of silymarin,the solid dispersion was prepared by the solvent method using PVP K30 as the hydrophilic carrier matrix.Direct compression method was used to prepare silymarin sustained-release tablets.The influence of matrix forming agents on silymarin release was investigated based on in vitro release and the formulation was optimized.The optimal formulation was obtained using compritol 888 ATO as the sustained-release matrix,microcrystalline cellulose as the filler and magnesium stearate as the lubricant.The prepared tablets have shown an ideal sustained-release of silymarin with good reproducibility and compressibility.

     

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