硬脂酸镁对盐酸特拉唑嗪胶囊溶出的影响

Effect of magnesium stearate on the dissolution of terazosin hydrochloride capsules

目的:通过对比溶出曲线,研究盐酸特拉唑嗪胶囊中硬脂酸镁对溶出的影响。方法:根据参比制剂,采用原辅料直接混合制备胶囊,以溶出曲线作为评价指标,考察不同厂家硬脂酸镁、硬脂酸镁用量、终混时间、混合方式对溶出的影响。结果:硬脂酸镁用量、终混时间及混合方式均会对硬脂酸镁的疏水作用产生显著性影响,从而影响药物的溶出,不同厂家的硬脂酸镁对溶出的影响差异较小。结论:硬脂酸镁在盐酸特拉唑嗪胶囊中除用作润滑剂外,其疏水作用会对胶囊溶出有延缓作用。

OBJECTIVE To study the effect of magnesium stearate on the dissolution of terazosin hydrochloride capsules by comparing the dissolution curves.METHODS According to the reference preparation,the capsules were filled with both active ingredient and excipients by mixing process.The dissolution curve was used as the index to investigate the influences of magnesium stearate from different manufacturers,the amount of magnesium stearate,the final mixing time and the mixing method on the dissolution.RESULTS The amount of magnesium stearate,the final mixing time and the mixing method,all had significant effects on the hydrophobic effect of magnesium stearate,thus affecting the dissolution of the drug.CONCLUSION Besides of being used as a lubricant,magnesium stearate can also produce the hydrophobic effect to decelerate the dissolution of active ingredient in capsules.