对乙酰氨基酚亲水凝胶缓释骨架片的处方优化

目的制备对乙酰氨基酚亲水凝胶缓释骨架片并对其处方进行优化。方法以体外释放度为指标,考察羟丙甲纤维素（HPMC）规格、HPMC用量和乳糖用量对药物体外释放度的影响,并通过分数法优选辅料的比例。结果每片含325mg对乙酰氨基酚、49mg HPMC K4M和56mg乳糖压制的亲水凝胶缓释骨架片,其累积释放度可分别满足1h时为5%～35%、4h时为35%～75%、8h时不少于60%。结论制备的对乙酰氨基酚亲水凝胶缓释骨架片具有缓释12h的效果,且处方与工艺简单、易行,适于工业化生产。

STUDY ON OPTIMIZATION OF ACETAMINOPHEN HPMC SUSTAINED - RELEASE MATRIX TABLETS

Objective To prepare acetaminophen sustained-release tablets and optimize its formulation. Methods To investigate influences of HPMC type,content of HPMC and lactose on drug release in vitro and optimize the ratio of excipients by fraction method were performed. Results In vitro release of the tablets containing acetaminophen （325mg）,HPMC K4M （49mg） and lactose （56mg） could achieve 5~35%,35~75% and which were more than 60% in 1h,4h and 8h. Conclusion Acetaminophen sustained release tablets have desirable sustained-release capacity in 12h,while the formulation and technique are simple and reliable to realize commercial process.