摘要
目的研究白藜芦醇口崩片制备工艺,确定最佳处方,并进行溶出度和粉体学方面的质量评价。方法以崩解时限、口感、硬度等为综合评价指标,开展Box-Benhnken中心组合试验,确定了采用粉末直接压片法工艺制备白藜芦醇口崩片的最优处方,采用溶出度测定方法考察口崩片的累积溶出度,以休止角、松密度、振实密度、压缩度为指标对口崩片的粉体学性质进行考察。结果最佳处方为白藜芦醇50 mg(22.5%)、微晶纤维素PH-101(MCC)63.5 mg(28.6%)、交联聚维酮(PVPP)18.6 mg(8.4%)、低取代羟丙基纤维素(L-HPC)10 mg(4.5%)、甘露醇78 mg(35.1%)、硬脂酸镁2 mg(0.9%),制备的白藜芦醇口崩片崩解时限合格,10 min白藜芦醇可溶出90%以上,粉体学研究表明物料有较好的流动性和填充性。结论白藜芦醇口崩片处方工艺可行,操作简便,能满足工业化大生产的要求。
Objective The process of preparing resveratrol orally disintegrating tablets was researched, the best prescription was determined and the quality of resveratrol orally disintegrating tablets about dissolution and micromeritics were evaluated. Methods The optimal prescription of direct powder compression method was determined by adopting Box-Benhnken center combination experiment design, with universal evaluation indexes, including disintegration time, mouthfeel, and hardness. The accumulative dissolution was tested by using dissolution test. The micromeritics about the angle of repose, loose density, tap density, and compressibility index were evaluated. Results The optimal prescription were 50 mg resveratrol（22.5%）, 63.5 mg MCC（28.6%）, 18.6 mg PVPP（8.4%）, 10 mg L-HPC（4.5%）, 78 mg（35.1%）, and 2 mg magnesium stearate（0.9%）. The disintegration time of resveratrol orally disintegrating tablets prepared with the optimized prescription was qualified. More than 90% resveratrol was dissoluted within 10 min. The micromeritics showed that the powder had good fluidity and filling property. Conclusion The process of preparation for orally disintegrating tablets by using direct compression method is feasible, it is easy to operate, and this method can meet the requirement in industry.
出处
《中草药》
CAS
CSCD
北大核心
2016年第2期227-232,共6页
Chinese Traditional and Herbal Drugs
基金
国家自然科学基金资助项目(81102817)
国家星火计划项目(2015GA690276)
江苏省大学生创新重点项目(201410324011Z)
盐城师范学院教研项目(13YCTCJY046)
盐城师范学院博士科研启动基金资助项目
关键词
白藜芦醇
口崩片
制备工艺
质量评价
溶出度
resveratrol
orally disintegrating tablets
preparation
quality evaluation
dissolution rate
