首页|处方和工艺对盐酸美金刚片含量均匀度的影响

处方和工艺对盐酸美金刚片含量均匀度的影响

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目的 研究处方中的辅料及工艺对盐酸美金刚片含量均匀度的影响.方法 采用粉末直接压片工艺,通过单因素试验,考察处方中填充剂种类及型号、混合工艺对含量均匀度的影响.结果 盐酸美金刚与5倍量的硅化微晶纤维素90加入混合机中预混10 min,再加入剩余的物料,8r·min-1混合30min,能实现最佳的含量均匀度.结论 本研究筛选出了适合粉末直压工艺填充剂硅化微晶纤维素90,考察了混合工艺,优选了 2次混合法,获得了良好含量均匀度.
Effect of prescription technology on the content uniformity of memantine hydrochloride tablets
Objective To determine the effect of excipients and prescriptions technology on the content uniformity of memantine hydrochloride tablets.Methods The effect of types,models of fillers,and mixing process on the content uniformity was determined by single factor experiments by direct powder compression.Results The optimal process with the best content uniformity was to pre-mix memantine hydrochloride with 5 times of silicified microcrystalline cellulose 90 for 10 min,and then adding the remaining materials,mixing for 30 min at 8 r·min-1.Conclusion This study silicified microcrystalline cellulose 90 as a filler and two-step mixing method,help achieve good content uniformity.

memantine hydrochloride tabletdirect tablet pressingcontent uniformity

肖颖、黄引、钟莹、蔡国伟、王健松

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广州白云山医药集团股份有限公司白云山制药总厂/广东省化学药原料与制剂关键技术研究企业重点实验室,广州 510515

盐酸美金刚片 直接压片 含量均匀度

广东省粤澳科技创新联合资助项目

2021A0505080010

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(3)
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