处方和工艺对盐酸美金刚片含量均匀度的影响  

Effect of prescription technology on the content uniformity of memantine hydrochloride tablets

作　　者：肖颖 黄引 钟莹 蔡国伟 王健松 XIAO Ying;HUANG Yin;ZHONG Ying;CAI Guo-wei;WANG Jian-song(Guangzhou Baiyunshan Pharmaceutical Group Co.,Ltd.,Baiyunshan Pharmaceutical General Factory/Guangdong Provincial Key Laboratory for Key Technologies of Chemical Pharmaceutical Raw Materials and Preparations,Guangzhou 510515)

机构地区：[1]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

出　　处：《中南药学》2024年第3期668-672,共5页Central South Pharmacy

基　　金：广东省粤澳科技创新联合资助项目(No.2021A0505080010)。

摘　　要：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,8 r·min^(-1)混合30 min,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。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.

关 键 词：盐酸美金刚片 直接压片 含量均匀度 

分 类 号：R927[医药卫生—药学] R94