不同处方工艺对非那雄胺片混合均匀度与含量均匀度的影响  

Influence of Different Formulation and Process on BlendingUniformity and Content Uniformity of Finasteride Tablets

作　　者：朱飞 辛洪亮[1] ZHU Fei;XIN Hongliang(Nanjing Medical University,Jiangsu Nanjing 211166,China)

机构地区：[1]南京医科大学,江苏南京211166

出　　处：《广州化工》2025年第5期137-140,152,共5页GuangZhou Chemical Industry

摘　　要：研究处方中辅料种类与用量及混合工艺对非那雄胺片混合均匀度及含量均匀度的影响。通过单因素试验,考察乳糖型号、填充剂(乳糖、微晶纤维素、预胶化淀粉)比例、硬脂酸镁用量、原料药粒度、混合方式与时间对混合均匀度及含量均匀度的影响。不同的乳糖型号(F100、G200、T80)、填充剂比例[乳糖∶微晶纤维素∶预胶化淀粉(10∶1∶3)^(10∶3∶1)]、硬脂酸镁用量在0.4%~0.8%的处方混合均匀度及含量均匀度均可符合要求;原料药粒径D90不超过20μm混合均匀度及含量均匀度均可符合要求,随粒径的增大混合均匀性有下降趋势,采用非那雄胺先与部分乳糖先进行手动混合后再与剩余辅料混合的方式,预混时间在5~15 min,总混时间在3~8 min混合均匀度及含量均匀度可符合要求。优选的处方工艺适用于非那雄胺片的含量均匀度和质量控制,可用于工业化生产。To investigate the impact of excipient types,dosages,and manufacturing process on the blending and content uniformity of finasteride tablets,through single-factor experiments,various factors were examined including the type of lactose,the ratio of fillers(lactose,microcrystalline cellulose,pregelatinized starch)and the amount of magnesium stearate.Additionally,the effects of API particle size,blending methods and time on blend and content uniformity were studied.The belnd and content uniformity of finasteride tablets met the required standards when using different types of lactose(F100,G200,T80),filler ratios(lactose∶microcrystalline cellulose∶pregelatinized starch)between 10∶1∶3 and 10∶3∶1,and magnesium stearate dosages ranging from 0.4%to 0.8%.When API particle size(D90)was less than 20μm,the blend and content uniformity also met the requirements,although there was a trend of decreasing blend uniformity with increasing particle size.By manually blending finasteride with a portion of lactose before combining with the remaining excipients,and maintaining a preblending time range from 5 to 15 min and a total blending time from^(3) to 8 min,the blend and content uniformity still met the standards.The optimized formulation and manufacturing process are suitable for ensuring content uniformity and quality control in finasteride tablets,which can be suitable for industrial manufacturing.

关 键 词：非那雄胺 混合均匀度 含量均匀度 

分 类 号：R944.4[医药卫生—药剂学]