药用辅料硅酸镁铝(IB型)黏度测定方法探讨  

Discussion on determination method of viscosity of medicinal excipient IB magnesium aluminium silicate

作　　者：李樾[1,2] 黄婷 杨锐 杨会英[1,2] LI Yue;HUANG Ting;YANG Rui;YANG Huiying(National Institutes for Food and Drug Control;NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical excipients,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院 [2]药用辅料质量研究与评价重点实验室,北京100050

出　　处：《中国药品标准》2024年第4期409-415,共7页Drug Standards of China

摘　　要：目的:确定硅酸镁铝(IB型)登记备案标准中黏度测定方法是否可行。方法:采用棒状高速搅拌器及旋转黏度计考察硅酸镁铝(IB型)黏度,采用破壁机及旋转黏度计考察硅酸镁铝(IB型)黏度。结果:采用棒状高速搅拌器及旋转黏度计考察硅酸镁铝(IB型)黏度时,样品均不符合规定,采用破壁机及旋转黏度计考察硅酸镁铝(IB型)黏度时,样品均符合规定。结论:硅酸镁铝(IB型)为触变性非牛顿流体,其黏度测定结果受高速搅拌器类型影响较大,建议药用辅料登记备案标准中明确使用的高速搅拌器类型,细化前处理方法。Objective:To discuss the feasibility of the viscosity determination method in the registration standard of type IB magnesium aluminum silicate.Methods:Two different types of high speed blender and rotary viscometer were used to investigate the viscosity of IB-type magnesium aluminum silicate.Results:When the viscosity of magnesium aluminum silicate(IB type)was investigated by rod high-speed stirrer and rotary viscometer,the samples did not meet the requirements.When the viscosity of magnesium aluminum silicate(IB type)was investigated by wall breaker and rotary viscometer,the samples met the requirements.Conclusion:IB type magnesium aluminum silicate is a thixotropic non-newtonian fluid,and the viscosity measurement results of it are greatly affected by the high speed blender.It is recommended that the type of high speed blender which is suitable for use in the test should be specified.

关 键 词：硅酸镁铝 药用辅料 黏度 高速搅拌器 前处理方法 

分 类 号：R921.2[医药卫生—药学]