首页|药用辅料硅酸镁铝(IB型)黏度测定方法探讨

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

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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 mag-nesium 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.

magnesium aluminium silicatepharmaceutical excipientsviscosityhigh-speed agitatorsprepara-tion method

李樾、黄婷、杨锐、杨会英

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中国食品药品检定研究院

药用辅料质量研究与评价重点实验室,北京 100050

硅酸镁铝 药用辅料 黏度 高速搅拌器 前处理方法

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(4)