激光粒度仪测定单硝酸异山梨酯缓释片中间产品粒度的方法学研究

目的 建立测定单硝酸异山梨酯缓释片中间产品粒度分布的方法。方法 采用Malvern Mastersizer 3000型激光粒度分析仪，Aero S型干法进样器。激光散射法干法检测参数为：样品折射率1.52、漏斗池高度1.0 mm、遮光度范围0.8%～3.0%、分散气体压力2.0 bar、进样速度50%、样品测量时间25 s。结果 同一批供试品，平行测定6次，不同操作人员在不同时间、使用相同仪器和相同方法，测得粒度分布结果的RSD值小于1.0%；三个批次供试品，相同操作人员使用相同仪器和相同方法测得批次间粒度分布结果的RSD值小于2.0%。结论 该方法重现性好、准确度高，操作简便，可用于单硝酸异山梨酯缓释片中间产品粒度分析。

Methodological study of partical size distribution of Intermediate products of isosorbide mononitrate sustained-release tablets by laser particle analyzer

Objective To establish an experimental method for the measurement of the particle size distribution of isosorbide mononitrate sustained release tablets intermediate products.Methods The Malvern Mastersizer 3000 type laser size analyzer was equipped with a MAZ3500 dry autosampler were used. The determination conditions were investigated as follows: sample refractive index of 1.52, funnel gap 1.0 mm, shading degree of 0.8%-3.0%, dispersed gas pressure 2.0 bar, sample measurement time 25 s.Results For the same batch of test samples, the RSD value of the particle size distribution results measured by different operators using the same instrument and the same method is less than 1.0%,and the same operator uses the same instrument and the same method to measure the three batches of test samples.The inter-batch RSD value of the particle size distribution result is less than 2.0%.Conclusion The method with good reproducibility, high accuracy and simple operation can be used for the particle size analysis of the intermediate product of isosorbide mononitrate sustained-release tablets.