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湿法制粒过程中的终点检测。

End-point detection in a wet granulation process.

作者信息

Holm P, Schaefer T, Larsen C

机构信息

Pharmaceutical Development, H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark.

出版信息

Pharm Dev Technol. 2001;6(2):181-92. doi: 10.1081/pdt-100000739.

Abstract

The purpose of the experiments in this paper was to evaluate granulation end-point control by power consumption measurement in a 25-L high shear mixer. The effect of impeller design, impeller speed, liquid addition rate, type of binder, and mixing ratio between lactose and starch on the correlation between power consumption and granule growth was investigated in the liquid addition phase of the process using a fractional factorial experimental design. There was found generally a linear correlation between power consumption and mean granule size, but this correlation was dependent on the impeller design, the impeller speed, and the type of binder. However, an end-point control based on power consumption was not found to be sensitive to variations in the lactose:starch ratio. It was concluded that it was possible to control the liquid addition by the level detection method by which the liquid addition is stopped at a predetermined level of power consumption. An end-point control based upon the peak detection method was not generally applicable, because a peak in the differentiated power consumption signal could not be identified in all the experiments.

摘要

本文实验的目的是通过在25升高剪切混合器中测量功耗来评估制粒终点控制。在工艺的液体添加阶段,采用分数析因实验设计,研究了叶轮设计、叶轮转速、液体添加速率、粘合剂类型以及乳糖与淀粉的混合比例对功耗与颗粒生长之间相关性的影响。通常发现功耗与平均颗粒尺寸之间存在线性相关性,但这种相关性取决于叶轮设计、叶轮转速和粘合剂类型。然而,基于功耗的终点控制对乳糖与淀粉比例的变化并不敏感。得出的结论是,可以通过液位检测方法控制液体添加,即当功耗达到预定水平时停止液体添加。基于峰值检测方法的终点控制通常并不适用,因为并非在所有实验中都能识别出微分功耗信号中的峰值。

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