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药物固体的混合。II:圆柱形剪切混合器中粘性粉末多组分混合的评估。

Mixing of pharmaceutical solids. II: Evaluation of multicomponent mixing of cohesive powders in cylindrical shear mixer.

作者信息

Chowhan Z T, Linn E E, Chi L H

出版信息

J Pharm Sci. 1981 Mar;70(3):243-7. doi: 10.1002/jps.2600700304.

DOI:10.1002/jps.2600700304
PMID:7264884
Abstract

The mixing of three organic carboxylic acids with micronized lactose, all cohesive in nature, was studied using a cylindrical shear mixer. Three mixing indexes (s/sigma A, s/sigma R, and the Ashton-Valentin mixing index) were used to evaluate mixing of the three drugs with lactose. The results suggested that maximum homogeneity was reached after 45 min of mixing. However, different mixing indexes showed different sensitivity to homogeneity of the individual components. The mixing index s/sigma A, which is based on setting standard specifications, appears to provide a better evaluation of homogeneity of individual components compared to the mixing indexes based on complete random mixing theory. The latter did not approach unity for any drug component used in this study. These results suggested that mixing of cohesive powders is a complex process and cannot be explained fully by simple theory based on complete random mixing.

摘要

使用圆柱形剪切混合器研究了三种本质上具有粘性的有机羧酸与微粉化乳糖的混合情况。使用了三种混合指数(s/σA、s/σR和阿什顿 - 瓦伦丁混合指数)来评估这三种药物与乳糖的混合情况。结果表明,混合45分钟后达到了最大均匀度。然而,不同的混合指数对各个组分均匀度的敏感性不同。基于设定标准规格的混合指数s/σA,与基于完全随机混合理论的混合指数相比,似乎能更好地评估各个组分的均匀度。对于本研究中使用的任何药物组分,基于完全随机混合理论的混合指数都未接近1。这些结果表明,粘性粉末的混合是一个复杂的过程,不能用基于完全随机混合的简单理论完全解释。

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