硬脂酸镁对药用粉末混合物中活性成分含量均匀度的影响。
Effect of magnesium stearate on the content uniformity of active ingredient in pharmaceutical powder mixtures.
作者信息
Swaminathan Vidya, Kildsig Dane O
机构信息
Pfizer Global R&D Groton Laboratories, Eastern Point Road, Groton, CT 06340, USA.
出版信息
AAPS PharmSciTech. 2002;3(3):E19. doi: 10.1208/pt030319.
The objective of this study was to determine the effect of magnesium stearate on the physical stability of polydisperse powder mixtures. The effects of concentration of magnesium stearate and the time of lubrication of mixtures with magnesium stearate on the content uniformity of the active ingredient in the mixtures were evaluated in a model mixture of lactose and aspirin. These effects were compared in a random mixture of non-interacting components and a mixture based on particle interaction. A statistical model that adequately described the relationship between the factors examined and the response was generated. The model indicated the presence of an interaction between magnesium stearate concentration and lubrication time. At a given concentration of magnesium stearate, there was a significant reduction in the content uniformity of aspirin as the time of lubrication of the mixture with magnesium stearate was increased. This effect was larger in mixtures based on particle interaction than in random mixtures of non-interacting components.
本研究的目的是确定硬脂酸镁对多分散粉末混合物物理稳定性的影响。在乳糖和阿司匹林的模型混合物中，评估了硬脂酸镁浓度以及混合物与硬脂酸镁润滑时间对混合物中活性成分含量均匀度的影响。在非相互作用组分的随机混合物和基于颗粒相互作用的混合物中对这些影响进行了比较。生成了一个能充分描述所研究因素与响应之间关系的统计模型。该模型表明硬脂酸镁浓度与润滑时间之间存在相互作用。在给定的硬脂酸镁浓度下，随着混合物与硬脂酸镁润滑时间的增加，阿司匹林的含量均匀度显著降低。这种影响在基于颗粒相互作用的混合物中比在非相互作用组分的随机混合物中更大。
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