Wurster Dale Eric, Likitlersuang Sukhon, Chen Yisheng
Division of Pharmaceutics, College of Pharmacy, The University of Iowa, Iowa City, Iowa 52242, USA.
Pharm Dev Technol. 2005;10(4):461-6. doi: 10.1080/10837450500299693.
Magnesium stearate is widely used as a lubricant in pharmaceutical dosage forms. A film of magnesium stearate, or other lubricant, around individual granules is generally considered to cause the softening of tablets. Maltodextrins were chosen as model excipients since maltodextrins possessing a series of molecular weights showed systematically changing consolidation mechanisms. As maltodextrin molecular weight increases, the plasticity of the material increases. The Hiestand Tableting Indices and other related mechanical properties were used to study the effect of magnesium stearate addition on the mechanical properties and consolidation mechanisms of single component maltodextrins. Magnesium stearate was shown to lower the tensile strengths of maltodextrin compacts. Additionally, magnesium stearate addition lowered both the Hiestand Bonding Index and the Hiestand Brittle Fracture Index. The lower values of the Hiestand Brittle Fracture Index indicate that magnesium stearate promotes greater plastic behavior in maltodextrin compacts.
硬脂酸镁在药物剂型中广泛用作润滑剂。单个颗粒周围的硬脂酸镁或其他润滑剂薄膜通常被认为会导致片剂软化。选择麦芽糊精作为模型辅料,因为具有一系列分子量的麦芽糊精显示出系统变化的固结机制。随着麦芽糊精分子量的增加,材料的可塑性增加。使用海斯坦压片指数和其他相关机械性能来研究添加硬脂酸镁对单一组分麦芽糊精的机械性能和固结机制的影响。结果表明,硬脂酸镁会降低麦芽糊精压块的抗张强度。此外,添加硬脂酸镁会降低海斯坦粘结指数和海斯坦脆性断裂指数。海斯坦脆性断裂指数较低的值表明硬脂酸镁促进麦芽糊精压块中更大的塑性行为。