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一种新型共处理淀粉赋形剂的压缩工艺及片剂性能研究。

A study of the compaction process and the properties of tablets made of a new co-processed starch excipient.

机构信息

Department of Pharmaceutical Technology, Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Czech Republic.

出版信息

Drug Dev Ind Pharm. 2011 May;37(5):576-82. doi: 10.3109/03639045.2010.530270.

DOI:10.3109/03639045.2010.530270
PMID:21469946
Abstract

This article deals with the study of the energetic relationships during compaction and the properties of tablets produced from a co-processed excipient based on starch and called StarCap 1500®. This article compares it with the substance Starch1500®. The study also includes the mixtures of StarCap 1500® and the granulated directly compressible lactose Pharmatose DCL®15. The tablet properties tested included tensile strength and disintegration time, examined in dependence on compression force, and also a 0.4% addition of magnesium stearate. The results show a better compressibility of StarCap 1500 in comparison with Starch 1500 and a lower elastic component of energy. The tablets were stronger and disintegrated more rapidly, but the substance possessed a higher sensitivity to an addition of a lubricant than Starch 1500. Increasing portions of StarCap 1500 in the mixtures with Pharmatose DCL 15 increased the tensile strength of tablets, disintegration period as well as the sensitivity to an addition of a lubricant. From the energetic viewpoint, energy for friction was decreasing, while the energy accumulated by the tablet during compaction and the elastic component of energy were increased.

摘要

本文研究了压缩过程中的能量关系以及基于淀粉的共处理赋形剂 StarCap 1500®制成的片剂的性质。本文将其与物质 Starch1500®进行了比较。该研究还包括 StarCap 1500®与直接可压性乳糖 Pharmatose DCL®15 颗粒的混合物。测试的片剂特性包括拉伸强度和崩解时间,根据压缩力进行检查,还检查了 0.4%硬脂酸镁的添加量。结果表明,StarCap 1500 的可压缩性优于 Starch 1500,且能量的弹性成分较低。片剂的强度更高,崩解速度更快,但与 Starch 1500 相比,该物质对润滑剂的添加更敏感。混合物中 StarCap 1500 比例的增加提高了片剂的拉伸强度、崩解周期以及对润滑剂添加的敏感性。从能量角度来看,摩擦力消耗的能量减少,而片剂在压缩过程中积累的能量和能量的弹性成分增加。

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