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六方氮化硼对微晶纤维素和改性淀粉直接压缩混合物的压缩参数

Compression parameters of hexagonal boron nitride on direct compression mixture of microcrystalline cellulose and modified starch.

作者信息

Halaçoğlu Mekin Doğa, Uğurlu Timuçin

机构信息

Department of Pharmaceutical Technology, Faculty of Pharmacy, Marmara University , Haydarpasa, Istanbul , Turkey.

出版信息

Pharm Dev Technol. 2015;20(6):747-54. doi: 10.3109/10837450.2014.920354. Epub 2014 May 20.

Abstract

The objective of this study was to investigate the effects of conventional lubricants including a new candidate lubricant "hexagonal boron nitride (HBN)" on direct compression powders. Lubricants such as magnesium stearate (MGST), glyceryl behenate, stearic acid, talc and polyethylene glycol6000 were studied and tablets were manufactured on a single station instrumented tablet press. This study comprised the continuation of our previous one, so mixture of microcrystalline cellulose and modified starch was used as a master formula to evaluate effects of lubricants on pharmaceutical excipients that undergo complete plastic deformation without any fragmentation under compression pressure. Bulk and tapped densities, and Carr's index parameters were calculated for powders. Tensile strength, cohesion index, lower punch ejection force and lubricant effectiveness values were investigated for tablets. The deformation mechanisms of tablets were studied during compression from the Heckel plots with or without lubricant. MGST was found to be the most effective lubricant and HBN was found very close to it. HBN did not show a significant negative effect on the crushing strength and disintegration time of the tablets when we compared with MGST. Based on the Heckel plots at the level of 1%, formulation prepared with HBN showed the most pronounced plastic character.

摘要

本研究的目的是研究包括新型候选润滑剂“六方氮化硼(HBN)”在内的传统润滑剂对直接压片粉末的影响。研究了硬脂酸镁(MGST)、山嵛酸甘油酯、硬脂酸、滑石粉和聚乙二醇6000等润滑剂,并在单站仪器化压片机上制备片剂。本研究是我们之前研究的延续,因此使用微晶纤维素和改性淀粉的混合物作为主配方,以评估润滑剂对在压缩压力下发生完全塑性变形而无任何破碎的药用辅料的影响。计算了粉末的堆密度、振实密度和卡尔指数参数。研究了片剂的抗张强度、内聚指数、下冲头顶出力和润滑剂效能值。通过有无润滑剂的赫克尔图研究了片剂在压缩过程中的变形机制。发现MGST是最有效的润滑剂,HBN与之非常接近。与MGST相比,HBN对片剂的抗压强度和崩解时间没有显著负面影响。基于1%水平的赫克尔图,用HBN制备的制剂表现出最明显的塑性特征。

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