von Eggelkraut-Gottanka Stephan G, Abed Salah Abu, Müller Wolfgang, Schmidt Peter C
Department of Pharmaceutical Technology, Auf der Morgenstelle 8, D-72076 Tübingen, Germany.
Pharm Dev Technol. 2002 Nov;7(4):447-55. doi: 10.1081/pdt-120015047.
The purpose of this study was to investigate the influence of roller compaction parameters and the amount of magnesium stearate used in dry granulation on granule and tablet properties of a dry herbal extract from St. John's wort (Hypericum perforatum L.). Two different extract batches were blended with magnesium stearate and compacted using a gap width and force controlled roller compactor. A 3(3) factorial design was used to evaluate the influence of the three independent variables, the amount of magnesium stearate, the roller compaction force, and the granulating sieve size on the mean particle size of granulated extracts and on the disintegration time of tablets containing these granulated extracts. The evaluation was done by multilinear stepwise regression analysis. The mean particle size d50 (R2 > 0.9) of both compacted extracts increased with increasing compaction force and with granulating sieve size. The disintegration time of the tablets was mostly in the range 5-15 min and increased slightly with increasing magnesium stearate concentration in the compacted extract and with decreasing compaction force of the roller compaction. The incorporation of magnesium stearate into the granulated extract reduced its potential negative influence on the disintegration time, while maintaining its functionality as a lubricant.
本研究的目的是考察干法制粒过程中滚压参数及硬脂酸镁用量对圣约翰草（贯叶连翘）干浸膏颗粒及片剂性质的影响。将两批不同的浸膏与硬脂酸镁混合，使用间隙宽度和压力可控的滚压机进行压制。采用3(3)析因设计来评估三个自变量，即硬脂酸镁用量、滚压压力和制粒筛网尺寸对制粒浸膏平均粒径以及含这些制粒浸膏片剂崩解时间的影响。通过多元线性逐步回归分析进行评估。两种压制浸膏的平均粒径d50（R2>0.9）均随压制压力和制粒筛网尺寸的增加而增大。片剂的崩解时间大多在5 - 15分钟范围内，且随着压制浸膏中硬脂酸镁浓度的增加以及滚压压力的降低而略有增加。将硬脂酸镁加入制粒浸膏中可降低其对崩解时间的潜在负面影响，同时保持其作为润滑剂的功能。
