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新配方丸剂制剂的评价。

The evaluation of formulations for the preparation of new formula pellets.

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Czech Republic.

出版信息

Pharm Dev Technol. 2011 Oct;16(5):520-8. doi: 10.3109/10837450.2010.502174. Epub 2010 Jul 22.

DOI:10.3109/10837450.2010.502174
PMID:20649408
Abstract

The aim of the study was to prepare pellets of maidenhair tree (Ginkgo biloba), motherwort (Leonurus cardiaca) and hawthorn (Crataegus monogyna) dry extracts by extrusion/spheronization method. The critical step of this process was the amount of added wetting liquid (water-ethanolic mixture) and the amount of extract in the formulation. The samples of pellets containing 30-50% of extracts were formulated: Pellets contained extracts of Ginkgo, Crataegi and Leonuri. The last sample was aimed at the formulation of pellets with the content of 30% of the mixture of Ginkgo, Leonuri and Crataegi extracts in a ratio of 1:5:6. The remainder of the solid compounds in all formulations was microcrystalline cellulose (Avicel® PH-101). It was not possible to find a way to adequately wet the formulations with the content of extracts higher than 30% because of the unsuitable properties of all three extracts used. On the basis of the experiments, pellets with mixtures of all three previously used extracts were prepared. These pellets showed perfect physico-mechanical properties: Hardness (10.00 ± 2.24 N), friability (0.06%), repose angle (20.99 ± 0.41°), flowability (6.97 ± 0.29 s/100g of pellets), sphericity (0.81 ± 0.05), compressibility index (4.65%), intraparticular porosity (0.09%) and interparticular porosity (45.11%), which predetermine them to other testing and usage (feeling into capsules, tableting, coating etc.).

摘要

本研究的目的是通过挤出/球形化方法制备白果(银杏)、益母草(益母草)和山楂(山楂)干提取物的丸剂。该过程的关键步骤是添加润湿液(水-乙醇混合物)的量和制剂中提取物的量。含有 30-50%提取物的丸剂样品进行了配方设计:丸剂含有银杏、山楂和益母草提取物。最后一个样品旨在制定含有 30%银杏、益母草和山楂提取物混合物的丸剂配方,其比例为 1:5:6。所有配方中其余的固体化合物均为微晶纤维素(Avicel® PH-101)。由于所用三种提取物的性质均不合适,因此无法找到一种方法来充分润湿提取物含量高于 30%的配方。根据实验结果,制备了含有三种先前使用的提取物混合物的丸剂。这些丸剂具有完美的物理机械性能:硬度(10.00±2.24N)、脆碎度(0.06%)、休止角(20.99±0.41°)、流动性(6.97±0.29s/100g 丸剂)、球形度(0.81±0.05)、可压缩性指数(4.65%)、颗粒内孔隙率(0.09%)和颗粒间孔隙率(45.11%),这使得它们适用于其他测试和用途(装入胶囊、压片、包衣等)。

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