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首页> 外文期刊>Open Pharmaceutical Sciences Journal >Preparation and Evaluation of Multi-Particulate System (Pellets) of Prasugrel Hydrochloride
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Preparation and Evaluation of Multi-Particulate System (Pellets) of Prasugrel Hydrochloride

机译：盐酸普拉格雷多颗粒系统的制备与评价

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Multiparticulate systems (pellets) of prasugrel hydrochloride were prepared by extrusion spheronizationmethod using MCC (micro crystalline cellulose). Optimum spheronization time and method of drying were selected as theprocess parameters for the preparation of final batches. Various pellet properties were evaluated like size & shape analysis,flow properties, bulk & tapped density, friability, moisture content, drug content, in vitro release rate and in vivopharmacodynamic studies. All pellet batches showed a narrow particle size distribution, good sphericity and excellentflow properties. Drug content and moisture content of different pellet batches were found in specified limits. The releasekinetics of drug loaded MCC pellets followed Peppas model with Fickian diffusion of prasugrel from the pellets. In vivopharmacodynamic studies exhibited improved bleeding time in pellet group when compared with the marketed tablet formulation.
机译：盐酸普拉格雷的多颗粒系统（小丸）是通过使用MCC（微晶纤维素）挤出滚圆法制备的。选择最佳的滚圆时间和干燥方法作为制备最终批次的工艺参数。评价了各种丸剂性质，例如大小和形状分析，流动性质，堆积和堆积密度，脆性，水分含量，药物含量，体外释放速率和体内药效学研究。所有粒料批次均显示出窄的粒度分布，良好的球形度和出色的流动性。发现不同批次药丸的药物含量和水分含量在规定的范围内。载药的MCC药丸的释放动力学遵循Peppas模型，普拉克格雷从药丸的Fickian扩散。与市售片剂相比，体内药效学研究显示丸剂组的出血时间有所改善。

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