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基于如果发生微晶纤维素(MCC)与药物不相容或微丸基质崩解不足的考虑,进行了在挤出-滚圆法制备微丸的工艺中采用其他辅料替代MCC的研究。以k-卡拉胶为滚圆助剂、壳聚糖为稀释剂和卡波姆974P为黏合剂的组合被应用于不含MCC的微丸制备,采用的模型药物为对乙酰氨基酚。考察了处方和工艺参数对微丸粒径、外形、细粉(fines)、收率和脆性的影响。统计分析结果显示,主要因素和一些二因素相互作用对
Based on the consideration that microcrystalline cellulose (MCC) is incompatible with drugs or the matrix of microcapsules is not enough to disintegrate, the research on replacing MCC with other excipients in the process of extrusion-spheronization pellets was carried out. The combination of k-carrageenan spheronization aid, chitosan as diluent and carbomer 974P as binder was applied to MCC-free pellets and the model drug used was paracetamol. The effects of formulation and process parameters on particle size, shape, fines, yield and friability of the pellets were investigated. Statistical analysis showed that the main factors and some two factors interact