Combined application of extrusion-spheronization and hot-melt coating technologies for improving moisture-proofing of herbal extracts.
Combined application of extrusion-spheronization and hot-melt coating technologies for improving moisture-proofing of herbal extracts.
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DOI：
10.1002/jps.21990
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发表时间：
2010-05
影响因子：
3.8
通讯作者：
Hao Chen;Shuai Shi;Aina Liu;Xing Tang
中科院分区：
文献类型：
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作者：
Hao Chen;Shuai Shi;Aina Liu;Xing Tang
本研究旨在探讨挤出滚圆法结合热熔涂膜技术对中药提取物的防潮效果及其机理。以具有高吸湿性的桂枝茯苓复方提取物为模型药物。在挤出滚圆过程中，制备含有100% GF的微丸，然后使用传统包衣锅用热熔包衣材料包衣。通过在一系列不同相对湿度下储存来测定GF的吸湿数据。当用硬脂酸和聚乙二醇6000的96：4混合物包衣微丸时，45 min时累积药物释放超过90%，而在75%RH下10天内的水分含量为4.9%。由于不同的吸湿机制，这些微丸比相同包衣水平的欧巴代AMB包衣微丸具有更好的防潮性。热熔涂层的吸湿行为可归因于水蒸气通过多孔基质系统扩散，而欧巴代AMB涂层系统涉及溶胀控制系统。Higuchi模型最适合所有配方中热熔涂层的吸湿，而欧巴代AMB涂层适合Nuttanan模型。
The aim of this research was to investigate the moisture-proofing effect and its mechanism for herbal extracts using extrusion-spheronization combined with hot-melt coating. Guizhi Fuling (GF) compound herbal extract with high hygroscopicity was used as a model drug. In the process of extrusion-spheronization, pellets containing 100% GF were prepared, and then coated with hot-melt coating material using a traditional coating pan. The moisture sorption data for GF were determined by storage at a series of different relative humidities. When the pellets were coated with a 96:4 mixture of stearic acid and polyethylene glycol 6000, the cumulative drug release was over 90% at 45 min while the moisture content was 4.9% at 75% RH within 10 days. These pellets have better moisture-proofing than those coated with Opadry AMB at the same coating level due to a different moisture sorption mechanism. The moisture sorption behavior of the hot-melt coating can be attributed to water vapor diffusion via a porous matrix system, while the Opadry AMB coating system involved a swelling controlled system. The Higuchi model was the best fit for the moisture sorption of the hot-melt coating in all formulations whereas the Opadry AMB coating fitted the Nuttanan model.