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口腔崩解片及在中药产品开发中的应用

Keywords: 中药,口腔崩解片,掩味技术,制备工艺,质量评价,开发

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Abstract:

口腔崩解片(orallydisintegratingtablets,ODT)是一种在口腔内能迅速崩解起效的新型固体制剂,具有服用方便、适用人群广、起效速度快、生物利用度高、患者顺应性好等优势,已成为近几年来新药研发的热点剂型。目前该剂型已在化学药物制剂中得到广泛应用,但在中成药中的应用仍处于发展阶段。对中药口腔崩解片的开发为中药新剂型研究提供了一种新的方向,加快了我国传统中药与世界接轨的步伐,加速中药现代化的实现。该剂型有着广阔的市场前景,其质量控制及评定标准、口感、崩解时限等体外评定方法是中药口腔崩解片产业化、规范化中的关键因素。因此,该文综合介绍了口腔崩解片的特点、制备工艺、掩味技术及新型质量评价技术,同时结合众多应用实例阐述口腔崩解片在中药产品开发中的应用,以期为中药口腔崩解片的开发和利用提供借鉴和参考。

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