口腔崩解片及在中药产品开发中的应用  

Technical scheme of real-time evaluation of traditional Chinese medicine orally disintegrating tablets

作　　者：秦冬[1,2] 陈旭东[1,3] 封亮[2] 顾俊菲[2] 袁嘉瑞 贾晓斌[1,2] 

机构地区：[1]江苏大学药学院组分结构中药协同创新中心,江苏镇江212000 [2]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,江苏南京210028 [3]苏州艾费堂医药科技有限公司,江苏苏州215125

出　　处：《中国中药杂志》2014年第24期4716-4722,共7页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81202906);江苏省自然科学基金项目(BK2012491);江苏省中医药领军人才项目(2006)

摘　　要：口腔崩解片(orally disintegrating tablets,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。Orally disintegrating tablets （ODT）, a kind of new solid tablet that rapidly disintegrates to work in the mouth, has became the hot form of new drug research in recent years with many advantages, such as the convenient taking, a widely applicable people, fast acting, high bioavailability, good compliance, and so on. ODT has been widely used in chemical medicines, while the application of it in traditional Chinese medicines （TCMs） is still in the stage of development. The development of TCMs ODT provides a new direction for the research of Chinese medicine new dosage, accelerates the pace of connecting to the world and modernization of Chinese medicine. This dosage has a broad market prospect, and its quality control and assessment standards, taste, the disintegration time in vitro and evaluation method are the key factors that affect the industrialization, standardization of Chinese medicine ODT. Therefore, this paper reviewed the characteristics, preparation, taste masking technology and quality evaluation with new technology of ODT. Meantime, numerous application examples of ODT used in traditional Chinese medicine were described. We expect to provide the reference and utilization for the development of traditional Chinese medicine orally disintegrating tablets.

关 键 词：中药 口腔崩解片 掩味技术 制备工艺 质量评价 开发 

分 类 号：R283.6[医药卫生—中药学]