分散片制备技术及质量评价研究进展  

Research advances in preparing technique and quality evaluation of dispersibletablets

作　　者：杨蕾 吴春芝[2] 谷福根[2] YANG Lei;WU Chunzhi;GU Fugen(School of Pharmacy,Inner Mongolia Medical University,Hohhot 010110,China;Affiliated Hospital,Inner Mongolia Medical University,Hohhot 010050,China)

机构地区：[1]内蒙古医科大学药学院,内蒙古呼和浩特010110 [2]内蒙古医科大学附属医院,内蒙古呼和浩特010050

出　　处：《药物评价研究》2023年第9期2046-2053,共8页Drug Evaluation Research

摘　　要：分散片是一种新型口服固体制剂,相较于普通片剂,具有服用方便、崩解迅速、吸收起效快、生物利用度高及不良反应小等优点。近年来,随着研究的不断深入,国内外出现了三维(3D)打印技术、掩味技术、增溶促溶技术、片剂分割技术等分散片制备新技术,另外还对其吸水率、润湿时间、崩解时间、分散时间和分散均匀性、混悬度等体外质量指标进行了深入研究探讨。总结分散片在制备技术和质量评价方面的研究进展,旨在为分散片研究开发和质量标准完善提供参考依据。Dispersible tablets are a new type of oral solid dosage form with many advantages such as convenient administration,fast disintegration,rapid in vivo absorption and onset of action,high bioavailability and few adverse reactions when compared with common oral tablets.In recent years,along with much deeper research,some new preparing processes and techniques of dispersible tablets including 3D printing,taste-masking,solubilization and tablet-splitting techniques have appeared,and meantime,a few novel quality evaluation indicators of dispersible tablets such as water absorption ratio,disintegration time,in vitro dispersion time and uniformity of dispersion,suspension degree also intensively explored at home and abroad.The progress in the preparing technique and quality evaluation of dispersible tablets is reviewed in order to provide an important reference for studying and developing dispersible tablets and further improving their quality standards in future.

关 键 词：分散片 3D打印技术 掩味技术 增溶技术 制备工艺 崩解时间 分散均匀度 质量评价 

分 类 号：R943[医药卫生—药剂学]