片剂崩解影响因素及崩解机制的研究进展  

A review on Infiuencing Factors and Mechanisms of Tablet Disintegration

作　　者：李婉婷 宿军慧 王雅雯 赵晓庆 徐冰[1,2,3] LI Wanting;SU Junhui;WANG Yawen;ZHAO Xiaoqing;XU Bing(Dept.of Chinese Medicine Informatics,Beijing University of Chinese Medicine,Beijing 102400;Beijing Key Lab.of Production Process Control and Quality Evaluation of Chinese Medicine,Beijing Municipal Commission of Science and Technology,Beijing 102400;Engineering Research Center of Ministry of Education for Chinese Medicine Pharmacy and New Drug Development,Beijing 102400)

机构地区：[1]北京中医药大学中药信息学系,北京102400 [2]北京市科学技术委员会中药生产过程控制与质量评价北京市重点实验室,北京102400 [3]中药制药与新药开发教育部工程研究中心,北京102400

出　　处：《中国医药工业杂志》2023年第8期1157-1165,共9页Chinese Journal of Pharmaceuticals

基　　金：国家自然科学基金项目(82074033);创新药物与高效节能降耗制药设备国家重点实验室开放基金项目(GZSYS202007);连云港市重大技术攻关“揭榜挂帅”项目(CGJBGS2101)。

摘　　要：文章对2010—2021年国内外发表的片剂崩解相关文献进行整理归纳,总结了片剂崩解过程的影响因素以及可能的崩解机制,为片剂设计中药用辅料筛选和配方优化提供参考。片剂崩解受原辅料性质、处方组成、工艺参数,以及崩解介质等多方面影响。片剂的崩解机制主要包括溶胀、形状恢复和芯吸等。常用的崩解功能性辅料中,淀粉及其衍生物、交联羧甲纤维素钠和羧甲淀粉钠主要通过溶胀发挥崩解作用,交联聚乙烯吡咯烷酮的崩解机制为形状恢复,纤维素及其衍生物则依靠较强的芯吸作用促进崩解。未来片剂崩解的研究方向包括:片剂工艺中关键物料属性、关键工艺参数和片剂崩解行为之间的关联建模;片剂崩解过程和行为的客观化、可视化和定量化表征;促进片剂崩解的新型药用辅料的开发与应用。This paper summarizes the relevant literature on tablet disintegration published at home and abroad from 2010 to 2021,and outlines the infiuencing factors and possible disintegration mechanisms of tablet disintegration process.The disintegration of tablets is affected by the properties of raw and auxiliary materials,formulation composition,process parameters and disintegration medium.The mechanisms of tablet disintegration mainly include swelling,shape recovery and wicking.Among the commonly used functional auxiliary materials for disintegration,starch and its derivatives,croscarmellose sodium and sodium carboxymethyl starch promote disintegration through swelling.The mechanism of polyvinylpolypyrrolidone promoting disintegration is shape recovery.Cellulose and its derivatives promote disintegration through strong wicking effect.Future research directions include:correlation modeling between critical material attributes,critical process parameters and tablet disintegration behavior in tablet technology;objective,visual and quantitative characterization of tablet disintegration process and behavior;development and application of new pharmaceutical excipients to promote tablet disintegration.

关 键 词：片剂 崩解机制 崩解剂 赋形剂 

分 类 号：R944.4[医药卫生—药剂学]