甘露醇的药物晶体学研究进展  

Progress in pharmaceutical crystallographic study of mannitol

作　　者：刘慧娜 张珂 缪妍 魏元锋[1] 高缘[1] LIU Huina;ZHANG Ke;MIAO Yan;WEI Yuanfeng;GAO Yuan(School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198,China;School of Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学中药学院,南京211198 [2]中国药科大学药学院,南京211198

出　　处：《中国药科大学学报》2025年第2期264-270,共7页Journal of China Pharmaceutical University

基　　金：国家自然科学基金项目(No.82104401,No.82274217,No.82204636,No.82373824)。

摘　　要：甘露醇作为一种药用辅料,具备热值低、引湿性低、稳定性高等性质,广泛应用于固体制剂、冻干制剂和吸入制剂等多种剂型中,其具有不同晶体结构的晶型(α,β和δ)和共晶,晶体结构的改变会影响药物的制剂性能。本文从甘露醇多晶型的结构特征、物理化学性质、制备方法以及共晶形成等方面进行了综述,并着重讨论了甘露醇多晶型之间的转变条件、监测方法以及晶型转变对制剂性能的影响,包括可成片性和崩解溶出性能等。通过对甘露醇晶体学研究的系统性总结,以期为新型药用辅料开发及在药物制剂中的应用提供新思路。As a pharmaceutical excipient with low caloric value,low hygroscopicity,and high stability,mannitol is widely used in various dosage forms,such as solid,lyophilized and inhalation preparations,etc.It has different crystal structures(α,β and δ)and cocrystal,and the changes in the crystal structure will affect formulation properties of pharmaceutical formulations.This paper reviews structural features,physicochemical properties,and preparation methods of mannitol polymorphs and cocrystal formation,with emphasis on polymorphic transformation pathways,monitoring methods and the effect of polymorphic transformation on properties and application in pharmaceutical formulations,including tabletability,disintegration and dissolution properties.By systematically summarizing the crystallographic study of mannitol,this study attempts to provide new ideas for the development of novel pharmaceutical excipients and applications in pharmaceutical formulations.

关 键 词：甘露醇 多晶型 共晶 多晶型转变 药用辅料 

分 类 号：R944[医药卫生—药剂学]