软材转矩流变特性的评价方法及在制剂工艺开发中的作用  

Evaluation method of torque rheological properties of soft materials and its role in preparation process development

作　　者：任雯霞 杜若飞[1] 赵立杰[1] 洪燕龙 王优杰[1] REN Wenxia;DU Ruofei;ZHAO Lijie;HONG Yanlong;WANG Youjie(Engineering Research Center of Modern Preparation Technology of TCM of Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Innovation Center of Traditional Chinese Medicine Health Service,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203 [2]上海中医药大学上海中医健康服务协同创新中心,上海201203

出　　处：《上海医药》2023年第1期73-77,共5页Shanghai Medical & Pharmaceutical Journal

基　　金：国家自然科学基金面上项目(81973490);上海市自然科学基金项目(20ZR1458400、18ZR1436600)。

摘　　要：湿法制粒过程中的颗粒生长主要取决于软材的流变学特性,因为对于粉末润湿成核以及较小的团聚体向较大的团聚体的生长,必须具有足够的黏度。本文综述了评价软材流变学特性的方法,介绍了利用混合转矩流变仪测试软材转矩流变特性的原理和方法,重点阐述了软材转矩流变特性的评价方法在制剂工艺开发中的应用。转矩流变特性可以评价软材关键特性,预测造粒行为和产品性能,提高高剪切、挤出微丸等湿法制粒工艺开发效率。The growth of particles mainly depends on the rheological properties of soft materials in the process of wet granulation because sufficient viscosity is necessary for the wetting nucleation of powder and the growth of smaller aggregates to larger aggregates.The methods for evaluating the rheological properties of soft materials are reviewed,the principle and method for testing the rheological properties of soft materials using mixer torque rheometer are introduced and the application of the evaluation method in preparation process development is emphatically expounded.The torque rheological properties can be used to evaluate the key properties of soft materials,predict the granulation behavior and product properties and improve the development efficiency of wet granulation processes such as high shear and extrusion pellets.

关 键 词：湿法制粒 软材 转矩流变特性 液固比 

分 类 号：R943[医药卫生—药剂学]