硬脂酸镁和香精物料属性及其润滑性能相关性研究  

Study on the relationship between material attributes and lubrication performance of magnesium stearate and flavor

作　　者：郑智元 刘正宇 何东升 孙春萌 涂家生 ZHENG Zhiyuan;LIU Zhengyu;HE Dongsheng;SUN Chunmeng;TU Jiasheng(NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients,Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs,Department of Pharmaceutics,School of Pharmacy,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国药科大学药学院药剂系,国家药品监督管理局药物制剂及辅料研究与评价重点实验室,中国药科大学药用辅料及仿创药物研发评价中心,江苏南京210009

出　　处：《药学研究》2022年第12期796-802,共7页Journal of Pharmaceutical Research

基　　金：国家药典委员会“国家药品标准提高课题”(No.2021Y23)。

摘　　要：润滑剂是口服固体制剂中常用的一类药用辅料,可以有效提高物料流动性、减小物料和机械摩擦系数等。然而,由于不同厂家采用的原料、工艺、质控要求等存在差异,可能导致“虽然润滑剂通用名一致,但不同来源润滑剂物料属性不一致”的情形,进而导致润滑性能存在差异。本研究征集了不同厂家来源的硬脂酸镁(magnesium stearate, MgSt)和香精作为研究对象,全面考察了其堆密度、振实密度、粒度分布、比表面积等粉体学性质和玻璃化转变温度、熔点等热力学性质,并研究其在压片时的出片力表现,明确了影响其润滑性能的关键物料属性,为相关辅料的质量控制和功能性相关指标研究提供参考。Lubricant is a kind of pharmaceutical excipients commonly used in oral solid preparations, which can effectively improve material fluidity and reduce material and mechanical friction coefficient.However, due to the differences in raw materials, processes and quality control requirements used by different manufacturers, it may lead to the situation that "although the common name of lubricants is the same, the properties of lubricants from different sources are not the same",thereby leading to differences in lubrication performance.In this study, magnesium stearate(MgSt) and flavors from different manufacturers were collected.The powder properties such as bulk density, vibration density, particle size distribution, specific surface area, and the thermodynamic properties such as glass transition temperature and melting point were investigated.The critical material attributes that affect the lubrication performance are clarified, which provides a reference for the quality control and the functionality-related characteristics of related lubricants.

关 键 词：硬脂酸镁 香精 润滑性能 关键物料属性 功能性相关指标 

分 类 号：TQ460.4[化学工程—制药化工]