一种评价中药固体制剂粉体流动性的新方法研究进展

Research progress of a new method for evaluating the fluidity of powder for solid preparation of Chinese medicine

寻找一种准确、快速评价粉体流动性方法对中药固体制剂处方设计、产品研究开发、药物质量控制等有着重要意义。粉体流动分析仪是基于中药固体制剂粉体开发的新型测试仪器,其通过压缩、剪切等测试模式测试粉体内聚力指数(CI)、结块强度(CS)、粉末流速依赖性(PFSD)等物理性质参数表征粉体流动性、压缩特性、流动稳定性,灵敏性好,测量结果科学客观、准确度高。能够为中药固体制剂基础理论阐释、处方工艺优化、质量控制研究提供理论支撑和技术方法。本文对近年来粉体流动分析仪在中药固体制剂物理性质评价的文献和报导进行分析总结,包括粉体流动分析仪在中药固体制剂粉体物理性质评价中应用到的硬件、软件、原理进行简述;对测定参数、参数定义、参数意义进行简述;对粉体流动分析仪在中药固体制剂粉体流动性、压缩特性、流动稳定性等物理性质评价、测定方法进行详细分析和评述,并与当前常用物理性质指标测量方法进行对比分析;以期推动粉体流动分析仪在药剂学领域粉体物理性质评价体系的应用发展,从而为药物制剂研究和开发提供新思路和新方法。

Finding an accurate and rapid method for evaluating powder flowability is of great significance for the prescription design, product R&D development, and drug quality control of traditional Chinese medicine solid formulations. The powder flow analyzer is a new type of testing instrument developed based on the solid preparation powder of traditional Chinese medicine. Its physical property parameters such as cohesion index(CI), agglomeration strength(CS), powder flow rate dependence(PFSD) are tested by compression and shear modes to characterize powder flow, compression characteristics, and flow stability, with good sensitivity, scientific and objective measurement results, and high accuracy. It can provide theoretical support and technical methods for the interpretation of basic theories, prescription process optimization, and quality control research of Chinese medicine solid formulations. This paper analyzes and summarizes the literature and reports on the application of powder flow analyzer in the evaluation of physical properties of Chinese medicine solid preparations in recent years, including a brief description of the hardware, software, and principles of the application of powder flow analyzer in the evaluation of physical properties of Chinese medicine solid preparations;a brief description of the measurement parameters, parameter definitions and parameter meanings;a detailed analysis and review on the evaluation and determination methods of powder flow analyzer in the physical properties of solid preparations of traditional Chinese medicine, such as flowability, compression characteristics, flow stability, etc, and a comparative analysis with the current commonly used physical property index measurement methods;in order to promote the development of the application of the powder flow analyzer in the field of pharmacy powder physical property evaluation system, so as to provide new ideas and new methods for drug formulation research and development.