安晨秀,邸东华,邹梅娟,朴洪宇,毛世瑞,陈蕾
AN Chenxiu,DI Donghua,ZOU Meijuan,PIAO Hongyu,MAO Shirui,CHEN Lei

• 1:沈阳药科大学药学院
• 2:国家药典委员会

摘要(Abstract)：

目的 堆密度、振实密度是粉体的重要参数，主要体现粉体的粒度和流动性。其测定条件对结果的影响较大。本研究旨在考察不同测定条件对结果的影响，为药用辅料或制剂中间体的粉体压缩性测定提供有意义的科学借鉴。方法 参考《中华人民共和国药典》(2020年版)四部附录固定质量法(I法)对三种压缩性的药用辅料进行堆密度及振实密度的测定，并计算得到压缩性指数及豪斯纳比率。结果 物料的装填速率是影响堆密度的关键因素，随装填速率增大，粉体堆密度增大，压缩性指数减小。在振实密度测定中，振幅高低对压缩性指数大的物料影响显著。结论 对比研究不同压缩性的药物辅料时，应在同一条件(如量筒体积、装填速率、装填量、振幅等)下进行检测。应用I法时，建议选用250 mL量筒、100 g样品及14 mm振幅条件下进行测定。
Objective Bulk density and tapped density are important indexes of powder, which mainly reflect the particle size and flowability of powder.The determination conditions have a great influence on the experimental results.The purpose of this study is to investigate the effects of different determination conditions on the experimental results, and to provide a meaningful scientific reference for the determination of powder compressibility of medicinal excipients or preparation.Methods With reference to the 2020 Chinese Pharmacopoeia fixed mass method(Method I),the bulk density and tapped density of three compressible pharmaceutical excipients were determined, and the Compressibility Index and Hausner Ratio were calculated.Results The filling rate of the materials was one of the key factors that affected the determination of the bulk density.With the increase of filling rate, the bulk density of powder increased and the compressibility index decreased.In the measurement of tapped density, the amplitude had a significant effect on the materials with large compressibility index.Conclusion In the comparative study of pharmaceutical excipients with different compressibility, it should be detected under the same conditions(such as volume, filling rate, filling quantity, amplitude, etc.).When using method I,it is recommended to choose 250 mL measuring cylinder, 100 g sample and 14 mm amplitude.

关键词(KeyWords)： 固定质量法;药用辅料;粉体压缩性;堆密度
fixed mass method;pharmaceutical excipients;powder compressibility;bulk density

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 安晨秀,邸东华,邹梅娟,朴洪宇,毛世瑞,陈蕾
AN Chenxiu,DI Donghua,ZOU Meijuan,PIAO Hongyu,MAO Shirui,CHEN Lei

DOI: 10.14066/j.cnki.cn21-1349/r.2021.0682

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