中国药物警戒 ›› 2024, Vol. 21 ›› Issue (2): 147-151.
DOI: 10.19803/j.1672-8629.20230434

• 不同分析方法在药品质量控制中的应用专栏 • 上一篇    下一篇

激光衍射法测定西格列他钠粒径分布

郭宁子1, 刘丽1, 岳瑞齐2, 冯慧庆3, 杨化新1, 魏宁漪1,*, 陈华1#   

  1. 1中国食品药品检定研究院,北京 102629;
    2国家药典委员会,北京 100061;
    3马尔文帕纳科有限公司,北京100040
  • 收稿日期:2023-07-21 出版日期:2024-02-15 发布日期:2024-02-06
  • 通讯作者: *魏宁漪,女,研究员,化学药品质量控制。E-mail：weiny@nifdc.org.cn。#为共同通信作者。
  • 作者简介:郭宁子,女,助理研究员,化学药品质量控制。
  • 基金资助:
    国家重点研发计划（2023YFC2410202）

Determination of particle size distribution of chiglitazar sodium by laser diffraction method

GUO Ningzi1, LIU Li1, YUE Ruiqi2, FENG Huiqing3, YANG Huaxin1, WEI Ningyi1,*, CHEN Hua1#   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2Chinese Pharmacopoeia Commission, Beijing 100061, China;
    3Malvernpanalytical Co., Ltd., Beijing 100040, China
  • Received:2023-07-21 Online:2024-02-15 Published:2024-02-06

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摘要： 目的 建立西格列他钠的粒径分布测定方法,为药物粒径测定的方法开发和质量控制提供参考。方法 采用MALVERN Mastersizer 3000激光衍射粒度仪和AEROS干法进样器建立西格列他钠的粒径分布方法。背景测量持续时间7 s;样品测量持续时间7 s;遮光度0.5%~5%;样品分散气压0.4 MPa;进样速度60%;文丘里管类型为高能文丘里管;料斗间隙2.5 mm。结果 3批样品粒径分布特征值d(0.1)在1.02~1.17 μm,d(0.5) 在5.94~6.69 μm,d(0.9)在20.70~22.40 μm,平均标准偏差（RSD）均小于1%。结论 建立了西格列他钠的粒度测定方法,可为其他易引湿药物的干法粒径测定方法开发提供参考。

关键词: 激光衍射法, 西格列他钠, 粒径分布, 易引湿药物, 干法测定

Abstract: Objective To establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium so as to provide reference for the development and quality control of methods for determination of drug particle size. Methods The Malvern Mastersizer 3000 laser particle size analyzer with an AEROS dry sampler was used to establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium. As for the AEROS injector, the conditions of determination were as follows: the duration of background measurement was 7 s, the duration of sample measurement was 7 s, obscuration ranged from 0.5% to 5%, the sample dispersion pressure was 0.4 MPa, the injection speed was 60%, high energy venturis were used, and the hopper gap was 2.5 mm. Results The particle size distribution value of the three batches of samples ranged from 1.02 to 1.17 μm in d(0.1), 5.94 to 6.69 μm in d(0.5), and 20.70 to 22.40 μm in d(0.9). The RSD of the above values was below 1%. Conclusion A particle size determination method has been established for chiglitazar sodium, which can provide reference for the development of dry particle size determination methods for other hygroscopic drugs.

Key words: laser diffraction method, chiglitazar sodium, particle size distribution, hygroscopic drugs, dry measurement

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