新型定量分装装置的研发及其在国家药品标准物质制备中的应用  

Research and development of new quantitative packaging device and its application to preparation of national pharmaceutical standard substances

作　　者：王丽[1] 赵宗阁[1] 姚晶 张琪[1] 王雅君[1] 刘明理[1] WANG Li;ZHAO Zongge;YAO Jing;ZHANG Qi;WANG Yajun;LIU Mingli(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药品标准》2024年第4期430-436,共7页Drug Standards of China

基　　金：中国食品药品检定研究院中青年发展研究基金(编号:2022A4)。

摘　　要：目的:优化标国家药品准物质的分装方式,研发一种新型可调的节定量分装设备,用于提高分装效率和生产质量。方法:采用不锈钢材质,制作可调节容积槽和配套刮板,固定体积进行粉末样品的分装。结果:使用分装装置选用化学药品、药用辅料等31种均匀粉末样品进行分装。其测试波动范围较小、准确性高,不同样本之间使用效果一致,分装效率与统天平单支称重的分装方式进行比较提高147%。结论:该装置能显著缩短分装时间,提高生产效率,满足药品标准物质分装规格要求。为药品标准物质的生产制备带来更为显著的便利和价值。Objective:To optimize the dispensing method of national drug standard substances and develop a novel adjustable quantitative dispensing device for improving dispensing efficiency and production quality.Methods:Stainless steel was used to fabricate an adjustable volume tank and a matching scraper for dispensing powder samples of fixed volume.Results:31 types of uniform powder samples,including chemicals and pharmaceutical excipients,were dispensed using the dispensing device.It showed a small test fluctuation range,high accuracy,and consistent effectiveness among different samples.The dispensing efficiency was improved by 147%compared to the conventional method of single-weight dispensing using a balance.Conclusion:The device can significantly reduce dispensing time,increase production efficiency,and meet the dispensing specifications for drug standard substances,which brings remarkable convenience and value to the production and preparation of drug standard substances.

关 键 词：国家药品标准物质 粉末 定量分装 可调节装量 提高生产效率 

分 类 号：R921.2[医药卫生—药学]