碱式硝酸铋的质量标准研究和探讨  

Investigation of the quality standard of bismuth subnitrate

作　　者：邱娟[1] 李玮玲[1] QIU Juan;LI Weiling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药品标准》2024年第6期624-627,共4页Drug Standards of China

摘　　要：目的:优化完善碱式硝酸铋的质量标准。方法:比较国内外碱式硝酸铋质量标准,结合样品的实验结果,主要对其中文名称、鉴别项、检查项及含量测定进行增修订。结果:按拟定质量标准测定15批样品,含量的结果在71.8%~73.9%之间。建立的碱式硝酸铋质量标准已完成公示。结论:本标准的建立,将为碱式硝酸铋原料药的应用提供质量保障。Objective:To optimize the quality standard of bismuth subnitrate.Methods:In combination with the results of the experiment,the title,identification,test and assay items were added and revised by comparing domestic and international quality standards of bismuth subnitrate.Results:According to the proposed quality standard,the content of 15 batches of samples was 71.8%-73.9%.The drafted standard of bismuth subnitrate has been established.Conclusion:The established standard will provide the quality guarantee for the application of bismuth subnitrate in medicines.

关 键 词：碱式硝酸铋 质量标准 银盐 铵盐 砷盐 含量测定 

分 类 号：R921.2[医药卫生—药学]