三硅酸镁质量标准的研究与探讨  

lnvestigation and discussion on identification of magnesium trisilicate

作　　者：张凤兰 赵画 郑烨 ZHANG Fenglan;ZHAO Hua;ZHENG Ye(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201200,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201200

出　　处：《中国药品标准》2020年第4期321-325,共5页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题:2019Y025。

摘　　要：目的:修订《中国药典》2015年版四部中三硅酸镁的质量标准。方法:按照《中国药典》2015年版的相关规定,参考现行标准及研究文献,考察本品的鉴别、重金属及砷盐。结果:修订了鉴别(1)、重金属及砷盐方法。结论:改进后的标准更易于观察到鉴别现象,提高了重金属项的可操作性和安全性,也避免了砷盐项中砷斑显色出现假阴性的结果。实验结果准确、可靠,为新版《中国药典》三硅酸镁质量标准修订提供了参考。Objective:To revise the specification of magnesium trisilicate in the Chinese Pharmacopoeia 2015 VolⅣ.Methods:The identification,heavy metal and arsenic salt of magnesium trisilicate were studied according to the relevant requirements in the Chinese Pharmacopoeia 2015 and referring to the current standard and research literature.Results:The test methods of identification(1),heavy metal and arsenic salt were revised.Conclusion:The revised methods make the observation of identification phenomenon easier,improves the operability and safety of heavy metal items,and avoids the false negative results of arsenic spots in arsenic salt items.The experimental results are accurate and reliable,which provide a reference for the revision of the specification of magnesium trisilicate in the new edition of the Chinese Pharmacopoeia.

关 键 词：三硅酸镁 中国药典 鉴别 砷盐 重金属 

分 类 号：R921.2[医药卫生—药学]