三硅酸镁质量标准的研究与探讨

lnvestigation and discussion on identification of magnesium trisilicate

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.