药品中残留溶剂的控制理念及测定方法的应用

发布时间：2018-03-14 22:11

本文选题：药品　切入点：残留溶剂　出处：《中国新药杂志》2017年17期 　论文类型：期刊论文

【摘要】：目的:介绍各国不同药典在药品残留溶剂测定中的控制理念并探讨方法的应用。方法:以头孢孟多酯钠的残留溶剂检测为例,探讨了2015版《中华人民共和国药典》如何解决残留溶剂检测中的不确定性难题,建立适合待测样品残留溶剂的检测方法。结果:应用《中华人民共和国药典》2015版通则0861残留溶剂测定法,对不同生产厂家的头孢孟多酯钠的残留溶剂进行了全面准确的测定。结论:不同药典在残留溶剂测定中的设计和控制理念并不尽相同,《中华人民共和国药典》2015版通则中的双柱定性方法可以快速、准确地鉴别出药品中未知的残留溶剂。
[Abstract]:Objective: to introduce the control concept of different pharmacopoeia in the determination of residual solvents in different countries and to explore the application of the method. This paper discusses how to solve the uncertainty problem in the detection of residual solvents in the 2015 edition of the Pharmacopoeia of the people's Republic of China. To establish a suitable method for the determination of residual solvents in the samples to be tested. Results: the method of determination of residual solvents in the Chinese Pharmacopoeia 2015 edition of General Rule 0861 was used. The residual solvents of cefmendium sodium from different manufacturers were determined completely and accurately. Conclusion: different pharmacopoeia have different design and control ideas in the determination of residual solvents. The Pharmacopoeia of the people's Republic of China 2015 Edition. The two-column qualitative method in the general principles can be used quickly. The unknown residual solvent in the drug was identified accurately.
【作者单位】：中国食品药品检定研究院;国家药典委员会;中国药学会;
【分类号】：R927.1

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