铂类药物杂质及其检测方法的研究进展

发布时间：2018-05-17 15:22

本文选题：铂类药物 + 杂质　；参考：《中国药房》2017年30期

【摘要】：目的:为铂类药物的工艺优化和质量控制提供参考。方法:收集近年国内外关于铂类药物杂质研究的文献,进行归纳、总结和综述。结果与结论:已经上市的铂类药物中应用最广泛的是顺铂、卡铂和奥沙利铂,《中国药典》《美国药典》《欧洲药典》《日本药典》中已收载了上述药物相关的一些杂质检查项目。铂类药物中的杂质可分为工艺杂质和降解杂质两类,工艺杂质可能有其银盐、水合物、光学异构体及所对应的羧酸等;降解杂质是其在光照、酸性条件、氯离子存在时降解或在水溶液中发生水合反应的产物。目前铂类药物的杂质检测方法主要有薄层色谱法、高效液相色谱法、电感耦合等离子体发射光谱法、电感耦合等离子体质谱法、流动注射电喷雾质谱法等。今后随着越来越多的全新结构的铂类药物问世,采用的杂质研究方法可能会有所不同,如何更准确、快速、高效地检出铂类药物中的杂质仍将是该类药物质量控制的一个重要议题。
[Abstract]:Objective: to provide reference for the optimization and quality control of platinum drugs. Methods: the literature about platinum drug impurity was collected, summarized and summarized in recent years. Results & conclusion: cisplatin, carboplatin and oxaliplatin are the most widely used platinum drugs on the market. Some impurity items related to the above drugs have been included in the Chinese Pharmacopoeia, American Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia. The impurities in platinum drugs can be divided into two categories: technological impurity and degradation impurity, which may have silver salt, hydrate, optical isomer and corresponding carboxylic acid, etc. The product of degradation or hydration in aqueous solution in the presence of chloride ions. At present, the main methods of impurity detection for platinum are thin layer chromatography, high performance liquid chromatography, inductively coupled plasma emission spectrometry, inductively coupled plasma mass spectrometry, flow injection electrospray mass spectrometry and so on. In the future, as more and more new structures of platinum drugs are introduced, the impurity research methods may be different, how to be more accurate and fast. Efficient detection of impurities in platinum drugs will remain an important issue in quality control of platinum drugs.
【作者单位】：中国医药工业研究总院上海医药工业研究院/创新药物与制药工艺国家重点实验室;
【分类号】：R927.1

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