色谱技术分析利培酮含量及有关物质的研究进展.pdfVIP

现代药物与临床 Drugs Clinic 第 27 卷 第 3 期 2012 年 5 月 • 317 • 色谱技术分析利培酮含量及有关物质的研究进展 1, 2 1 2 1* 颜晓丹 ，蔡振华 ，高 明 ，蒋庆峰 1. 天津药物研究院 分析测试中心，天津 300193 2. 天津中医药大学 研究生部，天津 300193 摘 要：利培酮是新一代的非典型抗精神病药，对精神分裂症有良好疗效，不良反应小。为了便于利培酮的质量控制研究， 归纳对比国家标准、美国药典、欧洲药典、英国药典所规定的质量标准；并综述了近年来国内外文献中使用色谱方法分析利 培酮原料药及其制剂的测定及有关物质，包括高效液相色谱法、高效毛细管电泳法、薄层色谱扫描法等。此外，重点总结了 各国药典对利培酮原料药及其制剂中各种有关物质的限度规定，为利培酮有关物质的研究提供了参考与借鉴。 关键词：利培酮；分析方法；有关物质；含量测定 中图分类号：R927.2 文献标志码：A 文章编号：1674 - 5515(2012)03 - 0317 - 06 Advance in studies on chromatographic technology used for analysis and determination of Risperidone and its related substances 1, 2 1 2 1 YAN Xiao-dan , CAI Zhen-hua , GAO Ming , JIANG Qing-feng 1. Center for Instrumentation Analysis, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China 2. Department of Graduate Student, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China Abstract: Risperidone is one of the promising atypical antipsychotic drugs, which is effective in the treatment of schizophrenia with few side effects. In order to facilitate the research on Risperidone, the quality standards of Risperidone in Chinese Standard, USP, EP and BP are compared. Besides, the determination methods of related substances and content in Risperidone and its pharmaceutical preparations in recent years were reviewed, including high performance liquid chromatography (HPLC), high performance capillary electrophoresis (HPCE), and thin layer chromatography scanning (TLCs). Furthermore, the limits of impurities in Risperidone and its pharmaceutical preparations are generalized, providing a reference for the research on related substances in Risperidone. Key words: Risperidone; methods of analysis; related substances; content determination 利培酮（Risperidone ）是新一代的非典型抗精 神病药，属于具有独特