氯氮平有关物质研究

Study on Related Substances in Clozapine

目的:对氯氮平及其制剂的有关物质进行分析研究。方法:采用《中国药典》及《美国药典》(USP)的方法进行对比分析。结果:国产原料与进口原料杂质谱基本一致,制剂杂质谱与原料杂质谱基本一致,USP所用方法对杂质的分离优于《中国药典》所用方法。结论:《中国药典》现行法定检验标准检验有待研究提高。

Objective： To study the related substances in clozapine and its preparations. Methods： Comparative analysis was adopted according to the method respectively described in Chinese pharmacopoeia and United States pharmacopoeia. Results： The impurity profile of clozapine from domestic and abroad was basically the same,and that of clozapine and its preparations was also basically the same. The method in United States pharmacopoeia was better than that in Chinese pharmacopoeia in terms of in terms of separation of the impurities. Conclusion： The current legal inspection standard for the related substances in clozapine described in Chinese pharmacopoeia should be improved.