论文部分内容阅读
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 analyze the related substances of clozapine and its preparations. Methods: The comparative analysis of “Chinese Pharmacopoeia” and “United States Pharmacopoeia” (USP) method. Results: The impurity spectra of domestic raw materials and imported raw materials were basically the same. The impurity spectrum of preparation was basically the same as the impurity spectrum of raw materials. The separation of impurities by USP method was better than the method of Chinese Pharmacopoeia. Conclusion: The current statutory test standard test of “Chinese Pharmacopoeia” needs further study.