药品质量标准中杂质的限度确定方式探讨  

Discussion on the Determination of Impurity Limits in Drug Quality Standards

作　　者：阚洪峰 宋锡瑞 KAN Hongfeng;SONG Xirui(Qilu Pharmaceutical Co.,Ltd.,Jinan 250100,China)

机构地区：[1]齐鲁制药有限公司,山东济南250100

出　　处：《品牌与标准化》2024年第5期128-130,共3页

摘　　要：本文将对创新药品质量标准中杂质的限度确定方式进行探讨,旨在寻找最优化的杂质限制策略,以提高药品质量,保障患者用药安全和公众健康。在这个过程中,本文将分析不同类型的药品杂质、它们的来源以及对药物疗效和安全性的影响,同时,还将探讨现有的杂质限定方法及其局限性,针对这些问题,提出更科学、合理的杂质限度确定方式和改进策略。This article will explore the method of determining the limit of impurities in innovative drug quality standards,aiming to find the optimal impurity restriction strategy to improve drug quality,ensure patient medication safety and public health.In this process,different types of drug impurities,their sources,and their impact on drug efficacy and safety will be analyzed.At the same time,existing impurity limitation methods and their limitations will be explored.To address these issues,more scientific and reasonable impurity limit determination methods and improvement strategies will be proposed.

关 键 词：药品质量标准 杂质 限度确定 方式探讨 

分 类 号：R95[医药卫生—药学]