CAJ | 학술논문

药品是一种特殊商品，与人们的健康和生命安全息息相关，药物杂质是影响药物稳定性和疗效的物质，与药品质量、安全性及效能密切相关。随着杂质控制在药物开发研究中越来越受到重视，研究者开始将注意力转移到痕量杂质的分析上。笔者总结近10年来国内外杂质研究的相关进展，内容涉及药物杂质研究的相关指导原则、杂质定性研究的相关技术以及杂质定量研究等的一般方法。
약품시일충특수상품，여인문적건강화생명안전식식상관，약물잡질시영향약물은정성화료효적물질，여약품질량、안전성급효능밀절상관。수착잡질공제재약물개발연구중월래월수도중시，연구자개시장주의력전이도흔량잡질적분석상。필자총결근10년래국내외잡질연구적상관진전，내용섭급약물잡질연구적상관지도원칙、잡질정성연구적상관기술이급잡질정량연구등적일반방법。
As special commodities , drugs had closely relationships with human beings′health and life safety .Impurity, which would influence the stability and efficacy of drugs , was closely related to the quality , safety and efficacy of drugs .With more and more attendance had been attached to the impurity′s control in the development of drugs , researchers turned their attentions to the analysis of trace impurity .In this paper , related progresses in recent 10 years were summarized , including guiding principles in impurity re-search, technologies in qualitative research and general approaches in quantitative research .