化学药品杂质控制的现状与展望

Current situation and the trend in impurity control of chemical drugs

对药品中杂质的控制是保证药品用药安全的重要环节.伴随着对药品杂质特性的深入了解,依据杂质的生理活性逐一制定每一个杂质限度的"杂质谱控制"理念已经被国内外普遍接受.与"杂质谱控制"相关的关键技术问题可概括为:复杂体系样本的分离分析、微量组分的结构分析和微量组分的毒性评价三方面.本文从杂质控制理念和杂质分析技术两方面,综述了化学药品杂质控制的现状,并就今后的发展提出自己的观点.

The safety of the drug therapy is closely related to the quality of drugs.The impurity profiling which means that analytical activities with the aim of detecting,identifying or elucidating the structure and quantitatively determining organic and inorganic impurities as well as residual solvents in pharmaceuticals,has become the most important activity in assuring the high quality of drugs,and the concept of impurity profiling control in specifications has currently been acceptable all over the world.After discussing the technique used in impurity profiling control with emphasis on impurity determination,impurity identification as well as impurity qualification,the trends of this field in China has been outlined.