药物中杂质的分析方法浅析

Talk about the Analysis Method of the Impurity in the Medicine

药物中主成分以外的杂质,可能是生产过程中带入的各种杂质,也可能是贮藏、运输过程中产生的降解产物等。药物的杂质控制对于保证药物的效能,降低药物的不良反应起着很关键的作用。由于其成份复杂,所以必须选择专属性强、灵敏度高、重现性好的分析方法。本文论述了药物中杂质的分析方法对药物安全性的影响以及杂质控制及检查方法,阐明了研究药物的杂质及杂质控制的重要意义。

The impurity of the medicine is taken during the producting or produced during store or conveyance. It is very important to centrol the impurity to ensure the effect of the medicine and reduce the adverse effect. Because it＇s composition is complicate, we must chose a analysis method that is strong speeifity, high sen sitivity and good reproducibility. The author discussed the irdluenee of the analysis method of the medicine impurity to the safety of the medicine, the impurity control and the analysis method, dariftied the important meaning to study the impurity of medicine and control it.