布洛芬原料药及部分杂质的细胞毒性研究

Cytotoxicity of Ibuprofen Raw Material and its Part of Impurities

目的:评价布洛芬原料药及6种杂质的细胞毒性。方法:不同浓度的布洛芬原料药及6种杂质作用于小鼠成纤维细胞(L929)72 h后,显微镜观察细胞毒性。结果:在布洛芬原料药中,杂质B的细胞毒性最弱,为轻微毒性;杂质N、D、J、V细胞毒性均呈中度毒性,杂质E的细胞毒性呈现重度细胞毒性。结论:在该原料药中,同等浓度条件下,杂质E的毒性最强,应对其在布洛芬制剂中的含量进行严格地控制。

Objective： To evaluate the cytotoxicity of ibuprofen and its 6 kinds of impurities. Methods： Different concentrations of ibuprofen and the impurities were used to act on mouse fibroblasts （L929） for 72 h, and the cytotoxicity was observed under a microscope. Results： In ibuprofen raw material, the cytotoxicity of impurity B was the weakest with slight toxicity, the cytotoxicity of impurity N, D, J and V was moderate, and that of impurity E was severe. Conclusion： At the same concentration, the toxicity of impurity E is the strongest, and its content in ibuprofen preparations should be strictly controlled.