依达拉奉注射剂质量标准和稳定性研究

Study on the quality standard and stability of edaravone injection

目的建立依达拉奉注射液的质量标准，并考察其稳定性。方法依达拉奉的含量测定应用HPLC法，检测波长242nm，理论塔板数以依达拉奉色谱峰计不低于2000，保留时间为12～15min；通过pH值、重金属含量、细菌内毒素、无菌检查等对其质量进行控制；通过影响因素试验，加速试验和室温留样观察试验考察注射液的稳定性。结果依达拉奉在1．5～7．5μg／μl 范围内浓度与吸光度成良好线性关系（r=0．9994），平均回收率为100．02％，RSD=0．96％。3批依达拉奉注射液中依达拉奉的含量分别为标示量的100．73％、98．37％、100．64％。3批依达拉奉注射液的pH值分别为2．8、2．9、2.8。重金属含量、细菌内毒素、无菌检查等符合药典规定。结论该试验方法简单，稳定性高，系统可重复性强，可有效控制依达拉奉注射液的质量并保证其稳定性。

Objective To establish the quality standard of edaravone injection and to investigate its stability. Methods The quantitative detection of edaravone injection was performed by HPLC, detection wavelength was 242nm, theoretical plate number based on the chromatogram of edaravone was more than 2000, retention time wasl2 - 15 min. The quality was controlled by pH, contents of heavy metals, bacterial endotoxin and sterility tests. The stability of edaravone injection was evaluated by influence factors test, acceleration test and room temperature storage observation test. Results From 1.5 to 7.5μg/μl,the concentration and absorbance of edaravone injection had a good linear relationship （ r = 0. 9994 ）, the average recovery rate was100.02%, and RSD was 0.96%. The pH of three batches injections was 2.8,2.9,2.8, respectively, moreover,the contents of heavy metals, bacterial endotoxin and sterility tests were consistent with pharmacopoeias regulation. Conclusion The method is simple, accurate, stable and repeatable, which can effectively control the quality of edaravone injection and can assure its stability.