CAJ | 학술논문

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242 nm，理论塔板数以依达拉奉色谱峰计不低于2000，保留时间为12～15 min；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。
목적：건립의체랍봉주사액적질량표준，병고찰기은정성。방법의체랍봉적함량측정응용HPLC법，검측파장242 nm，이론탑판수이의체랍봉색보봉계불저우2000，보류시간위12～15 min；통과pH치、중금속함량、세균내독소、무균검사등대기질량진행공제；통과영향인소시험，가속시험화실온류양관찰시험고찰주사액적은정성。결과의체랍봉재1．5～7．5μg/μl 범위내농도여흡광도성량호선성관계（ r ＝0．9994），평균회수솔위100．02％，RSD＝0．96％。3비의체랍봉주사액중의체랍봉적함량분별위표시량적100．73％、98．37％、100．64％。3비의체랍봉주사액적pH치분별위2．8、2．9、2．8。중금속함량、세균내독소、무균검사등부합약전규정。결론해시험방법간단，은정성고，계통가중복성강，가유효공제의체랍봉주사액적질량병보증기은정성。
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 242 nm, theoretical plate number based on the chromatogram of edaravone was more than 2000 , retention time was12 ~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 .