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学科主题: 临床医学
题名:
依达拉奉注射剂质量标准和稳定性研究
其他题名: Study on the quality standard and stability of edaravone injection
作者: 陈楠1; 盖春燕1; 陈刚1; 付宏征1
关键词: 依达拉奉注射液 ; 质量标准 ; 稳定性 ; edaravoneInjection ; quality standard ; stability
刊名: 河北医药
发表日期: 2014
DOI: 10.3969/j.issn.1002-7386.2014.14.006
期: 14, 页:2098-2100
收录类别: 中国科技核心期刊
文章类型: Journal Article
摘要: 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。 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 .
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/47528
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.北京大学第一医院, 北京市,100034
2.北京大学天然药物及仿生药物国家重点实验室

Recommended Citation:
陈楠,盖春燕,陈刚,等. 依达拉奉注射剂质量标准和稳定性研究[J]. 河北医药,2014(14):2098-2100.
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