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银杏内酯B注射液在生理盐水中的稳定性的研究
引用本文:宋玉乔,廖杰,陶忠华,李淑芬,梅世昌. 银杏内酯B注射液在生理盐水中的稳定性的研究[J]. 现代仪器, 2008, 14(1): 31-33
作者姓名:宋玉乔  廖杰  陶忠华  李淑芬  梅世昌
作者单位:1. 解放军总医院医学实验测试中心,北京,100853
2. 解放军总医院科技开发中心,北京,100853
摘    要:目的:采用高效液相法对银杏内酯B注射液在生理盐水中的稳定性进行研究,又采用HPLC-MS法对银杏内酯B注射液在生理盐水中经加热后所生成的降解产物进行研究。方法:高效液相条件为:色谱柱:Venusil XBP-C18(5μm,4.6×250mm),柱温:25℃,流动相∶甲醇∶水(40∶60),流速:1.0mL/min,检测波长:220nm。结果:在上述色谱条件下,本品在0.1~2mg/mL范围呈线性关系,回归方程为:Y=313.95X+0.8054,r=0.9999;精密度良好,RSD:0.86%;主峰与其它杂质峰分离良好。结论:银杏内酯B注射液在生理盐水中至少可放置3个月。

关 键 词:银杏内酯B  银杏内酯B注射液  HPLC HPLC-MS  有关物质

Study on stability of Ginkgolide B injection in the chloride sodium injection
Song Yuqiao,Liao Jie,Tao honghua,Lihufen,Meihichang. Study on stability of Ginkgolide B injection in the chloride sodium injection[J]. Modern Instruments, 2008, 14(1): 31-33
Authors:Song Yuqiao  Liao Jie  Tao honghua  Lihufen  Meihichang
Abstract:Objective To study the stability of Ginkgolide B injection in the chloride sodium injection by HPLC and its degradation after heating by HPLC-MS.Method Chromatographic condition:the colomn: Venusil XBP-C18(5μm,4.6mm×250mm);column temperature:25℃;the mobile phase:methanol:water(40/60,V/V);the flow rate:1.0mL/min;the detection wavelength:220nm.Result The relationship between amount of Ginkgolide B and peak areas can be described by the linear equation:Y=313.95X+0.8054(r=0.9999).The precision was good with RSD of 0.86%.A good separation was achived from Ginkgolide B and its related substances.Conclusion Ginkgolide B injection can keep stabile at least three years in the chloride sodium injection.
Keywords:Ginkgolide B Ginkgolide B injection HPLC HPLC-MS Related substances
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