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作 者:吴洋[1] 孙旭[1] 高媛[1] 李兴东[1] 马晓昱[1] 姚惠凤 陈瑶[1]
机构地区:[1]济南军区联勤部药品仪器检验所,济南250022 [2]济南军区第150医院
出 处:《中国药师》2016年第4期758-761,共4页China Pharmacist
基 金:总后勤部卫生部2014年度军队医疗机构制剂标准提高科研专项课题计划(编号:14ZJZ01-1)
摘 要:目的:建立平肝口服液中大黄素和单参素的含量测定方法。方法:采用HPLC法进行含量测定。大黄素的色谱条件为色谱柱:Agilent Eclipse XDB-C_(18)柱(150 mm×4.6 mm,5μm);流动相:甲醇-水(80∶20);检测波长:287 nm;流速:1.0 ml·min^(-1);柱温:25℃;进样量:20μl。丹参素的色谱条件为色谱柱:Agilent Eclipse SB-C_(18)柱(150 mm×4.6 mm,5μm);流动相:甲醇-1%醋酸溶液(2∶98);检测波长:280 nm;流速1.0 ml·min^(-1);柱温:30℃;进样量:20μl。结果:大黄素在26.75~428.00μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9),平均回收率为102.7%,RSD为0.76%(n=6)。丹参素钠在10.17~162.77μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9),平均回收率为100.5%,RSD为1.47%(n=6)。结论:该方法结果准确,重复性好,可作为该制剂的质量控制方法。Objective: To establish the method for the determination of emodin and danshensu Pinggan oral liquid. Methods: The contents were determined by HPLC. The chromatographic conditions for emodin were as follows: an Agilent Eclipse XDB-C_(18)column( 150 mm×4.6 mm,5 μm) was used and the mobile phase was methanol-water( 80 ∶20). The detection wavelength was 287 nm and the flow rate was 1.0 ml·min^(-1). The column temperature was 25℃ and the injection volume was 20 μl. The chromatographic conditions for Danshensu were as follows: an Agilent Eclipse SB-C_(18)column( 150 mm×4.6 mm,5 μm) was used and the mobile phase was methanol-1% acetic acid solution( 2 ∶98). The detection wavelength was 280 nm and the flow was 1.0 ml·min^(-1). The column temperature was 30℃ and the injection volume was 20 μl. Results: Emodin had a good linear relationship within the range of 26.75-428.00μg·ml^(-1)( r= 0.999 9). The average recovery was 102.7% and RSD was 0.76%( n= 6). Sodium Danshensu had a good linear relationship within the range of 10.17-162.77 μg·ml^(-1)( r= 0.999 9). The average recovery was 100.5% and RSD was 1.47%( n= 6).Conclusion: The method is simple,accurate and reproducible,which can be used for the quality control of the preparation.
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