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作 者:颜月园[1,2] 萧伟[2,3] 吴云[2,3] 王伟[2,3] 姜华[2,3] 张怡[2,3] 朱克近[2,3]
机构地区:[1]南京中医药大学,南京210000 [2]中药制药过程新技术国家重点实验室,江苏连云港222001 [3]江苏康缘药业股份有限公司,江苏连云港222001
出 处:《中国实验方剂学杂志》2012年第5期58-61,共4页Chinese Journal of Experimental Traditional Medical Formulae
基 金:国家科技部重大新药创制项目(2011ZX09201-201-20)
摘 要:目的:采用高效液相色谱法测定散结镇痛胶囊中黄酮类成分的指纹图谱。方法:采用50%甲醇超声提取黄酮类成分进行分析检测。色谱条件为Waters Symmetry@C18(4.6 mm×250 mm,5μm)色谱柱;流动相为乙腈-水,梯度洗脱;检测波长275 nm;流速1.0 mL.min-1;柱温30℃。采用国家药典委员会出版的《中药色谱指纹图谱相似度评价》(2004年A版)软件,对10批不同批次的散结镇痛胶囊中黄酮类成分指纹图谱进行相似度计算。结果:指纹图谱中标记了15个共有峰,共有峰面积之和大于总峰面积的95%,利用指纹图谱相似度测试软件,测定10批散结镇痛胶囊中黄酮类成分指纹图谱相似度均在0.99以上。结论:方法具有良好的精密度、重复性、稳定性,各共有峰间分离度高,可用于散结镇痛胶囊质量的综合评价。Objective:To establish the chromatographic fingerprint analysis for the quality control of the content of flavonoids in Sanjie Zhentong capsules.Method: Under the operation of ultrasonic extraction,the flavonoids from Sanjie Zhentong capsules were extracted in the 50% methanol.With Waters Symmetry@ C18(4.6 mm×250 mm,5 μm)column,and gradient elution was performed by mobile phase containing acetonitrile and water.The flow rate was 1.0 mL·min-1 and the detection wave length was at 203 nm.The temperature of column was maintained at 30 ℃.And data were analyzed by 'Similarity evaluation software for chromatographic Fingerprint of traditional Chinese medicine' software to compare the quanlity of 11 batches of capsules samples.Result: Fifty common peaks were selected in chromatography,and all the common peaks were separated effectively.Conclusion: The accuracy,repeatability,and stability of this method were satisfied.The method developed can be used to evaluate the quality of Sanjie Zhentong capsules synthetically.
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