Qualitative and Quantitative Analysis of Shanlameiye Granules by HPLC Fingerprint Atlas
摘 要
应用高效液相色谱法建立可同时对山蜡梅叶颗粒进行鉴别和有效成分含量测定的色谱指纹图谱.以Cosmosil C18色谱柱为分离柱,甲醇与甲酸混合溶液进行梯度洗脱,检测波长为365 nm.成分芦丁、槲皮素和山奈素的质量浓度均与峰面积呈线性关系,线性范围分别为4.6~110.4,1.0~24.0,1.5~36.0 mg·L-1.运用中药色谱指纹图谱相似度评价系统2004版进行分析,20批样品平均相似度为95%以上.颗粒剂中三个成分的含量分别为芦丁含量(130±20) μg·g-1,槲皮素含量(35±10) μg·g-1,山奈素含量(60±10) μg·g-1.建立的山蜡梅叶颗粒的色谱指纹图谱,为质量控制提供新方法.
Abstract
HPLC was applied to the establishment of chromatographic finger print atlas for qualitative and quantitative analysis of the “Shanlameiye” granules for its efficacious components.The Cosmosil C18 column was used for the separation and solutions of methanol and dil.formic acid mixed in different proportions were used in the gradient elution.Three components (i.e.,rutin,quercetin and kaempferol) in the granules were found and determined at the wavelength of 365 nm with UV-detector.Linear relationships between values of peak area and mass concentration were found in the ranges of 4.6-110.4 mg·L-1 (for rutin),1.0-24.0 mg·L-1 (for quercetin) and 1.5-36.0 mg·L-1 (for kaempferol).Values of average similarity of samples from 20 batches as analyzed by the estimation system for similarity of TCM′s by chromatographic finger print atlas,(2004 Edition) were found to be over 95%.Contents of the 3 components were found to be 130±20,35±10 and 60±10 μg·g-1 respectively.The chromatographic fingerprint atlas established was found to be feasible for quality control in the production of “Shanlameiye” granules.
中图分类号 O652.63
所属栏目 工作简报
基金项目 江西省自然科学基金课题(2007GZY1101)
收稿日期 2009/5/7
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备注欧阳婷(1981-),女,江西赣州人,硕士研究生,研究方向为药物分析.
引用该论文: OUYANG Ting,MAI Xi. Qualitative and Quantitative Analysis of Shanlameiye Granules by HPLC Fingerprint Atlas[J]. Physical Testing and Chemical Analysis part B:Chemical Analysis, 2010, 46(1): 54~56
欧阳婷,麦曦. 山蜡梅叶颗粒的高效液相色谱指纹图谱定性及定量分析[J]. 理化检验-化学分册, 2010, 46(1): 54~56
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参考文献
【1】WS-11315(ZD-1315)-2002山蜡梅叶颗粒质量标准[S].
【2】刘耀明,冯淑香,肖炳坤.山蜡梅颗粒的质量标准研究[J].中药新药与临床药理,2003,5(14):185-188.
【3】国家药品监督管理局.中药注射剂指纹图谱研究的技术要求(暂行)[J].中成药,2000,10(22):671-675.
【2】刘耀明,冯淑香,肖炳坤.山蜡梅颗粒的质量标准研究[J].中药新药与临床药理,2003,5(14):185-188.
【3】国家药品监督管理局.中药注射剂指纹图谱研究的技术要求(暂行)[J].中成药,2000,10(22):671-675.
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