HPLC法测定复方鼻咽洗剂中绿原酸含量.doc

HPLC法测定复方鼻咽洗剂中绿原酸含量[摘要] 目的：建立复方鼻咽洗剂中绿原酸含量的测定方法。方法：采用高效液相色谱法，色谱柱为DIKMA Diamonsil C18（150 mm×4.6 mm，5 μm），柱温40℃，流动相为乙腈-0.4%磷酸溶液(13∶87)，流速为1.0 ml/min，检测波长为327 nm。结果： 绿原酸的回归方程为Y=2 468 778.008 2X+2 128.139 3，相关系数r=0.999 6，线性范围0.04~0.40 μg，平均回收率为99.75%，RSD=1.82％(n=9)。结论：本法简便、准确、重现性好、适用性强，可作为复方鼻咽洗剂的质量控制方法。 [关键词] 高效液相色谱法；复方鼻咽洗剂；绿原酸；含量测定 [中图分类号]R917[文献标识码]A [文章编号]1673-7210（2007）08（b）-088-03 Content determination of chlorogenic acid in compound nasopharyngeal lotion by HPLC HUANG Xiao-ling1, PENG Jie-ren2, LIANG Xiang-feng2, LU Ri-ming 3 (1.Shenzhen Chronic Disease Prevention and Treatment Hospital, Shenzhen 518019,China; 2.The Second Affiliated Hospital of sun Yet-sen university, Guangzhou 510120,China; 3.Shenzhen Hospital of Chinese Medicing, Shenzhen 518033,China) [Abstract] Objective：To establish a method for the determination of chlorogenic acid in compound nasopharyngeal lotion. Methods: HPLC was used with chromatographic conditions including DIKMA Diamonsil Cl8(150 mm×4.6 mm,5 μm).The column temperature was 40℃，the mobile phase was acetonitrile-phosphoric acid (13∶87),the flow rate was 1.0 ml/min, and the detection wavelength was 327 nm. Results: The linear calibration curve (Y=2 468 778.008 2X+2 128.139 3，r=0.999 6) was obtained in the concentration range of 0.04~0.40 μg/ml，and the average recovery was 99.75% with RSD of 1.82％( n=9 ). Conclusion: The method is simple and accurate with good reproducibility，suitable for quality control of compound nasopharyngeal lotion. [Key words] HPLC; Chlorogenic acid; Compound nasopharyngeal lotion；Assay 复方鼻咽洗剂由白花蛇舌草、野菊花、银花、薄荷、天花粉等十二味中草药组成，具有清热解毒、排脓生肌、活血祛瘀、养阴血、扶正祛邪之功效，临床用于鼻咽癌放疗的辅助性治疗和护理作用，经医院临床应用具有良好的效果。为了加强该制剂的质量控制，完善其质量标准，本文采用HPLC法对该制剂中野菊花、银花药材所含的绿原酸进行了含量测定研究[1]。结果表明，本文实验方法成熟、可行，可为该制剂的质量控制提供定量依据。 1 仪器与试药 1.1 仪器 SPD-10AVP型色谱仪（日本岛津）；DIKMA Diamonsil C18色谱柱（150 mm×4.6 mm，5 μm）。 1.2 试剂 绿原酸对照品（中国药品生物制品检定所，批号0773-0508，供含量测定用）；水为纯水；乙腈为色谱纯；其他试剂均为分析纯；供试品（本院自制样品10批）。 2 方法与结果 2.1 色谱条件 C18色谱柱（DIK