摘要
目的:建立一贯煎方药的HPLC指纹图谱同时验证该方法的可行性,为进一步研究一贯煎制剂的质量控制提供参考。方法:采用Agilent ZORBAX EclipsePlus C18色谱柱(250mm×4.6mm,5μm),以含有0.1%甲酸的水溶液(A)-乙腈(B)为流动相进行梯度洗脱,流速0.8mL/min,检测波长280nm,柱温30℃。使用《中华人民共和国药典》委员会“中药色谱指纹图谱相似度评价系统”(2012.130723版)标定共有峰,指认特征峰。评价了10批来自不同药房的饮片,计算相似度并对指纹图谱进行了方法学验证(专属性、稳定性、专一性以及精密度)。结果:一贯煎样品的指纹图谱与对照品图谱一一比较后,标定了34个共有峰,指认。了5个共有峰。这5个峰代表的成分为阿魏酸(ferulic Acid,FA)、毛蕊异黄酮葡萄糖苷(Calycosin7-O--D-Glucopyranoside,acteoside)、香草酸(vanillic acid)、补骨脂素(psoralen)和槲皮素(quercetin)。方法学验证得到专属性良好,稳定性、专一性以及精密度的RSD均在1.20%以内。10批饮片的相似度均大于0.850。阿魏酸以及毛蕊异黄酮葡萄糖苷线性范围分别为0.5~10μg/mL和10.0-100.0μg/mL。结论:本文建立了中药一贯煎的HPLC指纹图谱,可用于实验中一贯煎的给药以及临床应用制剂的质量控制研究。同时,为一贯煎开发成中成药制剂提供质量控制的基础。
Objective:To establish a fingerprint method for Yiguanjian by high-performance liquid chromatography and also valid if the method was feasibility. At the same time,provide more reference for preparation technology of Yiguanjian Chinese patent medicine. Methods:Use Agilent ZORBAX EclipsePlus C18(250 mm×4.6 mm,5 μm)chromatography column,with purified water which contained 0.1% formic acid(A)-acetonitrile(B)as mobile phase,gradient elution,flow velocity was 0.8 mL/min and test wavelength was 280 nm and temperature was 30 ℃. Then use the software"Digitized Evaluation System for Super-Information Characteristics of TCM/HM Fingerprints"(2012.130723 edition)issued by Chinese Pharmacopoeia Commission to found their common peak and calculated the similarity. Results:Compared with the standard solution,there were 34 common peaks in the sample solution and 5 common peaks were identified. The peaks of ferulic acid,acteoside(calycosin7-O-β-D-glucopyranoside),vanillic acid,psoralen and quercetin were identified. The linear range of ferulic acid and acteoside were between 0.5-10.0 μg/mL and 10.0-100.0 μg/mL. Conclusion:This assay provided a reliable and efficient method for establishing the Yiguanjian fingerprint. The result could support the experiment dose control and also the quality control of Yiguanjian. At the same time,the assessment of quality of TCM and herb will be useful for developing Chinese patent medicine.
作者
赵青舟
刘文兰
曹丽
ZHAO Qingzhou;LIU Wenlan;CAO Li(Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100193,China;School of Traditional Chinese Medicine,Capital Medical University,Beijing 100069,China)
出处
《辽宁中医药大学学报》
CAS
2018年第12期51-54,共4页
Journal of Liaoning University of Traditional Chinese Medicine
基金
国家自然科学基金项目(81573879)
北京市自然科学基金项目(7182021)
关键词
一贯煎
肝损伤
阿魏酸
毛蕊异黄酮葡萄糖苷
指纹图谱
复方质量控制
Yiguanjian
liver damage
ferulic acid
calycosin7-O-β-D-glucopyranoside
fingerprint
quality control of formula decoction
