摘要
目的:研究从化州柚中提取的柚皮苷中的杂质。方法:采用HPLC-PDA/ESI-MS/MS法,通过波谱分析鉴定化合物结构。采用加校正因子的主成分自身对照法对主要杂质进行含量测定。结果:柚皮苷样品中主要杂质为野漆树苷和新北美圣草苷,二者与柚皮苷的校正因子分别为1.82和1.02。对6批样品进行测定,野漆树苷的含量为0.742%～0.926%,新北美圣草苷的含量为0.335%～0.464%,总杂质含量小于1.5%。结论:该检测方法快速、准确,柚皮苷中杂质种类和含量稳定,为柚皮苷应用的安全性提供理论基础。
Objective:To investigate the impurities in naringin extracted from Citrus grandis ‘Tomentosa'.Methods:High performance liquid chromatographies coupled with photodiode array and electrospray ionization mass spectrometry detectors ( HPLC-PDA/ESI-MS/MS)were applied to investigate the impurities,and their structures were elucidated by spectral data analyses.Quantification was carried out by main component self-compare with correction factor according to ICH guidelines.Results:Rhoifolin and neoeriocitrin were identified as major impurities.The correction factors of rhoifolin and neoeriocitrin were 1.82 and 1.02,respectively tested by HPLC method.The content of rhoifolin ranged from 0.742％ to 0.926％,and the content of neoeriocitrin ranged from 0.335％ to 0.464％.The gross impurities were less than 1.5％.Conclusion:The categories and quantities of impurities in naringin product are relatively stable.The research provides a way of specification and verification for the analysis of impurities and objective evidence for security assessment of naringin product.
出处
《中药材》
CAS
CSCD
北大核心
2012年第1期56-61,共6页
Journal of Chinese Medicinal Materials
基金
国家"重大新药创制"科技重大专项(2011ZX09102-011-03)
