文章摘要
刘艳萍,殷燕,苏玫匀,袁志兵,伍丽,谢和兵.藏药五味姜黄丸HPLC指纹图谱及指标成分含量测定研究[J].,2025,34(8):65-73
藏药五味姜黄丸HPLC指纹图谱及指标成分含量测定研究
Study on HPLC Fingerprint and Content Determination of Index Components of Zang Medicine Wuwei Jianghuang Pills
投稿时间:2024-08-01  
DOI:
中文关键词: 藏药五味姜黄丸  高效液相色谱法  含量测定  指纹图谱
英文关键词: Wuwei Jianghuang Pills of Zang Medicine  High Performance Liquid Chromatography  Content Determination  Chromatographic Fingerprinting
基金项目:国家自然科学基金资助项目(81470247);西藏自治区科技厅区域科技协同创新专项(QYXTZX-RKZ2022-07)。
作者单位
刘艳萍 江西中医药大学药学院 江西 南昌 330000
苏神猴医药研究有限公司 江苏 南通 226133
海门长三角药物高等研究院 江苏 南通 226133 
殷燕 江西中医药大学药学院 江西 南昌 330000
苏神猴医药研究有限公司 江苏 南通 226133 
苏玫匀 江西中医药大学药学院 江西 南昌 330000
苏神猴医药研究有限公司 江苏 南通 226133 
袁志兵 海门长三角药物高等研究院 江苏 南通 226133
西藏神猴药业有限责任公司西藏日喀则 857000 
伍丽 江西中医药大学药学院 江西 南昌 330000
苏神猴医药研究有限公司 江苏 南通 226133
海门长三角药物高等研究院 江苏 南通 226133 
谢和兵* 江西中医药大学药学院 江西 南昌 330000
苏神猴医药研究有限公司 江苏 南通 226133
海门长三角药物高等研究院 江苏 南通 226133
西藏神猴药业有限责任公司西藏日喀则 857000 
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中文摘要:
      目的:建立藏药五味姜黄丸HPLC指纹图谱,并同时测定指标成分没食子酸、木兰花碱、鞣花酸、药根碱、盐酸小檗碱、双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素的含量。方法:以自制的10批五味姜黄丸为研究样品,采用C18色谱柱,柱温30℃,以0.1%磷酸水(A)-乙腈(B)梯度洗脱,流速1.0mL/min,检测波长270nm,建立HPLC指纹图谱,并分析指纹图谱相似度和测定指标成分含量。结果:五味姜黄丸HPLC指纹图谱共标识出26个共有峰,指纹图谱相似度>0.99;指标成分没食子酸、木兰花碱、鞣花酸、药根碱、盐酸小檗碱、双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素分别在2.670~26.696μg/mL、9.126~91.260μg/mL、1.525~15.245μg/mL、0.812~8.121μg/mL、5.042~50.418μg/mL、4.037~40.366μg/mL、4.026~40.257μg/mL、4.709~47.088μg/mL的范围内线性良好,相关系数r分别为1.0000、1.0000、0.9993、1.0000、1.0000、0.9991、0.9993、0.9995;稳定性、精密度、重复性试验的RSD(n=6)均小于2%;平均回收率分别为93.969%、101.069%、100.961%、100.595%、99.614%、101.668%、99.894%、101.908%,RSD(n=6)分别为0.294%、1.835%、0.191%、0.229%、0.844%、0.861%、1.125%、0.411%。结论:建立的指纹图谱以及多指标含量测定方法准确稳定,重复性好,可为五味姜黄丸的质量控制以及标准建立提供参考。
英文摘要:
      Objective The HPLC fingerprints of Wuwei Jianghuang pills of Zang medicine were established , and the contents of the index components gallic acid , magnoflorine , ellagic acid , jatrorrhizine , berberine hydrochloride , bisdemethoxycurcumin , demethoxycurcumin and curcumin were determined at the same time. Methods Ten batches of Wuwei Jianghuang pills made in - house were used as the study samples , and the HPLC fingerprints were established by using a C 18 column at a column temperature of 30 ℃ with a gradient elution of 0. 1% phosphoric acid in water (A) - acetonitrile (B) , at a flow rate of 1 . 0 mL/min , and a detection wavelength of 270 nm , and the fingerprints were analysed for the similarity of the fingerprints and the determination of the content of indicator in- gredients. Results A total of 26 common peaks were identified in the HPLC fingerprint of Wuwei Jianghuang pills , and the similarity of the fingerprints was > 0. 99. The indicator concentrations of gallic acid , magnoflorine , ellagic acid , jatrorrhizine , berberine hydrochlo ride , bisdemethoxycurcumin , demethoxycurcumin and curcumin were in the range of 2. 670 - 26. 696 μg/mL , 9. 126 - 91 . 260 μg/ mL , 1 . 525 - 15. 245 μg/mL , 0. 812 - 8. 121 μg/mL , 5. 042 - 50. 418 μg/mL , 4. 037 - 40. 366 μg/mL , 4. 026 - 40. 257 μg/mL , and 4. 709 - 47. 088 μg/mL , respectively , and the correlation coefficients rwere good with a range of 1 . 0000 , 1 . 0000 , 0. 9993 ,1 . 0000 , 1 . 0000 , 1 . 0000 , 0. 9991 , 0. 9993 , 0. 9995 ; the RSDs of the stability , precision and reproducibility tests were less than 2% ; and the average recoveries were 93 . 969% , 101 . 069% , 100. 961% , 100. 595% , 99. 614% , 101 . 668% , 99. 894% ,101 . 908% , RSD ( n = 6) were 0. 294% , 1 . 835% , 0. 191% , 0. 229% , 0. 844% , 0. 861% , 1 . 125% , 0. 411% . Conclusion The established fingerprint and multi - indicator content determination method is accurate , stable and reproducible , which can provide a reference for the quality control of Wuwei Jianghuang pills and the establishment of standards.
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