机构地区:[1]江西中医药大学药学院,江西南昌330000 [2]江苏神猴医药研究有限公司,江苏南通226133 [3]海门长三角药物高等研究院,江苏南通226133 [4]西藏神猴药业有限责任公司,西藏日喀则857000
出 处:《中国民族民间医药》2025年第8期65-73,共9页Chinese Journal of Ethnomedicine and Ethnopharmacy
基 金: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)。
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C_(18)色谱柱,柱温30℃,以0.1%磷酸水(A)-乙腈(B)梯度洗脱,流速1.0 mL/min,检测波长270 nm,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。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 ingredients.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 hydrochloride,bisdemethoxycurcumin,demethoxycurcumin and curcumin were in the range of 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,and 4.709-47.088μg/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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