健脾五味丸HPLC指纹图谱的建立及多指标成分的含量测定研究
Study on HPLC Fingerprinting and Multi-index Content Determination of Jianpi Wuwei Pill
张玉婷 1莎日娜 2王焕芸 1何春龙 1张屏 1孙丽君1
作者信息
- 1. 内蒙古医科大学药学院,内蒙古呼和浩特 010110
- 2. 内蒙古医科大学第二附属医院,内蒙古呼和浩特 010110
- 折叠
摘要
目的 建立蒙药健脾五味丸指纹图谱和多指标含量测定方法,为其质量控制提供依据.方法 采用Sepax HP-C18(4.6 mm × 250 mm,5 μm)色谱柱,乙腈-0.1％甲酸溶液为流动相,梯度洗脱,流速为1 mL/min,检测波长为254 nm,柱温为28℃,进样量为10 μL;建立10批健脾五味丸的指纹图谱,并采用一测多评法测定其中7种成分的含量.结果 健脾五味丸HPLC指纹图谱确定了 11个共有峰,指认出原儿茶酸、没食子酸、胡黄连苷Ⅰ、胡黄连苷Ⅱ、鞣花酸、土木香内酯和异土木香内酯7个成分,通过一测多评法计算得到7个成分的含量值,与外标法比较10批样品含量测定结果一致.经方法学验证,线性关系良好(r≥0.999),加样回收率为96.68％～104.44％.结论 所建立的指纹图谱和多指标含量测定方法准确、高效、特征性强,可为健脾五味丸的质量评价和临床应用提供参考.
Abstract
Objective To establish the fingerprint and multi-index content determination method of the Mongolian drug Jianpi Wuwei Pill,providing a basis for its quality control.Methods Sepax HP-C18 column(4.6 mm × 250 mm,5 μm)was used,with acetonitrile-0.1％formic acid solution as the mobile phase for gradient elution at a flow rate of 1 mL/min.The detection wavelength was set at 254 nm,and the column temperature at 28 ℃.A sample quantity of 10 μL was used to establish the fingerprint map of 10 batches of Jianpi Wuwei Pill,and the content of 7 components was determined using the one-sample multi-evaluation method.Results The HPLC fingerprint map of Jianpi Wuwei Pill identified 11 common peaks,recognizing 7 components including protocatechuic acid,gallic acid,picroside Ⅰ,picroside Ⅱ,ellagic acid,alantolactone and isoalantolactone.The content values was the 7 components obtained through the one-sample multi-evaluation method were compared with the external standard method,showing consistent results for the content determination of 10 batches of Jianpi Wuwei Pill.Method validation demonstrated good linear relationships(r ≥ 0.999)and an average sample recovery rate was 96.68％to 104.44％.Conclusion The established fingerprint map and multi-index content determination method are accurate,efficient and characteristic,providing effective reference for the quality evaluation and clinical application of Jianpi Wuwei Pill.
关键词
健脾五味丸/指纹图谱/一测多评法/高效液相色谱法Key words
Jianpi Wuwei Pill/fingerprint map/quantitative analysis of multi-components by single-marker(QAMS)/high performance liquid chromatography引用本文复制引用
基金项目
内蒙古医科大学面上项目(202210132033)
内蒙古医科大学2022年学科建设项目(YKD2022XK011)
出版年
2024
NETL
NSTL
万方数据