黄芪注射液~1H NMR指纹图谱研究

~1H NMR fingerprints of Huangqi injection solution

建立黄芪注射液的~1H NMR指纹图谱,并对8批黄芪注射液进行初步的质量分析。采用核磁共振技术分别建立黄芪注射液的初级和次级代谢物~1H NMR指纹图谱,借助~1H-~1H化学位移相关谱(COSY)和~1H-^(13)C化学位移相关谱(HSQC),对黄芪注射液中的化学成分进行指认;结合相似度和相对含量分析对8批黄芪注射液进行质量分析。从黄芪注射液的核磁指纹图谱中共指认初级和次级代谢产物25个,对8批黄芪注射液的~1H NMR图谱分析结果显示,不同厂家的注射液产品之间在化学组成上存在较大差异,且初级代谢产物含量及波动范围远远高于次级代谢产物,是黄芪注射液质量均一性的主要影响成分。本研究初步分析了黄芪注射液产品的质量差异状况,为提升其质量控制水平奠定了研究依据。

The study established the -1H NMR-based fingerprinting and analyzed 8 batches of Huangqi injection solution.-1H NMR-based fingerprinting of both primary and secondary metabolites of Huangqi injection were established,and the ^1H-^1H chemical shift correlation spectroscopy（COSY） and ^1H-^13C chemical shift correlation spectroscopy（HSQC） were used to identify the chemical components in Huangqi injection solution.Coupled with similarity analysis and relative content determination,8 batches of Huangqi injection solution were analyzed.Twenty-five metabolites（both primary and secondary） were identified,and the significant differences were found in the chemical composition among these Huangqi samples.The content and content variation of the primary metabolites were much higher than those of the secondary metabolites,which was the major cause of the uniformity of the Huangqi injections.The results on the quality variations of Huangqi injections in this study will serve as a basis for improving the quality control.