核磁共振技术在首批中药化学对照品研制中的应用

核磁共振技术具有定性鉴别和定量测定的双重优势，既是有机化合物结构解析的重要工具，也是药品质量控制领域快速发展的现代定量分析技术。中药化学对照品主要从天然产物中提取精制而得，结构复杂多样且常存在异构体。结合首批中药化学对照品实例，阐述了核磁共振技术在定性鉴定结构相近成分、同分异构体和立体异构体中的解析要点，以及定量核磁共振技术测定结果与质量平衡法的比对分析。核磁共振技术为充分保障首批中药化学对照品结构与定值的准确性发挥了重要作用。

Application of Nuclear Magnetic Resonance in Development of First Batch of Traditional Chinese Medicine Chemical Reference Substances

Nuclear magnetic resonance (NMR) can realize qualitative identification and quantitative determination. NMR is an important tool to elucidate the structure of organic compounds and modern quantitative analysis technology with the rapid development in the field of drug quality control. Traditional Chinese medicine (TCM) chemical reference substances (CRSs) are mainly prepared and refined from natural products. Their structures are complicated and diverse, and isomers often exist. Taking the first batch of TCM CRSs as examples, this study illustrated the application of NMR in the qualitative identification of structurally similar compounds, isomers and stereoisomers, and then compared the determination results of quantitative NMR with the mass balance method. NMR plays an important role in ensuring the accuracy of structure and calibration of TCM CRSs.