定量核磁共振技术及其在中药注射剂质量控制中的应用展望

Quantitative NMR spectroscopy and its application in quality control of Chinese medicinal injection

中药注射剂是由中药或者复方中药中提取有效物质制成的注射剂型,是我国开创的一种中成药剂型,是中医药产业不可或缺的组成部分。中药注射剂的质量控制水平决定其安全性和有效性。与传统的色谱法相比,定量核磁共振技术具有非靶向、重现性高、测量时间短、样品制备容易、非侵入性和非破坏性、线性范围广、无需被测成分的对照物质等多项优势,能够提供被测样品中分子组成的信息。针对中药注射剂成分组成复杂、定量分析困难、中药对照品短缺等问题,提出利用定量核磁共振技术结合化学计量学方法,开展中药对照品、中药注射剂产品及生产过程中间体等样品的质量评价和中药注射剂稳定性研究,为定量核磁共振技术在中药注射剂质量控制中的应用提供参考。

Chinese medicinal injection,made of active components extracted from Chinese medicine or Chinese medicinal compound,is a novel dosage form of Chinese patent medicine in China and is pivotal in the traditional Chinese medicine(TCM)industry.The quality control standard of Chinese medicinal injection determines its safety and efficacy.The quantitative nuclear magnetic resonance(qNMR)spectroscopy is a non-targeted,non-invasive,and non-destructive technique with high reproducibility,short measurement time,convenient sample preparation,a broad range of linearity,and no requirement on the reference substance of tested components,which is advantageous as compared with traditional chromatographic methods,and it can provide information about the molecular composition of the tested samples.Therefore,in light of multiple challenges in the quality control of Chinese medicinal injection,such as complex composition,difficulties in quantitative analysis,and the shortage of reference substances,the application of qNMR spectroscopy combined with chemometrics techniques was proposed for the quality evaluation of Chinese medicine reference substances,Chinese medicinal injection,and intermediates in the production process,as well as for the stability analysis of Chinese medicinal injection.This study is expected to provide references for the application of qNMR spectroscopy in the quality control of Chinese medicinal injection.