Quantitative profiling of comprehensive composition in compound herbal injections: An NMR approach applied on Shenmai injection.

Abstract

Compound herbal injections (CHIs) can be regarded as a significant innovation in the modernisation of herbal medicine. Therefore, improving the quality control level of CHIs has always been an active research topic in traditional herbal medicine. In this study, Shenmai injection was used as a representative sample for investigating the ability of proton nuclear magnetic resonance (1 H NMR) in the quality evaluation of CHIs. A quantitative 1 H NMR method was developed to simultaneously determine the contents of total ginsenosides, polysorbate 80, and 20 primary metabolites in Shenmai injection. Multivariate statistical analysis was combined to compare differences between samples from different manufacturers. It was found that the combined measurement uncertainty of each component is less than 1.61%, which demonstrates the reliability of the method. Furthermore, the components determined by this method account for up to 92.64% of the total solids, which is an unprecedented success in the analysis of Shenmai injection. In the end, the method was applied to the quality comparison of Shenmai injection from six manufacturers. The results showed that the differences among the samples from the six manufacturers were reflected in multiple types of components. This study fully demonstrates the superiority of the quantitative 1 H NMR method in comprehensive composition profiling of CHIs, which is conducive to improving the quality control level of Shenmai injection. Further, the present study can be used as a reference study for the research on the quality and safety of CHIs.