Introduction: 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.Objectives: 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.Methods: 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.Results: 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. Conclusion: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.

Introduction: Trichosanthis Pericarpium injection (TPI) is a traditional Chinese medicine preparation obtained from Trichosanthis Pericarpium by extraction, purification and sterilisation. It contains amino acids, alkaloids, nucleotides and other components. Existing quantitative methods only analyse a few components in

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Dammarane-type saponins (DTSs) exist in various medicinal plants, which are a class of active ingredients with effects on improving myocardial ischemia and immunomodulation. In this study, a quantitative 1H NMR method of total DTSs in herbal medicines was developed based on the analytical procedure lifecycle. In the first stage (analytical procedure design), the Ishikawa diagram and failure mode effects and criticality analysis were used to conduct risk identification and risk ranking. Plackett–Burman design and central composite design were used to screen and optimize critical analytical procedure parameter. Then, the method operable design region was obtained through modeling. In the second stage (analytical procedure performance qualification), the performance of methodological indexes was investigated based on analytical quality by design. As examples of continued procedure performance verification, the method was successfully applied to determine the total DTSs in herbal pharmaceutical preparations and botanical extracts. As a general analytical method to quantify total DTSs in medicinal plants or pharmaceutical preparations, the developed method provides a new quality control strategy for various products containing dammarane-type saponin.