Novel method for quality control on polypeptide (oligopeptide) components in Shuxuetong injection

Abstract

The invention relates to a quality control method of a traditional Chinese medicine preparation. Particularly, an HPLC (high performance liquid chromatography) is used for separation, an MS (mass spectrum) is used for detection, MRM (multiple reaction monitoring) is combined, an LC-MS-MRM separation, detection and statistical identification combined quality control model for a Shuxuetong injection is established, and the model is used for performing quality control on polypeptide (oligopeptide) components in the Shuxuetong injection. Qualitative identification can be performed on the known active polypeptide (oligopeptide) components in the Shuxuetong injection quickly and effectively with the method, and the method is simple, quick, high in specificity, good in reproducibility and more beneficial to improvement on a quality control means for the Shuxuetong injection.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine analysis, and relates to a method for quality control of traditional Chinese medicine preparations. Specifically, a liquid chromatography (HPLC) separation, mass spectrometry (MS) detection, combined with multiple reaction monitoring (MRM) is used to establish a blood-thinning method. A quality control model combining LC-MS-MRM separation, detection, and statistical identification of Shuxuetong injection was established, and this model was used to control the quality of polypeptide (oligopeptide) components in Shuxuetong injection. Background technique [0002] The diverse and complex chemical components of traditional Chinese medicine and its preparations are precisely the diversity and complexity of their material basis, which together explain the overall treatment concept of traditional Chinese medicine and the material basis of multi-target effects. In recent years, research on the m...

AI Technical Summary

Problems solved by technology

The major components of Shuxuetong injection mainly include endogenous small molecular bases, free amino acids, free monosaccharides, small molecular polypeptides (oligopeptides), oligosaccharides or glycopeptides, etc. The small molecule polypeptide (oligopeptide) in Tongzhong may be the active component of Shuxuetong, but due to its very small content, it is difficult to obtain a good signal response by direct HPLC sample injection and conventional detector analysis. The national drug standard of Xuetong Injection adopts the conventional pre-column amino acid derivatization HPLC analysis method for indirect determination of the polypeptide components in it, mainly by determining the total amino acid content after hydrolysis of the sample and deducting the free amino acid content in the sample. To convert the content of polypeptide components, the test process is complicated and the operation is cumbersome. If the operation is not done properly, there may be problems of interference and low specificity, and the characterization of the real polypeptide (oligopeptide) components is not strong.

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