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A method for quality control of polypeptide (oligopeptide) components in Shuxuetong injection

A technology of injection and Shuxuetong, which is applied in the field of quality control of polypeptide (oligopeptide) components in Shuxuetong injection, which can solve the problems of difficult to obtain good signal response, weak representation of peptides, complicated test process, etc. problems, achieve rapid and effective qualitative identification, improve quality control methods, and ensure product safety

Active Publication Date: 2018-02-02
MUDANJIANG YOUBO PHARMA CO LTD
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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.

Method used

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  • A method for quality control of polypeptide (oligopeptide) components in Shuxuetong injection
  • A method for quality control of polypeptide (oligopeptide) components in Shuxuetong injection
  • A method for quality control of polypeptide (oligopeptide) components in Shuxuetong injection

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Embodiment

[0027] Instrument: HPLC model: Eksigent 425nano LC; MS model: AB SCIEX 6500;

[0028] Shuxuetong sample: produced by Mudanjiang Youbo Pharmaceutical Co., Ltd.

[0029] Sample treatment: take 1ml of Shuxuetong injection, carefully load the sample onto a pre-balanced Sephadex G15 chromatography column (column specification: 1.4cm*8cm), elute with deionized water and collect water in sections for elution solution, with 0.1M AgNO 3 The collection was stopped when white turbidity was detected, and the water eluate collected before was combined. As the test solution, carry out LC-MS-MRM analysis.

[0030] Chromatographic analysis conditions: self-made spray needle integrated column, 75μm×15cm, packing: Venusil×BP, C18(L), 5μm, (Agela Technologies Company), flow rate is 0.4μl / min, mobile phase A is 0.1% formic acid aqueous solution, mobile phase B is 0.1% formic acid acetonitrile solution, gradient elution conditions are as follows: 0~6min, B: 5%→ 8%; 6~40min, B: 8%→30%; 40~45...

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Abstract

The invention relates to a quality control method of a traditional Chinese medicine preparation, which specifically adopts liquid chromatography (HPLC) separation, mass spectrometry (MS) detection, combined with multiple reaction monitoring (MRM), to establish LC-MS-MRM of Shuxuetong injection A quality control model combining separation, detection, and statistical identification is used to control the quality of polypeptide (oligopeptide) components in Shuxuetong injection. This method can quickly and effectively identify the known active polypeptide (oligopeptide) components in Shuxuetong injection. Quality control means for injections.

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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 李振国陈艳明周剑波务勇圣郭亚芳
Owner MUDANJIANG YOUBO PHARMA CO LTD
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