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

An injection and Shuxuetong technology, which is applied in the new field of quality control of polypeptide (oligopeptide) components in Shuxuetong injection, can solve the problem of difficulty in obtaining a good signal response, poor characterization of peptides, and experimental procedures. complex problems, to achieve the effect of rapid and effective qualitative identification, improvement of quality control methods, and guarantee of product safety

CN104897840AActive Publication Date: 2015-09-09MUDANJIANG YOUBO PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2015-09-09

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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.
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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...

Examples

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%; 40~45m...