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Analysis method of bacitracin and components thereof

An analysis method, the technology of bacitracin, which is applied in the field of analysis of bacitracin and its components, can solve the problems of being unsuitable for mass spectrometry analysis and unable to realize online determination of unknown components, etc.

Inactive Publication Date: 2020-04-24
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the high-performance liquid chromatography (dipotassium hydrogen phosphate / acetonitrile / methanol system) adopted in the 40th edition of the United States Pharmacopoeia and the 9.6th edition of the European Pharmacopoeia selects a non-volatile mobile phase system, which is not suitable for direct mass spectrometry analysis and cannot be realized online. Determine the structure of unknown components

Method used

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  • Analysis method of bacitracin and components thereof
  • Analysis method of bacitracin and components thereof
  • Analysis method of bacitracin and components thereof

Examples

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Embodiment 1

[0055] This embodiment provides a new bacitracin named bacitracin HZ (bacitracin HZ). The components of the bacitracin are double-methylated and vinylated bacitracin A or double-methylated and ethylated bacitracin Y. Among them, the constituent units of methyleneized and vinylated bacitracin A include 1-position isoleucine, 2-position cysteine, 3-position leucine, 4-position glutamic acid, 5-position isoleucine , 6-lysine, 7-ornithine, 8-position isoleucine, 9-position phenylalanine, 10-position histidine, 11-position aspartic acid, 12-position asparagine, 1-position isoleucine Amino acid and 2-cysteine ​​form a thiazoline ring, and 6-12 amino acids form a cyclic 7-peptide. The constituent units of double-methylated and ethylated bacitracin Y include 1-position isoleucine, 2-position cysteine, 3-position leucine, 4-position glutamic acid, 5-position isoleucine, 6-lysine, 7-ornithine, 8-position isoleucine, 9-position phenylalanine, 10-position histidine, 11-position aspartic...

Embodiment 2

[0062] This example provides the application of Bacitracin HZ in medicine. A bacitracin bulk drug or pharmaceutical combination comprising bacitracin HZ and a pharmaceutical preparation comprising the aforementioned bulk drug or pharmaceutical composition.

[0063] The composition of the pharmaceutical preparation comprises bacitracin for injection, bacitracin ointment and bacitracin eye ointment.

[0064] Wherein, the specification of the injection is 1000 units per milliliter (dissolved in isotonic sodium chloride injection);

[0065] The specifications of the ointment are 1g: 500 units, 5g: 4000 units;

[0066] The specification of eye ointment is 1g: 500 units, 2g: 1000 units.

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Abstract

The invention discloses a novel bacitracin (Bacitracin) component and a high performance liquid chromatography-mass spectrometry (HPLC-MS) analysis method thereof. The component is verified to be bacitracin A subjected to double methylenation and vinylation or bacitracin Y subjected to double methylenation and ethylation through HPLC-MS (High Performance Liquid Chromatography-Mass Spectrometry) and secondary mass spectrometry, and the novel component is named Bacitracin HZ. The invention discloses the presence of novel non-protein amino acids, such as 2-amino-3-vinyl-5-hexenoic acid, 2-amino-4-vinyl-5-hexenoic acid, 3-vinylcysteine, 2-vinylcysteine and the like. The bacitracin HZ has antibacterial activity or toxicity different from antibacterial activity or toxicity of common bacitracin components and has potential application value; and the structure confirmation of the compounds also provides a research basis for strictly controlling the quality of bacitracin.

Description

[0001] technical background [0002] The invention relates to the field of pharmaceutical analytical chemistry, in particular to an analysis method for bacitracin and its components. Background technique [0003] Bacitracin (structure binding figure 1 and Table 1) are multicomponent antimicrobial peptides produced by Bacillus subtilis and Bacillus licheniformis, which can strongly inhibit Gram-positive bacteria and are mainly used for the treatment of penicillin-resistant staphylococcal infections. Bacitracin has a special antibacterial mechanism, which interferes with the synthesis of bacterial cell walls, and at the same time inhibits the regeneration of phospholipid receptors in the synthesis of peptidoglycan, making it have a broad antibacterial spectrum and is not easy to produce drug resistance. Zinc ions are added during medicinal use to enhance activity. [0004] R of table 1 bacitracin structural general formula A and B n the expression of [0005] [0006] B...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K7/66G01N30/02G01N30/72G01N33/68A61K38/12A61P31/04
CPCA61K38/00A61P31/04C07K7/66G01N30/02G01N30/72G01N33/6848G01N2410/00
Inventor 张含智刘浩赵敬丹秦峰闻宏亮裘亚
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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