A kind of norvancomycin hydrochloride preparation for injection and preparation method thereof

A technology for norvancomycin and injection, which is applied in the preparation methods of peptides, chemical instruments and methods, and pharmaceutical formulations, etc., can solve the problems of poor stability, many impurities, and low purity.

Active Publication Date: 2020-11-13
NORTH CHINA PHARMA COMPANY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved in the present invention is to provide a norvancomycin hydrochloride preparation for injection and a preparation method thereof, improve the purity of the norvancomycin intermediate; Poor and other shortcomings, so that the quality and stability of norvancomycin hydrochloride for injection are improved

Method used

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  • A kind of norvancomycin hydrochloride preparation for injection and preparation method thereof
  • A kind of norvancomycin hydrochloride preparation for injection and preparation method thereof
  • A kind of norvancomycin hydrochloride preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A. Chromatography: The new polymer filler is UniPMM40, with a volume of 200L, and a total of 6.131 billion units of norvancomycin feed solution is passed into it at a flow rate of 2BV / h, and the top water is 2min;

[0032] B. Pre-washing: prepare 1% methanol solution, adjust the pH to 7.2 with phosphoric acid, and pre-wash 2BV at a flow rate of 2BV / h;

[0033] C. Elution: prepare 10% methanol solution, adjust the pH to 7.0 with phosphoric acid, pass it into the chromatographic column at a flow rate of 2BV / h, and collect the eluate;

[0034] D. Membrane system concentration: After the eluate is concentrated by the membrane system, the residual solvent is washed away with purified water to obtain a vancomycin hydrochloride elution concentrate with a purity of 97.9%, colorless, and a yield of 76.6%.

[0035] E. The finished solution is freeze-dried, taken out of the box, and sub-packaged. After nitrogen replacement, the oxygen concentration is 1.24%.

Embodiment 2

[0037] A. Chromatography: The new polymer filler is UniPMM40, with a volume of 200L, and a total of 6.056 billion units of norvancomycin feed solution is passed into it at a flow rate of 3BV / h, and the top water is 2min;

[0038] B. Pre-washing: Prepare 1.5% ethanol solution, adjust the pH to 7.2 with phosphoric acid, and pre-wash 4BV at a flow rate of 2BV / h;

[0039] C. Elution: prepare 11% ethanol solution, adjust the pH to 7.0 with phosphoric acid, pass it into the chromatographic column with a flow rate of 3BV / h, and collect the eluent;

[0040] D. Membrane system concentration: After the eluate was concentrated by the membrane system, the residual solvent was washed away with purified water to obtain the vancomycin hydrochloride elution concentrate, with a purity of 97.5%, colorless, and a yield of 74.8%.

[0041] E. The finished solution is freeze-dried, taken out of the box, and sub-packaged. After nitrogen replacement, the oxygen concentration is 1.39%.

Embodiment 3

[0043] A. Chromatography: The new polymer filler is UniPSN40, with a volume of 200L, and a total of 4.621 billion units of norvancomycin feed solution is introduced at a flow rate of 2BV / h, and the top water is 2min;

[0044] B. Pre-washing: prepare 1% methanol solution, adjust the pH to 7.1 with phosphoric acid, and pre-wash 2BV at a flow rate of 2BV / h;

[0045] C. Elution: Prepare 8% methanol solution, adjust the pH to 7.0 with phosphoric acid, pass it into the chromatography column at a flow rate of 2BV / h, and collect the eluate;

[0046] D. Membrane system concentration: After the eluate is concentrated by the membrane system, the residual solvent is washed away with purified water to obtain the vancomycin hydrochloride elution concentrate, with a purity of 97.1%, colorless, and a yield of 71.2%.

[0047] E. The finished solution is freeze-dried, taken out of the box, and subpackaged, and the oxygen concentration is 1.15% after nitrogen replacement.

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Abstract

The invention discloses a norvancomycin hydrochloride preparation for injection. The norvancomycin hydrochloride preparation contains 0.8 g of norvancomycin hydrochloride. The preparation method of the norvancomycin hydrochloride preparation for injection comprises the following steps: firstly, preparing norvancomycin hydrochloride raw powder; then, preparing liquid medicine and carrying out filling of the liquid medicine; and finally, carrying out freeze-drying treatment. The preparation method is characterized in that the preparation process of the norvancomycin hydrochloride raw powder comprises a norvancomycin purification process and a raw powder packaging process, wherein the purification process comprises the following steps: (1) column chromatography; (2) membrane system concentration; and (3) finished solution freeze-drying, discharging of a finished solution from a box and packaging to obtain the norvancomycin hydrochloride raw powder. The product produced by the invention conforms to the standard specification in the aspects of purity, clarity, color, marking quantity, moisture, content, relevant substances, stability and the like, and in addition, the quality and the stability of the product are much higher than those of products produced at present.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a norvancomycin hydrochloride preparation for injection and a preparation method thereof. Background technique [0002] The norvancomycin hydrochloride-producing bacteria is a variant of Amycobacterium orientalis in the actinomycetes, and the polypeptide antibiotics are produced by its fermentation and metabolism. Norvancomycin can inhibit the synthesis of cell wall glycopeptide polymers, thereby preventing the formation of cell walls. It has high antibacterial activity against various Gram-positive bacteria, multidrug-resistant methicillin-resistant Staphylococcus (MRSA / MRSCoN), enterococci, etc. Anaerobic streptococci, Clostridium difficile, actinomycetes, diphtheria bacilli, and gonorrhoeae are also very sensitive to this product. Streptococcus viridans, Streptococcus bovis, Streptococcus faecalis, etc. also have certain sensitivity. In recent years, due to the in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/14A61K9/19A61P31/04C07K9/00C07K1/36C07K1/34C07K1/16
CPCA61K9/0019A61K9/19A61K38/14A61P31/04C07K9/008
Inventor 程林李彦朴李宁张娴张天兵张强蒋晓声王红霞刘英华贾灿谷旭林
Owner NORTH CHINA PHARMA COMPANY
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