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Pharmaceutical grade bacitracin and preparing device thereof

A bacitracin and pharmaceutical-grade technology, applied in the field of pharmaceutical-grade bacitracin and its preparation device, can solve the problems of greater source influence, and achieve the effects of improving yield, improving purity, content, potency, and good stability

Active Publication Date: 2016-04-20
雅赛利(台州)制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have found that although this method can improve the purity and content of bacitracin to a certain extent, it is greatly affected by the source of raw materials, that is, it can only process some specific fermentation broths, and there are large limitations in industrial applications. sex

Method used

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  • Pharmaceutical grade bacitracin and preparing device thereof
  • Pharmaceutical grade bacitracin and preparing device thereof
  • Pharmaceutical grade bacitracin and preparing device thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0050] Preparation Example 1: Preparation of Bacitracin Fermentation Broth

[0051] Take Bacillus subtilis, directly use soybean powder, starch, corn extract, molasses and inorganic salts as the medium, the inoculation amount is 5%, and the fermentation time is 30 hours; and the temperature at the initial stage of fermentation is 30°C, after 2-3 hours the temperature Increased to 37°C, the effective number of viable bacteria reached 1.1×10 9 CFU / g, that is.

preparation example 2

[0052] Preparation Example 2: Preparation of Bacitracin Fermentation Broth

[0053] The reference application publication number is the Chinese patent preparation of CN103232959A, and its preparation process includes: (1) primary seed culture: after bacillus licheniformis is activated on the beef extract peptone slant medium for 20 hours, transfer to the shake flask in the seed medium Cultivate for 16 hours, as seed culture liquid; (2) liquid state fermentation proliferating culture: transfer the first-level seed culture liquid to the inoculum size of 7% of the fermentation medium volume in the liquid state fermentation medium, the culture temperature is 35 ℃, cultivate After 20 hours, the number of effective viable bacteria reached 5.0×10 9 CFU / g, that is.

Embodiment 1

[0055] like figure 1 Shown, a kind of pharmaceutical grade bacitracin, its preparation method comprises the steps:

[0056] S1, get the bacitracin fermentation broth prepared in Preparation Example 1 (its effective viable count is 1.1×10 9 CFU / g) in the fermentation broth receiving tank, add 0.05M hydrochloric acid to acidify to pH 5.0-5.5; after stirring and mixing, transport the acidified bacitracin fermentation broth to the ceramic membrane unit (the material is activated alumina , the pore size of the ceramic membrane is 0.1-1.0 μm) to filter, and the ceramic membrane permeate is collected into the permeate collection tank through the pipeline;

[0057] S2, the dialyzate in the dialyzate collection tank enters the cation exchange chromatography column (the cation exchange chromatography column is BPG100 / 500, and the column filler is CaptoSpimpres) through the pipeline, and it passes through the NaCl aqueous solution of 0.1-2.5M and NaAc-HAc buffer solution with pH=3.0-5....

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Abstract

The invention aims to provide pharmaceutical grade bacitracin suitable for various raw material sources and a preparing device thereof. The preparation method of the pharmaceutical grade bacitracin comprises the steps of acidizing bacitracin fermentation broth, and conducting filtration with a ceramic membrane; conducting cation exchange chromatography on ceramic membrane dialysate, and collecting cation exchange chromatography column-loading liquid; conducting anion exchange on the cation exchange chromatography column-loading liquid, and collecting anion exchange column-loading liquid; conducting metal-chelating on the anion exchange column-loading liquid, and collecting metal-chelating column liquid; conducting nanofiltration on the metal-chelating column liquid, so that final nanofiltration product liquid is obtained; dissolving and filtering the final nanofiltration product liquid, and drying and smashing filtrate, so that the pharmaceutical grade bacitracin is obtained. The initial substance bacitracin fermentation broth can be replaced with low-content bacitracin solution, and the molecular weight cut-off of a nanofiltration membrane for final nanofiltration is 300-500 Da.

Description

technical field [0001] The present invention relates to a kind of bacitracin, more specifically, it relates to a kind of medical grade bacitracin and a preparation device thereof. Background technique [0002] Bacitracin is an effective narrow-spectrum polypeptide antibiotic. Its antibacterial spectrum is similar to that of penicillin. It is effective against Gram-positive bacteria, some Gram-negative bacteria, spirochetes, and actinomycetes. [0003] Bacitracin (Bacitracin), also known as subtilisin, subtilisin, is a white powder, easily soluble in water, ethanol, pyridine, acidic or neutral bacitracin aqueous solution is relatively stable, and the solution with a pH value of 5-7 It is stable for 4 weeks and degrades rapidly at room temperature when present in a solution with a pH greater than 9. Studies have found that bacitracin is an unstable polypeptide composed of a variety of amino acids, including A, A1, B, C...G and other components, and it is mainly composed of ba...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K7/08C07K14/32C07K1/34C07K1/18C12M1/00
CPCC07K7/08C07K14/32C12M47/10C12M47/12
Inventor 芦琦陈晓静
Owner 雅赛利(台州)制药有限公司
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