Preparation method of high-purity teicoplanin

A high-purity technology for teicoplanin, which is applied in the field of preparation of pharmaceutical raw materials, can solve problems such as poor control of the ratio, no mention of ratio control, cumbersome steps, etc., to achieve reliable quality, controllable content, and process simple effect

Active Publication Date: 2012-09-26
NCPC NEW DRUG RES & DEV
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Problems solved by technology

[0008] Chinese patent CN 101302248A discloses a production method of high-purity teicoplanin, which requires gel chromatography, macroporous resin separation, decolorization, ultrafiltration, nanofiltration, and crystallization processes for the crude product of teicoplanin to obtain the purity More than 93.1% teicoplanin powder, but the steps are cumbersome, and only control A 2 Group proportions, not mentioned for A 3 and A 2 Ratio control of each component
U.S. Patent US2005245481A1 discloses a production process of teicoplanin, which decolorizes the macroporous resin crude extract with activated carbon, separates the resin again, ultrafiltration, nanofiltration, and crystallizes to obtain teicoplanin with a purity greater than 95%. Powder, but for A 2 The proportion of each component cannot be well controlled, and it is difficult to produce teicoplanin powder that meets the European Pharmacopoeia standard

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preparation example Construction

[0027] A kind of preparation method of high-purity teicoplanin of the present invention comprises the following steps:

[0028] Step 1) Pretreatment: After the fermented liquid of teicoplanin is adsorbed, concentrated and crystallized by macroporous resin, the crude product of teicoplanin is obtained; the crude product of teicoplanin is dissolved in water or buffered with a pH value of 2-5 Saline solution is dissolved to make an aqueous solution or buffered saline solution of teicoplanin coarse powder; wherein the buffered saline solution is preferably phosphoric acid-diammonium hydrogen phosphate with a pH of 3.5 prepared with 10%~35% (v / v) methanol or ethanol solution.

[0029] Step 2) Chromatography: Add the teicoplanin coarse powder solution to the chromatographic column equipped with nano-polymer microspheres; sequentially use the mixture of polar solvents and water from low to high concentrations for gradient analysis, segmented Collect the analytical solution and perfo...

Embodiment 1

[0034] Take 10 g of the crude product of teicoplanin, with a purity of 81.4%, and dissolve it in 60 mL of deionized water to prepare an aqueous solution of the crude product of teicoplanin. The crude product aqueous solution was loaded on a PSA-30 nano-polymer microsphere chromatographic column with a column size of Ф5.5×50 cm and a loading capacity of 1000 mL. Use 1000mL 25% (v / v) ethanol aqueous solution as the mobile phase for washing, and then use 60% ethanol as the mobile phase to wash until the teicoplanin is resolved, and control the ethanol flow rate to 1500mL / h. Collect analysis solution in sections, according to the HPLC detection result of teicoplanin single component in each section analysis solution, merge analysis solution, make the content of six kinds of single components and A 2 and A 3 The proportion of the group complied with the provisions of the European Pharmacopoeia, and 1570 mL of the analytical solution was obtained. The analysis solution was passed ...

Embodiment 2

[0036] Take 10 g of the crude product of teicoplanin, with a purity of 82.6%, and add it to 50 mL of phosphoric acid-diammonium hydrogen phosphate solution at pH 3.5. The preparation of phosphoric acid-diammonium hydrogen phosphate solution is to dissolve diammonium hydrogen phosphate with a concentration of 5‰ in 30% methanol, and then adjust the pH value to 3.5 with phosphoric acid. After the teicoplanin was dissolved, a buffered saline solution of teicoplanin coarse powder was made, and the solution was loaded on a PS-30 nanopolymer microsphere column (Ф5.5×50cm), with a loading volume of 1000mL. Use 1000mL 30% concentration of methanol as the mobile phase for washing, 60% concentration of methanol as the mobile phase for washing until teicoplanin is completed, the flow rate is 1500mL / h, and the analysis solution is combined according to the HPLC detection results, so that the proportion of each component meets the requirements, and the analysis is obtained. Liquid 1370mL. ...

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Abstract

The invention relates to a preparation method of high-purity teicoplanin, which comprises the following steps: dissolving a crude teicoplanin product in water or a buffer salt solution, adding the sample to a chromatographic column filled with nano polymer microspheres, carrying out gradient analysis with a polar solvent / water mixed liquid to obtain a teicoplanin analysis solution in which the proportion of the components and impurities are satisfactory, decolorizing with activated carbon or resin, nanofiltering, desalting, concentrating, crystallizing, filtering, drying and the like to obtain the high-purity controllable-proportion teicoplanin fine powder. The method provided by the invention has the advantages of simple technique, high sample processing capacity and low solvent consumption, and can be used for large-scale preparation of medicinal teicoplanin fine powder.

Description

technical field [0001] The invention relates to a preparation method of traditional Chinese medicine raw materials in the technical field of industrial microorganisms, in particular to a method for preparing high-purity teicoplanin from crude teicoplanin produced from fermentation cultures. Background technique [0002] Teicoplanin (Teicoplanin) is a glycopeptide antibiotic produced by the fermentation of Actinomycetes mobilis. It is a new generation of glycopeptide antibiotic developed after vancomycin. It is currently the most promising anti-drug resistance in China. One of the antibiotics, compared with vancomycin, it has stronger fat solubility, longer half-life, good body fluid distribution, mild adverse drug reactions, can be administered intravenously or intramuscularly, and is more convenient to use. [0003] The mechanism of action of teicoplanin is similar to that of vancomycin and other glycopeptide antibiotics. It first non-specifically binds to the outer structu...

Claims

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Application Information

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IPC IPC(8): C07K9/00C07K1/36C07K1/34C07K1/16
Inventor 段宝玲张雪霞任风芝董爱华蒋沁张志江李宁李晓露王海燕朱秀良林毅陈书红成晓迅李丽红
Owner NCPC NEW DRUG RES & DEV
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