35 results about "Dalbavancin" patented technology

The invention discloses a fermentation technique of A40926, which comprises the following steps: inoculating a strain capable of producing A40926 in a fermentation culture medium, and carrying out fermentation and culture, wherein after the fermentation and culture are carried out for 72-112 hours, a solution containing 0.5-1.2 wt% of glucose (on the basis of the fermentation culture medium), 0.3-0.8 wt% of peptone and 0.05-0.12 wt% of L-valine is fed. The technique is simple to operate and low in cost, can implement large-scale production, and can maximally produce 720 mg / L Dalbavancin intermediate A40926.

The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue, under conditions where a protein-dalbavancin complex forms, or administering a protein-dalbavancin complex. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.

The invention provides a separation and purification method for dalbavancin. The method comprises the following steps: dissolving and filtering a crude dalbavancin extract; loading a sample of a crude solution obtained after filtering into a chromatographic column equipped with polystyrene high-molecular polymer microspheres for chromatography; carrying out gradient elution on a target product with an aqueous phosphoric acid solution and an organic solvent as mobile phases; and collecting solutions with a target peak value in sections and combining constituent solutions meeting requirements. The separation and purification method is simple, can realize large-scale production and has a high and stable recovery rate.

The invention provides methods and compositions for treatment of bacterial infections in adult and pediatric patients. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and skin structure. Dosing regimens include multiple dose administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.

The invention discloses a method for simultaneously detecting various glycopeptides antibiotics in animal derived food. The method mainly comprises the following steps: carrying out solution extraction on a sample; carrying out series purification and enrichment by using HLB solid-phase extraction columns and strong cation (MCX) solid-phase extraction columns; separating the sample by using reversed phase columns, and then detecting the sample by using an ultra-efficient liquid chromatography tandem mass spectrometry in a multi-reaction monitoring mode; and carrying out qualitative and quantitative analysis. Five glycopeptides antibiotics including telavancin, teicoplanin, oritavancin, dalbavancin and vancomycin in the sample animal derived food such as milk, eggs and chicken can be detected simultaneously. The detecting method is sensitive, accurate and rapid; and the five glycopeptides antibiotics can be qualitatively and quantitatively analyzed by six minutes displayed on an instrument. Moreover, the detecting method also has certain reference value for detection of other glycopeptides antibiotics.

The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.

The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.

The invention provides methods for treatment of bacterial infections in impaired renal patients. Methods of the invention include administration of a therapeutically effective dose of dalbavancin for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue.

The invention discloses a method of producing a dalbavancin precursor A40926. In particular, during a fermentation cultivation proves, 10-methyl undecanoic acid, or several 10-methyl undecanoic undecanoate solutions, is flow-fed to a fermentation liquid to increase the yield of the dalbavancin precursor A40926. The method is simple in operation, greatly increases fermentation yield, reduces production cost and is suitable for industrial production.

The invention provides methods and compositions for treatment of bacterial infections. The composition may be a combination of factors, which include A0, A1, B1, B2, C0, C1, isoB0, and MAG, in the presence of low level solvent. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimens include multiple dose administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection. Dosing regimens for renal patients are also included.

The invention relates to the technical field of medicine analysis and discloses a method for measuring dalbavancin impurities. 3-dimethylaminopropylamine in dalbavancin is detected by a direct sample introduction method. The method provided by the invention is simple in operation, universal and low in requirement on gaseous phase related equipment; and the measuring method provided by the invention is high in detection sensitivity and high in recovery rate. According to the detection method provided by the invention, the quality and the medication safety of the dalbavancin are improved.

The invention discloses a method for preparing dalbavancin. The method comprises the following steps: protecting carboxyl of a complex A40926, carrying out an amidation reaction with 3,3-dimethylamino-1-propylamine, hydrolyzing in an alkaline solution, acidifying and purifying, so as to obtain the dalbavancin. According to the preparation method disclosed by the invention, the reaction conditionsare mild, the yield is high, the impurities are easily removed, and the preparation cost of the dalbavancin can be effectively reduced.

The invention discloses a method for detecting dalbavancin and impurities thereof. The method comprises the following steps: 1), preparing a standard reference solution for the dalbavancin and the impurities thereof; 2), preparing a test sample solution; 3), measuring a chromatogram of the dalbavancin and the impurities thereof in the standard solution by using a reversed-phase high performance liquid chromatograph, so that the resolution between any adjacent substances is higher than or equal to 1.5; 4), measuring a chromatogram of the test sample solution by using the reversed-phase high performance liquid chromatograph, and according to an area normalization method, determining the contents of the dalbavancin and each impurity thereof in the test sample solution. The invention providesthe conventional reversed-phase high performance liquid chromatography; by the method, the dalbavancin B0 and the impurities thereof as well as different impurities can be effectively separated, so that the content of the dalbavancin B0 can be accurately detected; in addition, the stability and the reliability are high; meanwhile, the method is relatively easy to operate and easy to implement.

The present invention provides a pharmaceutical composition comprising dalbamycin (dalbavancin) and at least one effective stabilizer, wherein the dalbamycin contains approximately less than 3 mole percent MAG, wherein the pH of the composition is about 3 to 5, and wherein said composition is lyophilized.

The present invention relates to a method for the purification and preparation of glycopeptide antibiotic dalbavancin intermediate A40926. A40926 fermented liquid is subjected to alkalization, ceramic membrane filtration, polyamide chromatography, isoelectric precipitation, redissolution and gel chromatography. , to obtain high-purity A40926. The method maximizes the production efficiency of A40926, the purity reaches more than 95%, and the yield reaches more than 65%, thereby realizing the industrialization of high-purity A40926.

The invention discloses a method for detecting impurities in dalbavancin hydrochloride. According to the method, the 3-dimethylaminopropylamine in the dalbavancin hydrochloride is detected by adopting a pre-column derivatization reverse high-performance liquid chromatography. The detection method is suitable for detecting the content of 3-dimethylaminopropylamine in the acid compound dalbavancin, and is high in universality, good in system durability, good in stability and low in detection cost.

The invention discloses a fermentation technique of A40926, which comprises the following steps: inoculating a strain capable of producing A40926 in a fermentation culture medium, and carrying out fermentation and culture, wherein after the fermentation and culture are carried out for 72-112 hours, a solution containing 0.5-1.2 wt% of glucose (on the basis of the fermentation culture medium), 0.3-0.8 wt% of peptone and 0.05-0.12 wt% of L-valine is fed. The technique is simple to operate and low in cost, can implement large-scale production, and can maximally produce 720 mg / L Dalbavancin intermediate A40926.

The invention provides methods for drying dalbavancin. The method includes providing wet dalbavancin that includes dalbavancin, water, and a solvent. The wet dalbavancin is dried at at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less, until the water level of the wet dalbavancin is less than about 20% (w / w). Water is then added to the dalbavancin and the resulting wet dalbavancin is dried at least once more at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less, until the solvent level of the dalbavancin is less than about 3.0% (w / w).

The invention discloses a method for detecting dalbavancin and its impurities. The method comprises the steps of: 1) preparing a standard reference substance solution of dalbavancin and its impurities; 2) preparing a test sample solution; 3) using a reversed-phase high-performance liquid chromatograph to measure dalbavancin in the standard solution chromatogram of its impurities, so that the separation between any adjacent substances ≥ 1.5; 4) use reversed-phase high-performance liquid chromatography to measure the chromatogram of the test sample solution, and determine the concentration of the test sample solution according to the area normalization method. The content of dalbavancin and its impurities. The invention provides conventional reversed-phase high-performance liquid chromatography, which can make Bavancin B 0 Effective separation between impurities and impurities and impurities, so that dalbavancin B can be accurately detected 0 content, and high stability and reliability, while the operation is relatively simple and easy to implement.

The invention discloses a preparation method of a dalbavancin key intermediate A40926, which is suitable for industrial production. The method comprises the following steps: carrying out deacylation treatment on A40926 fermentation liquor, carrying out macroporous alkaline adsorption sample loading, and then carrying out acid desorption; enabling macroporous analysis combined liquid to be subjected to hydrophobic polymer microsphere chromatography, eluting high-polarity impurities preferentially, eluting structure difference impurities finally, wherein the separation degree of components and impurities is good, the impurities, pigments and the like are effectively removed while the components are reserved, and the content of all the components of A40926 and the proportion of the componentsare effectively controlled through collection and combination. A polymer microsphere chromatography combined solution is concentrated, precipitated and dried to obtain an A40926 product with the HPLCpurity of effective components (components A0, A1, B0, B1 and B2) being higher than 95% and the content being higher than 85%, and the quality requirement of dalbavancin for a key intermediate A40926is greatly met.

A water-soluble pharmaceutical composition comprises at least one therapeutically active substance and at least one substance capable of forming micelles, wherein the therapeutically active substance is selected from drugs having hydrophobic properties for treating cancer patients, and the at least one substance capable of forming micelles is selected from antibiotics of the lipoglycopeptide type, such as teicoplanin, dalbavancin and oritavancin.

The present invention provides a medical compound including dalbavancin and at least one effective stabilizer, wherein the dalbavancin contains about less than 3 mole percentage MAG, and the pH of the composition is about 3 to 5, and the composition is freeze-dry.