14 results about "Dalbavancin" patented technology

The present invention relates to the technical field of antibiotic production, and in particular to a dalbavancin intermediate A40926 and a separation and purification method thereof, comprising the following steps: S1, filtering a fermentation broth containing the dalbavancin intermediate A40926 to obtain a collected liquid; S2, adsorbing the collected liquid through a macroporous adsorption resin, eluting with ethanol, and collecting an eluate a having an A40926 unit greater than 100 mg / L; S3, ultrafiltrating and concentrating the eluate a to obtain a concentrated liquid having an A40926 unit of 15,000 to 16,000 mg / L; S4, subjecting the concentrated liquid to a chromatography exchange resin, top-washing with pure water, and gradient eluting with an ammonium acetate-ethanol solution, to collect an eluate b having an A40926 purity greater than 95%; S5, adjusting the pH of the eluate b to 8.0±0.2, adding acetone, adjusting the feed liquid temperature to 2 to 8°C, stirring for 6 to 7 hours, performing crystallization, and filtering and drying to obtain the dalbavancin intermediate A40926.

The invention relates to the field of inspection and detection of dalbavancin, in particular to a microbial limit inspection method of dalbavancin. Comprising the following steps: S1, preparation of a test solution: dissolving a test sample with sterilized water, and respectively preparing a 1: 10 test solution and a 1: 50 test solution; s2, checking the total number of aerobic bacteria and the total number of mould and saccharomycetes; and S3, inspection of control bacteria Escherichia coli. The technical problem to be solved by the invention is to provide the microbial limit detection method for the dalbavancin, which is scientific and effective and is beneficial to detection, so that the microbial limit quality of the dalbavancin variety is controllable. According to the invention, sterile water is screened as a diluent, so that the problem of dissolution of the dalbavancin bulk drug is solved, and the recovery ratio of test bacteria is increased; a membrane filtration method is adopted, a proper neutralizer is added into a flushing fluid, and a proper neutralizer is added into a TSA / SDA culture medium of a film, so that the antibacterial activity of the dalbavancin is effectively removed, and the recovery ratio of five test bacteria in microbe counting meets the requirements of pharmacopeia.

The invention relates to storage stable compositions of dalbavancin. In particular, the storage stable composition is an aqueous liquid solution comprising: dalbavancin or a pharmaceutically acceptable salt thereof; a neutral amino acid or a pharmaceutically acceptable salt thereof; and a non-ionic surfactant, wherein the pH of the composition is in the range of about 3.0 to about 7.0.

The present disclosure relates to a stable aqueous composition of dalbavancin, the process for making such compositions and use of such compositions for treatment of a patient in need thereof.

The invention relates to the technical field of medicine preparation, in particular to a synthesis method of dalbavancin demethylated B2 nitrosamine. The synthesis method comprises the following steps: S1, taking a dalbavancin precursor A-40926-B0 as a raw material, and carrying out methylation reaction to obtain an intermediate I; s2, performing esterification protection on the intermediate I to obtain an intermediate II; s3, carrying out condensation reaction on the intermediate II and 3-methylaminopropylamine to obtain an intermediate III, and carrying out alkaline hydrolysis to obtain an intermediate IV; s4, carrying out nitrosation on the intermediate IV through a nitrosation reagent to obtain dalbavancin demethylated B2 nitrosamine; the synthesis method is high in reaction yield, the purity of the demethylated B2 nitrosamine compound of the dalbavancin can be as high as that of the dalbavancin, and a reference substance is provided for quality control of the dalbavancin.

The invention relates to storage stable compositions of dalbavancin. In particular, the storage stable composition is an aqueous liquid solution comprising: dalbavancin or a pharmaceutically acceptable salt thereof; a non-ionic surfactant; and a polyol, wherein the pH of the composition is in the range of about 3.0 to about 7.0.

The invention relates to the technical field of medicine preparation, in particular to a method for preparing a nitrosamine compound. The method comprises the following steps: S1, carrying out esterification protection by taking a dalbavancin precursor A-40926-B0 as a raw material to obtain an intermediate I; s2, carrying out condensation reaction on the intermediate I and 3-methylaminopropylamine to obtain an intermediate II, and carrying out alkaline hydrolysis to obtain an intermediate III; s3, protecting secondary amine on a parent nucleus of the intermediate III through a protective reagent to obtain an intermediate IV; s4, carrying out nitrosation on the intermediate IV through a nitrosation reagent to obtain an intermediate V; s5, after the intermediate V is subjected to deprotection, dalbavancin demethylated B0 nitrosamine is obtained; the product prepared by the method is high in purity, a reference substance can be provided for quality control of dalbavancin, and important guiding significance is provided for safe medication.

The invention relates to application of dalbavancin in preparation of a medicine for preventing and / or treating chikungunya virus infection, and belongs to the technical field of biological medicine. According to the application, the anti-chikungunya virus activity of the dalbavancin is researched by selecting the dalbavancin, and an in-vitro cell experiment proves that the duplication and gene expression of the chikungunya virus can be effectively inhibited by exogenously adding the dalbavancin, so that the obvious antiviral activity is shown, and the dalbavancin is proved to have an obvious inhibition effect on the chikungunya virus; and the dalbavancin has anti-chikungunya virus activity at the cellular level, so that the feasibility of the dalbavancin in preparation of drugs for preventing and / or treating chikungunya virus infection is determined, and a new potential drug is provided for prevention and / or treatment of chikungunya virus infection.

The invention discloses a dalbavancin biological value detection method, which adopts bacillus subtilis (ATCC6633) as a verification bacterium, adopts a phosphate buffer solution as a final diluent of a test solution, and adopts a tube-disc method to measure the biological value of dalbavancin. The method for detecting the biological value of the dalbavancin, provided by the invention, is simple to operate, good in sensitivity, high in specificity, accurate in result and high in repeatability.

An aqueous pharmaceutical composition for intravenous administration that includes dalbavancin or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable buffer having a pH of from about 4.0 to about 8.0. The aqueous composition further includes either or both of a pharmaceutically acceptable divalent salt wherein the divalent salt is distinct from the buffer and / or a pharmaceutically acceptable cyclodextrin. The formulation demonstrates improved long-term stability for storage at room or elevated temperatures. Methods of using the aqueous pharmaceutical composition of dalbavancin to treat skin infections.

The present invention relates to stable aqueous ready-to-dilute compositions of dalbavancin or physiologically acceptable salts thereof, which are suitable for intravenous administration. The aqueous formulation provides improved long-term stability upon storage and does not require reconstitution prior to administration. This application relates to stable aqueous dalbavancin compositions and its use in the treatment of bacterial infections.

The present invention relates to compounds comprising a glycopeptide antibiotic, such as vancomycin, dalbavancin or teicoplanin, or a mitomycin C, one or more antibacterial agents, and a biodegradable linker linking the glycopeptide antibiotic, such as vancomycin, dalbavancin or teicoplanin, or the mitomycin C and the one or more antibacterial agents.

A method of using an aqueous solution of propylene glycol to inhibit degradation of dalbavancin hydrochloride, a dalbavancin injection formulation, a preparation method and a method of using the same are provided. In the method of using the aqueous solution of propylene glycol to inhibit degradation of dalbavancin hydrochloride, the volume ratio of propylene glycol to water for injection in the aqueous solution of propylene glycol is 2:8-6:4. In the dalbavancin injection formulation, the concentration of dalbavancin hydrochloride is 20-120 mg / mL, calculated as dalbavancin free base.

The present invention discloses the use of an aqueous solution of propylene glycol for inhibiting the degradation of dalbavancin hydrochloride, a dalbavancin injection preparation, a preparation method, and applications. The present invention applies an aqueous solution of propylene glycol to the dalbavancin injection preparation. The resulting dalbavancin injection preparation significantly reduces production costs compared to lyophilized preparations, further improving drug safety and ease of use. This not only brings significant economic benefits to manufacturers, but also provides more safe, effective, and cost-effective products to patients, generating immeasurable social benefits.