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Novel pharmaceutical composition of echinocandin antifungal agent

A technology for echinocandin and antifungal agent, applied in the field of preparation of the pharmaceutical composition, can solve the problems of poor stability of echinocandin compounds, prone to hydrolysis, dimerization or oxidation, and generation of various degradation impurities, etc.

Inactive Publication Date: 2021-05-04
JIANGSU HENGRUI MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the stability of echinocandin compounds is very poor, and they are easily hydrolyzed, dimerized or oxidized, resulting in a variety of degradation impurities

Method used

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  • Novel pharmaceutical composition of echinocandin antifungal agent
  • Novel pharmaceutical composition of echinocandin antifungal agent
  • Novel pharmaceutical composition of echinocandin antifungal agent

Examples

Experimental program
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Effect test

Embodiment 1

[0068] Prescription preparation method:

[0069] 1. Prepare 1M NaOH and 0.5M NaOH solutions for pH adjustment.

[0070] 2. Prepare a certain concentration of dilute acid solution for pH adjustment.

[0071] 3. Prepare the corresponding buffer system or a solution containing a pH regulator according to the prescription, and stir to dissolve.

[0072] 4. Add the corresponding excipients to the solution in step 3 according to the prescription, and stir to dissolve. Adjust to the target pH (0.02-0.04 slightly lower than 6) with HCl / NaOH or glacial acetic acid / sodium hydroxide, and store in a refrigerator at 4°C.

[0073] 5. Weigh the API according to the prescription amount, add it into the solution containing excipients, and stir to dissolve. Immediately after dissolving, adjust the pH with HCl / NaOH or glacial acetic acid / sodium hydroxide, and pack at constant volume. Dispense into (>) 10mL vials. During the process, the solution is kept in an ice-water bath, so that the tem...

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Abstract

The invention provides a novel pharmaceutical composition of an echinocandin antifungal agent. Specifically, the invention provides a pharmaceutical composition of the echinocandin antifungal agent comprising reduced glutathione and meglumine as excipients, which can be stably preserved at room temperature.

Description

technical field [0001] The invention relates to a novel pharmaceutical composition containing echinocandin antifungal agents for treating and / or preventing fungal infections, and also relates to a preparation method of the pharmaceutical composition. Background technique [0002] Echinocandins, also known as echinocandins, are a new class of antifungal drugs that interfere with the synthesis of fungal cell wall β-1,3-glucose by non-competitively inhibiting β-1,3-glucose synthase, resulting in Fungal cell wall permeability changes, cell lysis and death. Because human cells do not contain cell walls, but fungal cells have cell walls, echinocandin antifungal drugs can directly act on fungal cell wall components, so this type of drug has low toxicity to the human body and is the safest class of antifungal drugs so far. fungal drugs. Echinocandin has rapid fungicidal effect on most Candida species, including some strains resistant to azoles, has antifungal effect on most Asperg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/12A61K9/19A61K9/08A61K47/18A61K47/26A61P31/10
CPCA61K38/12A61K9/19A61K9/08A61K47/183A61K47/26A61P31/10
Inventor 鞠明珠韩江彬王捷
Owner JIANGSU HENGRUI MEDICINE CO LTD
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