Composite and freeze-dried powder containing polymyxin B sulfate, preparation methods thereof and application

A polymyxin and sulfuric acid-containing technology, which is applied in freeze-dried transportation, medical preparations of non-active ingredients, and pharmaceutical formulas, etc., can solve problems such as long reconstitution time, cracking, and shrinkage

Active Publication Date: 2020-07-17
SPH NO 1 BIOCHEM & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The problem to be solved by the present invention is to overcome the problems of shrinkage, shrinkage or cracking in the freeze-dried powder containing polymyxin B sulfate in the prior art, and the reconstitution time is longer, and there are many insoluble particles after reconstitution. And provide a composition containing polymyxin B sulfate, freeze-dried powder and its preparation method and application

Method used

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  • Composite and freeze-dried powder containing polymyxin B sulfate, preparation methods thereof and application
  • Composite and freeze-dried powder containing polymyxin B sulfate, preparation methods thereof and application
  • Composite and freeze-dried powder containing polymyxin B sulfate, preparation methods thereof and application

Examples

Experimental program
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Embodiment 1～4 and comparative example 1

[0070] The preparation method of the composition and lyophilized powder containing polymyxin B sulfate in Examples 1-4 and Comparative Examples 1-3 comprises the following steps:

[0071] Step (1): Add tert-butanol into 800mL water for injection, and stir evenly to obtain a tert-butanol solution;

[0072] Dissolving polymyxin B sulfate in tert-butanol solution and stirring until completely dissolved to obtain a mixed solution;

[0073] Measure the pH value of the mixed solution. If the pH value of the mixed solution is not 5.0-7.0, adjust the pH value of the mixed solution to 5.0-7.0 with sulfuric acid or sodium hydroxide, and dilute the adjusted pH value of the mixed solution to 1000mL, obtain the composition containing polymyxin B sulfate;

[0074] The above-mentioned composition containing polymyxin B sulfate is sterilized by filtering through a 0.2 μm microporous membrane;

[0075] Fill the above-mentioned sterilized mixed solution into a vial at 1 mL / bottle, and half st...

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Abstract

The invention discloses a composite and freeze-dried powder containing polymyxin B sulfate, preparation methods thereof and application. The composite containing polymyxin B sulfate comprises the polymyxin B sulfate, tert-butanol and water; and on the premise of 1L of the composite containing polymyxin B sulfate in volume, the concentration of polymyxin B sulfate is 50-77g/L, and the concentrationof tert-butanol is 3-16 g/L. The preparation method of the freeze-dried powder containing polymyxin B sulfate comprises the step that the composite containing polymyxin B sulfate is subjected to freeze-drying treatment. The freeze-dried powder containing polymyxin B sulfate has a compact and even structure and has good stability and redissolution effect, and the preparation method comprises simple, convenient and easy processes.

Description

technical field [0001] The invention relates to a composition containing polymyxin B sulfate, freeze-dried powder, a preparation method and application thereof. Background technique [0002] Polymyxin B is a cyclic peptide antibiotic isolated from the culture fluid of Polymyxa bacterium. Colistin was developed in the 1950s and used to treat Gram-negative bacterial infections in the 1960s, especially Infection caused by Pseudomonas aeruginosa. Due to its narrow antibacterial spectrum and obvious nephrotoxicity, especially after the 1980s some new broad-spectrum antibacterial drugs such as third-generation cephalosporins, carbapenems and other drugs appeared and widely used in clinic, resulting in Colistin was discarded. However, due to the widespread use of antibacterial drugs, especially the irrational use, the problem of bacterial resistance to β-lactams, quinolones and macrolides is becoming more and more prominent, especially multidrug resistant strains (MDR) infection ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/12A61K47/10A61K9/08A61K9/19A61P31/04
CPCA61K38/12A61K47/10A61K9/08A61K9/19A61K9/0019A61P31/04Y02A50/30
Inventor 闫志慧陈辰徐旭惠黄臻辉
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD
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